Corrigendum to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC 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 ( OJ L 396, 30.12.2006 )
Date: 2007-05-29
Institutions: Council of the European Union, European Parliament
Subjects: European Chemicals Agency, administrative formalities, chemical product, environmental risk prevention, market approval, marketing standard, product safety, scientific report

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Official Journal of the European Union

L 136/3

CORRIGENDA

Corrigendum to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December
2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing
a European Chemicals Agency, amending Directive 1999/45/EC 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

(Official Journal of the European Union L 396 of 30 December 2006)

Regulation (EC) No 1907/2006 should read as follows:

REGULATION (EC) No 1907/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 18 December 2006

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

(Text with EEA relevance)

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),

Having regard to the opinion of
Regions (2),

the Committee of

the

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

laid down in

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. This Regulation should also promote the
development of alternative methods for the assessment of
hazards of substances.

functioning of

for
The efficient
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 (OJ C 280 E,
18.11.2006, p. 303), Council Common Position of 27 June 2006 (OJ
C 276 E, 14.11.2006, p. 1) and Position of the European Parliament of
13 December 2006 (not yet published in the Official Journal). Council
Decision of 18 December 2006.

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 sustainable
development. That legislation should be applied in a non-
discriminatory manner whether substances are traded on
the internal market or internationally in accordance with
the Community's international commitments.

(4)

to the

Pursuant
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 signifi-
cant adverse effects on human health and the environ-
ment.

(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 administrative
provisions relating to the classification, packaging and
substances (1), Council Direc-
labelling of dangerous
tive 76/769/EEC of 27 July 1976 on the approximation
of the laws, regulations and administrative provisions 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
the Council of 31 May 1999
Parliament and of
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

(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 Commission

Directive 2006/139/EC (OJ L 384, 29.12.2006, p. 94).

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

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).

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
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 indi-
vidual 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)

This Regulation should apply without prejudice to the
prohibitions and restrictions laid down in Council Direc-
tive 76/768/EEC of 27 July 1976 on the approximation
of the laws of the Member States relating to cosmetic
products (7) in so far as substances are used and marketed
as cosmetic ingredients and are within the scope of this
Regulation. A phase-out of testing on vertebrate animals
for the purpose of protecting human health as specified
in Directive 76/768/EEC should take place with regard to
the uses of those substances in cosmetics.

This Regulation will generate information on substances
and their uses. Available information,
including that
generated by this Regulation, should be used by the rele-
vant actors in the application and implementation of
appropriate Community legislation,
for example that
covering products, and Community voluntary instru-
ments, such as the eco-labelling scheme. The Commission
should consider in the review and development of rele-
vant Community legislation and voluntary instruments
how information generated by this Regulation should be
used, and examine possibilities for establishing a Euro-
pean quality mark.

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.

(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.
(7) OJ L 262, 27.9.1976, p. 169. Directive as last amended by Commission

Directive 2007/1/EC (OJ L 25, 1.2.2007, p. 9).

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(16)

This Regulation lays down specific duties and obligations
importers and downstream users of
on manufacturers,
substances on their own,
and in
in preparations
articles. This Regulation is based on the principle that
industry should manufacture,
import or use substances
or place them on the market with such responsibility and
care as may be required to ensure that, under reasonably
foreseeable conditions, human health and the environ-
ment are not adversely affected.

(17) All available and relevant information on substances on
in preparations and in articles should be
their own,
collected to assist in identifying hazardous properties,
and recommendations about risk management measures
should systematically be conveyed through supply chains,
as reasonably necessary, to prevent adverse effects on
human health and the environment. In addition, commu-
nication of technical advice to support risk management
should be encouraged in the supply chain, where appro-
priate.

(18)

(19)

(20)

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.

the registration provisions

Therefore,
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.

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 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 evalua-
tion, relying on the competent authorities of Member
States, ensure that this substance is evaluated.

(21) Although the information yielded on substances through
evaluation should be used in the first place by manufac-

(22)

(23)

(24)

(25)

(26)

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 procedures.

The authorisation provisions should ensure the good
functioning of the internal market while assuring that the
risks from substances of very high concern are properly
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 justified for
socio-economic reasons and no suitable alternatives are
available, which are economically and technically 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
subject to total or partial bans or other restrictions, 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,
importers and down-
Member States, manufacturers,
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 available
appropriate technical guidance, in due time, with regard
to the deadlines introduced by this Regulation.

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
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.

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

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(27)

(28)

(29)

transparency,

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

normally

should

the

Scientific research and development normally takes place
in quantities below one 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 innova-
tion, product and process oriented research and develop-
ment 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 indefinite
number of customers because its application in prepara-
tions or articles still requires further research and devel-
opment performed by the potential registrant himself or
in cooperation with a limited number of known custo-
mers.
is appropriate to provide for a
exemption to downstream users using the
similar
the purposes of product and process
substance for
the
oriented research and development, provided that
risks
are
environment
adequately controlled in accordance with the require-
ments of legislation for the protection of workers and
the environment.

to human health and the

In addition,

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
high concern which are present in articles above 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 also be
empowered to request that a registration be submitted if
it has grounds for suspecting that
the release of a
substance from the article may present a risk to human
health or the environment and the substance is present
in those articles in quantities totalling over one 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 articles poses
a risk to human health or the environment that is not
adequately controlled.

(30)

The requirements for undertaking chemical safety assess-
ments by manufacturers and importers should be 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.

(31)

in close cooperation with industry,
The Commission,
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
including assessment of substances incorpo-
scenarios)
rated into special preparations — such as metals incorpo-
rated 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.

(32) 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 authorisation.
These provisions should apply equally to preparations
that are solid mixtures of substances until a specific
shape is given to such a preparation that transforms it
into an article.

(33)

(34)

(35)

(36)

information on
Joint submission and the sharing of
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
that all
the required information is submitted, while
allowing sharing of the costs burden. A registrant should
be able to submit information directly to the Agency in
certain specified cases.

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 ecotoxico-
logical information should only be required for priority
substances between 1 and 10 tonnes.
For other
substances in that quantity range there should be incen-
to
to encourage manufacturers and importers
tives
provide this information.

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.

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.

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(37)

(38)

(39)

(40)

If tests are performed, they should comply with the rele-
vant requirements of protection of
laboratory animals,
set out in Council Directive 86/609/EEC of 24 November
1986 on the approximation of
laws, regulations and
administrative provisions of the Member States regarding
the protection of animals used for experimental and
other scientific purposes (1), and, in the case of ecotoxico-
logical and toxicological tests, good laboratory practice,
set out in Directive 2004/10/EC of the European Parlia-
ment and of the Council of 11 February 2004 on the
laws, regulations and administrative
harmonisation of
provisions relating to the application of the principles of
good laboratory practice and the verification of
their
application for tests on chemical substances (2).

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 structure
activity models or from structurally 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 constitutes such justification.

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.

The Commission, Member States,
industry and other
stakeholders should continue to contribute to the promo-
tion of alternative test methods on an international and
national level including computer supported methodolo-
gies, in vitro methodologies, as appropriate, those based
on toxicogenomics, and other relevant methodologies.
The Community's strategy to promote alternative test
methods is a priority and the Commission should ensure
that within its future Research Framework Programmes
and initiatives such as the Community Action Plan on
the Protection and Welfare of Animals 2006 to 2010
this remains a priority topic. Participation of stakeholders
and initiatives involving all interested parties should be
sought.

(41)

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.

(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.

(42)

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.

(43) 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.

(44)

(45)

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.

of

European

Inventory

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

(46)

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.

(47)

In accordance with Directive 86/609/EEC, it is necessary
to replace, reduce or refine testing on vertebrate animals.
Implementation of this Regulation should be based on
the use of alternative test methods, suitable for the assess-
ment of health and environmental hazards of chemicals,
wherever possible. The use of animals should be avoided
by recourse to alternative methods validated by the
Commission or international bodies, or recognised by the
Commission or the Agency as appropriate to meet the
information requirements under this Regulation. To this
end, the Commission, following consultation with rele-
vant stakeholders, should propose to amend the future
Commission Regulation on test methods or this Regu-
lation, where appropriate, to replace, reduce or refine
animal testing. The Commission and the Agency should
ensure that reduction of animal testing is a key considera-
tion in the development and maintenance of guidance for
stakeholders and in the Agency's own procedures.

(49)

(50)

(51)

(52)

(53)

(54)

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(48)

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

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.

potential registrants, who must provide and be supplied
with any information relevant to the registration of their
substances, and other participants, who may receive
financial compensation for studies they hold but are not
entitled to request information. In order to ensure the
that system they should fulfil
smooth functioning of
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. In cases where a substance has not
been pre-registered, measures should be taken to help
downstream users find alternative sources of supply.

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-
ticular in the case of information involving tests on verte-
brate animals, under conditions
that ensure a fair
compensation for the company that has undertaken the
tests.

(55) Manufacturers and importers of a substance on its own
or in a preparation should be encouraged to communi-
cate with the downstream users of the substance with
regard to whether they intend to register the substance.
Such information should be provided to a downstream
user sufficiently in advance of the relevant registration
deadline if the manufacturer or importer does not intend
to register the substance, in order to enable the down-
stream user to look for alternative sources of supply.

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

(56)

In order to respect the legitimate property rights of those
generating testing data, the owner of such data should,
for a period of 12 years, be able to claim compensation
from those registrants who benefit from that data.

In order to allow a potential registrant of a phase-in
substance 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.
For non-phase-in substances, the Agency may ask for
evidence that a potential registrant has paid the owner of
the
a study before the Agency gives permission for
potential registrant to use that information in his registra-
tion.

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 Forums (SIEF) to help
exchange of
information on the substances that have
been registered. SIEF participants should include all rele-
vant actors submitting information to the Agency on the
same phase-in substance. They should include both

In addition, producers or

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 distribu-
importers of articles
tors.
should supply information on the safe use of articles to
industrial and professional users, and consumers on
request. 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.

(57) 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.

(58)

In order to have a chain of responsibilities, downstream
users should be responsible for assessing the risks arising
from their uses of substances if
those uses are not
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
substances.
is appropriate that any
it
producer or importer of an article containing a substance
of very high concern should provide sufficient informa-
tion to allow safe use of such an article.

In addition,

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(59)

(60)

(66)

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
one 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.

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.

The Agency should also be empowered to require further
information from manufacturers,
importers or down-
stream 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 Com-
munity rolling action plan for
substance evaluation
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
the competent
authorities of the Member States should also be allowed
to require further information, when justified.

isolated intermediates on site,

(61)

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

it

(62)

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.

(67)

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 subsi-
diarity, 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 centra-
lised procedure. If the Member State Committee fails to
reach unanimous agreement,
the Commission should
adopt a decision in accordance with a Committee proce-
dure.

(63)

(64)

(65)

It is also necessary to ensure that generation of informa-
information needs. To this end
tion is tailored to real
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,

(68)

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.

In order to prevent unnecessary animal testing, interested
parties should have a period of 45 days during which
they may provide scientifically valid information and
studies that address the relevant substance and hazard
end-point, which is addressed by the testing proposal.
The scientifically valid information and studies received
by the Agency should be taken into account for decisions
on testing proposals.

(69)

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

To ensure a sufficiently high level of protection for
human health, including having regard to relevant human
population groups and possibly to certain vulnerable
sub-populations, and the environment, substances of very
high concern should,
in accordance with the precau-
tionary principle, be subject to careful attention. Authori-
sation should be granted where natural or legal persons
applying for an authorisation demonstrate to the granting
authority that the risks to human health and the environ-
ment 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 from the
use of 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.

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(70) Adverse effects on human health and the environment
from substances of very high concern should be
prevented through the application of appropriate risk
management measures to ensure that any risks from the
uses of a substance are adequately controlled, and with a
view to progressively substituting these substances with a
suitable safer
substance. Risk management measures
should be applied to ensure, when substances are manu-
factured, placed on the market and used, that exposure to
these substances
including discharges, emissions and
the whole life-cycle is below the
losses,
threshold level beyond which adverse effects may occur.
For any substance for which authorisation has been
granted, and for any other substance for which it is not
possible to establish a safe level of exposure, measures
should always be taken to minimise, as far as technically
and practically possible, exposure and emissions with a
view to minimising the likelihood of adverse effects.
Measures to ensure adequate control should be identified
in any Chemical Safety Report. These measures should be
applied and, where appropriate, recommended to other
actors down the supply chain.

throughout

(71) 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 allow
thresholds where appropriate to be used while ensuring a
high level of protection of human health and the envir-
onment.

(72)

(73)

(74)

To support the aim of eventual replacement of substances
of very high concern by suitable alternative substances or
technologies, all applicants
for authorisation should
provide an analysis of alternatives considering their risks
and the technical and economic feasibility of substitution,
including information on any research and development
the applicant
is undertaking or intends to undertake.
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.

Substitution of a substance on its own, in a preparation
or in an article should be required when manufacture,
use or placing on the market of that substance causes an
unacceptable risk to human health or to the environ-
ment, taking into account the availability of suitable safer
alternative substances and technologies, and the socio-
economic benefits from the uses of the substance posing
an unacceptable risk.

Substitution of a substance of very high concern by
technologies
suitable
should be considered by all those applying for authorisa-

safer alternative

substances or

(75)

(76)

(77)

tions of uses of such substances on their own, in prepara-
tions or for incorporation of substances into articles by
making an analysis of alternatives, the risks involved in
using any alternative and the technical and economic
feasibility of substitution.

and articles

The possibility of introducing restrictions on the manu-
facturing, placing on the market and use of dangerous
substances, preparations
to all
substances falling within the scope of this Regulation,
with minor exemptions. Restrictions on the placing on
the market and the use of substances which are carcino-
genic, mutagenic or toxic to reproduction, category 1 or
2, for their use by consumers on their own or in prepara-
tions should continue to be introduced.

applies

level shows that substances
Experience at international
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. The criteria in
Annex XIII should be reviewed taking into account the
current and any new experience in the identification of
these substances and if appropriate, be amended with a
view to ensuring a high level of protection for human
health and the environment.

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.

(78)

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 developments.

(79) 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 substances for which applications can be submitted
and added to the list of restricted substances.

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(80)

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

further

(81)

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
including whether or not the substance is
those uses,
adequately
socio-economic
controlled and on any
analysis submitted to it by third parties. These opinions
should be taken into account by the Commission when
considering whether or not to grant an authorisation.

(82)

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.

(83)

(84)

(85)

It is suitable in these circumstances that final decisions
granting or refusing authorisations be adopted by the
Commission pursuant to a regulatory procedure in order
to allow for an examination of their wider implications
within the Member States and to associate the latter
more closely with the decisions.

times, should be replaced.

In order to accelerate the current system the restriction
procedure should be restructured and Directive 76/769/
EEC, which has been substantially amended and adapted
several
In the interests of
clarity and as a starting point for this new accelerated
restriction procedure, all the restrictions developed under
that Directive should be incorporated into this Regu-
lation. Where appropriate, the application of Annex XVII
of this Regulation should be facilitated by guidance devel-
oped by the Commission.

In relation to Annex XVII Member States should be
allowed to maintain for a transitional period more strin-
these restrictions have
gent restrictions, provided that
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-

(86)

(87)

(88)

(89)

(90)

tory of these restrictions. This would provide an opportu-
nity for
the Commission to review the measures
concerned with a view to possible harmonisation.

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-
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 insuffi-
cient 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 of,
the manufacture, placing on the market or use. Therefore
it is necessary to list such restrictions and any amend-
ments 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 Com-
munity, the Commission and the interested 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 main-
tain a list of substances for which a restriction dossier is
being prepared.

(91)

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.

(92)

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

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(93)

to finalise the procedure in due time,

the
In order
Agency should submit
its opinions on the suggested
action and its impact on the basis of a draft opinion
prepared by a rapporteur.

there is relevant expertise in the field of general financial
and legal matters.

(94)

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.

(95)

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-
fore essential. For this reason, it is vital to ensure its inde-
pendence, high scientific, technical and regulatory capaci-
ties, as well as transparency and efficiency.

(99)

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

(100) 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.

(101) The Management Board of the Agency should have the
necessary powers to establish the budget, check its imple-
mentation, draw up internal rules, adopt financial regula-
tions and appoint the Executive Director.

(102) Through a Committee for Risk Assessment and a
Committee for Socio-economic Analysis,
the Agency
should take over the role of the Scientific Committees
attached to the Commission in issuing scientific opinions
in its field of competence.

(96)

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.

(103) 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.

(97)

(98)

The effective communication of information on chemical
risks and how they can be managed is an essential part
of the system established by this Regulation. Best practice
from the chemicals and other sectors should be consid-
ered in the preparation of guidance by the Agency to all
stakeholders.

(104)

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 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 represent
each Member State, the Commission and other interested
parties appointed by the Commission in order to ensure
the involvement of stakeholders, and the European Parlia-
ment 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

(105)

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 there-
fore provide a Forum for Member States to exchange
information on and to coordinate their activities related
to the enforcement of chemicals legislation. The currently
informal cooperation between Member States in this
respect would benefit from a more formal framework.

(106) 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.

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the

European Communities.

(107) The Agency should be financed partly by fees paid by
natural or legal persons and partly by the general budget
of
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-
the bodies referred to in Article 185 of
lation for
Council Regulation (EC, Euratom) No 1605/2002 on the
Financial Regulation applicable to the general budget of
the European Communities (1).

should otherwise be without prejudice to the competence
conferred on the EMEA,
the EFSA and the Advisory
Committee on Safety, Hygiene and Health Protection at
Work by Community legislation.

(112)

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

(108) 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.

(113) The classification and labelling for any substance either
subject to registration or covered by Article 1 of Direc-
tive 67/548/EEC and placed on the market should there-
fore be notified to the Agency to be included in the
inventory.

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

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

(111)

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 Regulation
(EC) No 726/2004 of the European Parliament and of
the Council of 31 March 2004 laying down Community
the authorisation and supervision of
procedures for
medicinal products for human and veterinary use and
establishing a European Medicines Agency (2), 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 (3) and the
Advisory Committee on Safety, Hygiene and Health
Protection at Work set up by the Council Decision of
22 July 2003 (4). 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

(1) OJ L 357, 31.12.2002, p. 72.
(2) OJ L 136, 30.4.2004, p. 1. Regulation as amended by Regulation (EC)

No 1901/2006 (OJ L 378, 27.12.2006, p. 1).

(3) 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).

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

(114) To ensure a harmonised protection for the general public,
and,
in particular, for persons who come into contact
with certain substances, and the proper functioning of
other Community legislation relying on the classification
and labelling, an inventory should record the classifica-
tion in accordance with Directive 67/548/EEC and Direc-
tive 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
the work and experience accumulated in
account of
under Directive
connection with
67/548/EEC, including the classification and labelling of
specific substances or groups of substances listed in
Annex I of Directive 67/548/EEC.

activities

the

(115) 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 respiratory sensi-
tiser, or in respect of other effects on a case-by-case basis.
Provision should be made to enable competent authori-
ties to submit proposals to the Agency. The Agency
should give its opinion on the proposal while interested
parties should have an opportunity to comment. The
Commission should take a decision subsequently.

(116) Regular reports by the Member States and the Agency on
the operation of this Regulation will be an indispensable
means of monitoring the implementation of this Regu-
lation 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.

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(117) 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
the European Parliament and
Directive 2003/4/EC of
of the Council of 28 January 2003 on public access to
environmental information (1), Regulation (EC) No 1049/
2001 of the European Parliament and of the Council of
30 May 2001 regarding public access to European Parlia-
ment, Council and Commission documents (2) and with
the UNECE Convention on Access to Information, Public
Participation in Decision-Making and Access to Justice in
Environmental Matters,
to which the European Com-
munity is a party.

(118) Disclosure of

information under

this Regulation is
subject to the specific requirements of Regulation (EC)
No 1049/2001. That Regulation sets binding deadlines
for the release of information as well as procedural guar-
antees,
including the right of appeal. The Management
Board should adopt the practical arrangements for appli-
cation of those requirements to the Agency.

(119) Apart from their participation in the implementation of
Community legislation, Member State competent authori-
ties should, because of their closeness to stakeholders in
the Member States, play a role in the exchange of infor-
mation on risks of substances and on the obligations of
natural or legal persons under chemicals legislation. At
the same time, close cooperation between the Agency,
the Commission and the competent authorities of the
Member States is necessary to ensure the coherence and
efficiency of the global communication process.

(120)

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

the Agency

(121)

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
reported.

results should be

(122)

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 penalties
for non-compliance, as non-compliance can result
in
damage to human health and the environment.

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

(124)

In particular, power should be conferred on the Commis-
sion to amend the Annexes in certain cases, to set rules
on test methods,
to vary the percentage of dossiers
selected for compliance checking and to modify the
criteria for their selection, and to set the criteria defining
what constitutes adequate justification that testing is tech-
nically not possible. Since these measures are of general
scope and are designed to amend non-essential elements
of
this Regulation by
adding new non-essential elements thereto, they should
be adopted in accordance with the regulatory procedure
with scrutiny provided for in Article 5a of Decision
1999/468/EC.

this Regulation or supplement

(125)

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 Executive
Director itself.

(126) To take full advantage of

the work performed under
Regulation (EEC) No 793/93 as well as under Direc-
tive 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 reduc-
tion measures.

(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. Decision as amended by Decision

2006/512/EC (OJ L 200, 22.7.2006, p. 11).

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(127)

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.

(128) This Regulation replaces Directive 76/769/EEC, Commis-
sion Directive 91/155/EEC (1), Commission Directive 93/
93/105/EC (3),
67/EEC (2),
Commission Directive
Regulation
(EEC) No 793/93 and Commission Regulation (EC)
No 1488/94 (5). These Directives and Regulations should
therefore be repealed.

Directive
2000/21/EC (4),

Commission

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

(130) 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 subsidiarity as set out
in Article 5 of the Treaty. In accordance with the prin-
ciple of proportionality, as set out in that Article, this
Regulation does not go beyond what
is necessary in
order to achieve those objectives.

(131) The Regulation observes the fundamental rights and prin-
in the
ciples which are acknowledged in particular
Charter of
European
Union (6). 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

the

HAVE ADOPTED THIS REGULATION:

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

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

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

(4) 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).
(5) Commission Regulation (EC) No 1488/94 of 28 June 1994 laying
down the principles for the assessment of risks to man and the environ-
ment of existing substances in accordance with Council Regulation
(EEC) No 793/93 (OJ L 161, 29.6.1994, p. 3).

(6) 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

18

18

19

22

22

27

28

29

31

32

32

32

33

35

37

39

39

40

42

42

44

44

46

50

50

50

50

52

53

63

64

66

66

66

72

84

93

94

98

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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 ONE TONNE OR MORE

ANNEX VIII

STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFAC-
TURED OR IMPORTED IN QUANTITIES OF 10 TONNES OR MORE

ANNEX IX

ANNEX X

ANNEX XI

STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFAC-
TURED OR IMPORTED IN QUANTITIES OF 100 TONNES OR MORE

STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFAC-
TURED OR IMPORTED IN QUANTITIES OF 1 000 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 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

Page

99

103

107

111

116

119

122

124

125

126

128

129

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TITLE I

GENERAL ISSUES

CHAPTER 1

Aim, scope and application

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, including the
promotion of alternative methods for assessment of hazards of
substances, as well as the free circulation of substances on the
internal market while enhancing competitiveness and innova-
tion.

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 Direc-
tive 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

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

substances

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

(1) OJ L 159, 29.6.1996, p. 1.
(2) OJ L 114, 27.4.2006, p. 9.

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.

4.

This Regulation shall apply without prejudice to:

(a) Community workplace

and

environmental

legislation,
including Council Directive 89/391/EEC of 12 June 1989
on the introduction 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 inte-
grated pollution prevention 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 frame-
work for Community action in the field of water policy (5)
and Directive 2004/37/EC;

(b) Directive 76/768/EEC as regards testing involving vertebrate

animals within the scope of that Directive.

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

5.
the extent that a substance is used:

(a) in medicinal products for human or veterinary use within
the scope of Regulation (EC) No 726/2004, Directive 2001/
82/EC of the European Parliament and of the Council of
6 November 2001 on the Community code relating to
veterinary medicinal products (6) and Directive 2001/83/EC
of
the Council of
6 November 2001 on the Community code relating to
medicinal products for human use (7);

the European Parliament

and of

(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 laws of the Member States
concerning food additives authorised for use in food-
stuffs intended for human consumption (8);

(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 Regulation
(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 (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 (OJ L 136, 30.4.2004, p. 58).

(7) OJ L 311, 28.11.2001, p. 67. Directive as last amended by Regulation

(EC) No 1901/2006.

(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 Regu-
lation (EC) No 1831/2003 of the European Parliament
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 as defined in Directive 76/768/EEC;

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

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

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 Regu-

lation (EC) No 1831/2003;

(iv) in animal nutrition within the scope of Directive

82/471/EEC.

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

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

(EC) No 1882/2003.

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

2006/253/EC (OJ L 91, 29.3.2006, p. 48).

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

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 Commission

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

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 undertaking
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

(b) Title VII.

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.

3.

4.

5.

preparation: means a mixture or solution composed of two
or more substances;

article: means an object which during production is given a
special shape, surface or design which determines its func-
tion to a greater degree than does its chemical composition;

producer of an article: means any natural or legal person
who makes or assembles an article within the Community;

polymer: means a substance consisting of molecules charac-
terised 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;

6. 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;

7.

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;

8. manufacturing: means

production

or

extraction

of

substances in the natural state;

9. manufacturer: means any natural or legal person established
within the Community who manufactures a substance
within the Community;

10.

import: means the physical introduction into the customs
territory of the Community;

11.

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

12. 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;

14. 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;

15.

intermediate: means a substance that is manufactured for
and consumed in or used for chemical processing in order
to be transformed into another
substance (hereinafter
referred to as synthesis):

(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
vessel,
its ancillary equipment, and any equipment
through which the substance(s) pass(es) during a contin-
uous flow or batch process as well as the pipework 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
the intermediate and the
where the manufacture of
synthesis of
inter-
from that
mediate take place on the same site, operated by one or
more legal entities;

(an)other substance(s)

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

16. site: means a single location, in which, if there is more than
one manufacturer of (a) substance(s), certain infrastructure
and facilities are shared;

17. actors in the supply chain: means all manufacturers and/or
importers and/or downstream users in a supply chain;

18. Agency: means the European Chemicals Agency as estab-

lished by this Regulation;

19. competent authority: means the authority or authorities or
bodies established by the Member States to carry out the
obligations arising from this Regulation;

20. 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);

13. 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 profes-
sional activities. A distributor or a consumer is not a down-
stream user. A re-importer exempted pursuant to Article 2
(7)(c) shall be regarded as a downstream user;

(b) it was manufactured in the Community, or in the coun-
tries 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 documen-
tary evidence of this;

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(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 Direc-
tive 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;

21. 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;

22. 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;

23. scientific research and development: means any scientific
experimentation, analysis or chemical research carried out
under controlled conditions in a volume less than one
tonne per year;

24. 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;

25. registrant's own use: means an industrial or professional

use by the registrant;

26.

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 down-
stream user;

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

28. 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;

29. 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;

least

three consecutive years, quantities
factured for at
per year shall be calculated on the basis of the average
production or import volumes for the three preceding
calendar years;

31. restriction: means any condition for or prohibition of the

manufacture, use or placing on the market;

32. 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;

33. supplier of an article: means any producer or importer of
an article, distributor or other actor in the supply chain
placing an article on the market;

34. recipient of a substance or a preparation: means a down-
stream user or a distributor being supplied with a substance
or a preparation;

35. recipient of an article: means an industrial or professional
user, or a distributor, being supplied with an article but
does not include consumers;

36. 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);

37. exposure scenario: means the set of conditions, including
operational conditions and risk management measures, that
describe how the substance is manufactured or used during
its
importer
controls, or recommends downstream users to control,
exposures of humans and the environment. These exposure
scenarios may cover one specific process or use or several
processes or uses as appropriate;

life-cycle and how the manufacturer or

38. use and exposure category: means an exposure scenario
covering a wide range of processes or uses, where the
processes or uses are communicated, as a minimum,
in
terms of the brief general description of use;

39. substances which occur in nature: means a naturally occur-
ring 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;

40. 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 transformation, for instance to remove impu-
rities;

41. alloy: means a metallic material, homogenous on a macro-
scopic scale, consisting of
so
combined that they cannot be readily separated by mechan-
ical means.

two or more elements

30. per year: means per calendar year, unless stated otherwise,
for phase-in substances that have been imported or manu-

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

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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 53 involving discussions with other manu-
facturers,
In
these cases, the identity of a manufacturer or importer or down-
stream user who has appointed a representative shall not
normally be disclosed by the Agency to other manufacturers,
importers, or, where relevant, downstream users.

importers, or where relevant downstream users.

TITLE II

REGISTRATION OF SUBSTANCES

CHAPTER 1

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) 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 one tonne or more per year.

A submission for registration shall be accompanied by the

4.
fee required in accordance with Title IX.

Article 7

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:

(a) the substance is present in those articles in quantities total-
ling over one tonne per producer or importer per year;

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

reasonably foreseeable conditions of use.

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

Any producer or importer of articles shall notify the
2.
Agency,
if a
in accordance with paragraph 4 of this Article,
substance meets the criteria in Article 57 and is identified in
accordance with Article 59(1), if both the following conditions
are met:

Article 6

(a) the substance is present in those articles in quantities total-
ling over one tonne per producer or importer per year;

General obligation to register substances on their own or
in preparations

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

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

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

Paragraph 2 shall not apply where the producer or
3.
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.

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:

4.

The information to be notified shall include the following:

(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;

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

2.3.4 of Annex VI;

information on the supply of the latest update of the safety data
sheet referred to in Article 31.

(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);

(f) the tonnage range of

the substance(s),

such as 1 to

10 tonnes, 10 to 100 tonnes and so on.

5.
The Agency may take decisions requiring producers or
importers of articles to submit a registration, in accordance with
this Title, for any substance in those articles, if all the following
conditions are met:

(a) the substance is present in those articles in quantities total-
ling over one tonne per producer or importer per year;

(b) the Agency has grounds for suspecting that:

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

(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.

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

For the purpose of paragraph 1,

2.
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;

From 1 June 2011 paragraphs 2, 3 and 4 of this Article
7.
shall apply six months after a substance is identified in accord-
ance with Article 59(1).

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

Annex VI;

Any measures for the implementation of paragraphs 1 to
8.
7 shall be adopted in accordance with the procedure referred to
in Article 133(3).

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

of Annex VI, if any;

(d) the estimated quantity as

specified in section 3.1 of

Annex VI;

Article 8

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

their names and addresses.

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 36, shall keep available and up-to-date infor-
mation on quantities imported and customers sold to, as well as

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, or producer of articles concerned. The Agency shall
also communicate this information to the competent authority
of the Member State(s) concerned.

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listed customers as referred to in paragraph 2(e)

The Agency may decide to impose conditions with the
4.
aim of ensuring that the substance or the preparation or article
in which the substance is incorporated will be handled only by
staff of
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.

Article 10

Information to be submitted for general

registration

purposes

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

(a) a technical dossier including:

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

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

specified in section 1 of Annex VI;

the
In the absence of any indication to the contrary,
5.
manufacturer or importer of the substance or the producer or
importer of articles may manufacture or import the substance
or produce or import the articles not earlier than two weeks
after the notification.

(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 exposure
categories;

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

(iv) the classification and labelling of
specified in section 4 of Annex VI;

the substance as

The Agency may decide to extend the five-year exemption
7.
period by a further maximum of five years or, in the case of
substances to be used exclusively in the development of medic-
inal products for human or veterinary use, or for substances
that are not placed on the market, 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
justified by the research and development programme.

8.
The Agency shall forthwith communicate any draft deci-
sions to the competent authorities of each Member State in
import, production or product and
which the manufacture,
process orientated 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 Agency and the competent authorities of the Member
States concerned shall always keep confidential the information
submitted in accordance with paragraphs 1 to 8.

An appeal may be brought,

10.
in accordance with Arti-
cles 91, 92 and 93, against Agency decisions under paragraphs 4
and 7 of this Article.

(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;

(viii) an indication as to which of the information 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;

(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;

(xi) a request as to which of the information in Article 119
(2) the manufacturer or importer considers should not
be made available on the Internet in accordance with
including a justification as to why
Article 77(2)(e),
publication could be harmful
for his or any other
concerned party's commercial interests.

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 (vi) and (vii) for the purpose of registra-
tion;

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(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 appropriate,
the relevant use and exposure categories.

lead to substantial commercial detriment or the nature of the
disagreement, as the case may be.

A submission for registration shall be accompanied by the

4.
fee required in accordance with Title IX.

Article 11

Joint submission of data by multiple registrants

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, and/or is subject to registration under
Article 7, the following shall apply.

Information to be submitted depending on tonnage

Article 12

(vi),

(vii) and (ix), and any relevant

Subject to paragraph 3, the information specified in Article 10
(a)(iv),
indication under
Article 10(a)(viii) shall first be submitted by the one registrant
acting with the agreement of the other assenting registrant(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 rele-
vant 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 relevant
indication under Article 10(a)(viii) separately or whether one
registrant is to submit this information on behalf of the others.

2.
Each registrant need only comply with 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.

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 one 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 one tonne or more per year per
manufacturer or importer which do not meet either of the
criteria specified in Annex III;

(c) the information specified in Annexes VII and VIII

substances manufactured or
10 tonnes or more per year per manufacturer or importer;

for
imported in quantities of

A registrant may submit the information referred to in

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

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

information jointly; or

(d) the information specified in Annexes VII and VIII and
testing proposals for the provision of the information speci-
fied in Annex IX for substances manufactured or imported
in quantities of 100 tonnes or more per year per manufac-
turer or importer;

(b) submitting the information jointly would lead to disclosure
of information which he considers to be commercially sensi-
tive and is likely to cause him substantial commercial detri-
ment; or

(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.

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

information.

If points (a), (b) or (c) apply, the registrant shall submit, along
with the dossier, an explanation as to why the costs would be
disproportionate, why disclosure of information was likely to

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 the additional information he would
require under paragraph 1. Article 26(3) and (4) shall apply
adapted as necessary.

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This Article shall apply to producers of articles adapted as

3.
necessary.

Article 13

General requirements for generation of

information on

intrinsic properties of substances

1.
Information on intrinsic properties of substances may be
generated by means other than tests, provided that the condi-
tions set out in Annex XI are met. In particular for human toxi-
city, information shall be generated whenever possible by means
other than vertebrate animal tests, through the use of alternative
methods, for example, in vitro methods or qualitative or quanti-
tative structure-activity relationship models or from information
from structurally related substances (grouping or read-across).
Testing in accordance with Annex VIII, Sections 8.6 and 8.7,
Annex IX and Annex X may be omitted where justified by infor-
mation on exposure
and implemented risk management
measures as specified in Annex XI, section 3.

stakeholders,

if appropriate,

involved. The Commission,
shall, as

2.
These methods shall be regularly reviewed and improved
with a view to reducing testing on vertebrate animals and the
following
number of animals
consultation with relevant
soon as
possible, make a proposal,
to amend the
Commission Regulation on test methods adopted in accordance
with the procedure referred to in Article 133(4), and the
Annexes of this Regulation, if relevant, so as to replace, reduce
or refine animal
testing. Amendments to that Commission
Regulation shall be adopted in accordance with the procedure
specified in paragraph 3 and amendments to the Annexes of
this Regulation shall be adopted in accordance with the proce-
dure referred to in Article 131.

3. Where tests on substances are required to generate infor-
mation on intrinsic properties of substances,
they shall be
conducted in accordance with the test methods laid down in a
Commission Regulation or in accordance with other interna-
the
test methods recognised by the Commission or
tional
Agency as being appropriate. The Commission shall adopt that
Regulation, designed to amend the non-essential elements of
this Regulation by supplementing it,
in accordance with the
procedure referred to in Article 133(4).

Ecotoxicological and toxicological tests and analyses shall
4.
be carried out in compliance with the principles of good labora-
tory 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 Direc-
tive 86/609/EEC, if applicable.

5.
If a substance has already been registered, a new registrant
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 same as 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.

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 in quantities of 10 tonnes or
more per year per registrant.

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 an article or a group of
substances.

in a preparation or

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 in the
preparation is less than the lowest of any of the following:

(a) the applicable concentrations defined in the table of

Article 3(3) of Directive 1999/45/EC;

(b) the concentration limits given in Annex I to Directive 67/

548/EEC;

(c) the concentration limits given in Part B of Annex II to

Directive 1999/45/EC;

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.

(d) the concentration limits given in Part B of Annex III to

Directive 1999/45/EC;

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(e) the concentration limits given in an agreed entry in the clas-
sification and labelling inventory established under Title XI
of this Regulation;

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

(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:

Any registrant

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

(a) human health hazard assessment;

CHAPTER 2

(b) physicochemical hazard assessment;

Substances regarded as being registered

(c) environmental hazard assessment;

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

tent and very bioaccumulative (vPvB) assessment.

Article 15

4.
If, as a result of carrying out steps (a) to (d) of paragraph 3,
the registrant 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 additional 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 exposure
categories), exposure assessment and risk characterisation shall
address all identified uses of the registrant.

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 (1);

(b) in cosmetic products within the scope of Directive 76/768/

EEC.

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

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 Council Directive 91/414/EEC (2) or in
Commission Regulation (EEC) No 3600/92 (3), Commission
Regulation (EC) No 703/2001 (4), Commission Regulation (EC)
No 1490/2002 (5), or Commission Decision 2003/565/EC (6)
and for any substance for which a Commission 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) 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 2006/136/EC (OJ
L 349, 12.12.2006, p. 42).

(3) 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 Direc-
tive 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).

(4) 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).

(5) 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 (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).

(6) Commission Decision 2003/565/EC of 25 July 2003 extending the
in Article 8(2) of Council Directive

time period provided for
91/414/EEC (OJ L 192, 31.7.2003, p. 40).

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Active substances manufactured or imported for use in
2.
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 (1) or in Commission Regulation (EC)
No 2032/2003 (2)on the second phase of the 10-year work
programme referred to in Article 16(2) of Directive 98/8/EC,
until the date of the decision referred to in the second sub-
paragraph 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 16

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

1.
The Commission or the relevant Community body shall
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 1 December 2008.

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

(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.

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

Article 18

Registration of transported isolated intermediates

Article 17

Registration of on-site isolated intermediates

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

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

A registration for a transported isolated intermediate shall

2.
include all the following information:

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

(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

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

to 2.3.4 of Annex VI;

Annex VI;

(c) the classification of the intermediate as specified in Section 4

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

of Annex VI;

to 2.3.4 of Annex VI;

(c) the classification of the intermediate as specified in Section 4

of Annex VI;

(1) OJ L 123, 24.4.1998, p. 1. Directive as last amended by Commission

Directive 2006/140/EC (OJ L 414, 30.12.2006, p. 78).

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

(EC) No 1849/2006 (OJ L 355, 15.12.2006, p. 63).

(d) any available existing information on physicochemical,
the inter-
human health or environmental properties of
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;

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

Community by one or more manufacturers and/or imported by
one or more importers, the following shall apply.

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.
A registration for a transported isolated intermediate in
quantities of more than 1 000 tonnes per year per manufacturer
or importer shall include the information specified in Annex VII
in addition to the information required under paragraph 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;

(b) procedural and control technologies shall be used that mini-

mise emission and any resulting exposure;

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’).

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

2.
A manufacturer or importer may submit the information
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 sensi-
tive and is likely to cause him substantial commercial detri-
ment; 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.

(c) only properly trained and authorised personnel handle the

substance;

A submission for registration shall be accompanied by the

3.
fee required in accordance with Title IX.

(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.

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

Article 19

Joint submission of data on isolated intermediates by
multiple registrants

transported
1. When an on-site isolated intermediate or
isolated intermediate is intended to be manufactured in the

CHAPTER 4

Common provisions for all registrations

Article 20

Duties of the Agency

The Agency shall assign a submission number to each
1.
registration, which is
to be used for all correspondence
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.

The Agency shall undertake a completeness check of each
2.
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
the
completeness check shall not
quality or the adequacy of any data or justifications submitted.

include an assessment of

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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.

If a registration is incomplete, the Agency shall inform the regis-
trant, before expiry of the three-week or three-month period
referred to in the second subparagraph, as to what further infor-
mation 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 registra-
tion 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 correspond-
ence 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:

(a) the registration dossier together with the submission or

registration number;

(b) the submission or registration date;

(c) the result of the completeness check; and

An appeal may be brought, in accordance with Articles 91,
5.
92 and 93, against Agency decisions under paragraph 2 of this
Article.

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 21

Manufacturing and import of substances

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, such a regis-
trant 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 the submission date or,
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 from that deadline, without prejudice to Article 27
(8).

In the case of an update of a registration according to Article 22
a registrant may continue the manufacture or import of the
substance, or the production or import of the article, 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).

(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.

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 manufac-
ture or import of a substance or production or import of an
article if there is no indication to the contrary from the Agency
the
within the three weeks after receipt by the Agency of
further
registration,
information necessary to complete his
without prejudice to Article 27(8).

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.

3.
If a lead registrant submits parts of the registration on
behalf of one or more other registrants, as provided for in Arti-
cles 11 or 19, any of the other registrants may manufacture or
import the substance or produce or import the articles 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 the Agency in respect of the registration of the
lead registrant acting on behalf of the others and his own regis-
tration.

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Article 22

Further duties of registrants

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:

In cases covered by Articles 11 or 19, each registrant shall
4.
submit separately the information specified in paragraph 1(c) of
this Article.

An update shall be accompanied by the relevant part of

5.
the fee required in accordance with Title IX.

CHAPTER 5

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

Transitional provisions applicable to phase-in substances and
notified substances

(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 or in the quantities of substances present
in articles produced 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
in which cases a testing proposal

Annex IX or Annex X,
shall be developed;

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

tration.

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

A registrant shall submit to the Agency an update of the
2.
registration containing the information required by the decision
made in accordance with Articles 40, 41 or 46 or take into
account a decision made in accordance with Articles 60 and 73,
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.

a

completeness

The Agency

shall undertake

check
3.
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.

Article 23

Specific provisions for phase-in substances

Article 5, Article 6, Article 7(1), Article 17, Article 18 and
1.
Article 21 shall not apply until 1 December 2010 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 one tonne or more per
year per manufacturer or per importer, at least once after
1 June 2007;

(b) phase-in substances classified as very toxic to aquatic organ-
isms which may cause long-term adverse effects in the
aquatic environment (R50/53) in accordance with Directive
67/548/EEC, and manufactured in the Community or
imported in quantities reaching 100 tonnes or more per
year per manufacturer or per importer, at least once after
1 June 2007;

(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
1 June 2007.

2.
Article 5, Article 6, Article 7(1), Article 17, Article 18 and
Article 21 shall not apply until 1 June 2013 to phase-in
substances manufactured in the Community or imported,
in
quantities reaching 100 tonnes or more per year per manufac-
turer or per importer, at least once after 1 June 2007.

3.
Article 5, Article 6, Article 7(1), Article 17, Article 18 and
Article 21 shall not apply until 1 June 2018 to phase-in
in
substances manufactured in the Community or imported,
quantities reaching one tonne or more per year per manufac-
turer or per importer, at least once after 1 June 2007.

4. Without prejudice to paragraphs 1 to 3, a registration can
be submitted at any time before the relevant deadline.

This Article shall also apply to substances registered under

5.
Article 7 adapted as necessary.

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Article 24

Notified substances

A notification in accordance with Directive 67/548/EEC
1.
shall be regarded as a registration for the purposes of this Title
and the Agency shall
registration number by
assign a
1 December 2008.

If the quantity of a notified substance manufactured or
2.
the next
imported per manufacturer or
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

TITLE III

DATA SHARING AND AVOIDANCE OF UNNECESSARY
TESTING

CHAPTER 1

Objectives and general rules

Article 25

Objectives and general rules

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.

submission of

The sharing and joint

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

registered in accordance with Article 28, shall inquire from the
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:

(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.
inform the potential
than 12 years earlier, the Agency shall
registrant without delay of
the
previous registrant(s) and of the relevant summaries or robust
study summaries, as the case may be, already submitted by
them.

the names and addresses of

Studies involving vertebrate animals shall not be repeated.

The Agency shall simultaneously inform the previous registrants
of the name and address of the potential registrant. The avail-
able studies shall be shared with the potential registrant in
accordance with Article 27.

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

the same substance,

the Agency shall

Any study summaries or

3.
robust study summaries of
studies submitted in the framework of a registration under this
Regulation at least 12 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

Article 26

Duty to inquire prior to registration

Article 27

Sharing of existing data in the case of registered substances

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

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

animals; and

(b) may, in the case of information not involving tests on verte-

brate animals,

Every potential registrant of a non-phase-in substance, or
1.
potential registrant of a phase-in substance who has not pre-

from the previous registrant(s)

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

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

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-discrimina-
tory way. This may be facilitated by following cost sharing
guidance based on those principles which is adopted by the
Agency in accordance with Article 77(2)(g). Registrants are only
required to share in the costs of
information that they are
required to submit to satisfy their registration requirements.

On agreement on the sharing of

the
4.
previous registrant shall make available to the new registrant the
agreed information and shall give the new registrant the permis-
sion to refer to the previous registrant's full study report.

the information,

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

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 in quantities of one 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;

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

(c) the envisaged deadline for the registration and the tonnage

band;

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, subject to the potential registrant
providing, upon request by the Agency, proof that he has paid
the previous registrant(s) for that information a share of cost
incurred. The previous registrant(s) shall have a claim on the
potential
the cost
incurred by him. Calculation of the proportionate share may be
facilitated by the guidance adopted by the Agency in accordance
with Article 77(2)(g). Provided he makes the full study report
available to the potential registrant, the previous registrant(s)
shall have a claim on the potential registrant for an equal share
of the cost incurred by him, which shall be enforceable in the
national courts.

for a proportionate share of

registrant

7.
An appeal may be brought, in accordance with Articles 91,
92 and 93, against Agency decisions under paragraph 6 of this
Article.

The

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

(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
application of
Sections 1.3 and 1.5 of Annex XI.

information is

relevant

the

for

2.
The information referred to in paragraph 1 shall be
submitted within a time period starting on 1 June 2008 and
ending on 1 December 2008.

Registrants who do not submit the information required

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

4.
The Agency shall by 1 January 2009 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, and the first envisaged registration deadline.

5.
After the publication of the list a downstream user of a
substance not appearing on the list may notify the Agency of
his interest in the substance, his contact details and the details
of his current supplier. The Agency shall publish on its website
the substance and on request provide contact
the name of
details of the downstream user to a potential registrant.

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Potential registrants who manufacture or import for the
6.
first time a phase-in substance in quantities of one tonne or
more per year or use for the first time a phase-in substance in
the context of production of articles or import for the first time
an article containing a phase-in substance that would require
registration, after 1 December 2008, shall be entitled to rely on
Article 23 provided that they submit the information referred to
in paragraph 1 of this Article to the Agency within six months
of
importing or using the substance in
quantities of one tonne or more per year and no later than 12
months before the relevant deadline in Article 23.

first manufacturing,

7. Manufacturers or
importers of phase-in substances in
quantities of less than one tonne per year that appear on the list
published by the Agency in accordance with paragraph 4 of this
Article, as well as downstream users of those substances and
third parties holding information on those substances, may
submit
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.

the information referred to in paragraph 1 of

Article 29

Substance Information Exchange Forums

All potential

1.
registrants, downstream users and third
parties who have submitted information to the Agency in
accordance with Article 28, or whose information is held by the
Agency in accordance with Article 15, for the same phase-in
substance, or registrants who have submitted a registration for
that phase-in substance before the deadline set out in Article 23
(3), 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 potential registrants, thereby avoiding the duplica-
tion of studies; and

(b) agree classification and labelling where there is a difference
in the classification and labelling of the substance between
potential registrants.

SIEF participants shall provide other participants with
3.
existing studies, react to requests by other participants for infor-
mation, collectively identify needs for further studies for the
purposes of paragraph 2(a) and arrange for such studies to be
carried out. Each SIEF shall be operational until 1 June 2018.

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 partici-
inquire whether a relevant study is available by
pant shall

communicating within his SIEF. If a relevant study involving
tests on vertebrate animals is available within the SIEF, a partici-
pant of that SIEF shall request that study. If a relevant study not
involving tests on vertebrate animals is available within the SIEF,
a SIEF participant may request that study.

Within one month 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 facili-
tated by following any cost sharing guidance which is based on
those principles and is adopted by the Agency in accordance
with Article 77(2)(g). 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. Registrants are only
required to share in the costs of
information that they are
required to submit to satisfy their registration requirements.

If a relevant study involving tests is not available within
2.
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
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.

the

relevant

fulfilling

3.
If the owner of a study as referred to in paragraph 1
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 regis-
tration until he provides the information to the other partici-
pants(s). The other participant(s) shall proceed with registration
without
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 registra-
tion containing this information has already been submitted by
another registrant, the Agency shall give the other participant(s)
permission to refer to the information in his registration dossier
(s). The other registrant shall have a claim on the other partici-
pant(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.

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If the owner of a study as referred to in paragraph 1
4.
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 91,
92 and 93, 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
this Article, shall be penalised in accordance with
or 4 of
Article 126.

TITLE IV

INFORMATION IN THE SUPPLY CHAIN

Article 31

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-
sification as dangerous in accordance with Directives 67/
548/EEC or 1999/45/EC; or

(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; or

(c) where a substance is included in the list established in
accordance with Article 59(1) for reasons other than those
referred to in points (a) and (b).

2.
Any actor in the supply chain who is required, under Arti-
cles 14 or 37, 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.

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

(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

least one substance that

persistent, bioaccumulative and toxic or very persistent and
very bioaccumulative in accordance with the criteria set out
in Annex XIII or has been included for reasons other than
those referred to in point (a) in the list established in accord-
ance with Article 59(1); or

(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.

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.

The safety data sheet shall be dated and shall contain the

6.
following headings:

1.

2.

3.

4.

5.

6.

7.

8.

9.

identification of
company/undertaking;

the substance/preparation and of

the

hazards identification;

composition/information on ingredients;

first-aid measures;

fire-fighting measures;

accidental release measures;

handling and storage;

exposure controls/personal protection;

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.

Any actor in the supply chain who is required to prepare a
7.
chemical safety report according to Articles 14 or 37 shall place
the relevant exposure scenarios (including use and exposure
categories where appropriate) in an annex to the safety data
sheet covering identified uses and including specific conditions
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.

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relevant

Any distributor shall pass on relevant exposure scenarios, and
use other
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 37(2).

information,

A safety data sheet shall be provided free of charge on

8.
paper or electronically.

latest at the time of the first delivery of a substance on its own
or in a preparation after 1 June 2007.

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;

Suppliers shall update the safety data sheet without delay

9.
on the following occasions:

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

(a) as soon as new information which may affect

the risk
management measures, or new information on hazards
becomes available;

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

(c) once a restriction has been imposed.

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

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

(c) once a restriction has been imposed.

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.

Article 33

Duty to communicate information on substances in articles

1.
Any supplier of an article containing a substance meeting
the criteria in Article 57 and identified in accordance with
Article 59(1) in a concentration above 0,1 % weight by weight
(w/w) shall provide the recipient of the article with sufficient
information, available to the supplier, to allow safe use of the
article including, as a minimum, the name of that substance.

2.
On request by a consumer any supplier of an article
containing a substance meeting the criteria in Article 57 and
identified in accordance with Article 59(1) in a concentration
above 0,1 % weight by weight (w/w) shall provide the consumer
with sufficient information, available to the supplier, to allow
safe use of the article including, as a minimum, the name of
that substance.

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

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

The relevant
within 45 days of receipt of the request.

information shall be provided,

free of charge,

(b) if the substance is subject to authorisation and details of any
in this

authorisation granted or denied under Title VII
supply chain;

(c) details of any restriction imposed under Title VIII;

(d) any other available and relevant

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

resulting from the

information about

conditions

Article 34

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:

The information referred to in paragraph 1 shall be
2.
communicated free of charge on paper or electronically at the

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

uses concerned;

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(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.

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.

Article 35

Access to information for workers

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.

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 36

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-
turer, importer, downstream user or distributor shall submit 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, downstream user or distributor
ceasing activity, or transferring part or all of his operations to a
third party, the party responsible for liquidating the registrant,
downstream user or distributor's undertaking or assuming
responsibility for the placing on the market of the substance or
preparation concerned shall be bound by the obligation in para-
graph 1 in place of the registrant, downstream user or distri-
butor.

TITLE V

DOWNSTREAM USERS

Article 37

For registered substances, the manufacturer,

3.
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
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 in his update of the registration in accordance with
Article 22(1)(d).

including these reason(s)

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

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.

2.
Any downstream user shall have the right to make a use,
as a minimum the brief general description of use, known in
to the manufacturer,
writing (on paper or electronically)
importer, downstream user or distributor who supplies him

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;

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

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

total quantity of less than one tonne per year;

in accordance with Article 37(4); or

(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;

(b) the downstream user
Article 37(4)(c) or (f).

is relying on the exemptions in

The information reported by the downstream user shall

2.
include the following:

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

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

Annex VI;

(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 environ-
ment are adequately controlled in accordance with the
requirements of
legislation for the protection of workers
and the environment.

Any downstream user shall

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

recommend,

identify, apply and where
to adequately

(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.

8.
A chemical safety report prepared in accordance with
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).

Article 38

Obligation for downstream users to report information

(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 37(4)(c), a proposal for additional testing on
vertebrate animals, where this is considered necessary by the
downstream user to complete his chemical safety assess-
ment.

The downstream user

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

shall update this

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

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

5.
Except where a downstream user is relying on the exemp-
tion in Article 37(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 one tonne per year for
that particular use.

Article 39

Application of downstream user obligations

Downstream users shall be required to comply with the
1.
requirements of Article 37 at
the latest 12 months after
receiving a registration number communicated to them by their
suppliers in a safety data sheet.

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 downstream user
shall report to the Agency the information specified in para-
graph 2 of this Article, in the following cases:

Downstream users shall be required to comply with the
2.
requirements of Article 38 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

Dossier evaluation

Article 40

(e) a decision in accordance with points (a), (b) or (c), if several
registrants or downstream users 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 or downstream users, as appropriate,
to perform the test on behalf of all of them.

The registrant or downstream user shall submit the infor-

4.
mation required to the Agency by the deadline set.

Examination of testing proposals

Article 41

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.

Information relating to testing proposals involving tests
2.
on vertebrate animals shall be published on the Agency website.
The Agency shall publish on its website the name of
the
substance, the hazard end-point for which vertebrate testing is
proposed, and the date by which any third party information is
required. It shall invite third parties to submit, using the format
provided by the Agency, scientifically valid information and
studies that address the relevant substance and hazard end-
point, addressed by the testing proposal, within 45 days of the
date of publication. All such scientifically valid information and
studies received shall be taken into account by the Agency in
preparing its decision in accordance with paragraph 3.

On the basis of the examination under paragraph 1, the
3.
Agency shall draft one of the following decisions and that deci-
sion shall be taken in accordance with the procedure laid down
in Articles 50 and 51:

(a) a decision requiring the registrant(s) or downstream user(s)
concerned to carry out the proposed test and setting a dead-
line for submission of the study summary, or the 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;

Compliance check of registrations

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.

2.
The list of dossiers being checked for compliance by the
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 accord-
ance with the procedure laid down in Articles 50 and 51.

(d) a decision rejecting the testing proposal;

The registrant shall submit the information required to the

4.
Agency by the deadline set.

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To ensure that registration dossiers comply with this Regu-
5.
lation, the Agency shall select a percentage of those 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:

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

(vi)

(b) the dossier is for a substance manufactured or imported in
quantities of one 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 44(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(4). The Agency shall consider this information
together with the
to
Article 124 when checking and selecting dossiers.

information submitted

according

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 133(4).

Article 43

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 40(3) 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 40(3):

the Agency shall

(a) by 1 December 2012 for all

registrations received by
1 December 2010 containing proposals for testing in order
to fulfil the information requirements in Annexes IX and X;

(b) by 1 June 2016 for all registrations received by 1 June 2013
containing proposals for testing in order to fulfil the infor-
mation requirements in Annex IX only;

(c) by 1 June 2022 for any registrations containing testing

proposals received by 1 June 2018.

The list of registration dossiers being evaluated under

3.
Article 40 shall be made available to Member States.

CHAPTER 2

Substance evaluation

Article 42

Article 44

Check of information submitted and follow-up to dossier
evaluation

1.
The Agency shall examine any information submitted in
consequence of a decision taken under Articles 40 or 41, 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 conclusions
made. The competent authorities shall use the information
obtained from this evaluation for the purposes of Article 45(5),
Article 59(3) and Article 69(4). The Agency shall use the infor-
the purposes of
mation obtained from this evaluation for
Article 44.

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. Priori-
tisation 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-accumulate,
suggesting that the substance or one or more of its transfor-
mation products has properties of concern or is persistent
and liable to bio-accumulate;

(b) exposure information;

(c) tonnage, including aggregated tonnage from the registrations

submitted by several registrants.

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The Agency shall use the criteria in paragraph 1 for the
2.
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 information in
the registration dossier) that a given substance constitutes a risk
to human health or the environment. The Agency shall submit
the first draft rolling action plan to the Member States by
1 December 2011. 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 76(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 45.

the substances

Article 45

Competent authority

1.
The Agency shall be responsible for coordinating the
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.

2.
A Member State may choose (a) substance(s) from the
draft Community rolling action plan, with the aim of becoming
a competent authority for the purposes of Articles 46, 47 and
In the event of a substance from the draft Community
48.
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 46, 47 and 48 shall be
determined in accordance with the following procedure.

refer

the matter

to the Member State
The Agency shall
Committee,
in order to agree which authority shall be the
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 133(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.

is in possession of

information which suggests that

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
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.

Article 46

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 50
and 52.

The registrant shall submit the information required to the

2.
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.

4.
The competent authority shall finish its evaluation activ-
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-
the evaluation shall be
ingly.
deemed to be finished.

this deadline is exceeded,

If

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Article 47

Coherence with other activities

1.
An evaluation of a substance shall be based on all relevant
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 51 or Article 52, any draft decision requiring further
information under Article 46 may be justified only by a change
of circumstances or acquired knowledge.

2.
In order to ensure a harmonised approach to requests for
further information, the Agency shall monitor draft decisions
under Article 46 and shall develop criteria and priorities. Where
appropriate, implementing measures shall be adopted in accord-
ance with the procedure referred to in Article 133(3).

(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 question.

The procedure provided for in the first paragraph may be under-
taken 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.

CHAPTER 4

Common provisions

Article 50

Article 48

Registrants' and downstream users' rights

Follow-up to substance evaluation

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 59(3),
Article 69(4) and Article 115(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 49

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 57, arises from the use of an on-site
isolated intermediate and that risk is not properly controlled, it
may:

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

1.
The Agency shall notify any draft decision under Arti-
cles 40, 41 or 46 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 46)
and the Agency (for decisions taken under Articles 40 and 41)
shall take any comments received into account and may amend
the draft decision accordingly.

2.
If a registrant has ceased the manufacture or import of the
substance, or the production or import of an article, or the
downstream user the use, he shall inform the Agency of this
fact with the consequence that the registered volume in his
registration, if appropriate, 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 or the production or import of the
article, or the downstream user notifies the restart of the use.
the
The Agency shall
Member State in which the registrant or downstream user is
located.

inform the competent authority of

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

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Notwithstanding paragraphs 2 and 3, further information
4.
may be required in accordance with Article 46 in either or both
of the following cases:

(a) where the competent authority prepares a dossier in accord-
ance with Annex XV concluding that there is a potential
long-term risk to human health or the environment justi-
fying the need for further information;

(b) where the exposure to the substance manufactured or
imported by the registrant(s), or to the substance in the
article produced or imported by the registrant(s), or to the
substance used by the downstream user(s) contributes signif-
icantly to that risk.

Article 52

Adoption of decisions under substance evaluation

The competent authority shall circulate its draft decision
1.
in accordance with Article 46, 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 51(2) to (8) shall apply mutatis

2.
mutandis.

The procedure in Articles 69 to 73 shall apply mutatis mutandis.

Article 53

Article 51

Adoption of decisions under dossier evaluation

1.
The Agency shall notify its draft decision in accordance
with Articles 40 or 41, 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 30-day
period referred to in paragraph 2.

the end of

5.
The Agency shall forthwith communicate any proposal 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 133(3).

8.
An appeal may be brought, in accordance with Articles 91,
92 and 93, against Agency decisions under paragraphs 3 and 6
of this Article.

Cost sharing for tests without an agreement between regis-
trants 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
registrants or downstream users and to inform the
other
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

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

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

The person performing and submitting the study shall
4.
have a claim against
the others accordingly. Any person
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 remu-
neration to an arbitration board and accept
the arbitration
order.

Article 54

Publication of information on evaluation

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 55

Aim of authorisation and considerations for substitution

The aim of this Title is to ensure the good functioning of the
internal market while assuring that the risks from substances of
these
very high concern are properly controlled and that
substances are progressively replaced by suitable alternative
substances or technologies where these are economically and
technically viable. To this end all manufacturers, importers and
downstream users applying for authorisations shall analyse the
availability of alternatives and consider their risks, and the tech-
nical and economic feasibility of substitution.

Article 56

General provisions

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 accord-
ance with Articles 60 to 64; 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 accordance
with Article 58(2); or

(e) in cases where the substance is placed on the market,
authorisation for that use has been granted to his immediate
downstream user.

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

tive 91/414/EEC;

(b) uses in biocidal products within the scope of Directive 98/8/

EC;

(c) use as motor fuels covered by Directive 98/70/EC of the
the Council of 13 October

European Parliament and of
1998 relating to the quality of petrol and diesel fuels (1);

(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 57(a), (b) or (c) or
because they are identified in accordance with Article 57(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.

Paragraphs 1 and 2 shall not apply to the use of

6.
substances when they are present in preparations:

(a) for substances referred to in Article 57(d), (e) and (f), below
a concentration limit of 0,1 % weight by weight (w/w);

(c) the date referred to in Article 58(1)(c)(i) has not been

reached; or

(d) the date referred to in Article 58(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

(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.

(1) OJ L 350, 28.12.1998, p. 58. Directive as amended by Regulation (EC)

No 1882/2003.

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Article 57

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 58:

(a) substances meeting the criteria for classification as carcino-
genic category 1 or 2 in accordance with Directive 67/548/
EEC;

(b) substances meeting the criteria for classification as muta-
genic category 1 or 2 in accordance with Directive 67/548/
EEC;

(c) substances meeting the criteria for classification as toxic for
reproduction category 1 or 2 in accordance with Direc-
tive 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 59.

Article 58

Inclusion of substances in Annex XIV

1. Whenever a decision is taken to include in Annex XIV
substances referred to in Article 57, such a decision shall be
taken in accordance with the procedure
referred to in
Article 133(4). 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 57;

(c) transitional arrangements:

(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;

(ii) a date or dates at least 18 months before the sunset date
(s) by which applications must be received if the appli-
cant 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 para-
graph 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 Agen-
cy'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 1 June 2009. The
Agency shall make further recommendations at
least every
second year with a view to including further substances in
Annex XIV.

4.
Before the Agency sends its recommendation to the
Commission it shall make it publicly available on its website,
clearly indicating the date of publication, taking into account
Articles 118 and 119 on access to information. The Agency
shall
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.

invite all

The Agency shall update its
account the comments received.

recommendation,

taking into

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Subject to paragraph 6, after inclusion of a substance in
5.
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.

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

the environment

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.

8.
Substances which as a result of new information no
longer meet the criteria of Article 57 shall be removed from
Annex XIV in accordance with the procedure referred to in
Article 133(4).

Article 59

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 57 in the dossier to the
Agency.

6.
If the Agency does not receive or make 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 58(3).

7. When comments are made or received, 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 paragraph 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 58(3).

9.
If the Member State Committee fails to reach a unanimous
agreement, the Commission shall prepare a draft proposal on
the identification of
the substance within three months of
receipt of the opinion of the Member State Committee. A final
decision on the identification of the substance shall be taken in
accordance with the procedure referred to in Article 133(3).

Identification of substances referred to in Article 57

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

this
The procedure set out in paragraphs 2 to 10 of
1.
Article shall apply for the purpose of identifying substances
meeting the criteria referred to in Article 57 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 83(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 57. The dossier may be limited, if appropriate, to a refer-
ence to an entry in Annex I of Directive 67/548/EEC. The
Agency shall make this dossier available to the Member States.

3.
Any Member State may prepare a dossier in accordance
with Annex XV for substances which in its opinion meet the
criteria set out in Article 57 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.

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

CHAPTER 2

Granting of authorisations

Article 60

Granting of authorisations

The Commission shall be responsible for taking decisions

1.
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, taking into account the opinion of
the Committee for Risk Assessment referred to in Article 64(4)
(a). When granting the authorisation, and in any conditions
imposed therein, the Commission shall take into account all
including risks arising from
discharges, emissions and losses,
diffuse or dispersive uses, known at the time of the 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 regulated
by Council Directive 90/385/EEC of 20 June 1990 on the
approximation of the laws of the Member States relating to
active implantable medical devices (1), Council Directive 93/42/
EEC of 14 June 1993 concerning medical devices (2) or Direc-
tive 98/79/EC of the European Parliament and of the Council of
27 October 1998 on in vitro diagnostic medical devices (3).

into account the appropriateness and effectiveness of risk
management measures;

(b) the technical and economic feasibility of alternatives for the

applicant.

A use shall not be authorised if this would constitute a

6.
relaxation of a restriction set out in Annex XVII.

3.

Paragraph 2 shall not apply to:

(a) substances meeting the criteria in Article 57(a), (b), (c) or (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 57(d) or (e);

(c) substances identified under Article 57(f) having persistent,
bioaccumulative and toxic properties or very persistent and
very bioaccumulative properties.

4.
If an authorisation cannot be granted under paragraph 2
or for substances listed in paragraph 3, an authorisation may
only 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 alter-
native substances or technologies. This decision shall be taken
after consideration of all of the following elements and taking
into account the opinions of the Committee for Risk Assess-
ment and the Committee for Socio-economic Analysis referred
to in Article 64(4)(a) and (b):

(a) the risk posed by the uses of the substance, including the
appropriateness and effectiveness of the risk management
measures proposed;

(b) the socio-economic benefits arising from its use and the
to authorise as

socio-economic implications of a refusal
demonstrated by the applicant or other interested parties;

(c) the analysis of the alternatives submitted by the applicant
under Article 62(4)(e) or any substitution plan submitted by
the applicant under Article 62(4)(f), and any third party
contributions submitted under Article 64(2);

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

5. When assessing whether suitable alternative substances or
technologies are available, all relevant aspects shall be taken into
account by the Commission, including:

(a) whether the transfer to alternatives would result in reduced
overall risks to human health and the environment, taking

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

(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.

An authorisation shall be granted only if the application is

7.
made in conformity with the requirements of Article 62.

8.
Authorisations shall be subject to a time-limited review
without prejudice to any decision on a future review period and
shall normally be subject to conditions, including monitoring.
The duration of the time-limited review for any authorisation
shall be determined on a case-by-case basis taking into account
all relevant information including the elements listed in para-
graph 4(a) to (d), as appropriate.

9.

The authorisation shall specify:

(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 61

Review of authorisations

1.
Authorisations granted in accordance with Article 60 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
the holder of an
application for the current authorisation,
authorisation may submit only the number of
the current
third and fourth sub-
authorisation, subject
paragraphs.

to the second,

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and any
If

A holder of an authorisation granted in accordance with
Article 60 shall submit an update of the analysis of alternatives
referred to in Article 62(4)(e), including information about any
relevant research and development activities by the applicant, if
appropriate,
substitution plan submitted under
the analysis of alternatives
Article 62(4)(f).
shows that there is a suitable alternative available taking into
account the elements in Article 60(5), he shall submit a substi-
tution plan, including a timetable for proposed actions by the
applicant.
the holder cannot demonstrate that the risk is
adequately controlled, he shall also submit an update of the
socio-economic analysis contained in the original application.

the update of

If

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

6.
If a use of a substance is subsequently prohibited or other-
wise restricted in Regulation (EC) No 850/2004 of the European
Parliament and of the Council of 29 April 2004 on persistent
organic pollutants (1),
the Commission shall withdraw the
authorisation for that use.

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

Article 62

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

Applications for authorisations

An application for an authorisation shall be made to the

1.
Agency.

When any updated information is submitted in accordance with
this paragraph, any decision to amend or withdraw the authori-
sation in the context of the review shall be taken in accordance
with the procedure referred to in Article 64 applied mutatis
mutandis.

2.

Authorisations may be reviewed at any time if:

(a) the

circumstances of

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

the original

Applications for authorisation may be made by the manu-
2.
facturer(s),
the
substance. Applications may be made by one or several persons.

and/or downstream user(s) of

importer(s)

3.
Applications may be made for one or several substances,
that meet the definition of a group of substances in Section 1.5
of Annex XI, 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.

(b) new information on possible substitutes becomes available.

An application for

4.
following information:

authorisation shall

include

the

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 deci-
sion in accordance with Article 64.

In its review decision the Commission may,

3.
if circum-
stances have changed and taking into account the principle of
proportionality, amend or withdraw the authorisation, if under
the changed circumstances it would not have been granted or if
suitable alternatives in accordance with Article 60(5) become
available. In the latter case the Commission shall require the
holder of the authorisation to present a substitution plan if he
has not already done so as part of his application or update.

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.

(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;

(e) an analysis of the alternatives considering their risks and the
substitution and
if appropriate information about any relevant

technical and economic feasibility of
including,
research and development activities by the applicant;

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

(1) OJ L 158, 30.4.2004, p. 7, corrected in OJ L 229, 29.6.2004, p. 5.
Regulation as amended by Council Regulation (EC) No 1195/2006 (OJ
L 217, 8.8.2006, p. 1).

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(f) where the analysis referred to in point

(e) shows that
suitable alternatives are available, taking into account the
elements in Article 60(5), a substitution plan including a
timetable for proposed actions by the applicant.

5.

The application may include:

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

Annex XVI;

(b) 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.

The application shall not

6.
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 64

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 118 and 119
on access to information,
for which applications have been
received and for reviews of authorisations, with a deadline by
which information on alternative substances or technologies
may be submitted by interested third parties.

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 62 that is relevant to its remit.
in consultation with each
If necessary, the Committees shall,
other, make a joint request to the applicant for additional infor-
mation to bring the application into conformity with the
requirements of Article 62. 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.

Article 63

4.

The draft opinions shall include the following elements:

Subsequent applications for authorisation

If an application has been made for a use of a substance, a
1.
subsequent applicant may refer to the appropriate parts of the
previous application submitted in accordance with Article 62(4)
(d), (e) and (f) and (5)(a), provided that the subsequent applicant
has permission from the previous applicant to refer to these
parts of the application.

If an authorisation has been granted for a use of a
2.
substance, a subsequent applicant may refer to the appropriate
parts of the previous application submitted in accordance with
Article 62(4)(d), (e) and (f) and (5)(a), provided that the subse-
quent applicant has permission from the holder of the authori-
sation to refer to these parts of the application.

3.
Before referring to any previous application in accordance
with paragraphs 1 and 2, the subsequent applicant shall update
the information of the original application as necessary.

(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, including the appropriateness and
effectiveness of the risk management measures 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
use(s) of the substance as described in the application, when
an application is made in accordance with Article 62 and of
any third party contributions submitted under paragraph 2
of this Article.

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.

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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

the draft opinion. The Committees

If the applicant wishes to comment, he shall send his written
argumentation to the Agency within two months of the receipt
of
the
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.

shall consider

6.
The Agency shall determine in accordance with Arti-
cles 118 and 119 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 63(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 133(3).

Summaries of the Commission decisions,

9.
including the
authorisation number and the reasons for the decision, in par-
ticular where suitable alternatives exist, shall be published in the
Official
the European Union and shall be made
publicly available in a database established and kept up to date
by the Agency.

Journal of

In cases covered by Article 63(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 65

Obligation of holders of authorisations

Holders of an authorisation, as well as downstream users
including the substances in a
referred to in Article 56(2)
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 authorisation number has been
made publicly available in accordance with Article 64(9).

Article 66

Downstream users

1.
Downstream users using a substance in accordance with
Article 56(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.

TITLE VIII

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

CHAPTER 1

General issues

Article 67

General provisions

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.

stringent

and more

Until 1 June 2013, a Member State may maintain any
3.
existing
in relation to
Annex XVII on the manufacture, placing on the market or use
of a substance, provided that those restrictions have been noti-
fied according to the Treaty. The Commission shall compile and
publish an inventory of these restrictions by 1 June 2009.

restrictions

CHAPTER 2

Restrictions process

Article 68

Introducing new and amending current restrictions

1. When there is an unacceptable risk to human health or
the environment, arising from the manufacture, use or placing
on the market of substances, which needs to be addressed on a
Community-wide basis, Annex XVII shall be amended in accord-
ance with the procedure referred to in Article 133(4) by
adopting new restrictions, or amending current restrictions in
Annex XVII, for the manufacture, use or placing on the market
of substances on their own,
in preparations or in articles,
pursuant to the procedure set out in Articles 69 to 73. Any
such decision shall take into account the socio-economic impact
of the restriction, including the availability of alternatives.

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The first subparagraph shall not apply to the use of a substance
as an on-site isolated intermediate.

For a substance on its own,

in a preparation or in an
2.
article which meets the criteria for classification as carcinogenic,
mutagenic or toxic to reproduction, category 1 or 2, and could
be used by consumers and for which restrictions to consumer
use are proposed by the Commission, Annex XVII shall be
amended in accordance with the procedure referred to in
Article 133(4). Articles 69 to 73 shall not apply.

refer

to any dossier,
The Agency or Member States shall
chemical safety report or risk assessment submitted to the
Agency or Member State under this Regulation. The Agency or
Member States shall also refer to any relevant risk assessment
submitted for the purposes of other Community Regulations or
Directives. To this end other bodies, such as agencies, established
under Community law and carrying out a similar task shall
provide information to the Agency or Member State concerned
on request.

Article 69

Preparation of a proposal

1.
If the Commission considers that the manufacture, placing
on the market or use of a substance on its own, in a preparation
or in an article poses a risk to human health or the environ-
ment
to be
addressed, it shall ask the Agency to prepare a dossier which
conforms to the requirements of Annex XV.

is not adequately controlled and needs

that

After

the date referred to in Article 58(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
controlled.
the risk is not
adequately controlled, it shall prepare a dossier which conforms
to the requirements of Annex XV.

the environment
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.

that

is not adequately controlled and needs

4.
If a Member State considers that the manufacture, placing
on the market or use of a substance on its own, in a preparation
or in an article poses a risk to human health or the environ-
ment
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 notification
to the Agency. If this dossier demonstrates that action on a
Community-wide basis
is necessary, beyond any measures
already in place, the Member State shall submit it to the Agency
in order to initiate the
in the format outlined in Annex XV,
restrictions process.

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 Committees, other-
wise the procedure under this Chapter shall be terminated. The
Agency shall publish without delay the intention of
the
Commission or of a Member State to instigate a restriction
procedure for a substance and shall inform those who submitted
a registration for that substance.

5.
The Agency shall maintain a list of substances for which a
dossier conforming to the requirements of Annex XV is planned
or underway by either the Agency or a Member State for the
purposes of a proposed restriction. If a substance is on the list,
no other such dossier shall be prepared. If it 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 proce-
dure referred to in Article 133(2) based on evidence presented
by the Member State or the Agency.

6. Without prejudice to Articles 118 and 119, the Agency
shall make publicly available on its website all dossiers
conforming with Annex XV including the restrictions suggested
pursuant to paragraphs 3 and 4 of this Article without delay,
clearly indicating the date of publication. The Agency shall
invite all
individually or jointly
within six months of the date of publication:

interested parties to submit

(a) comments on dossiers and the suggested restrictions;

(b) a socio-economic analysis, or information which can contri-
bute to one, of the suggested restrictions, examining the
advantages and drawbacks of the proposed restrictions. It
shall conform to the requirements in Annex XVI.

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Article 70

Agency opinion: Committee for Risk Assessment

Within nine months of the date of publication referred to in
Article 69(6), the Committee for Risk Assessment shall 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 Article 69(6)(a).

Article 71

Agency opinion: Committee for Socio-economic Analysis

1. Within 12 months of the date of publication referred to
in Article 69(6), the Committee for Socio-economic Analysis
shall formulate an opinion on the suggested restrictions, based
on its consideration of the relevant parts of the dossier and the
socio-economic impact. It shall prepare a draft opinion on the
suggested restrictions and on the related socio-economic impact,
taking account of
the analyses or information according to
Article 69(6)(b), if there are any. The Agency shall publish the
draft opinion on its website without delay. The Agency shall
invite interested parties to give their comments on the draft
opinion no later than 60 days from the publication of that draft
opinion.

2.
The Committee for Socio-economic Analysis shall without
delay adopt its opinion, taking into account where appropriate
further comments received by the deadline set. This opinion
shall
the comments and socio-economic
analyses of interested parties submitted under Article 69(6)(b)
and under paragraph 1 of this Article.

take account of

3. Where the opinion of the Committee for Risk Assessment
diverges significantly from the restrictions suggested, the Agency
may postpone the deadline for the opinion of the Committee
for Socio-economic Analysis by a maximum of 90 days.

Article 72

Submission of an opinion to the Commission

The Agency shall submit to the Commission without delay
1.
the opinions of the Committees for Risk Assessment and Socio-
economic Analysis on restrictions suggested for substances on
their own, in preparations or in articles. If one or both of the
Committees do not formulate an opinion by the deadline set in
inform the
Article 70 and Article 71(1)
Commission accordingly, stating the reasons.

the Agency shall

2. Without prejudice to Articles 118 and 119 the Agency
shall publish the opinions of the two Committees on its website
without delay.

The Agency shall provide the Commission and/or Member
3.
State on request with all documents and evidence submitted to
or considered by it.

Article 73

Commission decision

1.
If the conditions laid down in Article 68 are fulfilled, the
Commission shall prepare a draft amendment to Annex XVII,
within three months of receipt of the opinion of the Committee
the deadline
for Socio-economic Analysis or by the end of
established under Article 71 if that Committee does not form
an opinion, whichever is the earlier.

it does not

Where the draft amendment diverges from the original proposal
or if
take the opinions from the Agency into
account, the Commission shall annex a detailed explanation of
the reasons for the differences.

2.
A final decision shall be taken in accordance with the
procedure referred to in Article 133(4). The Commission shall
send the draft amendment to the Member States at least 45 days
before voting.

TITLE IX

FEES AND CHARGES

Article 74

Fees and charges

The fees that are required according to Article 6(4),
1.
Article 7(1) and (5), Article 9(2), Article 11(4), Article 17(2),
Article 18(2), Article 19(3), Article 22(5), Article 62(7) and
Article 92(3) shall be specified in a Commission Regulation
adopted in accordance with the procedure referred to in
Article 133(3) by 1 June 2008.

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 96(1) is sufficient to
cover the cost of the services delivered. The fees set for registra-
tion shall take into account the work that may be done pursuant
to Title VI.

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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 take into account whether information has been submitted
jointly or separately.

In the case of a request made under Article 10(a)(xi), the struc-
ture and amount of
the work
take into account
required by the Agency in assessing the justification.

fees shall

4.
The Regulation referred to in paragraph 1 shall specify 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 75

Establishment and review

1.
the
A European Chemicals Agency is established for
purposes of managing and in some cases carrying out the tech-
nical, scientific and administrative aspects of this Regulation and
to ensure consistency at Community level in relation to these
aspects.

2.

The Agency shall be subject to a review by 1 June 2012.

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 (here-
inafter referred to as the Forum) which shall coordinate a
network of Member States authorities responsible for enfor-
cement 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 purpose
they shall adopt, in accordance with their rules of procedure,
to these
precise arrangements
working groups.

for delegating certain tasks

The Committees and the Forum may, if they consider it
3.
appropriate, seek advice on important questions of a general
scientific or ethical nature from appropriate sources of expertise.

Article 76

Composition

Article 77

Tasks

1.

The Agency shall comprise:

(a) a Management Board, which shall exercise the responsibil-

ities set out in Article 78;

(b) an Executive Director, who shall exercise the responsibilities

set out in Article 83;

(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

1.
The Agency shall provide the Member States and the insti-
tutions of the Community with the best possible scientific 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;

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(d) performing the tasks allotted to it under Title VIII;

(o) provision of formats for submission of information to the

Agency.

(e) establishing and maintaining database(s) with information
on all registered substances, the classification and labelling
inventory and the harmonised classification and labelling
list. It shall make the information identified in Article 119
(1) and (2)
in the database(s) publicly available, free of
charge, over the Internet, except where a request made
under Article 10(a)(xi) is considered justified. The Agency
shall make other information in the databases available on
request in accordance with Article 118;

(f) making publicly

available

to which
substances are being, and have been evaluated within 90
days of receipt of the information at the Agency, in accord-
ance with Article 119(1);

information as

(g) providing technical and scientific guidance and tools where
appropriate for the operation of this Regulation in particu-
lar to assist the development of chemical safety reports (in
accordance with Article 14, Article 31(1) and Article 37(4))
and application of Article 10(a)(viii), Article 11(3) and
Article 19(2) by industry and especially by SMEs; and tech-
nical and scientific guidance for the application of Article 7
by producers and importers of articles;

(h) providing technical and scientific guidance on the operation
of this Regulation for Member State competent authorities
and providing support
to the helpdesks established by
Member States under Title XIII;

(i) providing guidance to stakeholders including Member State
competent authorities on communication to the public of
information on the risks and safe use of substances, on
their own, in preparations or in articles;

(j) providing advice and assistance to manufacturers and
registering a substance in accordance with

importers
Article 12(1);

(k) preparing explanatory information on this Regulation for

other stakeholders;

(l) 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;

3.

The Committees shall undertake the following tasks:

(a) performing the tasks allotted to them under Titles VI to XI;

(b) at the Executive Director's request, providing technical and
scientific support for steps to improve cooperation between
the Community, its Member States, international organisa-
tions 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 activities
on sound management of chemicals in developing coun-
tries;

(c) at the Executive Director'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) proposing, coordinating and evaluating harmonised enforce-

ment projects and joint inspections;

(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,

taking particular account of

specific needs of SMEs, and other stakeholders,
relevant international organisations, as necessary;

the
including

(h) examining proposals for restrictions with a view to advising

on enforceability.

Article 78

Powers of the Management Board

The Management Board shall appoint the Executive Director
pursuant to Article 84 and an accounting officer in accordance
with Article 43 of Regulation (EC, Euratom) No 2343/2002.

(m) keeping a Manual of Decisions and Opinions based on
conclusions from the Member State Committee regarding
interpretation and implementation of this Regulation;

(a) by 30 April each year, the general report of the Agency for

the previous year;

(n) notification of decisions taken by the Agency;

Agency for the coming year;

(b) by 31 October each year the work programme of

the

It shall adopt:

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(c) the final budget of the Agency pursuant to Article 96 before
the beginning of the financial year, adjusting it, where neces-
sary, according to the Community contribution and any
other revenue of the Agency;

The terms of office of the Chairman and the Deputy-
2.
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.

(d) a multiannual 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 96, 97 and 103.

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 89.

It shall appoint the members of the Agency committees as set
out in Article 85.

It shall
outcome of
Article 96(6).

forward annually any information relevant

to the
the evaluation procedures in accordance with

Article 79

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 and in addi-
tion two independent persons appointed by the European Parlia-
ment.

Each Member State shall nominate a member to the Manage-
ment Board. The members thus nominated shall be appointed
by the Council.

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.

The duration of the term of office shall be four years. The
3.
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.

Article 81

Meetings of the Management Board

1.
The meetings of 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 76(1)(c) to (f), are entitled to
attend the meetings of the Management Board without voting
rights.

Article 82

Voting of the Management Board

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.

Article 83

Duties and powers 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

Article 80

providers;

Chairmanship of the Management Board

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.

(f) the preparation of the statement of revenue and expendi-
ture and the implementation of the budget of the Agency
pursuant to Articles 96 and 97;

(g) all staff matters;

(h) providing the secretariat for the Management Board;

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(i) preparing draft opinions of

concerning the proposed rules of procedure of
Committees and of the Forum;

the Management Board
the

(j) making arrangements, upon request from the Management
Board, for the execution of any further function(s) (within
the remit of Article 77) allotted to the Agency by delega-
tion from the Commission;

(k) establishing and maintaining a regular dialogue with the

European Parliament;

(l) determining the terms and conditions for use of software

packages;

(m) rectifying a decision made by the Agency following an
appeal and after consulting the Chairman of the Board of
Appeal.

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 eval-
uated, the number of applications for authorisation received,
the number of proposals for restriction received by the
Agency and opined upon, the time taken for completion of
the associated procedures, and the substances authorised,
dossiers rejected, substances restricted; complaints received
and the action taken; an overview of the activities of the
Forum;

(b) a draft work-programme for the coming year;

(c) the draft annual accounts;

(d) the draft forecast budget for the coming year;

(e) a draft multiannual work programme.

The Executive Director shall, following approval by the Manage-
ment Board, forward the work programme for the coming year
and the multiannual work programme to the Member States,
the European Parliament, the Council and the Commission, and
shall have them published.

The Executive Director shall, following approval by the Manage-
ment Board, forward the Agency's general report to the Member
States, the European Parliament, the Council, the Commission,
the European Economic and Social Committee and the Court of
Auditors, and shall have it published.

Article 84

Appointment of the Executive Director

proposed by the Commission following a call for expressions of
interest published in the Official Journal of the European Union
and in other periodicals or on Internet sites.

The Executive Director shall be appointed on the grounds of
merit and documented administrative and management skills, as
well as his relevant experience in the fields of chemical safety or
regulation. The Management Board shall take its decision by a
two-thirds majority of all members with a right to vote.

to dismiss the Executive Director shall

Power
Management Board, in accordance with the same procedure.

lie with the

Before being appointed, the candidate selected by the Manage-
ment Board shall be invited as soon as possible to make a state-
ment before the European Parliament and to answer questions
from Members of Parliament.

2.
The term of the office of the Executive Director shall be
five years. It may be prolonged by the Management Board once
for another period of up to five years.

Article 85

Establishment of the Committees

Each Member State may nominate candidates to member-
1.
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, without prejudice to
Article 88(1). 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 77(3).

2.
Each Member State may nominate candidates to member-
ship of the Committee for Socio-economic Analysis. The Execu-
tive Director shall establish a list of the nominees, which shall
be published on the Agency's website, without prejudice to
Article 88(1). 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 77(3).

The Executive Director of the Agency shall be appointed
1.
by the Management Board on the basis of a list of candidates

Each Member State shall appoint one member to the

3.
Member State Committee.

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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.

lishment of a procedure for the urgent adoption of opinions.
The Chairman of each Committee shall be an employee of the
Agency.

Members of the Committees shall be appointed for a term of
three years which shall be renewable.

Article 86

The members of the Management Board may not be members
of the Committees.

Establishment of the Forum

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
of
the Committees and working groups convened by the
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.

The members of each Committee appointed following
5.
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.

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
that
they have nominated. Each Member State competent
authority shall facilitate the activities of the Committees and
their working groups.

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, responsibil-
ities 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, including their grounds. The minority
position(s), including their grounds, shall also be published.

Each Member State shall appoint, for a three-year term,
1.
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 expertise
among its members. To this end the Forum may co-opt 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. Members of the
Management Board may not be members of the Forum.

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. Stakeholders
may also be invited to attend meetings as observers, as appro-
priate, at the request of Forum members, or the Management
Board.

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.

facilitate the activities of

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 competent
authority shall
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 indi-
vidual tasks of those persons or with the tasks and responsibil-
ities of the Forum.

9.
Each Committee shall draft a proposal for its own rules of
procedure, to be approved by the Management Board, within six
months of the Committees first being appointed.

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.

These rules shall in particular lay down the procedures for repla-
cing members, the procedures for delegating certain tasks to
working groups, the creation of working groups and the estab-

These rules shall
in particular lay down the procedures for
appointing and replacing the Chairman, replacing members and
the procedures for delegating certain tasks to working groups.

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Article 87

Article 88

Rapporteurs of Committees and use of experts

Qualification and interests

1. Where,
in accordance with Article 77, a Committee is
required to provide an opinion or consider whether a Member
State dossier conforms with the requirements 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 their duties
interests in writing. A member of a
and a declaration of
Committee shall not be appointed rapporteur for a particular
case if he indicates any interest that might be prejudicial to the
independent
case. The Committee
concerned may replace the rapporteur or co-rapporteur by
another one of its members at any time, if, for example, they
are unable to fulfil their duties within the prescribed time limits,
or if a potentially prejudicial interest comes to light.

consideration of

that

2. Member States shall transmit to the Agency the names of
experts with proven experience in the tasks
required by
Article 77, who would be available to serve on working groups
of the Committees, together with an indication of their qualifi-
cations and specific areas of expertise.

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.

The provision of services by Committee members or any
3.
expert serving on a working group of
the Committees or
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.

The provision of services for which there are several
for an expression of

4.
potential providers may require a call
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.

The membership of the Committees and of the Forum
1.
shall be made public. Individual members may request that their
names not be made public if they believe that such publication
could place them at risk. The Executive Director shall decide
whether to agree to such requests. When each appointment is
published, the professional qualifications of each member shall
be specified.

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 and, without prejudice to paragraph 1,
be entered in a register held by the Agency which is accessible
to the public, on request, at the Agency's offices.

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 prejudicial
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.

Article 89

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 a list of
candidates proposed by the Commission following a call for
expressions of interest published in the Official Journal of the
European Union and in other periodicals or on Internet sites.
They shall be appointed 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 candi-
dates 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.

The Management Board shall adopt the appropriate procedures
on a proposal from the Executive Director.

The qualifications required for the members of the Board
4.
of Appeal shall be determined by the Commission in accordance
with the procedure referred to in Article 133(3).

The Agency may use the services of experts for
5.
discharge of other specific tasks for which it is responsible.

the

The Chairman and the members shall have equal voting

5.
rights.

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Article 90

addressed to another person, is of direct and individual concern
to the former.

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

The members of the Board of Appeal shall be indepen-
2.
dent. In making their decisions they shall not be bound by any
instructions.

The members of the Board of Appeal may not perform

3.
any other duties in the Agency.

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
and the Commission, after obtaining the opinion of
the
Management Board, takes a decision to this effect.

5. Members of the Board of Appeal may not take part in any
appeal proceedings if they have any personal interest therein, or
if they have previously been involved as representatives of one
of the parties to the proceedings, or if they participated in the
decision under appeal.

6.
If a member of the Board of Appeal considers for reasons
mentioned in paragraph 5 that he must not take part in a
specific 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 91

Decisions subject to appeal

the
An appeal may be brought against decisions of
1.
Agency taken pursuant to Article 9, Article 20, Article 27(6),
Article 30(2) and (3) and Article 51.

2.
An appeal
suspensive effect.

lodged pursuant to paragraph 1 shall have

Article 92

Persons entitled to appeal, time-limits, fees and form

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

A fee may be payable by persons bringing an appeal

3.
against an Agency decision, in accordance with Title IX.

Article 93

Examination and decisions on appeal

1.
If, after consultation with the Chairman of the Board of
Appeal, the Executive Director considers the appeal to be admis-
founded he may rectify the decision within
sible and well
30 days of the appeal being filed in accordance with Article 92
(2).

2.
In cases other than those referred to in paragraph 1 of
this Article, the Chairman of the Board of Appeal shall examine
whether the appeal is admissible within 30 days of the appeal
being filed in accordance with Article 92(2). In the affirmative,
the appeal shall be remitted to the Board of Appeal for examina-
tion of the grounds. Parties to the appeal proceedings shall be
entitled to make an oral presentation during the procedure.

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 133(3).

Article 94

Actions before the Court of First Instance and the Court of
Justice

1.
An action may be brought before the Court of First
Instance or the Court of Justice, in accordance with Article 230
the Treaty, contesting a decision taken by the Board of
of
Appeal or,
lies before the
Board, by the Agency.

in cases where no right of appeal

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 Article 232 of the
Treaty.

Any natural or legal person may appeal against a decision
1.
addressed to that person, or against a decision which, although

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.

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Article 95

Conflicts of opinion with other bodies

The Agency shall take care to ensure early identification of
1.
potential sources of conflict between its opinions and those of
other bodies established under Community law, including Com-
munity 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 iden-
technical points which are potentially
tify the scientific or
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.

On the basis of the estimate, the Commission shall enter
7.
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 appropriations

8.
for the subsidy to the Agency.

The budgetary authority shall adopt the establishment plan for
the Agency.

9.
The budget of the Agency shall be adopted by the Manage-
ment Board. It shall become final following final adoption of
the general budget of the European Communities. Where appro-
priate, it shall be adjusted accordingly.

Any modification to the budget, including the establish-

10.
ment plan, shall follow the procedure referred to above.

Article 96

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

2.
administrative, infrastructure and operational expenses.

the Agency shall

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 anticipated
for the following financial year, and shall forward this preli-
minary draft to the Management Board together with an estab-
lishment 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.

11.
The Management Board shall, without delay, notify the
budgetary authority of its intention to implement any project
which may have significant
the
funding of its budget, in particular any projects relating to prop-
erty such as the rental or purchase of buildings. It shall inform
the Commission thereof.

implications

financial

for

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.

Article 97

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 conso-
lidate the provisional accounts of the institutions and decentra-
lised bodies in accordance with Article 128 of Council Regu-
lation (EC, Euratom) No 1605/2002 of 25 June 2002 on the
Financial Regulation applicable to the general budget of the
European Communities (1).

(1) OJ L 248, 16.9.2002, p. 1. Regulation as amended by Regulation (EC,

Euratom) No 1995/2006 (OJ L 390, 30.12.2006, p. 1).

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By 31 March at the latest following each financial year, the
4.
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.
Agency's provisional accounts, pursuant to Article 129 of Regu-
lation (EC, Euratom) No 1605/2002,
the Executive Director
shall draw up the Agency's final accounts under his own respon-
sibility and forward them to the Management Board for an
opinion.

The Management Board shall deliver an opinion on the

6.
Agency's final accounts.

7.
By 1 July of the following year at the latest, the Executive
Director shall send the final accounts, together with the opinion
the
the Management Board, to the European Parliament,
of
Council, the Commission and the Court of Auditors.

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 99

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.

Article 100

8.

The final accounts shall be published.

Legal personality of the Agency

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.

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.

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.

2.

The Agency shall be represented by its Executive Director.

Article 98

Combating fraud

Article 101

Liability of the Agency

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) (1) shall apply without restrictions to the
Agency.

2.
The Agency shall be bound by the Interinstitutional Agree-
ment 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) (2) and shall
issue,
without delay, the appropriate provisions applicable to all of its
staff.

(1) OJ L 136, 31.5.1999, p. 1.
(2) OJ L 136, 31.5.1999, p. 15.

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.

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.

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

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Article 102

Article 107

Privileges and immunities of the Agency

Participation of international organisations

The Protocol on the Privileges and Immunities of the European
Communities shall apply to the Agency.

Article 103

Staff rules and regulations

1.
The staff of the Agency shall be subject to the Regulations
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

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 necessary
to carry out its tasks. The Agency shall recruit its personnel on
the basis of a staffing plan to be included in the multiannual
work programme referred to in Article 78(d).

Article 104

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.

The translation services required for the functioning of the
the

2.
Agency shall be provided by the Translation Centre of
bodies of the European Union.

Article 105

Duty of confidentiality

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.

Article 106

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.

(1) OJ 17, 6.10.1958, p. 385/58. Regulation as last amended by Council

Regulation (EC) No 920/2005 (OJ L 156, 18.6.2005, p. 3).

in agreement with the relevant
The Management Board may,
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 108

Contacts with stakeholder organisations

The Management Board shall, in agreement with the Commis-
sion, develop appropriate contacts between the Agency and rele-
vant stakeholder organisations.

Article 109

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
information
concerning the safety of substances on their own, in prepara-
tions or in articles which is not of a confidential nature.

technical

Article 110

Relations with relevant Community bodies

The Agency shall cooperate with other Community bodies
their

1.
in the accomplishment of
to ensure mutual support
respective tasks in particular to avoid duplication of work.

2.
The Executive Director, having consulted the Committee
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.

The Executive Director, having consulted the Committee
4.
on Risk Assessment,
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.

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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.

tion in order for it to be included in the inventory in accordance
with Article 114, unless submitted as part of the registration:

Article 111

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 accordance
with Article 12(1).

(a) the identity(ies) of the manufacturer(s), producer(s) of arti-
cles or importer(s) 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;

(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.

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.

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.

TITLE XI

The information listed in paragraph 1 shall be updated by

3.
the notifier(s) whenever:

CLASSIFICATION AND LABELLING INVENTORY

Article 112

Scope

This Title shall apply to:

(a) substances subject to registration;

(b) substances within the scope of Article 1 of Directive 67/
548/EEC, which meet
the criteria for classification as
dangerous in accordance with that Directive, and which are
placed on the market either on their own, or in a prepara-
tion above the concentration limits specified in Direc-
tive 1999/45/EC, where relevant, which results in the classi-
fication of the preparation as dangerous.

Article 113

Obligation to notify the Agency

(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 para-
graph 2.

Article 114

Classification and labelling inventory

1.
A classification and labelling inventory, listing the infor-
mation referred to in Article 113(1), both for information noti-
fied under Article 113(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 119(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).

1.
Any manufacturer, producer of articles or importer, or
group of manufacturers or producers of articles or importers,
who place on the market a substance within the scope of
Article 112, shall notify to the Agency the following informa-

The Agency shall update the inventory when it receives updated
information in accordance with Article 113(3).

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In addition to the information referred to in paragraph 1,
2.
the Agency shall record the following information, where appro-
priate, against each entry:

(a) whether, in respect of the entry, there is a harmonised classi-
fication 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 115

Harmonisation of classification and labelling

Harmonised classification and labelling at Community
1.
level shall, from 1 June 2007, 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 label-
ling in accordance with Annex XV.

The Committee for Risk Assessment

2.
shall adopt an
opinion on the proposal, giving parties concerned the opportu-
nity 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.

their respective territories, including sections on evaluation and
enforcement as described in Article 127.

The first report shall be submitted by 1 June 2010.

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 separately.

The first report shall be submitted by 1 June 2011.

in accordance with the
3.
Every three years the Agency,
objective of promoting non-animal
shall
testing methods,
submit to the Commission a report on the status of implemen-
tation and use of non-animal test methods and testing strategies
used to generate information on intrinsic properties and for risk
assessment to meet the requirements of this Regulation.

The first report shall be submitted by 1 June 2011.

Every five years, the Commission shall publish a general

4.
report on:

(a) the experience acquired with the operation of this Regu-
lation, including the information referred to in paragraphs 1,
2 and 3 and;

(b) the amount and distribution of funding made available by
the Commission for the development and evaluation of
alternative test methods.

The first report shall be published by 1 June 2012.

Article 116

Article 118

Transitional arrangements

Access to information

The obligations
1 December 2010.

set out

in Article 113 shall apply from

Regulation (EC) No 1049/2001 shall apply to documents

1.
held by the Agency.

TITLE XII

INFORMATION

Article 117

Reporting

2.
Disclosure of the following information shall normally be
deemed to undermine the protection of the commercial interests
of the concerned person:

(a) details of the full composition of a preparation;

(b) without prejudice to Article 7(6) and Article 64(2),

the
function or application of a substance or
precise use,
preparation, including information about its precise use as
an intermediate;

Every five years, Member States shall submit

to the
1.
Commission a report on the operation of this Regulation in

(c) the precise tonnage of the substance or preparation manu-

factured or placed on the market;

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(d) links between a manufacturer or importer and his distribu-

tors or downstream 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 paragraph.

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 registrant
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;

for

The Management Board shall adopt the practical arrange-
3.
implementing Regulation (EC) No 1049/2001,
ments
including appeals or remedies necessary for reviewing a partial
or full rejection of a confidentiality request, by 1 June 2008.

(b) the total tonnage band (i.e. 1 to 10 tonnes, 10 to 100
tonnes, 100 to 1 000 tonnes or over 1 000 tonnes) within
which a particular substance has been registered;

Decisions taken by the Agency pursuant to Article 8 of
4.
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.

(c) the study summaries or robust study summaries of

the

information referred to in paragraph 1(d) and (e);

(d) information, other than that listed in paragraph 1, contained

in the safety data sheet;

Article 119

Electronic public access

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 77(2)(e):

(a) the name in the IUPAC Nomenclature,

for dangerous
substances within the meaning of Directive 67/548/EEC,
without prejudice to paragraph 2(f) and (g);

(b) if applicable, the name of the substance as given in EINECS;

(c) the classification and labelling of the substance;

(d) physicochemical data concerning the substance and on

pathways and environmental fate;

(e) the result of each toxicological and ecotoxicological study;

(f) any derived no-effect level
concentration (PNEC)
Annex I;

(DNEL) or predicted no-effect
established in accordance with

(g) the guidance on safe use provided in accordance with

Sections 4 and 5 of Annex VI;

(h) 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 avail-
in accordance with
able,
Article 77(2)(e) except where a party submitting the information

free of charge, over

the Internet

(e) the trade name(s) of the substance;

(f) the name in the IUPAC Nomenclature for non-phase-in
substances which are dangerous within the meaning of
Directive 67/548/EEC for a period of six years;

(g) the name in the IUPAC Nomenclature for dangerous
substances within the meaning of Directive 67/548/EEC that
are only used as one or more of the following:

(i) as an intermediate;

(ii) in scientific research and development;

(iii) in product and process orientated research and develop-

ment.

Article 120

Cooperation with third countries and international organi-
sations

Notwithstanding Articles 118 and 119, information received by
the Agency under this Regulation may be disclosed to any
government or national authority of a third country or an inter-
national organisation in accordance with an agreement
concluded between the Community and the
third party
concerned under Regulation (EC) No 304/2003 of the European
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;

(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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(b) the third party protects the confidential

information as

mutually agreed.

TITLE XIII

COMPETENT AUTHORITIES

Article 121

Appointment

Member States shall appoint the competent authority or compe-
tent authorities responsible for performing the tasks allotted to
competent authorities under this Regulation and for cooperating
with the Commission and the Agency in the implementation of
this Regulation. Member States 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.

Article 122

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 123

Communication to the public of information on risks of
substances

The competent authorities of the Member States shall inform
the general public about the risks arising from substances where
this is considered necessary for the protection of human health
or the environment. The Agency, in consultation with compe-
tent authorities and stakeholders and drawing as appropriate on
relevant best practice, shall provide guidance for the communi-
cation of information on the risks and safe use of chemical
substances, on their own, in preparations or in articles, with a
view to coordinating Member States in these activities.

Article 124

Other responsibilities

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 particu-
lar whether enforcement or monitoring activities have identified
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 77(2)(g).

TITLE XIV

ENFORCEMENT

Article 125

Tasks of the Member States

Member States shall maintain a system of official controls and
other activities as appropriate to the circumstances.

Article 126

Penalties for non-compliance

Member States shall lay down the provisions on penalties applic-
able for infringement of the provisions of this Regulation and
shall take all measures necessary to ensure that they are imple-
mented. The penalties provided for must be effective, propor-
tionate and dissuasive. The Member States shall notify those
provisions to the Commission no later than 1 December 2008
and shall notify it without delay of any subsequent amendment
affecting them.

Article 127

Report

in relation to
The report referred to in Article 117(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 125 and 126 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 128

Free movement

Subject to paragraph 2, Member States shall not prohibit,
1.
restrict or impede the manufacturing,
import, placing on the
market or use of a substance, on its own, in a preparation or in
an article, falling within the scope of this Regulation, which
complies with this Regulation and, where appropriate, with
Community acts adopted in implementation of this Regulation.

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Nothing in this Regulation shall prevent Member States
2.
from maintaining or laying down national rules to protect
workers, human health and the environment applying in cases
where this Regulation does not harmonise the requirements on
manufacture, placing on the market or use.

Article 129

Safeguard clause

justifiable grounds

1. Where a Member State has
for
believing that urgent action is essential to protect human health
or the environment in respect of a substance, on its own, in a
preparation or in an article, even if satisfying the requirements
of this Regulation, it may take appropriate provisional measures.
The Member State shall immediately inform the Commission,
the Agency and the other Member States thereof, giving reasons
for its decision and submitting the scientific or technical infor-
mation on which the provisional measure is based.

The Commission shall take a decision in accordance with
2.
the procedure referred to in Article 133(3) within 60 days of
receipt of the information from the Member State. This decision
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 paragraph 2
(a), the provisional measure taken by the Member State consists
in a restriction on the placing on the market or use of a
substance, the Member State concerned shall
initiate a Com-
munity restrictions procedure by submitting to the Agency a
dossier, in accordance with Annex XV, within three months of
the date of the Commission decision.

In the case of a decision as referred to in paragraph 2(a),
4.
the Commission shall consider whether this Regulation needs to
be adapted.

Article 130

Statement of reasons for decisions

The competent authorities, the Agency and the Commission
shall state the reasons for all decisions they take under this
Regulation.

Article 131

Amendments to the Annexes

The Annexes may be amended in accordance with the proce-
dure referred to in Article 133(4).

Article 132

Implementing legislation

The measures necessary to put the provisions of this Regulation
efficiently into effect shall be adopted in accordance with the
procedure referred to in Article 133(3).

Article 133

Committee procedure

1.

The Commission shall be assisted by a Committee.

2. Where reference is made to this paragraph, Articles 3 and
7 of Decision 1999/468/EC shall apply, having regard to the
provisions of Article 8 thereof.

3. Where reference is made to this paragraph, Articles 5 and
7 of Decision 1999/468/EC shall apply, having regard to the
provisions of Article 8 thereof.

The period laid down in Article 5(6) of Decision 1999/468/EC
shall be set at three months.

4. Where reference is made to this paragraph, Article 5a(1)
to (4), and Article 7 of Decision 1999/468/EC shall apply,
having regard to the provisions of Article 8 thereof.

5.

The Committee shall adopt its Rules of Procedure.

Article 134

Preparation of establishment of the Agency

The Commission shall afford the necessary support

1.
towards the establishment of the Agency.

2.
For that purpose, until such time as the Executive Director
takes up his duties following his appointment by the Manage-
ment Board of the Agency in accordance with Article 84, the
Commission, on behalf of the Agency, and using the budget
provided for the latter, may:

(a) appoint personnel, including a person who shall fulfil the
administrative functions of the Executive Director on an
interim basis; and

(b) conclude other contracts.

Article 135

Transitional measures regarding notified substances

1.
The requests to notifiers to provide further information to
the competent authority in accordance with Article 16(2) of
Directive 67/548/EEC, shall be considered as decisions adopted
in accordance with Article 51 of this Regulation.

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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 accord-
ance with Article 52 of this Regulation.

Article 137

Transitional measures regarding restrictions

Such substance shall be regarded as being included in the Com-
munity rolling action plan in accordance with Article 44(2) of
this Regulation and shall be regarded as being chosen in accord-
ance with Article 45(2) of this Regulation by the Member State
whose competent authority has requested further information in
accordance with Article 7(2) and Article 16(1) of Directive 67/
548/EEC.

Article 136

Transitional measures regarding existing substances

1.
The requests to manufacturers and importers to submit
information to the Commission made by a Commission 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 52 of this Regulation.

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 46(3) and Article 48 of
this Regulation.

2.
The requests to manufacturers and importers to submit
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 52 of this Regulation. The Agency shall iden-
tify the competent authority for the substance to carry out the
tasks of Article 46(3) and Article 48 of this Regulation.

3.
A Member State whose rapporteur has not forwarded by
1 June 2008 the risk evaluation and, where appropriate, the
strategy for limiting the risks, in accordance with Article 10(3)
of Regulation (EEC) No 793/93, shall:

(a) document information on hazard and risk in accordance

with Annex XV, Part B of this Regulation;

(b) apply Article 69(4) of this Regulation on the basis of the

information referred to in point (a); and

(c) prepare a documentation of how it considers that any other
risks identified would need to be addressed by action other
than an amendment of Annex XVII of this Regulation.

By 1 June 2010,

1.
if necessary,
prepare a draft amendment to Annex XVII in accordance with
either of the following:

the Commission shall,

(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;

(b) any proposal, which has been submitted to the relevant
institutions but has not yet been adopted, concerning the
introduction or the amendment of restrictions under Direc-
tive 76/769/EEC.

Until 1 June 2010, any dossier referred to in Article 129
2.
(3) shall be submitted to the Commission. The Commission
shall, if necessary, prepare a draft amendment to Annex XVII.

3.
Any amendment to the restrictions adopted under Direc-
tive 76/769/EEC from 1 June 2007 shall be incorporated in
Annex XVII with effect from 1 June 2009.

Article 138

Review

1.
By 1 June 2019, 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
obligation because they are not subject to registration or subject
to registration but manufactured or imported in quantities of
less than 10 tonnes per year. However, for substances meeting
the criteria for classification as carcinogenic, mutagenic or toxic
for reproduction, category 1 or 2,
in accordance with Direc-
tive 67/548/EEC, the review shall be carried out by 1 June
2014. When carrying out the review the Commission shall take
into account all relevant factors, including:

(a) the costs for manufacturers and importers of drawing up

the chemical safety reports;

(b) the distribution of costs between actors in the supply chain

and the downstream user;

(c) the benefits for human health and the environment.

The information referred to above shall be submitted to the
Agency by 1 December 2008.

On the basis of these reviews, the Commission may, if appro-
priate, present legislative proposals to extend this obligation.

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The Commission may present legislative proposals as soon
2.
as a practicable and cost-efficient way of selecting polymers for
registration on the basis of sound technical and valid scientific
criteria can be established, and after publishing a report on the
following:

By 1 June 2019, the Commission shall carry out a review
8.
to assess whether or not to extend the scope of Article 33 to
cover other dangerous substances, taking into account the prac-
tical experience in implementing that Article. On the basis of
that review, the Commission may, if appropriate, present legisla-
tive proposals to extend that obligation.

(a) the risks posed by polymers in comparison with other

substances;

(b) the need, if any, to register certain types of polymer, taking
account of competitiveness and innovation on the one hand
and the protection of human health and the environment
on the other.

The report, referred to in Article 117(4), on the experience
3.
acquired with the operation of this Regulation shall include a
review of the requirements relating to registration of substances
manufactured or imported only in quantities starting at one
tonne but less than 10 tonnes per year per manufacturer or
importer. On the basis of that review, the Commission may
present legislative proposals to modify the information require-
ments for substances manufactured or imported in quantities of
one tonne or more up to 10 tonnes per year per manufacturer
or importer, taking into account the latest developments, for
example in relation to alternative testing and (quantitative) struc-
ture-activity relationships ((Q)SARs).

4.
The Commission shall carry out a review of Annexes I, IV
and V by 1 June 2008, with a view to proposing amendments,
if appropriate,
to them in accordance with the procedure
referred to in Article 131.

9.
In accordance with the objective of promoting non-animal
testing and the replacement, reduction or refinement of animal
testing required under this Regulation, the Commission shall
review the testing requirements of Section 8.7 of Annex VIII by
1 June 2019. On the basis of this review, while ensuring a high
level of protection of health and the environment, the Commis-
sion may propose an amendment in accordance with the proce-
dure referred to in Article 133(4).

Article 139

Repeals

Directive 91/155/EEC shall be repealed.

Directives 93/105/EC and 2000/21/EC and Regulations (EEC)
No 793/93 and (EC) No 1488/94 shall be repealed with effect
from 1 June 2008.

Directive 93/67/EEC shall be repealed with effect from 1 August
2008.

Directive 76/769/EEC shall be repealed with effect from 1 June
2009.

References to the repealed acts shall be construed as references
to this Regulation.

The Commission shall carry out a review of Annex XIII by
5.
1 December 2008, to assess the adequacy of the criteria for
identifying substances which are persistent, bioaccumulative and
toxic or very persistent and very bioaccumulative, with a view
to proposing an amendment to it, if appropriate, in accordance
with the procedure referred to in Article 133(4).

Article 140

Amendment of Directive 1999/45/EC

Article 14 of Directive 1999/45/EC shall be deleted.

6.
By 1 June 2012 the Commission shall carry out a review
to assess whether or not to amend the scope of this Regulation
to avoid overlaps with other relevant Community provisions.
On the basis of that review, the Commission may, if appropriate,
present a legislative proposal.

Article 141

Entry into force and application

7.
By 1 June 2013 the Commission shall carry out a review
to assess whether or not, taking into account latest develop-
ments in scientific knowledge, to extend the scope of Article 60
(3) to substances identified under Article 57(f) as having endo-
crine disrupting properties. On the basis of that review the
Commission may, if appropriate, present legislative proposals.

1.

This Regulation shall enter into force on 1 June 2007.

Titles II, III, V, VI, VII, XI and XII as well as Articles 128

2.
and 136 shall apply from 1 June 2008.

3.

4.

Article 135 shall apply from 1 August 2008.

Title VIII and Annex XVII shall apply from 1 June 2009.

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This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 18 December 2006.

For the European Parliament

The President

J. BORRELL FONTELLES

For the Council

The President

M. VANHANEN

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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 ONE TONNE OR MORE. . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . .

ANNEX VIII

STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR
IMPORTED IN QUANTITIES OF 10 TONNES OR MORE. . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . .

ANNEX IX

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

ANNEX X

STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR
IMPORTED IN QUANTITIES OF 1 000 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 . . . . . . . . . . . . .

72

84

93

94

98

99

103

107

111

116

119

122

124

ANNEX XIV

LIST OF SUBSTANCES SUBJECT TO AUTHORISATION . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . .

125

ANNEX XV

DOSSIERS . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . .. . . . . . .

126

ANNEX XVI

SOCIO-ECONOMIC ANALYSIS. . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . .

128

ANNEX XVII RESTRICTIONS ON THE MANUFACTURE, PLACING ON THE MARKET AND USE OF CERTAIN
DANGEROUS SUBSTANCES, PREPARATIONS AND ARTICLES . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . ..

129

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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. This Annex shall
also apply adapted as necessary to producers and importers of articles required to make a chemical safety assess-
ment as part of a registration.

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 assess-
ment 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 sufficient
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 ‘cate-
gory’ 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-characterised
risk may also be sufficient to control other potential risks, which will not therefore need to be characterised
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 recommended
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, exposures
of humans and the environment. These sets of conditions contain a description of both the risk management
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. Expo-
sure 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, irritation
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 Regulation as speci-
fied in Article 13(3). 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, distinguishing
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 interna-
tionally 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, relevance 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 demonstrating 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:
However, if human information is available, it shall be presented, if possible in the form of a table.

‘No human information is available’.

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 expo-
sure 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 environ-
ment) 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 established 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 expo-

sure 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 duration,
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 is more than
one study 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 assessment
factor expresses the difference between effects values derived for a limited number of species from laboratory 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 expo-
sure 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 derogation 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 manu-
facturer 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/concen-
tration 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 demon-
strate adequate control. The refinement of hazard assessment may require generation of additional hazard informa-
tion. 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
(1) emission estimation;
annex to the safety data sheet. The exposure estimation entails three elements:
(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 manufacture
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 properties 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 environmental 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 (including 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 (including 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 clas-
sified 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 protec-
tion 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, propor-
tionate 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 dero-
gations.

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 Direc-
tive 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 actually
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 Community,
whether it is the manufacturer, importer or distributor. Give the full address and telephone number of this 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 preparation
presents to man and the environment.

Distinguish clearly between preparations which are classified as dangerous and preparations which are not classified
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 label-
ling inventory according to Title XI.

3.

COMPOSITION/INFORMATION ON INGREDIENTS

3.1.

3.2.

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.

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 indi-
cated, 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 accord-
ance 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 indicated,
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.

The classification (derived either from Articles 4 and 6 of Directive 67/548/EEC, from Annex I 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 relevant 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’.

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.

3.4.

3.5.

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.), reduction

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 Direc-
tive 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 organi-

sational 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 approximation
of the laws of the Member States relating to personal protective equipment (1) and make reference to the appro-
priate CEN standards:

(a) R e s p i r a t o r y p r o te 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 te 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 ti 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), conduc-
tivity, 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 equipment and
protective systems intended for use in potentially explosive atmospheres (1)), auto-ignition temperature, etc.

Note 1

The above properties shall be determined in accordance with the specifications laid down in the Commission Regu-
lation on testing methods referred to in Article 13(3) 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 available
to the classifier, and cases where negative test results are available. If it is considered necessary to give information
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 appropriate,
delayed, immediate and chronic effects from short- and long-term exposure such as sensitisation, narcosis, carcino-
genicity, mutagenicity and reproductive toxicity (developmental toxicity and fertility). It shall also include informa-
tion 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 avail-
able data with the criteria given in Directive 67/548/EEC for CMR, categories 1 and 2, following paragraph 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 rele-
vant organisms, such as birds, bees and plants, shall be included when available. Where the substance or prepara-
tion 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 preparation ( 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, even-
tually, to pass through the food chain, with reference to the octanol-water partition coefficient (Kow) and biocon-
centration 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 appro-
priate, 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 packaging
(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

Indicate if a Chemical Safety Assessment has been carried out for the substance (or a substance in the preparation).

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 incorpo-

rated 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
consists primarily of calcium carbonate

sedimentary rock.

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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L 136/95

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

It consists
Extractives and their physically modified derivatives.
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

Extractives and their physically modified derivatives.
It consists
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.
It consists
primarily of the glycerides of the fatty acids erucic, linoleic and oleic
(Brassica napus, Cruciferae).

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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29.5.2007

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 No: 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 No: 19-005-00.

67701-03-5

266-929-0

Fatty acids, C8-18 and C18-unsaturated
This substance is identified by SDA Substance Name: C8-C18 and C18
unsaturated alkyl carboxylic acid and SDA Reporting No: 01-005-00.

67701-05-7

266-930-6

Fatty acids, C14-18 and C16-18-unsaturated
This substance is identified by SDA Substance Name: C14-C18 and
C16-C18 unsaturated alkyl carboxylic acid and SDA Reporting No: 04-
005-00.

67701-06-8

266-932-7

Fatty acids, C16-C18 and C18-unsaturated
This substance is identified by SDA Substance Name: C16-C18 and C18
unsaturated alkyl carboxylic acid and SDA Reporting No: 11-005-00.

67701-08-0

266-948-4

Glycerides, C16-18 and C18-unsaturated
This substance is identified by SDA Substance Name: C16-C18 and C18
unsaturated trialkyl glyceride and SDA Reporting No: 11-001-00.

67701-30-8

267-007-0

Fatty acids, C14-18 and C16-18-unsaturated., Me esters
This substance is identified by SDA Substance Name: C14-C18 and
C16-C18 unsaturated alkyl carboxylic acid methyl ester and SDA Reporting
No: 04-010-00.

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 No: 13-005-00.

67762-36-1

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L 136/97

EINECS No

268-099-5

Name/group

Fatty acids, C14-22 and C16-22 unsaturated
This substance is identified by SDA Substance Name: C14-C22 and
C16-C22 unsaturated alkyl carboxylic acid and SDA Reporting No: 07-
005-00.

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-unsaturated. 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 No: 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-unsaturated

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

L 136/98

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29.5.2007

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 articles

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 inhibitor,
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, 40, 41 and 46. 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 registration
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 literature
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 redu-
cing 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, epidemiological 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 addition
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 justifica-
tion.

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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 a lead registrant on behalf of other
registrants.

In this case, the lead registrant shall identify the other registrants specifying:

— their name, address, telephone number, fax number and e-mail address,

— parts of the present registration which apply to other registrants.

Mention the number(s) given in this Annex or Annexes VII to X, as appropriate.

Any other registrant shall identify the lead registrant submitting on his behalf specifying:

— his name, address, telephone number, fax number and e-mail address,

— parts of the registration which are submitted by the lead registrant.

Mention the number(s) given in this Annex or Annexes VII to X, as appropriate.

1.3

Third party appointed under Article 4

1.3.1. Name, address, telephone number, fax number and e-mail address

1.3.2. Contact person

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 suffi-
cient to allow the methods to be reproduced.

3.

INFORMATION ON MANUFACTURE AND USE(S) OF THE SUBSTANCE(S)

3.1. Overall manufacture, quantities used for production of an article that is subject to registration, and/or imports in

tonnes per registrant per year in:

the calendar year of the registration (estimated quantity)

3.2.

In the case of a manufacturer or producer of articles: brief description of the technological process used in manu-
facture or production of articles.

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 down-
stream 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 manufacture of the substance, the use in
articles 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 recom-
mendations 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).

The resulting hazard label for the substance(s), resulting from the application of Articles 23, 24 and 25 of Directive
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.

4.2.

4.3.

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)

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5.8. Disposal considerations

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 ONE TONNE OR MORE (1)

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 adap-
tation 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 (2).

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) This Annex shall apply to producers of articles that are required to register in accordance with Article 7 and to other downstream users that

are required to carry out tests under this Regulation adapted as necessary.

(2) Note: 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(3) 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 recognised
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’
method shall be performed.

in water, a limit test up to the detection limit of the analytical

7.8.

Partition
octanol/water

coefficient

n-

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 concen-

tration 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 granular
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 shall comprise the
following consecutive steps:
the
(1) an assessment of
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 shall comprise the
following consecutive steps:
the
(1) an assessment of
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 shall comprise the
following consecutive steps:
the
(1) an assessment of
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.

In vitro gene mutation study
in bacteria

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 available.

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 registrant may consider
long-term toxicity testing
instead of short-term.

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. Growth
aquatic
preferred)

inhibition
plants

study
(algae

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

STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN
QUANTITIES OF 10 TONNES OR MORE (1)

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 (2).

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 or in
vitro micronucleus study

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) This Annex shall apply to producers of articles that are required to register in accordance with Article 7 and to other downstream users that

are required to carry out tests under this Regulation adapted as necessary.

(2) Note: 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(3) that are not repeated in column 2, also apply.

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COLUMN 1
STANDARD INFORMATION
REQUIRED

8.4.3.

In vitro gene mutation study
if a
in mammalian cells,
negative result in Annex VII,
Section
and
Annex VIII, Section 8.4.2.

8.4.1.

COLUMN 2
SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1

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 absorption

through the skin.

8.6.

Repeated dose toxicity

8.6.1.

Short-term repeated dose
toxicity study (28 days),
one
and
species, male
appropriate
female, most
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 absorption

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;

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COLUMN 1
STANDARD INFORMATION
REQUIRED

COLUMN 2
SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1

and one of the following conditions is met:

— 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 40 or 41 in case of:

— failure to identify a NOAEL in the 28 or the 90 days study, unless the reason for the failure to iden-

tify 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 (Annex IX, 8.7.2) or a two-generation reproductive toxicity

study (Annex IX, Section 8.7.3) 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.

Screening for reproductive/
developmental toxicity, one
species
(OECD 421 or
422), if there is no evidence
from available information
related
on
substances,
from (Q)SAR
estimates or from in vitro
methods that the substance
may be a developmental
toxicant

structurally

8.8.

Toxicokinetics

behaviour

8.8.1. Assessment of the toxicoki-
the
netic
substance to the extent that
can be derived from the
relevant available informa-
tion

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
testing instead of
short-
term.

9.1.4. Activated sludge respiration
inhibition testing

9.1.4.

9.2.

Degradation

9.2.

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

— 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

STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN
QUANTITIES OF 100 TONNES OR MORE (1)

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 (2).

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,
column 2 of this Annex or in Annex XI, this fact and the reasons shall also be clearly stated.

it is proposed not to provide information for other reasons than those mentioned in

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) This Annex shall apply to producers of articles that are required to register in accordance with Article 7 and to other downstream users that

are required to carry out tests under this Regulation adapted as necessary.

(2) Note: 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(3) 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),
one
and
species, male
female, most
appropriate
administration,
route
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 admin-

istration 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 40 or 41 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 Regulation
on test methods as speci-
fied in Article 13(3) 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

reproduc-
Two-generation
study,
toxicity
tive
and
one
species, male
appropriate
female, most
route
administration,
having regard to the likely
route of human exposure, if
the 28-day or 90-day study
indicates adverse effects on
reproductive
or
tissues.

organs

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-
mate degradation in 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 adsorption 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
in
study
the
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 on soil micro-organ-
isms

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

STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN
QUANTITIES OF 1 000 TONNES OR MORE (1)

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 physicochem-
ical, 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 (2).

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,
column 2 of this Annex or in Annex XI, this fact and the reasons shall also be clearly stated.

it is proposed not to provide information for other reasons than those mentioned in

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 considered.

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 40 or 41 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) This Annex shall apply to producers of articles that are required to register in accordance with Article 7 and to other downstream users that

are required to carry out tests under this Regulation adapted as necessary.

(2) Note: 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(3) 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 40 or 41 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 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 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 available),
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 considered.

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
administration,
having regard to the likely
route of human exposure
(OECD 414).

of

and

8.7.3. Two-generation reproductive
toxicity study, one species,
male
female, most
appropriate route of adminis-
tration, having regard to the
likely route of human expo-
sure, unless already provided
as part of Annex IX require-
ments

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 40 or 41 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/or
degradation products

9.3.4. Further testing shall be proposed by the registrant or may be required by the Agency in accordance with
Articles 40 or 41 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 unli-
kely.

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:

— one 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 dossier evaluation the Agency 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(3)

Data shall be considered to be equivalent to data generated by the corresponding test methods referred to in
Article 13(3) 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(3)

Data shall be considered to be equivalent to data generated by the corresponding test methods referred to in
Article 13(3) 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(3);

(3) exposure duration comparable to or longer than the corresponding test methods referred to in Article 13(3) 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 predict-
ability 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 assump-
tion/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(3) 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 indicate
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 infor-
mation foreseen in Annexes VII or VIII or proposed confirmation requiring testing beyond the information fore-
seen 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 rele-
vant 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. Appli-
cation of the group concept requires that physicochemical properties, human health effects and environmental
effects or environmental fate may be predicted from data for reference substance(s) within the group by interpola-
tion to other substances in the group (read-across approach). This avoids the need to test every substance for every
endpoint. The Agency, after consulting with relevant stakeholders and other interested parties, shall issue guidance
on technically and scientifically justified methodology for the grouping of substances sufficiently in advance of the
first registration deadline for phase-in substances.

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(3),

— cover an exposure duration comparable to or longer than the corresponding test method referred to in

Article 13(3) 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(3),
more specifically on the technical limitations of a specific method, shall always be respected.

3.

3.1.

3.2.

3.3.

SUBSTANCE-TAILORED EXPOSURE-DRIVEN TESTING

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 expo-
sure 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.

The Commission shall adopt the measures designed to amend non-essential elements of this Regulation by supple-
menting it, in accordance with the procedure referred to in Article 133(4), to set the criteria defining what consti-
tutes adequate justification under Section 3.2 by 1 December 2008.

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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 identified uses further
down the supply chain. The assessment shall consider the use of the substance on its own, in a preparation 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 Regu-
lation. 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 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 rele-
vant 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 neces-
sary for producing his Chemical Safety Report the downstream user shall gather this information. Where this information
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 38. 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 information
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 59

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 57(a), (b) or (c), a PBT according to Article 57(d), a vPvB according to Article 57(e), or a substance
of equivalent concern according to Article 57(f).

Justification

A comparison of the available information with the criteria in Annex XIII for PBT according to Article 57(d), and
vPvBs according to Article 57(e), or an assessment of the hazards and a comparison with Article 57(f), according to
the relevant parts of Sections 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.

L 136/128

EN

Official Journal of the European Union

29.5.2007

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 62(5)(a), or in connection with a proposed restriction, as specified in
Article 69(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 111.

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 develop-
ment,
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,

innovation, one-off and operating costs (e.g. compliance,

— 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,

— 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.

29.5.2007

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Official Journal of the European Union

L 136/129

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.

Shall not be used. However,

the following use of
1.
installations and fluids which were in service
equipment,
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.

2.
The Member State may, for reasons of protection of
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.

The placing on the second-hand market of equipment,
3.
plant and fluids covered by paragraph 1 which are not
intended for disposal shall be prohibited.

is not
4. Where the Member State considers that
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 conditions of
maintenance of equipment,
the level of
liquids containing PCTs in properly functioning existing
installations purchased before 1 October 1985.

to supplement

it

5.
The Member State may, provided prior notification
stating the reasons is sent to the Commission, grant deroga-
tions from the ban on the placing on the market and use
of primary and intermediate substances or preparations, in
so far as they consider that these derogations have no dele-
terious effects on human health and the environment.

to the

6. Without prejudice to the implementation of other
Community provisions
labelling of
relating
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 understood
in the territory where it is being used.

L 136/130

EN

Official Journal of the European Union

29.5.2007

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.

4. Tris (2,3 dibromopropyl) phosphate

CAS No 126-72-7

5. Benzene

CAS No 71-43-2
EINECS No 200-753-785

1.

Shall not be used in:

— ornamental objects, intended to produce light or colour
effects by means of different phases, for example in
ornamental lamps and ashtrays,

— 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, the packaging of substances and preparations covered
by paragraph 2, where intended for use in lamps, must be
marked legibly and indelibly as follows:

‘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.

Not permitted in toys or parts of toys as placed on
1.
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 Direc-
tive 2006/12/EC.

29.5.2007

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Official Journal of the European Union

L 136/131

Designation of the substance, of the groups of substances or of
the preparation

Conditions of restriction

1.
The placing on the market and use of these fibres 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
their service life, or until suitable asbestos-free
end of
substitutes become available, whichever is the sooner. The
Commission will review this derogation before 1 January
2008.

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
the
labelling of dangerous substances and preparations,
placing on the market and use of these fibres and of articles
containing these fibres, as permitted according to the
preceding derogations, shall be permitted only if the articles
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 bombs

2.
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

roots of Helleborus

viridis

and

roots of Veratrum album and

the

the

Powder of
Helleborus niger
Powder of
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

L 136/132

EN

Official Journal of the European Union

29.5.2007

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.

However, this provision shall not 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 2 Pb CO3-Pb

(OH)2
CAS No 1319-46-6
EINECS No 215-290-6

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

29.5.2007

EN

Official Journal of the European Union

L 136/133

Designation of the substance, of the groups of substances or of
the preparation

Conditions of restriction

18. Mercury compounds

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 equip-

ment;

(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 equip-

ment;

(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 inorganic
compounds of
the copper, chromium, arsenic
(CCA) type C. Wood so treated shall not be placed
on the market before fixation of the preservative is
completed.

(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:

L 136/134

EN

Official Journal of the European Union

29.5.2007

Designation of the substance, of the groups of substances or of
the preparation

Conditions of restriction

— as structural timber in public and agricultural
industrial

buildings,

and

buildings, office
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 Com-
munity provisions on the classification, packaging
and labelling of dangerous substances and prepara-
tions, all treated wood placed on the market shall
be individually labelled ‘For professional and indus-
trial 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.

29.5.2007

EN

Official Journal of the European Union

L 136/135

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

1.
for use as
substances and constituents of preparations when acting as
biocides in free association paint.

2.
Shall not be placed on the market or used as
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 arti-
cles, 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 pentachlorophenol (PCP)
in quantities greater than those prescribed by existing legis-
lation:
(a) in the treatment of wood.

However, treated wood shall not be used:

— inside buildings whether for decorative purposes or
their purpose (residence, employ-

not, whatever
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, intermediate or finished products
destined for human and/or animal consump-
tion;

(iii) other materials

that may contaminate the

products mentioned in (i) and (ii);

L 136/136

EN

Official Journal of the European Union

29.5.2007

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 hexachlorodibenzo-
paradioxin (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
Community provisions concerning the classification, packa-
ging and labelling of dangerous substances and prepara-
tions, the packaging of substances and preparations covered
by paragraphs 1 and 2 shall be marked clearly and indel-
ibly:

‘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 production
of coloured masterbatch [3901 10] (3),

— cellulose acetate (CA) [3912 11] [3912 12] (3),
— cellulose acetate butyrate (CAB) [3912 11] [3912

12] (3),

— epoxy resins [3907 30] (3),
— melamine — formaldehyde (MF) resins [3909 20]

(3),

— 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);

23. Cadmium

CAS No 7440-43-9
EINECS No 231-152-8
and its compounds

29.5.2007

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Official Journal of the European Union

L 136/137

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 be

2.
coloured for safety reasons.

3.
Shall not be used to stabilise the finished articles
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 furniture, coachwork or the like [3926 30]

(3),

— articles of apparel and clothing accessories (including

gloves) [3926 20] (3),

— floor and wall coverings [3918 10] (3),

— impregnated,

coated,
fabrics [5903 10] (3),

covered or

laminated textile

— 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
industry (3),

steel

sheet used in construction or

in

— 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.

However, paragraph 3 does not apply to finished arti-

4.
cles using cadmium-based stabilisers for safety reasons.

L 136/138

EN

Official Journal of the European Union

29.5.2007

Designation of the substance, of the groups of substances or of
the preparation

Conditions of restriction

5. Within the meaning of
‘cadmium
plating’ means any deposit or coating of metallic cadmium
on a metallic surface.

this Regulation,

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]
[8421 22]

[8421 11]
[8438] [8476 11] (3),

[8417 20]
[8422]

[8435]

[8419 81]
[8437]

— 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/applications
listed in points (a) and (b) above and of articles manufac-
tured in the sectors listed in point
(b) above shall be
prohibited.

The provisions referred to in paragraph 5 are also
6.
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

[8425]
[8431] (3),

[8426]

equipment
[8428]

[8427]

and machinery
[8430]
[8429]

— road and agricultural vehicles [chapter 87] (3),
— rolling stock [chapter 86] (3),
— vessels [chapter 89] (3).

29.5.2007

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Official Journal of the European Union

L 136/139

Designation of the substance, of the groups of substances or of
the preparation

Conditions of restriction

However, the restrictions in paragraphs 5 and 6 do

7.
not apply to:

— articles and components of the articles used in the aero-
nautical,
and nuclear
aerospace, mining, offshore
sectors whose applications require high safety standards
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 Article 133(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.

24. Monomethyl — tetrachlorodiphenyl methane

Trade name: Ugilec 141
CAS No 76253-60-6

However, Member States may, on grounds of human
health
protection,
prohibit within their territory the use of such plant or
machinery before it is disposed of;

environmental

protection

and

(b) in the case of the maintenance of plant and machinery
already in service within a Member State on 18 June
1994.

The placing on the second-hand market of

this
3.
substance and
substance, preparations containing this
plant/machinery containing this substance, shall be prohib-
ited.

The placing on the market and use of this substance and of
preparations and articles containing it shall be prohibited.

25. Monomethyl-dichloro-diphenyl methane
Trade name: Ugilec 121, Ugilec 21;
CAS No — unknown

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 prohibited.

27. Nickel

CAS No 7440-02-0
EINECS No 231-111-4
and its compounds

1.

Shall not be used:

(a) in all post assemblies which are inserted into pierced
ears and other pierced parts of the human body unless
the rate of nickel release from such post assemblies is
less than 0,2 μg/cm2/week (migration limit);

(b) in articles intended to come into direct and prolonged

contact with the skin such as:

— earrings,

— necklaces, bracelets and chains, anklets, finger rings,

L 136/140

EN

Official Journal of the European Union

29.5.2007

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.

Without prejudice to the other parts of this Annex the
following shall apply to entries 28 to 30:

1.
Shall not be used in substances and preparations
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

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’.

2.
By way of derogation, paragraph 1 shall not apply to:
(a) medicinal or veterinary products as defined by Directive

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.

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
‘May cause cancer’ or risk
(T)’ with risk phrase R 45:
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.

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.

30. Substances which appear

in Annex I

to Directive
67/548/EEC classified as toxic to reproduction cate-
toxic to reproduction category 2 and
gory 1 or
labelled with risk phrase R60:
‘May impair fertility’
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.

29.5.2007

EN

Official Journal of the European Union

L 136/141

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

(c) distillates (coal tar), naphthalene oils; naphthalene

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

1.
Shall not be used as substances or in preparations in
the treatment of wood. Furthermore, wood so treated shall
not be placed on the market.

2.

However by way of derogation:

(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 treat-
ment 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, e.
g. on railways, in electric power transmission and tele-
communications, for fencing, for agricultural purposes
(e.g. stakes for tree support) and in harbours and water-
ways;

(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 2

3.
(b) and (c) shall not be used:

— inside buildings, whatever their purpose,

— in toys,

L 136/142

EN

Official Journal of the European Union

29.5.2007

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
materials, intermediate or finished products destined
for human and/or animal consumption,

— 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 Directive

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
market for the general public for entertainment and decora-
tive purposes such as the following:

— metallic glitter intended mainly for decoration,

— artificial snow and frost,

— ‘whoopee’ cushions,

— silly string aerosols,

29.5.2007

EN

Official Journal of the European Union

L 136/143

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).

4.
The articles referred to in paragraphs 1 and 2 shall
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, chloro (short-chain chlorinated paraf-

fins) (SCCPs)
EINECS No 287-476-5

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.

Azodyes which, by reductive cleavage of one or more
1.
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 methods listed in
Appendix 10, shall not be used in textile and leather arti-
cles 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,

L 136/144

EN

Official Journal of the European Union

29.5.2007

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.

2.
Furthermore, the textile and leather articles referred
to in paragraph 1 above shall not be placed on the market
unless they conform to the requirements set out in that
paragraph.

3.
Azodyes, which are contained in Appendix 9, ‘List of
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.

1.
Shall not be placed on the market or used as a
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.

29.5.2007

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L 136/145

Designation of the substance, of the groups of substances or of
the preparation

Conditions of restriction

47. Cement

48. Toluene

CAS No 108-88-3

49. Trichlorobenzene
CAS No 120-82-1

50. Polycyclic-aromatic hydrocarbons (PAH)

1. Benzo(a)pyrene (BaP)
CAS No 50-32-8
2. Benzo(e)pyrene (BeP)
CAS No 192-97-2

3. Benzo(a)anthracene (BaA)

CAS No 56-55-3

4. Chrysen (CHR)

CAS No 218-01-9

5. Benzo(b)fluoranthene (BbFA)

CAS No 205-99-2

6. Benzo(j)fluoranthene (BjFA)

CAS No 205-82-3

7. Benzo(k)fluoranthene (BkFA)

CAS No 207-08-9

8. Dibenzo(a, h)anthracene (DBAhA)

CAS No 53-70-3

Cement and cement-containing preparations shall not
1.
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.

2.
If reducing agents are used, then without prejudice to
the application of other Community provisions on the clas-
sification, packaging and labelling of dangerous substances
the packaging of cement or cement-
and preparations,
containing preparations
shall be legibly and indelibly
marked with information on the packing date, as well as on
the storage conditions and the storage period appropriate
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.

Shall not be placed on the market or used as a substance or
constituent of preparations in a concentration equal to or
higher than 0,1 % by mass in adhesives and spray paints
intended for sale to the general public.

Member States shall apply these measures from 15 June
2007.

Shall not be placed on the market or used as a substance or
constituent of preparations in a concentration equal to or
higher than 0,1 % by mass for all uses except:

— as an intermediate of synthesis, or
— as a process solvent in closed chemical applications for

chlorination reactions, or

— in the manufacture of 1,3,5 — trinitro — 2,4,6 — tria-

minobenzene (TATB).

Member States shall apply these measures from 15 June
2007.

1.
Extender oils shall not be placed on the market and
used for the production of tyres or parts of tyres, if they
contain:

— more than 1 mg/kg BaP, or

— more than 10 mg/kg of the sum of all listed PAHs.
These limits are regarded as kept, if the polycyclic aromatics
(PCA) extract is less than 3 % by mass, as measured by the
Institute of Petroleum standard IP346: 1998 (Determin-
ation of PCA in unused lubricating base oils and asphaltene
free petroleum fractions — Dimethyl sulphoxide extraction
refractive index method), provided that compliance with
the limit values of BaP and of the listed PAHs, as well as
the correlation of
the measured values with the PCA
extract, is controlled by the manufacturer or importer every
six months or after each major operational change, which-
ever is earlier.

L 136/146

EN

Official Journal of the European Union

29.5.2007

Designation of the substance, of the groups of substances or of
the preparation

Conditions of restriction

Furthermore,

the tyres and treads

2.
retreading
manufactured after 1 January 2010 may not be placed on
the market if they contain extender oils exceeding the limits
indicated in paragraph 1.

for

These limits are regarded as kept, if the vulcanised rubber
compounds do not exceed the limit of 0,35 % Bay protons
as measured and calculated by ISO 21461 (Rubber vulca-
nised — Determination of aromaticity of oil in vulcanised
rubber compounds).
3.
By way of derogation, paragraph 2 shall not apply to
retreaded tyres if their tread does not contain extender oils
exceeding the limits referred to in paragraph 1.

4. Member States
1 January 2010.

shall apply these measures

from

Shall not be used as substances or as constituents of
preparations, at concentrations higher than 0,1 % by mass
of the plasticised material, in toys and childcare articles (5).

Toys and childcare articles containing these phthalates in a
concentration higher than 0,1 % by mass of the plasticised
material shall not be placed on the market.

The Commission shall re-evaluate, by 16 January 2010, the
measures provided for in relation to this point in the light
of new scientific information on such substances and their
substitutes, and if justified, these measures shall be modified
accordingly.

Shall not be used as substances or as constituents of
preparations, at concentrations higher than 0,1 % by mass
of the plasticised material, in toys and childcare articles (5)
which can be placed in the mouth by children.

Toys and childcare articles containing these phthalates in a
concentration higher than 0,1 % by mass of the plasticised
material shall not be placed on the market.

The Commission shall re-evaluate, by 16 January 2010, the
measures provided for in relation to this point in the light
of new scientific information on such substances and their
substitutes, and if justified, these measures shall be modified
accordingly.

51. The following phthalates (or other CAS- and EINECS

numbers covering the substance):
bis (2-ethylhexyl) phthalate (DEHP)

CAS No 117-81-7

Einecs No 204-211-0

dibutyl phthalate (DBP)

CAS No 84-74-2

Einecs No 201-557-4

benzyl butyl phthalate (BBP)

CAS No 85-68-7

Einecs No 201-622-7

52. The following phthalates (or other CAS- and EINECS

numbers covering the substance):
di-‘isononyl’ phthalate (DINP)

CAS No 28553-12-0 and 68515-48-0

Einecs No 249-079-5 and 271-090-9

di-‘isodecyl’ phthalate (DIDP)

CAS No 26761-40-0 and 68515-49-1

Einecs No 247-977-1 and 271-091-4

di-n-octyl phthalate (DNOP)

CAS No 117-84-0

Einecs No 204-214-7

(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 426/2006 (OJ L 79, 16.3.2006, p. 1).
(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).
(5) For the purposes of this point ‘childcare article’ shall mean any product intended to facilitate sleep, relaxation, hygiene, the feeding of

children or sucking on the part of children.

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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 the following:

Note A:

The name of the substance must appear on the label in the form of one of the designations given in Annex I to Directive
67/548/EEC (see Article 23(2)(a) of that Directive).

In Annex I to Directive 67/548/EEC, use is sometimes made of a general description such as ‘… compounds’ or ‘… salts’.
In this case, the manufacturer or any other person who places such a substance on the market is required to state on the
label the correct name, due account being taken of the Chapter entitled ‘Nomenclature’ of the Foreword to that Annex.

Directive 67/548/EEC also requires that the symbols, indications of danger, R- and S-phrases to be used for each substance
shall be those shown in Annex I to that Directive (Article 23(2)(c), (d) and (e) of that Directive).

For substances belonging to one particular group of substances included in Annex I to Directive 67/548/EEC, the
symbols, indications of danger, R- and S-phrases to be used for each substance shall be those shown in the appropriate
entry in that Annex.

For substances belonging to more than one group of substances included in Annex I to Directive 67/548/EEC, the
symbols, indications of danger, R- and S-phrases to be used for each substance shall be those shown in both the appro-
priate entries given in that Annex. In cases where two different classifications are given in the two entries for the same
hazard, the classification reflecting the more severe hazard classification shall be used.

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’.

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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 classified
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 H:

The classification and label shown for this substance applies to the dangerous property(ies) indicated by the risk phrase(s)
in combination with the category(ies) of danger shown. The requirements of Article 6 of Directive 67/548/EEC on manu-
facturers, distributors, and importers of this substance apply to all other aspects of classification and labelling. The final
label shall follow the requirements of section 7 of Annex VI to Directive 67/548/EEC.

This note applies to certain coal- and oil-derived substances and to certain entries for groups of substances in Annex I to
Directive 67/548/EEC.

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 or mutagen 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). If the substance is not classified as a carcinogen or mutagen, at least
the S-phrases (2-)9-16 should apply. This note applies to certain complex oil-derived substances in Annex I to Directive
67/548/EC

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 of Directive 67/548/EEC (see section 8 of Annex VI of
that Directive).

29.5.2007

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Official Journal of the European Union

L 136/149

Appendix 1

Point 28 — Carcinogens: category 1

Substances

Index No

EC No

CAS No

Notes

Chromium (VI) trioxide

024-001-00-0

215-607-8

1333-82-0

E

Zinc chromates including zinc potassium chromate

024-007-00-3

Nickel monoxide

Nickel dioxide

Dinickel trioxide

Nickel sulphide

Nickel subsulphide

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

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

Lead hydrogen arsenate

033-005-00-1

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

Benzene

Triethyl arsenate

601-020-00-8

200-753-7

71-43-2

601-067-00-4

427-700-2

15606-95-8

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

D

E

E

E

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 thiophene.)

L 136/150

EN

Official Journal of the European Union

29.5.2007

Substances

Index No

EC No

CAS No

Notes

Tar, coal, high-temperature; Coal tar

648-082-00-2

266-024-0

65996-89-6

(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. 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-temperature; Coal oil

648-083-00-8

266-025-6

65996-90-9

(The condensation product obtained by cooling, to approximately ambient
the gas evolved in low temperature (less than 700 °C)
temperature,
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 hydrocarbons, their alkyl deri-
vates, heteroaromatics and one- and two-ring phenols boiling in the range
of approximately 150 °C to 360 °C.)

Tar, brown-coal, low temperature;

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), light paraffinic; Unrefined or mildly refined base oil

649-050-00-0

265-051-5

64741-50-0

(A complex combination of hydrocarbons produced by vacuum distillation
of the residuum from atmospheric distillation 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 satu-
rated 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 distillation 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 satu-
rated 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 distillation 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

29.5.2007

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Official Journal of the European Union

L 136/151

Substances

Index No

EC No

CAS No

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 distillation 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; Unrefined or mildly
refined base oil

(A complex combination of hydrocarbons obtained as a raffinate from a
sulfuric acid treating 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), acid-treated light naphthenic; Unrefined or mildly
refined base oil

(A complex combination of hydrocarbons obtained as a raffinate from a
sulfuric acid treating 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.)

Distillates (petroleum), acid-treated heavy paraffinic; Unrefined or mildly
refined base oil

(A complex combination of hydrocarbons obtained as a raffinate from a
sulfuric acid process. It consists predominantly of saturated 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.)

Distillates (petroleum), acid-treated light paraffinic; Unrefined or mildly
refined base oil

(A complex combination of hydrocarbons obtained as a raffinate from a
sulfuric acid treating 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.)

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 predominantly of hydrocar-
bons 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 aliphatic hydrocarbons.)

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

L 136/152

EN

Official Journal of the European Union

29.5.2007

Substances

Index No

EC No

CAS No

Notes

Distillates (petroleum), chemically neutralised heavy 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 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.)

649-060-00-5

265-135-1

64742-34-3

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
relatively few normal paraffins.)

649-061-00-0

265-136-7

64742-35-4

(petroleum), catalytic cracked naphtha depropaniser overhead,

Gases
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

H, K

Gases (petroleum), catalytic cracker; Petroleum gas

649-063-00-1

270-756-6

68477-74-7

H, 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.)

649-064-00-7

270-757-1

68477-75-8

H, K

Gases (petroleum), catalytic polymd. naphtha stabiliser overhead, C2-4-rich;
Petroleum gas

(A complex combination of hydrocarbons obtained from the fractionation
stabilisation of catalytic polymerised naphtha.
It consists of aliphatic
hydrocarbons having carbon numbers in the range of C2 through C6,
predominantly C2 through C4.)

649-065-00-2

270-758-7

68477-76-9

H, K

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.)

649-066-00-8

270-760-8

68477-79-2

H, K

29.5.2007

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Official Journal of the European Union

L 136/153

Substances

Index No

EC No

CAS No

Notes

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.)

649-067-00-3

270-765-5

68477-83-8

H, K

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.)

649-068-00-9

270-767-6

68477-85-0

H, K

Gases (petroleum), deethaniser overheads; Petroleum gas

649-069-00-4

270-768-1

68477-86-1

H, K

(A complex combination of hydrocarbons produced from distillation of
It
the gas and gasoline fractions from the catalytic cracking process.
contains predominantly ethane and ethylene.)

Gases (petroleum), deisobutaniser tower overheads; Petroleum gas

649-070-00-X

270-769-7

68477-87-2

H, 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

H, 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

H, 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 hydrocar-
bons having carbon numbers in the range of C1 through C4, predomi-
nantly propane.)

649-073-00-6

270-777-0

68477-94-1

H, K

L 136/154

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Official Journal of the European Union

29.5.2007

Substances

Index No

EC No

CAS No

Notes

Gases (petroleum), Girbatol unit feed; Petroleum gas

649-074-00-1

270-778-6

68477-95-2

H, K

(A complex combination of hydrocarbons that is used as the feed into the
Girbatol unit to remove hydrogen sulfide. It consists of aliphatic hydrocar-
bons 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

H, 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 predomi-
nantly in the range of C1 through C6.)

Tail gas (petroleum), catalytic cracked naphtha stabilisation absorber; Petro-
leum 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.)

Tail gas (petroleum), catalytic cracker, catalytic reformer and hydrodesul-
phuriser combined fractionater; Petroleum gas

(A complex combination of hydrocarbons obtained from the fractionation
of products from catalytic cracking, catalytic reforming and hydrodesul-
phurising processes treated to remove acidic impurities. It consists predo-
minantly 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 stabiliser
tail gas. It consists predominantly of hydrocarbons having carbon numbers
in the range of C1 through C5, predominantly methane and ethane.)

649-076-00-2

270-802-5

68478-21-7

H, K

649-077-00-8

270-803-0

68478-22-8

H, K

649-078-00-3

270-804-6

68478-24-0

H, K

649-079-00-9

270-806-7

68478-26-2

H, K

649-080-00-4

270-813-5

68478-32-0

H, K

649-081-00-X

270-814-0

68478-33-1

H, K

29.5.2007

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Official Journal of the European Union

L 136/155

Substances

Index No

EC No

CAS No

Notes

Tail gas (petroleum), vacuum residues thermal cracker; Petroleum gas

649-082-00-5

270-815-6

68478-34-2

H, 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

H, 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.)

(petroleum), hydrocracking depropaniser off, hydrocarbon-rich;

Gases
Petroleum gas

(A complex combination of hydrocarbon produced by the distillation of
It consists predominantly of
products from a hydrocracking process.
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

H, K

649-085-00-1

271-001-3

68513-16-6

H, K

Gases (petroleum), light straight-run naphtha stabiliser off; Petroleum gas

649-086-00-7

271-002-9

68513-17-7

H, 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.)

649-087-00-2

271-010-2

68513-66-6

H, K

Hydrocarbons, C1-4; Petroleum gas
(A complex combination of hydrocarbons provided by thermal cracking
and absorber operations and by distillation of crude oil. 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.)

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.)

649-088-00-8

271-032-2

68514-31-8

H, K

649-089-00-3

271-038-5

68514-36-3

H, K

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Official Journal of the European Union

29.5.2007

Substances

Index No

EC No

CAS No

Notes

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

H, K

Hydrocarbons, C1-4, debutaniser fraction; Petroleum gas

649-091-00-4

271-261-8

68527-19-5

H, K

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

H, K

Hydrocarbons, C2-4; Petroleum gas

649-093-00-5

271-734-9

68606-25-7

H, K

Hydrocarbons, C3; Petroleum gas

649-094-00-0

271-735-4

68606-26-8

H, K

Gases (petroleum), alkylation feed; Petroleum gas

649-095-00-6

271-737-5

68606-27-9

H, K

(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.)

Gases (petroleum), depropaniser bottoms fractionation off; Petroleum gas

649-096-00-1

271-742-2

68606-34-8

H, 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

H, 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.)

Gases (petroleum), catalytic cracking; Petroleum gas

649-098-00-2

272-203-4

68783-64-2

H, 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

H, K

29.5.2007

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L 136/157

Substances

Index No

EC No

CAS No

Notes

Gases (petroleum), crude oil fractionation off; Petroleum gas

649-100-00-1

272-871-7

68918-99-0

H, 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

H, K

(A complex combination of hydrocarbons obtained by the fractionation of
combined naphtha streams. It consists of saturated aliphatic hydrocarbons
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 hydrocarbons
having carbon numbers predominantly in the range of C1 through C5.)

649-102-00-2

272-878-5

68919-05-1

H, K

Gases (petroleum), naphtha unifiner desulphurisation stripper off; Petro-
leum gas

(A complex combination of hydrocarbons produced by a naphtha unifiner
desulphurisation process and stripped from the naphtha product.
It
consists of saturated aliphatic hydrocarbons having carbon numbers predo-
minantly in the range of C1 through C4.)

649-103-00-8

272-879-0

68919-06-2

H, K

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.)

649-104-00-3

272-882-7

68919-09-5

H, K

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.)

649-105-00-9

272-893-7

68919-20-0

H, K

Gases (petroleum), straight-run stabiliser off; Petroleum gas

649-106-00-4

272-883-2

68919-10-8

H, 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 predo-
minantly 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

H, K

(A complex combination of hydrocarbons obtained from fractionation of
catalytic cracked naphtha.
It consists of hydrocarbons having carbon
numbers predominantly in the range of C1 through C4.)

L 136/158

EN

Official Journal of the European Union

29.5.2007

Substances

Index No

EC No

CAS No

Notes

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 hydro-
carbons having carbon numbers predominantly in the range of C1 through
C4.)

649-108-00-5

273-170-9

68952-77-2

H, K

Tail gas (petroleum),
absorber; Petroleum gas

thermal-cracked distillate, gas oil and naphtha

649-109-00-0

273-175-6

68952-81-8

H, K

(A complex combination of hydrocarbons obtained from the separation of
thermal-cracked distillates, naphtha and gas oil. It consists predominantly
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
It consists of hydrocarbons having carbon numbers predomi-
process.
nantly in the range of C1 through C6.)

649-110-00-6

273-176-1

68952-82-9

H, K

Gases (petroleum, light steam-cracked, butadiene conc.; Petroleum gas

649-111-00-1

273-265-5

68955-28-2

H, 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
reforming of straight-run naphtha and the fractionation of
the total
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

H, K

Hydrocarbons, C4; Petroleum gas

649-113-00-2

289-339-5

27741-01-3

H, K

Alkanes, C1-4, C3-rich; Petroleum gas

649-114-00-8

292-456-4

90622-55-2

H, K

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.)

649-115-00-3

295-404-9

92045-22-2

H, K

649-116-00-9

295-405-4

92045-23-3

H, K

29.5.2007

EN

Official Journal of the European Union

L 136/159

Substances

Index No

EC No

CAS No

Notes

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.)

649-117-00-4

295-463-0

92045-80-2

H, K

Raffinates (petroleum), steam-cracked C4
fraction cuprous ammonium
acetate extraction, C3-5 and C3-5 unsaturated, butadiene-free; Petroleum gas

649-119-00-5

307-769-4

97722-19-5

H, K

Gases (petroleum), amine system feed; Refinery gas

649-120-00-0

270-746-1

68477-65-6

H, K

(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.)

Gases (petroleum), benzene unit hydrodesulphuriser off; Refinery gas

649-121-00-6

270-747-7

68477-66-7

H, K

(Off gases produced by the benzene unit. It consists primarily of hydrogen.
Carbon monoxide and hydrocarbons having carbon numbers predomi-
nantly 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

H, 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

H, 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.)

Gases (petroleum), catalytic reformed naphtha stripper overheads; Refinery
gas

(A complex combination of hydrocarbons obtained from stabilisation of
catalytic reformed naphtha. It consists of hydrogen and saturated hydrocar-
bons having carbon numbers predominantly in the range of C1 through
C4.)

649-124-00-2

270-759-2

68477-77-0

H, K

L 136/160

EN

Official Journal of the European Union

29.5.2007

Substances

Index No

EC No

CAS No

Notes

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.)

649-125-00-8

270-760-3

68477-80-5

H, K

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-
bons having carbon numbers in the range of C1
through C5 and
hydrogen.)

649-126-00-3

270-762-9

68477-81-6

H, K

Gases (petroleum), C6-8 catalytic reformer recycle, hydrogen-rich; Refinery
gas

649-127-00-9

270-763-4

68477-82-7

H, 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

H, K

Gases (petroleum), dry sour, gas-concentration-unit-off; Refinery gas

649-129-00-X

270-774-4

68477-92-9

H, 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 concentration reabsorber distillation; Refinery gas

649-130-00-5

270-776-5

68477-93-0

H, 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

H, K

(A complex combination obtained by absorbing hydrogen from a
hydrogen rich stream. It consists of hydrogen, carbon monoxide, nitrogen,
and methane with small amounts of C2 hydrocarbons.)

Gases (petroleum), hydrogen-rich; Refinery gas

649-132-00-6

270-780-7

68477-97-4

H, 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.)

29.5.2007

EN

Official Journal of the European Union

L 136/161

Substances

Index No

EC No

CAS No

Notes

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

H, K

Gases (petroleum), recycle, hydrogen-rich; Refinery gas

649-134-00-7

270-783-3

68478-00-2

H, 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 hydro-
carbons 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

H, 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

H, K

(A complex combination obtained from the reforming hydrotreating
It consists primarily of hydrogen, methane, and ethane with
process.
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

H, 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

H, 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.)

L 136/162

EN

Official Journal of the European Union

29.5.2007

Substances

Index No

EC No

CAS No

Notes

Gases (petroleum), thermal cracking distillation; Refinery gas

649-139-00-4

270-789-6

68478-05-7

H, K

(A complex combination produced by distillation of products from a
It consists of hydrogen, hydrogen sulphide,
thermal cracking process.
carbon monoxide, carbon dioxide and hydrocarbons having carbon
numbers predominantly in the range of C1 through C6.)

Tail gas (petroleum), catalytic cracker refractionation absorber; Refinery gas

649-140-00-X

270-805-1

68478-25-1

H, K

(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.)

Tail gas (petroleum), catalytic reformed naphtha separator; Refinery gas

649-141-00-5

270-807-2

68478-27-3

H, 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

H, 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

H, K

(A complex combination of hydrocarbons obtained by treating cracked
It consists of
distillates with hydrogen in the presence of a catalyst.
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 hydrodesulphuri-
sation of straight-run naphtha.
It consists of hydrogen and saturated
aliphatic hydrocarbons having carbon numbers predominantly in the
range of C1 through C6.)

649-144-00-1

270-810-9

68478-30-8

H, K

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.)

649-145-00-7

270-999-8

68513-14-4

H, K

29.5.2007

EN

Official Journal of the European Union

L 136/163

Substances

Index No

EC No

CAS No

Notes

Gases (petroleum), reformer effluent high-pressure flash drum off; Refinery
gas

(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.)

649-146-00-2

271-003-4

68513-18-8

H, K

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

H, K

Gases (petroleum), oil refinery gas distillation off; Refinery gas

649-148-00-3

271-258-1

68527-15-1

H, K

(A complex combination separated by distillation of a gas
stream
containing hydrogen, carbon monoxide, carbon dioxide and hydrocarbons
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 depentanising.
It consists primarily of hydrogen, ethane and propane with 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

H, 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

H, K

Petroleum products, refinery gases; Refinery gas

649-151-00-X

271-750-6

68607-11-4

H, 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

H, K

(A complex combination obtained by the liquid-vapour separation of the
hydrocracking process
It consists predominantly of
hydrogen and saturated hydrocarbons having carbon numbers predomi-
nantly in the range of C1 through C3.)

reactor effluent.

L 136/164

EN

Official Journal of the European Union

29.5.2007

Substances

Index No

EC No

CAS No

Notes

Gases (petroleum), refinery; Refinery gas

649-153-00-0

272-338-9

68814-67-5

H, 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

H, 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.)

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 predomi-
nantly in the range of C4 through C5.)

649-155-00-1

272-775-5

68911-58-0

H, K

Gases (petroleum), hydrotreated sour kerosine flash drum; Refinery gas

649-156-00-7

272-776-0

68911-59-1

H, 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.)

Gases (petroleum), distillate unifiner desulphurisation stripper off; Refinery
gas

(A complex combination stripped from the liquid product of the unifiner
desulphurisation process.
It consists of hydrogen sulphide, methane,
ethane, and propane.)

649-157-00-2

272-873-8

68919-01-7

H, K

Gases (petroleum), fluidised catalytic cracker fractionation off; Refinery gas

649-158-00-8

272-874-3

68919-02-8

H, K

(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.)

Gases (petroleum), fluidised catalytic cracker scrubbing secondary absorber
off; Refinery gas

(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.)

649-159-00-3

272-875-9

68919-03-9

H, K

649-160-00-9

272-876-4

68919-04-0

H, K

29.5.2007

EN

Official Journal of the European Union

L 136/165

Substances

Index No

EC No

CAS No

Notes

(petroleum), platformer

Gases
Refinery gas

stabiliser off,

light ends

fractionation;

649-161-00-4

272-880-6

68919-07-3

H, 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 distillation; Refinery gas

649-162-00-X

272-881-1

68919-08-4

H, K

(A complex combination produced from the first tower used in the distilla-
tion of crude oil. It consists of nitrogen and saturated aliphatic hydrocar-
bons having carbon numbers predominantly in the range of C1 through
C5.)

Gases (petroleum), tar stripper off; Refinery gas

649-163-00-5

272-884-8

68919-11-9

H, 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

H, K

(A combination of hydrogen and methane obtained by fractionation of the
products from the unifiner unit.)

Tail gas
Refinery gas

(petroleum), catalytic hydrodesulphurised naphtha separator;

(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

H, K

Tail gas (petroleum), straight-run naphtha hydrodesulphuriser; Refinery gas

649-166-00-1

273-174-0

68952-80-7

H, K

(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.)

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

H, K

Gases (petroleum), crude distillation and catalytic cracking; Refinery gas

649-168-00-2

273-563-5

68989-88-8

H, 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.)

L 136/166

EN

Official Journal of the European Union

29.5.2007

Substances

Index No

EC No

CAS No

Notes

Gases (petroleum), gas oil diethanolamine scrubber off; Refinery gas

649-169-00-8

295-397-2

92045-15-3

H, K

(A complex combination produced by desulphurisation of gas oils with
diethanolamine. It consists predominantly of hydrogen sulphide, hydrogen
and aliphatic hydrocarbons having carbon numbers in the range of C1
through C5.)

Gases (petroleum), gas oil hydrodesulphurisation effluent; Refinery gas

649-170-00-3

295-398-8

92045-16-4

H, 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.)

Gases (petroleum), gas oil hydrodesulphurisation purge; Refinery gas

649-171-00-9

295-399-3

92045-17-5

H, 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

H, 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.)

Gases (petroleum), naphtha steam cracking high-pressure residual; Refinery
gas

(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.)

649-173-00-X

295-401-2

92045-19-7

H, K

Gases (petroleum), residue visbaking off; Refinery gas

649-174-00-5

295-402-8

92045-20-0

H, 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.)

Gases (petroleum), C3-4; Petroleum gas
(A complex combination of hydrocarbons produced by distillation of
It consists of hydrocarbons
products from the cracking of crude oil.
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

H, K

29.5.2007

EN

Official Journal of the European Union

L 136/167

Substances

Index No

EC No

CAS No

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

H, K

Tail gas (petroleum), catalytic polymerisation naphtha fractionation stabi-
liser; 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

H, 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.)

649-180-00-8

269-619-3

68308-00-9

H, K

Tail gas (petroleum), cracked distillate hydrotreater stripper; Petroleum gas

649-181-00-3

269-620-9

68308-01-0

H, K

(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.)

649-182-00-9

269-630-3

68308-10-1

H, K

Tail gas (petroleum), gas oil catalytic cracking absorber; Petroleum gas

649-183-00-4

269-623-5

68308-03-2

H, K

(A complex combination of hydrocarbons obtained from the distillation of
products from the catalytic cracking of gas oil. It consists predominantly
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

H, K

(A complex combination of hydrocarbons from the distillation of products
from miscellaneous hydrocarbon streams.
It consists predominantly of
hydrocarbons having carbon numbers predominantly in the range of C1
through C5.)

L 136/168

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Official Journal of the European Union

29.5.2007

Substances

Index No

EC No

CAS No

Notes

Tail gas (petroleum), gas recovery plant deethaniser; Petroleum gas

649-185-00-5

269-625-6

68308-05-4

H, K

(A complex combination of hydrocarbons from the distillation of products
It consists of hydrocarbon
from miscellaneous hydrocarbon streams.
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 hydrocar-
bons having carbon numbers predominantly in the range of C1 through
C5.)

Tail gas (petroleum), hydrodesulphurised vacuum gas oil stripper, hydrogen
sulphide-free; Petroleum gas

(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.)

649-186-00-0

269-626-1

68308-06-5

H, K

649-187-00-6

269-627-7

68308-07-6

H, K

Tail gas
light
sulphide-free; Petroleum gas

(petroleum),

straight-run naphtha stabiliser, hydrogen

649-188-00-1

269-629-8

68308-09-8

H, K

(A complex combination of hydrocarbons obtained from fractionation
stabilisation of
light straight-run 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 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 hydrocar-
bons 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 hydrocar-
bons having carbon numbers predominantly in the range of C1 through
C6.)

649-189-00-7

269-631-9

68308-11-2

H, K

649-190-00-2

269-632-4

68308-12-3

H, K

Gases (petroleum), catalytic cracked overheads; Petroleum gas

649-191-00-8

270-071-2

68409-99-4

H, 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.)

29.5.2007

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Official Journal of the European Union

L 136/169

Substances

Index No

EC No

CAS No

Notes

Alkanes, C1-2; Petroleum gas

649-193-00-9

270-651-5

68475-57-0

H, K

Alkanes, C2-3; Petroleum gas

649-194-00-4

270-652-0

68475-58-1

H, K

Alkanes, C3-4; Petroleum gas

649-195-00-X

270-653-6

68475-59-2

H, K

Alkanes, C4-5; Petroleum gas

649-196-00-5

270-654-1

68475-60-5

H, K

Fuel gases; Petroleum gas

649-197-00-0

270-667-2

68476-26-6

H, K

(A combination of light gases. It consists predominantly of hydrogen and/
or low molecular weight hydrocarbons.)

Fuel gases, crude oil of distillates; Petroleum gas

649-198-00-6

270-670-9

68476-29-9

H, 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

H, K

Hydrocarbons, C4-5; Petroleum gas

649-200-00-5

270-682-4

68476-42-6

H, K

Hydrocarbons, C2-4, C3-rich; Petroleum gas

649-201-00-0

270-689-2

68476-49-3

H, K

Petroleum gases, liquefied; Petroleum gas

649-202-00-6

270-704-2

68476-85-7

H, K, S

(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.)

Petroleum gases, liquefied, sweetened; Petroleum gas

649-203-00-1

270-705-8

68476-86-8

H, K, S

(A complex combination of hydrocarbons obtained by subjecting liquefied
petroleum gas mix to a sweetening process to convert mercaptans or to
It consists of hydrocarbons having carbon
remove acidic impurities.
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 saturated
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 saturated
and unsaturated aliphatic hydrocarbons usually ranging in the carbon
numbers C3 through C6. It consists of saturated and unsaturated hydrocar-
bons having carbon numbers in the range of C3 through C6, predomi-
nantly piperylenes.)

649-204-00-7

270-724-1

68477-33-8

H, K

649-205-00-2

270-726-2

68477-35-0

H, K

L 136/170

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Official Journal of the European Union

29.5.2007

Substances

Index No

EC No

CAS No

Notes

Gases (petroleum), butane splitter overheads; Petroleum gas

649-206-00-8

270-750-3

68477-69-0

H, 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.)

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.)

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.)

Tail gas (petroleum), isomerised naphtha fractionation stabiliser; Petroleum
gas

(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.)

649-207-00-3

270-751-9

68477-70-3

H, K

649-208-00-9

270-752-4

68477-71-4

H, K

649-209-00-4

270-754-5

68477-72-5

H, K

649-210-00-X

269-628-2

68308-08-7

H, K

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

29.5.2007

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Official Journal of the European Union

L 136/171

Appendix 2

Point 28 — Carcinogens: category 2

Substances

Index No

EC No

CAS No

Notes

Beryllium

004-001-00-7

231-150-7

7440-41-7

Beryllium compounds with the exception of aluminium beryllium sili-
cates

004-002-00-2

Beryllium oxide

004-003-00-8

215-133-1

1304-56-9

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

Isobutyl nitrite

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

007-017-00-2

208-819-7

542-56-3

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

Dimethylsulfamoylchloride

Potassium dichromate

Ammonium dichromate

Sodium dichromate anhydrate

Sodium dichromate, dihydrate

016-023-00-4

201-058-1

016-027-00-6

200-589-6

77-78-1

64-67-5

016-032-00-3

214-317-9

1120-71-4

016-033-00-9

236-412-4

13360-57-1

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

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

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

E

E

E

E

E

E

E

E

E

E

E

E

L 136/172

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Official Journal of the European Union

29.5.2007

Substances

Index No

EC No

CAS No

Notes

Cadmium oxide

Cadmium fluoride

Cadmium chloride

Cadmium sulphate

Cadmium sulphide

Cadmium (pyrophoric)

Isoprene (stabilised)

2-Methyl-1,3-butadiene

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

048-010-00-4

215-147-8

1306-23-6

048-011-00-X

231-152-8

7440-43-9

601-014-00-5

201-143-3

78-79-5

E

E

E

E

E

E

D

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

E

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

602-027-00-9

201-167-4

79-01-6

Chloroprene (stabilised)

2-Chlorobuta-1,3-diene

602-036-00-8

204-818-0

126-99-8

D, E

α-Chlorotoluene; benzyl chloride

602-037-00-3

202-853-6

100-44-7

α,α,α-Trichlorotoluene; benzotrichloride

602-038-00-9

202-634-5

98-07-7

1,2,3-Trichloropropane

1,3-Dichloro-2-propanol

Hexachlorobenzene

1,4-Dichlorobut-2-ene

602-062-00-X

202-486-1

96-18-4

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

α,α,α,4-Tetrachlorotoluene

p-Chlorobenzotrichloride

Ethylene oxide; oxirane

602-093-00-9

226-009-1

5216-25-1

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

E

D

E

E

E

E

29.5.2007

EN

Official Journal of the European Union

L 136/173

Substances

Index No

EC No

CAS No

Notes

2,3-Epoxypropan-1-ol; glycidol oxiranemethanol

603-063-00-8

209-128-3

556-52-5

Phenyl glycidyl ether; 2,3-epoxypropyl phenyl ether; 1,2-epoxy-3-
phenoxypropane

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

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

4,4'-Bis(dimethylamino)benzophenone

606-073-00-0

202-027-5

90-94-8

Michler's ketone

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

Oxiranemethanol, 4-methylbenzene-sulfonate, (S)-

607-411-00-X

417-210-7

70987-78-9

E

E

E

E

E

Acrylonitrile

2-Nitropropane

608-003-00-4

203-466-5

107-13-1

D, E

609-002-00-1

201-209-1

79-46-9

2,4-Dinitrotoluene [1]; dinitrotoluene [2]; dinitrotoluene,
grade

technical

609-007-00-9

204-450-0 [1]

121-14-2 [1]

E

246-836-1 [2]

25321-14-6 [2]

5-Nitroacenaphthene

2-Nitronaphthalene

4-Nitrobiphenyl

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

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

2-Nitrotoluene

Azobenzene

609-055-00-0

210-581-4

619-15-8

609-065-00-5

201-853-3

88-72-2

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
phenyl)azo)
Direct Brown 95

{5-[(4′-((2,6-hydroxy-3-((2-hydroxy-5-sulphophenyl)azo)
cuprate(2-); CI
(1,1′-biphenyl)-4-yl)azo]salicylato(4-)}

611-005-00-8

240-221-1

16071-86-6

E

E

E

E

E

E

E

L 136/174

EN

Official Journal of the European Union

29.5.2007

Substances

Index No

EC No

CAS No

Notes

4-o-Tolylazo-o-toluidine;
garnet GBC base; AAT; o-aminoazotoluene

4-amino-2′,3-dimethylazobenzene;

fast

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 excep-
tion of those specified elsewhere in Annex I to Directive 67/548/EEC

611-024-00-1

—

—

Disodium 4-amino 3-[[4′-[(2,4-diaminophenyl)azo][1,1′-biphenyl]-4-
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

Tetrasodium
hydroxynaphthalene-2,7-disulphonate]; C.I. Direct Blue 6

3,3′-[[1,1′-biphenyl]-4,4′-dylbis(azo)]bis[5-amino-4-

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 of those mentioned elsewhere in Annex I to Directive 67/
548/EEC

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)
phenylazo]-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'''-tetrao-
lato-O, O', O'', O''']copper(II)

(Methylenebis(4,1-phenylenazo(1-(3-(dimethylamino)propyl)-1,2-
dihydro-6-hydroxy-4-methyl-2-oxopyridine-5,3-diyl)))-1,1'-dipyridi-
nium dichloride dihydrochloride

611-063-00-4

413-590-3

164058-22-4

611-099-00-0

401-500-5

—

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]

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′-
ylenediamine

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

E

E

E

E

29.5.2007

EN

Official Journal of the European Union

L 136/175

Substances

Index No

EC No

CAS No

Notes

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; salts of 4,4′-methyle-
nebis(2-chloroaniline)

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

4,4′-Methylenedi-o-toluidine

612-085-00-7

212-658-8

838-88-0

2,2′-(Nitrosoimino)bisethanol

612-090-00-4

214-237-4

1116-54-7

o-Toluidine

Nitrosodipropylamine

612-091-00-X

202-429-0

95-53-4

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

Diaminotoluene, technical product — mixture of [2] and [3]

612-151-00-5

246-910-3[1]

25376-45-8 [1]

E

methyl-phenylenediamine [1]

4-methyl-m-phenylene diamine [2]

2-methyl-m-phenylene diamine [3]

4-Chloro-o-toluidine [1]

4-chloro-o-toluidine hydrochloride [2]

2,4,5-Trimethylaniline [1]

2,4,5-trimethylaniline hydrochloride [2]

202-453-1 [2]

95-80-7 [2]

212-513-9 [3]

823-40-5 [3]

612-196-00-0

202-441-6 [1]

95-69-2 [1]

221-627-8 [2]

3165-93-3 [2]

612-197-00-6

205-282-0 [1]
[2]

-

137-17-7 [1]

21436-97-5 [2]

4,4'-Thiodianiline [1] and its salts

612-198-00-1

205-370-9 [1]

139-65-1 [1]

4,4'-Oxydianiline [1] and its salts

p-Aminophenyl ether [1]

2,4-Diaminoanisole [1]

4-methoxy-m-phenylenediamine

2,4-diaminoanisole sulphate [2]

612-199-00-7

202-977-0 [1]

101-80-4 [1]

612-200-00-0

210-406-1 [1]

615-05-4 [1]

254-323-9 [2]

39156-41-7 [2]

N, N,N',N'-tetramethyl-4,4'-methylendianiline

612-201-00-6

202-959-2

101-61-1

C.I. Basic Violet 3 with ≥ 0,1 % of Michler's ketone (EC No 202-027-
5)

612-205-00-8

208-953-6

548-62-9

6-Methoxy-m-toluidine

p-cresidine

Ethyleneimine; aziridine

612-209-00-X

204-419-1

120-71-8

613-001-00-1

205-793-9

151-56-4

2-Methylaziridine; propyleneimine

613-033-00-6

200-878-7

75-55-8

Captafol
phthalimide

(ISO);

1,2,3,6-tetrahydro-N-(1,1,2,2-tetrachloroethylthio)

613-046-00-7

219-363-3

2425-06-1

E

E

E

E

E

E

E

L 136/176

EN

Official Journal of the European Union

29.5.2007

Substances

Index No

EC No

CAS No

Notes

Carbadox (INN); methyl 3-(quinoxalin-2-ylmethylene)carbazate 1,4-
dioxide; 2-(methoxycarbonylhydrazonomethyl) quinoxaline 1,4-dioxide

613-050-00-9

229-879-0

6804-07-5

A mixture of: 1,3,5-tris(3-aminomethylphenyl)-1,3,5-(1H,3H,5H)-tria-
zine-2,4,6-trione;

a mixture of oligomers of 3,5-bis(3-aminomethylphenyl)-1-poly[3,5-
bis(3-aminomethylphenyl)-2,4,6-trioxo-1,3,5-(1H,3H,5H)-triazin-1-yl]-
1,3,5-(1H,3H,5H)-triazine-2,4,6-trione

613-199-00-X

421-550-1

—

Acrylamide

Thioacetamide

of: N-[3-hydroxy-2-(2-methylacryloylamino-methoxy)
A mixture
propoxymethyl]-2-methylacrylamide;
N-[2,3-Bis-(2-methylacryloyla-
mino-methoxy)propoxymethyl]-2-methylacrylamide; methacrylamide;
2-methyl-N-(2-methyl-acryloylaminomethoxymethyl)-acrylamide;
N-
2,3-dihydroxypropoxymethyl)-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
It consists of hydrocarbons having carbon numbers
primarily in the range of C4 to C10 and distilling in the approximate
range of 80 to 160 °C.)

tar.

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
to 250 °C. Composed primarily of aliphatic and aromatic hydrocar-
bons 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 distilla-
tion range below 100 °C. Composed primarily of C4 to C6 aliphatic
hydrocarbons.)

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 to 200 °C.)

648-004-00-7

309-984-9

101896-26-8

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, inter-
mediate boiling

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), distillation 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

J

J

J

J

J

J

J

J

J

29.5.2007

EN

Official Journal of the European Union

L 136/177

Substances

Index No

EC No

CAS No

Notes

Aromatic hydrocarbons, C8-9, hydrocarbon resin polymerisation by-
product; Light oil redistillate, high boiling

(A complex combination of hydrocarbons obtained from the evapora-
tion of solvent under vacuum from polymerised hydrocarbon resin. It
consists predominantly of aromatic hydrocarbons having carbon
numbers predominantly in the range of C8 through C9 and boiling in
the range of approximately 120 to 215 °C.)

648-012-00-0

295-281-1

91995-20-9

Aromatic hydrocarbons, C9-12, benzene distillation; Light oil redistillate,
high boiling

648-013-00-6

295-551-9

92062-36-7

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 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 mononuc-
lear aromatic hydrocarbons boiling in the range of 85 to 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.)

Extract residues (coal),
extract residues, low boiling

light oil alk., distillation overheads; Light oil

(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.)

648-014-00-1

295-323-9

91995-61-8

648-015-00-7

309-868-8

101316-63-6

648-016-00-2

298-725-2

93821-38-6

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 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

(The distillate from either high temperature coal tar, coke oven light
oil, or coal tar oil alkaline extract residue having an approximate distil-
lation range of 130 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.)

J

J

J

J

J

J

J

J

J

L 136/178

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Official Journal of the European Union

29.5.2007

Substances

Index No

EC No

CAS No

Notes

Distillates (coal tar), light oils, neutral fraction; Light oil extract resi-
dues, high boiling

(A distillate from the fractional distillation of high temperature coal tar.
Composed primarily of alkyl-substituted one ring aromatic hydrocar-
bons boiling in the range of approximately 135 to 210 °C. May also
include unsaturated hydrocarbons such as indene and coumarone.)

Distillates (coal tar), light oils, acid extracts; 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 to 215 °C.)

648-021-00-X

309-971-8

101794-90-5

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
It consists of aromatic and other hydrocarbons, phenolic
coal tar.
compounds and aromatic nitrogen compounds and distills at
the
approximate range of 150 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 to 250 °C. Composed primarily of naphtha-
lene, alkylnaphthalenes, phenolic compounds, and aromatic nitrogen
bases.)

Extract residues (coal), light oil alk., acid extract; Carbolic oil extract
residue

(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.)

648-026-00-7

292-624-7

90641-01-3

Extract residues (coal), tar oil alkaline; 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 deriva-
tives.)

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, formalde-
hyde or paraformaldehyde.)

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 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.)

J

J

J

J

J

J

J

J

J

Tar bases, coal, lutidine fraction; Distillate bases

648-031-00-4

293-766-2

91082-52-9

J

29.5.2007

EN

Official Journal of the European Union

L 136/179

Substances

Index No

EC No

CAS No

Notes

Extract oils (coal), tar base, collidine fraction; Distillate bases

648-032-00-X

273-077-3

68937-63-3

aromatic oils, neutralisation, and distillation of

(The extract produced by the acid extraction of bases from crude coal
the bases.
tar
Composed primarily of collidines, aniline, toluidines,
lutidines, xyli-
dines.)

Tar bases, coal, collidine fraction; Distillate bases

648-033-00-5

295-543-5

92062-28-7

(The distillation fraction boiling in the range of approximately 181 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 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.)

Tar bases, coal, toluidine fraction; Distillate bases

648-035-00-6

293-767-8

91082-53-0

Distillates (petroleum), alkene-alkyene manuf. pyrolysis oil, mixed with
high-temperature 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 to
190 °C.)

Distillates (coal), coal tar-residual pyrolysis oils, naphthalene oils; Redis-
tillates

(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 to 270 °C. Composed primarily of substi-
tuted dinuclear aromatics.)

Extract oils (coal), coal tar-residual pyrolysis oils, naphthalene oil, redis-
tillate; 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 to 230 °C. It consists predominantly of unsubstituted
and substituted dinuclear aromatic hydrocarbons.)

Extract oils (coal), coal tar-residual pyrolysis oils, naphthalene oils;
Redistillates

(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 to 255 °C. Composed primarily of
substituted dinuclear aromatic hydrocarbons.)

Extract oils (coal), coal tar residual pyrolysis oils, naphthalene oil, distil-
lation 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 to 260 °C. Composed primarily of substi-
tuted dinuclear aromatic and heterocyclic hydrocarbons.)

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

648-039-00-8

310-170-0

122070-79-5

648-040-00-3

310-171-6

122070-80-8

J

J

J

J

J

J

J

J

J

L 136/180

EN

Official Journal of the European Union

29.5.2007

Substances

Index No

EC No

CAS No

Notes

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 two-
ringed aromatic and heterocyclic hydrocarbons boiling in the range of
approximately 260 to 290 °C.)

648-041-00-9

309-851-5

101316-45-4

M

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 crystallisa-
tion of tar oil. It consists of aromatic and polycyclic hydrocarbons
primarily fluorene and some acenaphthene.)

Creosote oil, acenaphthene fraction, acenaphthene-free; Wash oil redis-
tillate

648-043-00-X

292-606-9

90640-85-0

H

remaining after

(The oil
acenaphthene from acenaphthene oil
primarily of naphthalene and alkylnaphthalenes.)

removal by a crystallisation process of
tar. Composed

from coal

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 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 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
100 to 450 °C. Composed primarily of
two to four membered
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 bitumi-
nous high temperature tar. Composed primarily of tri- and polynuclear
aromatic hydrocarbons and boiling in the range of approximately 300
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
treatment of pitch. Composed primarily of two-to four-ring aromatic
compounds boiling in the range of 200 to greater than 400 °C.)

Distillates (coal tar), heavy oils, pyrene fraction; Heavy anthracene oil
redistillate

(The redistillate obtained from the fractional distillation of pitch distil-
late boiling in the range of approximately 350 to 400 °C. Consists
predominantly of
tri- and polynuclear aromatic and heterocyclic
hydrocarbons.)

648-050-00-8

295-304-5

91995-42-5

M

29.5.2007

EN

Official Journal of the European Union

L 136/181

Substances

Index No

EC No

CAS No

Notes

Distillates (coal tar), pitch, pyrene fraction; Heavy anthracene oil redis-
tillate

(The redistillate obtained from the fractional distillation of pitch distil-
late and boiling in the range of approximately 380 to 410 °C.
Composed primarily of tri- and polynuclear aromatic hydrocarbons
and heterocyclic compounds.)

Paraffin waxes (coal), brown-coal high-temperature 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
constituents 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-temperature 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 consti-
tuents and impurities. It consists predominantly of saturated straight
and branched chain hydrocarbons having carbon numbers predomi-
nantly greater than C12.)

648-051-00-3

295-313-4

91995-52-7

M

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 temperature; Pitch

648-055-00-5

266-028-2

65996-93-2

(The residue from the distillation of high temperature coal tar. A black
solid with an approximate softening point
from 30 to 180 °C.
Composed primarily of a complex mixture of three or more membered
condensed ring aromatic hydrocarbons.)

Pitch, coal tar, high temperature, 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 to
180 °C. Composed primarily of a complex mixture of three or more
membered condensed ring aromatic hydrocarbons.)

Pitch, coal tar, high temperature, 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 to 170 °C according to DIN 52025.
Composed primarily of
tri- and polynuclear aromatic compounds
which also contain heteroatoms.)

Residues (coal tar), pitch distillation; 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 to 470 °C. Composed primarily of poly-
nuclear aromatic hydrocarbons, and heterocyclic compounds.)

Tar, coal, high-temperature, distillation and storage residues; Coal tar
solids residue

(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 components.)

648-059-00-7

295-535-1

92062-20-9

M

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
primarily of coal tar and carbonaceous particulate matter.)

tar

storages. Composed

L 136/182

EN

Official Journal of the European Union

29.5.2007

Substances

Index No

EC No

CAS No

Notes

Tar, coal, high-temperature, 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-temperature, 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

648-064-00-4

294-285-0

91697-23-3

M

(The residue from extraction of dried coal.)

Paraffin waxes (coal), brown-coal-high-temperature tar; Coal tar extract

648-065-00-X

295-454-1

92045-71-1

M

(A complex combination of hydrocarbons obtained from lignite carbo-
nisation tar by solvent crystallisation (solvent deoiling), by sweating or
an adducting process.
straight and
branched chain saturated hydrocarbons having carbon numbers predo-
minantly greater than C12.)

It consists predominantly of

Paraffin waxes (coal), brown-coal-high-temperature tar, hydrotreated;
Coal tar extract

(A complex combination of hydrocarbons obtained from lignite carbo-
nisation tar by solvent crystallisation (solvent deoiling), by sweating or
an adducting process treated with hydrogen in the presence of a cata-
lyst. 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, 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 consti-
tuents and impurities. It consists predominantly of saturated straight
and branched chain hydrocarbons having carbon numbers predomi-
nantly 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,
boiling

low-temperature, distillation residues; Tar oil,

intermediate

648-068-00-6

309-887-1

101316-85-2

M

(Residues from fractional distillation of low temperature coal tar to
remove oils
in a range up to approximately 300 °C.
Composed primarily of aromatic compounds.)

that boil

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 approxi-
mate range of 40 to 180 °C. Composed primarily of a complex
mixture of hydrocarbons.)

29.5.2007

EN

Official Journal of the European Union

L 136/183

Substances

Index No

EC No

CAS No

Notes

Pitch, coal tar, low-temperature, oxidised; Pitch residue, oxidised

648-070-00-7

292-654-0

90669-59-3

M

(The product obtained by air-blowing, at elevated temperature,
low-
temperature coal tar pitch. It has a softening-point within the approxi-
mate range of 70to 180 °C. Composed primarily of a complex mixture
of hydrocarbons.)

Pitch, coal tar,
Pitch residue, heat-treated

low-temperature, heat-treated; Pitch residue, oxidised;

(A complex black solid obtained by the heat treatment of low tempera-
ture coal tar pitch. It has a softening point within the approximate
range of 50 to 140 °C. Composed primarily of a complex mixture of
aromatic compounds.)

648-071-00-2

292-653-5

90669-58-2

M

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 to 450 °C.
Composed primarily of
to four-membered condensed ring
aromatic hydrocarbons.)

three-

Aromatic hydrocarbons, C20-28, polycyclic, mixed coal-tar pitch-poly-
ethylene-polypropylene pyrolysis-derived; Pyrolysis products

(A complex combination of hydrocarbons obtained from mixed coal
tar pitch-polyethylene-polypropylene pyrolysis. Composed primarily of
polycyclic aromatic hydrocarbons having carbon numbers predomi-
nantly in the range of C20 through C28 and having a softening point of
100 to 220 °C according to DIN 52025.)

Aromatic hydrocarbons, C20-28, polycyclic, mixed coal-tar pitch-poly-
ethylene 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 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 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

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 to 180 °C.
Composed primarily of a complex combination of
three or more
membered condensed ring aromatic hydrocarbons.)

Phenanthrene, distillation 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 to 420 °C. It consists predominantly of
phenanthrene, anthracene and carbazole.)

L 136/184

EN

Official Journal of the European Union

29.5.2007

Substances

Index No

EC No

CAS No

Notes

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 crystallisa-
It consists of aromatic polycyclic hydrocarbons,
tion of
primarily diphenyl, dibenzofuran and acenaphthene.)

tar oil.

Residues (coal tar), creosote oil distillation; Wash oil redistillate

648-080-00-1

295-506-3

92061-93-3

H

(The residue from the fractional distillation of wash oil boiling in the
approximate range of 270 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 prefractio-
nation (continuous distillation) of coke oven light oil. It consists predo-
minantly 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 naphtha-
lenes and phenolic compounds.)

Distillates (coal tar), naphthalene oil crystn. mother liquor; Naphtha-
lene 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 to 230 °C. Contains chiefly
naphthalene, thionaphthene and alkylnaphthalenes.)

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.)

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 naphtha-
lenes.)

Distillates (coal tar), naphthalene oils, naphthalene-free, alk. extracts;
Naphthalene oil extract residue

(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., distillation overheads;
Naphthalene oil extract residue

(The distillation from alkali-washed naphthalene oil having an approxi-
mate distillation range of 180 to 220 °C. Composed primarily of
naphthalene, alkylbenzenes, indene and indan.)

Distillates (coal
Methylnaphthalene oil

tar), naphthalene oils, methylnaphthalene fraction;

(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
to 255 °C.)

648-086-00-4

284-898-1

84989-09-3

J, M

648-087-00-X

295-310-8

91995-49-2

J, M

648-088-00-5

310-166-9

121620-47-1

J, M

648-089-00-0

310-167-4

121620-48-2

J, M

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

29.5.2007

EN

Official Journal of the European Union

L 136/185

Substances

Index No

EC No

CAS No

Notes

Distillates (coal tar), naphthalene oils, indole-methylnaphthalene frac-
tion; 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 to 255 °C.)

648-093-00-2

309-972-3

101794-91-6

J, M

Distillates (coal tar), naphthalene oils, acid extracts; 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 to 255 °C. Contains chiefly
1(2)-methylnaphthalene,
and
biphenyl.)

dimethylnaphthalene

naphthalene,

Extract
Methylnaphthalene oil extract residue

residues

(coal), naphthalene oil alk., distillation residues;

(The residue from the distillation of alkali-washed naphthalene oil
having an approximate distillation range of 220 to 300 °C. Composed
primarily of naphthalene, alkylnaphthalenes and aromatic nitrogen
bases.)

Extract oils (coal), acidic, tar-base free; Methylnaphthalene oil extract
residue

(The extract oil boiling in the range of approximately 220 to 265 °C
from coal tar alkaline extract residue produced by an acidic wash such
sulfuric acid after distillation to remove tar bases.
as aqueous
Composed primarily of alkylnaphthalenes.)

648-095-00-3

292-628-9

90641-05-7

J, M

648-096-00-9

284-901-6

84989-12-8

J, M

Distillates (coal tar), benzole fraction, distillation residues; Wash oil

648-097-00-4

310-165-3

121620-46-0

J, M

(A complex combination of hydrocarbons obtained from the distilla-
tion of crude benzole (high temperature coal tar). It may be a liquid
with the approximate distillation range of 150 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, acenaphthene fraction

648-098-00-X

292-605-3

90640-84-9

Wash oil

Creosote oil

648-099-00-5

263-047-8

61789-28-4

Creosote oil, high-boiling distillate; Wash oil

648-100-00-9

274-565-9

70321-79-8

(The high-boiling distillation fraction obtained from the high tempera-
ture 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.)

Creosote

648-101-00-4

232-287-5

8001-58-9

Extract residues (coal), creosote oil acid; Wash oil extract residue

648-102-00-X

310-189-4

122384-77-4

(A complex combination of hydrocarbons from the base-freed fraction
from the distillation of coal tar, boiling in the range of approximately
250 to 280 °C. It consists predominantly of biphenyl and isomeric
diphenylnaphthalenes.)

H

H

H

H

H

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 centrifu-
ging of anthracene oil. It is composed primarily of anthracene, carba-
zole and phenanthrene.)

L 136/186

EN

Official Journal of the European Union

29.5.2007

Substances

Index No

EC No

CAS No

Notes

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
is
anthracene-rich solid (anthracene paste)
composed primarily of
three and four membered aromatic
compounds.)

from anthracene oil.

two,

It

Residues (coal tar), anthracene oil distillation; 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 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
anthracene obtained by the crystallisation of anthracene oil from bitu-
minous high temperature tar and boiling in the range of 330 to 350 °
C. It contains chiefly anthracene, carbazole and phenanthrene.)

Anthracene oil, anthracene paste, carbazole fraction; Anthracene oil
fraction

(A complex combination of hydrocarbons from the distillation of
anthracene obtained by crystallisation of anthrancene oil from bitumi-
nous coal high temperature tar and boiling in the approximate range
of 350 to 360 °C.
It contains chiefly anthracene, carbazole and
phenanthrene.)

Anthracene oil, anthracene paste, distillation lights; Anthracene oil
fraction

(A complex combination of hydrocarbons from the distillation of
anthracene obtained by crystallisation of anthracene oil from bitumi-
nous light temperature tar and boiling in the range of approximately
It contains chiefly trinuclear aromatics and their
290 to 340 °C.
dihydro derivatives.)

648-106-00-1

295-275-9

91995-15-2

J, M

648-107-00-7

295-276-4

91995-16-3

J, M

648-108-00-2

295-278-5

91995-17-4

J, M

Tar oils, coal, low-temperature; 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
hydrocarbons, phenolic compounds and aromatic nitrogen bases
boiling in the range of approximately 160 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-tempera-
ture (less than 700 °C) destructive distillation of coal. It consists predo-
minantly of a mixture of monohydric and dihydric phenols.)

Distillates (coal tar), light oils, alkaline extracts; 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 alkaline; 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.)

29.5.2007

EN

Official Journal of the European Union

L 136/187

Substances

Index No

EC No

CAS No

Notes

Distillates (coal tar), naphthalene oils, alkaline extracts; 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
phenols

residues (coal),

tar oil alkaline, carbonated,

limed; Crude

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 tar distillate. Composed
primarily of phenol and phenol homologs.)

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.)

Tar acids, distillation 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 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 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, recov-
ered 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
distillation 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 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.)

L 136/188

EN

Official Journal of the European Union

29.5.2007

Substances

Index No

EC No

CAS No

Notes

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 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 distil-
late boiling in the range of approximately 200 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

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 deriva-
tives.)

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, distillation residues; Distillate bases

648- 133 -00-9

274-544-0

92062-29-8

J, M

(The distillation residue remaining after the distillation of the neutra-
lised, acid-extracted base-containing tar fractions obtained by the distil-
lation 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 approxi-
mately 70 to 120 °C.)

Hydrocarbon oils, arom., mixed with polyethylene, pyrolysed, light oil
fraction; Heat treatment products

(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 to 120 °C.)

Hydrocarbon oils, arom., mixed with polystyrene, pyrolysed, light oil
fraction; 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 to 210 °C.)

Extract residues (coal), tar oil alkaline, naphthalene distillation residues;
Naphthalene 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.)

648-134-00-4

309-745-9

100801-63-6

J, M

648-135-00-X

309-748-5

100801-65-8

J, M

648-136-00-5

309-749-0

100801-66-9

J, M

648-137-00-0

277-567-8

736665-18-6

J, M

29.5.2007

EN

Official Journal of the European Union

L 136/189

Substances

Index No

EC No

CAS No

Notes

Creosote oil, low-boiling distillate; Wash oil

648-138-00-6

274-566-4

70321-80-1

H

(The low-boiling distillation fraction obtained from the high tempera-
ture 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.)

Tar acids, cresylic, sodium salts, caustic solutions.; 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 deriva-
tives.)

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), liquid solvent extraction;

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, liquid solvent extraction solution.;

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
sulfur
hydrocarbons,
compounds, phenolic and other aromatic oxygen compounds and
their alkyl derivatives.)

compounds,

aromatic

aromatic

nitrogen

Coal liquids, liquid solvent extraction;

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), liquid solvent extraction, primary;

648-148-00-0

302-688-0

94114-52-0

J

J

(The liquid product of condensation of vapours emitted during the
in a liquid solvent and boiling in the range of
digestion of coal
approximately 30 to 300 °C. Composed primarily of partly hydroge-
nated 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.)

L 136/190

EN

Official Journal of the European Union

29.5.2007

Substances

Index No

EC No

CAS No

Notes

Distillates (coal), solvent extraction, hydrocracked;

648-149-00-6

302-689-6

94114-53-1

(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 to 300 °C.
Composed primarily of
and
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.)

aromatic, hydrogenated aromatic

Naphtha (coal), solvent extraction, hydrocracked;

648-150-00-1

302-690-1

94114-54-2

(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 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 extraction, hydrocracked naphtha;

648-151-00-7

302-691-7

94114-55-3

(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 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 extraction, hydrocracked middle;

648-152-00-2

302-692-2

94114-56-4

(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 to 300 °C.
Composed primarily of two-ring aromatic, hydrogenated aromatic and
their alkyl derivatives and alkanes having
naphthenic compounds,
carbon numbers predominantly in the range of C9
through C14.
Nitrogen, sulfur and oxygen-containing compounds are also present.)

Distillates
middle;

(coal),

solvent

extraction, hydrocracked hydrogenated

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
approximately 180 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
coal.
Composed primarily of C6-10 hydrocarbons.)

than 700 °C) destructive distillation of

(less

Extracts (petroleum), light naphthenic distillate solvent

649-001-00-3

265-102-1

64742-03-6

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

J

J

J

J

J

J

H

H

H

29.5.2007

EN

Official Journal of the European Union

L 136/191

Substances

Index No

EC No

CAS No

Notes

H

H

H

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
to six-membered
condensed ring aromatic hydrocarbons.)

four-

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
distillation 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 to 600 °C. This stream is likely to contain 5 wt % more of four-
to six-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 hydrocar-
bons having carbon numbers predominantly in the range of C15
through C35 and boiling in the range of approximately 260 to 500 °C.
This stream is likely to contain 5 wt % or more of four- to six-
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
fraction from distillation of the products from a catalytic cracking
process. It consists of hydrocarbons having carbon numbers predomi-
nantly greater than C20 and boiling above approximately 350 °C. This
stream is likely to contain 5 wt % or more of four- to six-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
fraction 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.)

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
from a thermal cracking
fraction from distillation of
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.)

the product

L 136/192

EN

Official Journal of the European Union

29.5.2007

Substances

Index No

EC No

CAS No

Notes

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 to 480 °C. This stream is likely to contain 5 wt % or more or
four- to six-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 to
600 °C. This stream is likely to contain 5 wt % or more of four- to
six-membered condensed ring aromatic hydrocarbons.)

Residues (petroleum) hydrodesulphurised atmospheric tower; Heavy
fuel oil

(A complex combination of hydrocarbons obtained by treating an
atmospheric tower residuum with hydrogen in the presence of a cata-
lyst 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
to six-membered
condensed ring aromatic hydrocarbons.)

four-

649-016-00-5

265-181-2

64742-78-5

Gas oils (petroleum), hydrodesulphurised heavy vacuum; Heavy fuel oil

649-017-00-0

265-189-6

64742-86-5

(A complex combination of hydrocarbons obtained from a catalytic
hydrodesulphurisation process.
It consists of hydrocarbons having
carbon numbers predominantly in the range of C20 through C50 and
boiling in the range of approximately 350 to 600 °C. This stream is
likely to contain 5 wt % or more of four- to six-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 predomi-
nantly of unsaturated hydrocarbons having carbon numbers predomi-
nantly greater than C14 and boiling above approximately 260 °C. This
stream is likely to contain 5 wt % or more of four- to six-membered
condensed ring aromatic hydrocarbons.)

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
to six-membered
condensed ring aromatic hydrocarbons.)

four-

29.5.2007

EN

Official Journal of the European Union

L 136/193

Substances

Index No

EC No

CAS No

Notes

Clarified oils (petroleum), hydrodesulphurised catalytic cracked; Heavy
fuel oil

(A complex combination of hydrocarbons obtained by treating cata-
lytic 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 four- to six-membered condensed ring aromatic hydrocarbons.)

649-020-00-7

269-782-0

68333-26-6

Distillates
cracked; Heavy fuel oil

(petroleum), hydrodesulphurised intermediate

catalytic

649-021-00-2

269-783-6

68333-27-7

(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 hydrocar-
bons having carbon numbers predominantly in the range of C11
through C30 and boiling in the range of approximately 205 to 450 °C.
It contains a relatively large proportion of tricyclic aromatic hydrocar-
bons.)

Distillates (petroleum), hydrodesulphurised 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 hydrocar-
bons having carbon numbers predominantly in the range of C15
through C35 and boiling in the range of approximately 260 to 500 °C.
This stream is likely to contain 5 wt % or more of four- to six-
membered condensed ring aromatic hydrocarbons.)

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 distillation;
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

Residues (petroleum), heavy coker gas oil and vacuum gas oil; Heavy
fuel oil

(A complex combination of hydrocarbons produced as the residual
fraction from the distillation of heavy coker gas oil and vacuum gas
oil. It predominantly consists of hydrocarbons having carbon numbers
predominantly 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
fraction from the distillation of heavy coker gas oil and light vacuum
gas oil.
It consists predominantly of hydrocarbons having carbon
numbers predominantly greater than C13 and boiling above approxi-
mately 230 °C.)

L 136/194

EN

Official Journal of the European Union

29.5.2007

Substances

Index No

EC No

CAS No

Notes

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 the atmospheric distillation of crude oil. It consists of hydrocar-
bons 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 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 m2s-1 at 37,7
°C to a maximum of 197 10-5 m2s-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
residual fraction from the topping plant distillation of crude oil. It is
the residuum 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
predominantly in the range of C7 through C35 and boiling in the range
of approximately 121 to 510 °C.)

Residues (petroleum), coker scrubber, Condensed-ring-arom.-contg.;
Heavy fuel oil

(A very complex combination of hydrocarbons produced as the resi-
dual
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 four- to six-membered condensed ring
aromatic hydrocarbons.)

649-033-00-8

272-187-9

68783-13-1

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
distillation 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
distillation of the residuum from atmospheric distillation of crude oil.
It consists of hydrocarbons having carbon numbers predominantly in
the range of C14 through C42 and boiling in the range of approximately
250 to 545 °C. This stream is likely to contain 5 wt % or more of
four- to six-membered condensed ring aromatic hydrocarbons.)

29.5.2007

EN

Official Journal of the European Union

L 136/195

Substances

Index No

EC No

CAS No

Notes

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
distillation of the residuum from atmospheric distillation of crude oil.
It consists of hydrocarbons having carbon numbers predominantly in
the range of C11 through C35 and boiling in the range of approximately
250 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
distillation 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 to 600 °C. This stream is likely to contain 5 wt % or more of
four- to six-membered condensed ring aromatic hydrocarbons.)

Gas oils (petroleum), hydrodesulphurised coker heavy vacuum; Heavy
fuel oil

(A complex combination of hydrocarbons obtained by hydrodesul-
phurisation of heavy coker distillate stocks. It consists predominantly
of hydrocarbons having carbon numbers predominantly in the range
C18 to C44 and boiling in the range of approximately 304 to 548 °C.
Likely to contain 5 wt % or more of four- to six-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 produc-
tion 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
hydrocarbons having carbon numbers predominantly greater than C24
and boiling above approximately 390 °C.)

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 predomi-
nantly 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
fraction 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 approxi-
mately 200 °C.)

Distillates
(petroleum),
degraded; Heavy fuel oil

intermediate

catalytic

cracked,

thermally

649-044-00-8

295-990-6

92201-59-7

(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 to 450 °C. This stream is likely to
contain organic sulfur compounds.)

L 136/196

EN

Official Journal of the European Union

29.5.2007

Substances

Index No

EC No

CAS No

Notes

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 fractionation 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 predomi-
nantly 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 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
fraction 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 to 400 °C. This stream is
likely to contain 5 wt % or more of four- or six-membered condensed
ring aromatic hydrocarbons.)

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 cate-
gory 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 depropaniser overhead,
C3-rich acid-free; Petroleum gas
(A complex combination of hydrocarbons obtained from fractionation
of catalytic cracked hydrocarbons and treated to remove acidic impuri-
ties. 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 predomi-
nantly of aliphatic hydrocarbons having carbon numbers predomi-
nantly 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
hydrocarbons having carbon numbers in the range of C1 through C6,
predominantly C1 through C5.)

649-064-00-7

270-757-1

68477-75-8

K

29.5.2007

EN

Official Journal of the European Union

L 136/197

Substances

Index No

EC No

CAS No

Notes

Gases (petroleum), catalytic polymd. naphtha stabiliser overhead, C2-4-
rich; Petroleum gas

(A complex combination of hydrocarbons obtained from the fractiona-
tion stabilisation of catalytic polymerised naphtha.
It consists of
aliphatic 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 hydrocar-
bons having carbon numbers in the range of C1 through C6, predomi-
nantly 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 alkylation 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.)

649-065-00-2

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

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 atmo-
spheric distillation of a butane-butylene stream. It consists of aliphatic
hydrocarbons 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; Petro-
leum gas

(A complex combination of hydrocarbons obtained by fractionation of
miscellaneous hydrocarbon streams.
It consists predominantly of
hydrocarbons having carbon numbers in the range of C1 through C4,
predominantly propane.)

649-073-00-6

270-777-0

68477-94-1

K

L 136/198

EN

Official Journal of the European Union

29.5.2007

Substances

Index No

EC No

CAS No

Notes

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
hydrocarbons having carbon numbers predominantly in the range of
C2 through C4.)

Gases (petroleum), isomerised naphtha fractionator, C4-rich, hydrogen
sulfide-free; Petroleum gas

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
predominantly 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 stabilisa-
tion of catalytic cracked naphtha. It consists predominantly of hydro-
carbons having carbon numbers predominantly in the range of C1
through C6.)

Tail gas (petroleum), catalytic cracker, catalytic reformer and hydrode-
sulphuriser combined fractionater; Petroleum gas

(A complex combination of hydrocarbons obtained from the fractiona-
tion of products from catalytic cracking, catalytic reforming and hydro-
desulphurising processes treated to remove acidic impurities. It consists
predominantly 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 fractiona-
tion stabilisation of catalytic reformed naphtha. It consists predomi-
nantly of hydrocarbons having carbon numbers predominantly in the
range of C1 through C4.)

Tail gas (petroleum), saturate gas plant mixed stream, C4-rich; Petro-
leum gas

(A complex combination of hydrocarbons obtained from the fractiona-
tion stabilisation of straight-run naphtha, distillation tail gas and cata-
lytic 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
stabiliser tail gas. It consists predominantly of hydrocarbons having
carbon numbers in the range of C1
through C5, predominantly
methane and ethane.)

649-077-00-8

270-803-0

68478-22-8

K

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.)

29.5.2007

EN

Official Journal of the European Union

L 136/199

Substances

Index No

EC No

CAS No

Notes

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),
Petroleum gas

full-range straight-run naphtha dehexaniser off;

649-084-00-6

271-000-8

68513-15-5

K

(A complex combination of hydrocarbons obtained by the fractiona-
tion 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.)

Gases (petroleum), light straight-run naphtha stabiliser off; Petroleum
gas

(A complex combination of hydrocarbons obtained by the stabilisation
of light straight-run naphtha. It consists of saturated aliphatic hydro-
carbons 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.
consists of hydrocarbons having carbon
numbers in the range of C4 through C5, predominantly butane, and
boiling in the range of approximately - 11,7 to 27,8 °C.)

It

Hydrocarbons, C1-4, sweetened; Petroleum gas
(A complex combination of hydrocarbons obtained by subjecting
hydrocarbon 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 to - 0,5 °C.)

Hydrocarbons, C1-3; Petroleum gas
(A complex combination of hydrocarbons having carbon numbers
predominantly in the range of C1 through C3 and boiling in the range
of approximately - 164 to - 42 °C.)

649-085-00-1

271-001-3

68513-16-6

K

649-086-00-7

271-002-9

68513-17-7

K

649-087-00-2

271-010-2

68513-66-6

K

649-089-00-3

271-038-5

68514-36-3

K

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 hydro-
carbons 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

K

K

K

K

L 136/200

EN

Official Journal of the European Union

29.5.2007

Substances

Index No

EC No

CAS No

Notes

Gases (petroleum), alkylation feed; Petroleum gas

649-095-00-6

271-737-5

68606-27-9

K

(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.)

Gases (petroleum), depropaniser bottoms fractionation off; Petroleum
gas

(A complex combination of hydrocarbons obtained from the fractiona-
tion of depropaniser bottoms. It consists predominantly of butane,
isobutane and butadiene.)

649-096-00-1

271-742-2

68606-34-8

K

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.)

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 predomi-
nantly 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
petroleum distillate to a sweetening process to convert mercaptans or
to remove acidic impurities. It consists predominantly of saturated and
unsaturated hydrocarbons having carbon numbers predominantly in
the range of C2 through C4 and boiling in the range of approximately
- 51 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 fractiona-
tion 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 fractiona-
tion of combined naphtha streams. It consists of saturated aliphatic
hydrocarbons having carbon numbers predominantly in the range of
C1 through C5.)

Gases (petroleum),
off; Petroleum gas

light straight run gasoline fractionation stabiliser

649-102-00-2

272-878-5

68919-05-1

K

(A complex combination of hydrocarbons obtained by the fractiona-
tion of
light straight-run gasoline. It consists of saturated aliphatic
hydrocarbons having carbon numbers predominantly in the range of
C1 through C5.)

Gases (petroleum), naphtha unifiner desulphurisation stripper off;
Petroleum gas

(A complex combination of hydrocarbons produced by a naphtha
unifiner desulphurisation process and stripped from the naphtha
product. It consists of saturated aliphatic hydrocarbons having carbon
numbers predominantly in the range of C1 through C4.)

649-103-00-8

272-879-0

68919-06-2

K

29.5.2007

EN

Official Journal of the European Union

L 136/201

Substances

Index No

EC No

CAS No

Notes

Gases (petroleum), straight-run naphtha catalytic reforming off; Petro-
leum 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; Petro-
leum gas

(A complex combination of hydrocarbons produced by the fractiona-
tion of the charge to the C3-C4 splitter. It consists predominantly of C3
hydrocarbons.)

649-104-00-3

272-882-7

68919-09-5

K

649-105-00-9

272-893-7

68919-20-0

K

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 fractiona-
tion 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

(A complex combination of hydrocarbons obtained from fractionation
of catalytic cracked naphtha. It consists of hydrocarbons having carbon
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 fractiona-
tion of catalytic cracked naphtha and distillate. It consists predomi-
nantly of hydrocarbons having carbon numbers predominantly in the
range of C1 through C4.)

Tail gas (petroleum), thermal-cracked distillate, gas oil and naphtha
absorber; Petroleum gas

(A complex combination of hydrocarbons obtained from the separa-
It consists
tion of thermal-cracked distillates, naphtha and gas oil.
predominantly of hydrocarbons having carbon numbers predominantly
in the range of C1 through C6.)

Tail gas (petroleum), thermal cracked hydrocarbon fractionation stabi-
liser, petroleum coking; Petroleum gas

(A complex combination of hydrocarbons obtained from the fractiona-
tion stabilisation of thermal cracked hydrocarbons from a petroleum
coking process. It consists of hydrocarbons having carbon numbers
predominantly in the range of C1 through C6.)

649-107-00-X

273-169-3

68952-76-1

K

649-108-00-5

273-170-9

68952-77-2

K

649-109-00-0

273-175-6

68952-81-8

K

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 hydrocar-
bons having a carbon number predominantly of C4.)

L 136/202

EN

Official Journal of the European Union

29.5.2007

Substances

Index No

EC No

CAS No

Notes

Gases (petroleum), straight-run naphtha catalytic reformer stabiliser
overhead; Petroleum gas

(A complex combination of hydrocarbons obtained by the catalytic
reforming of straight-run naphtha and the fractionation of the total
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

649-115-00-3

295-404-9

92045-22-2

K

K

K

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 approxi-
mately - 70 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 to 5 °C.)

Petroleum gases, liquefied, sweetened, C4 fraction; Petroleum gas
(A complex combination of hydrocarbons obtained by subjecting a
liquified petroleum gas mix to a sweetening process to oxidise mercap-
tans or to remove acidic impurities. It consists predominantly of C4
saturated and unsaturated hydrocarbons.)

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 extraction, C3-5 and C3-5 unsaturated., 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

(Off gases produced by the benzene unit.
hydrogen. Carbon monoxide
numbers predominantly in the range of C1 through C6,
benzene, may also be present.)

It consists primarily of
and hydrocarbons having carbon
including

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
It consists primarily of hydrogen with
various small amounts of carbon monoxide and hydrocarbons having
carbon numbers in the range of C1 through C6.)

the benzene unit.

29.5.2007

EN

Official Journal of the European Union

L 136/203

Substances

Index No

EC No

CAS No

Notes

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
hydrocarbons having carbon numbers predominantly in the range of
C1 through C5.)

Gases (petroleum), catalytic reformed naphtha stripper overheads;
Refinery gas

(A complex combination of hydrocarbons obtained from stabilisation
of catalytic reformed naphtha. It consists of hydrogen and saturated
hydrocarbons 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 may also
contain various small amounts of carbon monoxide, carbon dioxide,
nitrogen, and hydrocarbons having carbon numbers predominantly in
the range of C1 through C6.)

It consists primarily of hydrogen.

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 hydro-
carbons having carbon numbers in the range of C1 through C5 and
hydrogen.)

649-124-00-2

270-759-2

68477-77-0

K

649-125-00-8

270-761-3

68477-80-5

K

649-126-00-3

270-762-9

68477-81-6

K

Gases
Refinery gas

(petroleum), C6-8 catalytic reformer

recycle, hydrogen-rich;

649-127-00-9

270-763-4

68477-82-7

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,
such as
and ethylene.
methane, ethane, and ethylene with small amounts of hydrogen,
nitrogen and carbon monoxide.)

contains predominantly hydrocarbons

It

649-128-00-4

270-766-0

68477-84-9

K

K

Gases (petroleum), dry sour, gas-concentration-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 concentration reabsorber distillation; Refinery
gas

(A complex combination of hydrocarbons produced by distillation of
products from combined gas streams in a gas concentration reab-
sorber.
It consists predominantly of hydrogen, carbon monoxide,
carbon dioxide, nitrogen, hydrogen sulphide and hydrocarbons having
carbon numbers in the range of C1 through C3.)

649-130-00-5

270-776-5

68477-93-0

K

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
hydrogen rich stream.
It consists of hydrogen, carbon monoxide,
nitrogen, and methane with small amounts of C2 hydrocarbons.)

L 136/204

EN

Official Journal of the European Union

29.5.2007

Substances

Index No

EC No

CAS No

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
It consists primarily of hydrogen with various small
by chilling.
amounts of carbon monoxide, nitrogen, methane, and C2 hydrocar-
bons.)

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

It consists
(A complex combination obtained from the reformers.
primarily of hydrogen with various
small amounts of carbon
monoxide and aliphatic hydrocarbons having carbon numbers predo-
minantly 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 hydrocar-
bons 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 satu-
rated aliphatic hydrocarbons having carbon numbers predominantly in
the range of C2 through C5.)

Gases (petroleum), reforming hydrotreater make-up, hydrogen-rich;
Refinery gas

(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.)

649-138-00-9

270-788-0

68478-04-6

K

Gases (petroleum), thermal cracking distillation; 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.)

29.5.2007

EN

Official Journal of the European Union

L 136/205

Substances

Index No

EC No

CAS No

Notes

Tail gas (petroleum), catalytic cracker refractionation absorber; Refinery
gas

(A complex combination of hydrocarbons obtained from refractiona-
tion 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 hydro-
carbons 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 stabilisa-
tion of catalytic reformed naphtha. It consists of hydrogen and hydro-
carbons having carbon numbers predominantly in the range of C1
through C6.)

Tail gas (petroleum), cracked distillate hydrotreater separator; Refinery
gas

(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.)

649-143-00-6

270-809-3

68478-29-5

K

gas

Tail
separator; Refinery gas

(petroleum),

hydrodesulphurised

straight-run

naphtha

649-144-00-1

270-810-9

68478-30-8

K

(A complex combination of hydrocarbons obtained from hydrodesul-
phurisation of straight-run naphtha. It consists of hydrogen and satu-
rated aliphatic hydrocarbons having carbon numbers predominantly in
the range of C1 through C6.)

Gases (petroleum), catalytic reformed straight-run naphtha stabiliser
overheads; 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.)

Gases (petroleum), reformer effluent high-pressure flash drum off;
Refinery gas

(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.)

649-145-00-7

270-999-8

68513-14-4

K

649-146-00-2

271-003-4

68513-18-8

K

Gases (petroleum), reformer effluent
Refinery gas

low-pressure flash drum off;

649-147-00-8

271-005-5

68513-19-9

K

(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.)

L 136/206

EN

Official Journal of the European Union

29.5.2007

Substances

Index No

EC No

CAS No

Notes

Gases (petroleum), oil refinery gas distillation 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
depentanising. It consists primarily of hydrogen, ethane and propane
with 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.)

Gases (petroleum), secondary absorber off, fluidised catalytic cracker
overheads fractionator; Refinery gas

(A complex combination produced by the fractionation of the over-
head products from the catalytic cracking process in the fluidised cata-
lytic cracker.
It consists of hydrogen, nitrogen, and hydrocarbons
having carbon numbers predominantly in the range of C1 through C3.)

649-149-00-9

271-623-5

68602-82-4

K

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 hydrocracking process reactor effluent. It consists predominantly
of hydrogen and saturated hydrocarbons having carbon numbers
predominantly 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
operations. 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
It consists of hydrogen and saturated
aliphatic hydrocarbons having carbon numbers predominantly in the
range of C2 through C4.)

to aromatics.

Gases (petroleum), hydrotreated sour kerosine depentaniser stabiliser
off; Refinery gas

(The complex combination obtained from the depentaniser stabilisa-
tion 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

29.5.2007

EN

Official Journal of the European Union

L 136/207

Substances

Index No

EC No

CAS No

Notes

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.)

Gases (petroleum), distillate unifiner desulphurisation stripper off;
Refinery gas

(A complex combination stripped from the liquid product of
unifiner desulphurisation process.
methane, ethane, and propane.)

the
It consists of hydrogen sulphide,

Gases (petroleum), fluidised catalytic cracker fractionation off; Refinery
gas

(A complex combination produced by the fractionation of the over-
head 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.)

Gases (petroleum),
absorber off; Refinery gas

fluidised catalytic cracker scrubbing secondary

(A complex combination produced by scrubbing the overhead gas
from the fluidised catalytic cracker. It consists of hydrogen, nitrogen,
methane, ethane and propane.)

(petroleum), heavy distillate hydrotreater desulphurisation

Gases
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.)

649-157-00-2

272-873-8

68919-01-7

K

649-158-00-8

272-874-3

68919-02-8

K

649-159-00-3

272-875-9

68919-03-9

K

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 distillation; Refinery gas

649-162-00-X

272-881-1

68919-08-4

K

(A complex combination produced from the first tower used in the
distillation of crude oil. It consists of nitrogen and saturated aliphatic
hydrocarbons having carbon numbers predominantly in the range of
C1 through C5.)

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.)

L 136/208

EN

Official Journal of the European Union

29.5.2007

Substances

Index No

EC No

CAS No

Notes

Tail gas (petroleum), catalytic hydrodesulphurised naphtha separator;
Refinery gas

(A complex combination of hydrocarbons obtained from the hydrode-
sulphurisation of naphtha. It consists of hydrogen, methane, ethane,
and propane.)

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.)

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.)

Gases (petroleum), crude distillation and catalytic cracking; Refinery
gas

(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.)

649-165-00-6

273-173-5

68952-79-4

K

649-166-00-1

273-174-0

68952-80-7

K

649-167-00-7

273-269-7

68955-33-9

K

649-168-00-2

273-563-5

68989-88-8

K

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
diethanolamine.
It consists predominantly of hydrogen sulphide,
hydrogen and aliphatic hydrocarbons having carbon numbers in the
range of C1 through C5.)

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 predo-
minantly of hydrogen, hydrogen sulphide and aliphatic hydrocarbons
having carbon numbers predominantly in the range of C1 through C3.)

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 predomi-
nantly of hydrogen and aliphatic hydrocarbons having carbon
numbers predominantly 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

the hydrogenation reaction.

(A complex combination of gases obtained from flash of the effluents
after
consists predominantly of
hydrogen and aliphatic hydrocarbons having carbon numbers predo-
minantly in the range of C1 through C6.)

It

29.5.2007

EN

Official Journal of the European Union

L 136/209

Substances

Index No

EC No

CAS No

Notes

Gases (petroleum), naphtha steam cracking high-pressure residual;
Refinery gas

(A complex combination obtained as a mixture of the non-conden-
sable 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 hydrocarbons having carbon numbers predominantly in the
range of C1 through C5 with which natural gas may also be mixed.)

649-173-00-X

295-401-2

92045-19-7

K

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 paraf-
finic 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 perco-
lation process to remove the trace amounts of polar compounds and
impurities present. It consists predominantly of branched chain hydro-
carbons 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 to - 1 °C.)

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
It consists predominantly of hydrocarbons having carbon
naphtha.
numbers in the range of C1 through C4.)

Tail gas (petroleum), catalytic polymerisation naphtha fractionation
stabiliser; Petroleum gas

(A complex combination of hydrocarbons from the fractionation stabi-
lisation products from polymerisation of naphtha. It consists predomi-
nantly of hydrocarbons having carbon numbers in the range of C1
through C4.)

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 predomi-
nantly of hydrocarbons having carbon numbers predominantly in the
range of C1 through C4.)

649-177-00-1

268-629-5

68131-75-9

K

649-178-00-7

269-617-2

68307-98-2

K

649-179-00-2

269-618-8

68307-99-3

K

649-180-00-8

269-619-3

68308-00-9

K

L 136/210

EN

Official Journal of the European Union

29.5.2007

Substances

Index No

EC No

CAS No

Notes

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 predominantly in the range of C1 through C6.)

649-181-00-3

269-620-9

68308-01-0

K

gas

Tail
straight-run
(petroleum),
hydrogen sulphide-free; Petroleum gas

distillate

hydrodesulphuriser,

649-182-00-9

269-630-3

68308-10-1

K

(A complex combination of hydrocarbons obtained from catalytic
hydrodesulphurisation 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.)

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 distilla-
tion of products from the catalytic cracking of gas oil. It consists
predominantly 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 predo-
minantly of hydrocarbons having carbon numbers predominantly in
the range of C1 through C5.)

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
hydrocarbon having carbon numbers predominantly in the range of C1
through C4.)

Tail gas (petroleum), hydrodesulphurised distillate and hydrodesul-
phurised 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.)

Tail gas (petroleum), hydrodesulphurised vacuum gas oil stripper,
hydrogen sulphide-free; Petroleum gas

(A complex combination of hydrocarbons obtained from stripping
stabilisation 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
stabilisation of light straight-run naphtha and from which hydrogen
sulphide has been removed by amine treatment. It consists predomi-
nantly of hydrocarbons having carbon numbers predominantly in the
range of C1 through C5.)

649-186-00-0

269-626-1

68308-06-5

K

649-187-00-6

269-627-7

68308-07-6

K

649-188-00-1

269-629-8

68308-09-8

K

29.5.2007

EN

Official Journal of the European Union

L 136/211

Substances

Index No

EC No

CAS No

Notes

Tail gas (petroleum), propane-propylene alkylation feed prep deetha-
niser; Petroleum gas

(A complex combination of hydrocarbons obtained from the distilla-
tion of the reaction products of propane with propylene. It consists of
hydrocarbons having carbon numbers predominantly in the range of
C1 through C4.)

Tail gas (petroleum), vacuum gas oil hydrodesulphuriser, hydrogen
sulphide-free; Petroleum gas

(A complex combination of hydrocarbons obtained from catalytic
hydrodesulphurisation of vacuum gas oil and from which hydrogen
sulphide has been removed by amine treatment. It consists predomi-
nantly of hydrocarbons having carbon numbers predominantly in the
range of C1 through C6.)

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 hydrocar-
bons 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

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.)

Fuel gases, crude oil of distillates; Petroleum gas

649-198-00-6

270-670-9

68476-29-9

(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
predominantly in the range of C3 through C7 and boiling in the range
of approximately - 40 °C to 80 °C.)

K

K

K

K

K

K

K

K

K

K

L 136/212

EN

Official Journal of the European Union

29.5.2007

Substances

Index No

EC No

CAS No

Notes

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

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 distilla-
tion 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 predomi-
nantly 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 hydro-
carbons having carbon numbers in the range of C3 through C5, predo-
minantly C4.)

Gases (petroleum), catalytic-cracked naphtha debutaniser bottoms, C3-5-
rich; Petroleum gas

(A complex combination of hydrocarbons obtained from the stabilisa-
tion of catalytic cracked naphtha. It consists of aliphatic hydrocarbons
having carbon numbers predominantly in the range of C3 through C5.)

Tail gas (petroleum), isomerised naphtha fractionation stabiliser; Petro-
leum gas

(A complex combination of hydrocarbons obtained from the fractiona-
tion stabilisation products from isomerised naphtha. It consists predo-
minantly of hydrocarbons having carbon numbers predominantly in
the range of C1 through C4.)

649-208-00-9

270-752-4

68477-71-4

K

649-209-00-4

270-754-5

68477-72-5

K

649-210-00-X

269-628-2

68308-08-7

K

29.5.2007

EN

Official Journal of the European Union

L 136/213

Substances

Index No

EC No

CAS No

Notes

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
hydrocarbons 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
petroleum 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.)

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 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 (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 hydrocarbons 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.)

L 136/214

EN

Official Journal of the European Union

29.5.2007

Substances

Index No

EC No

CAS No

Notes

Distillates (petroleum), chemically neutralised middle; Gas oil — unspe-
cified

(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

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 perco-
lation process to remove the trace amounts of polar compounds and
impurities present. 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.)

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 — unspeci-
fied

(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 (petroleum), catalytic reformer fractionator residue, high-
boiling; Gas oil — unspecified

(A complex combination of hydrocarbons from the distillation of cata-
lytic reformer fractionator residue. It boils in the range of approxi-
mately 343 °C to 399 °C.)

649-223-00-0

265-183-3

64742-80-9

N

649-228-00-8

270-719-4

68477-29-2

N

Distillates (petroleum), catalytic reformer fractionator residue,
mediate-boiling; Gas oil — unspecified

inter-

649-229-00-3

270-721-5

68477-30-5

N

(A complex combination of hydrocarbons from the distillation of cata-
lytic reformer fractionator residue. It boils in the range of approxi-
mately 288 °C to 371 °C.)

Distillates (petroleum), catalytic reformer fractionator residue,
boiling; Gas oil — unspecified

low-

649-230-00-9

270-722-0

68477-31-6

N

(The complex combination of hydrocarbons from the distillation of
catalytic reformer fractionator residue. It boils approximately below
288 °C.)

29.5.2007

EN

Official Journal of the European Union

L 136/215

Substances

Index No

EC No

CAS No

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,
centrifugation, atmospheric distillation, vacuum distillation, acidifica-
tion, neutralisation and clay treatment. It consists predominantly of
hydrocarbons having carbon numbers predominantly in the range of
C10 through C20.)

Distillates (petroleum) catalytic reformer, heavy aromatic concentrate;
Gas oil — unspecified

(A complex combination of hydrocarbons obtained from the distilla-
tion of a catalytically reformed petroleum cut. It consists predomi-
nantly of aromatic hydrocarbons having carbon numbers predomi-
nantly 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
approximately 190 °C to 330 °C.)

Naphtha (petroleum), solvent-refined hydrodesulphurised heavy; Gas
oil — unspecified

649-234-00-0

307-035-3

97488-96-5

649-235-00-6

307-659-6

97675-85-9

N

N

Hydrocarbons, C16-20, hydrotreated middle distillate, distillation 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 distillate with hydrogen. It consists predominantly of hydrocar-
bons 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.)

Hydrocarbons, C12-20, hydrotreated paraffinic, distillation lights; Gas oil
— unspecified

(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 predo-
minantly 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 — unspe-
cified

(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.)

649-236-00-1

307-660-1

97675-86-0

N

649-237-00-7

307-757-9

97722-08-2

N

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 redistilla-
tion 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.)

L 136/216

EN

Official Journal of the European Union

29.5.2007

Substances

Index No

EC No

CAS No

Notes

Distillates (petroleum), carbon-treated light paraffinic; Gas oil —
unspecified

(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 hydrocarbons 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
constituents and impurities. It consists predominantly of hydrocarbons
having carbon numbers predominantly in the range of C16 through
C36.)

Distillates (petroleum), intermediate paraffinic, clay-treated; Gas oil —
unspecified

(A complex combination of hydrocarbons obtained by the treatment
of petroleum with bleaching earth for the removal of trace polar
constituents 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

649-241-00-9

309-669-6

100683-99-6

N

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
predominantly 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
predominantly 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
treatment 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.)

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 satu-
rated straight and branched hydrocarbons having carbon numbers
predominantly 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 predomi-
nantly of saturated straight and branched chain hydrocarbons having
carbon numbers predominantly greater than C20.)

29.5.2007

EN

Official Journal of the European Union

L 136/217

Substances

Index No

EC No

CAS No

Notes

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 satu-
rated straight and branched chain hydrocarbons having carbon
numbers predominantly 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 hydrocarbons 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 predominantly 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 predominantly 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 predominantly greater than C12.)

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
petroleum 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
predominantly 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
petrolatum.)

L 136/218

EN

Official Journal of the European Union

29.5.2007

Substances

Index No

EC No

CAS No

Notes

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 Al2O3 to remove polar components and impurities. It
consists predominantly of saturated, crystalline, and liquid hydrocar-
bons having carbon numbers predominantly greater than C25.)

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, micro-
crystalline, and liquid hydrocarbons having carbon numbers predomi-
nantly 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
hydrocarbons 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
petrolatum 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.)

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 predomi-
nantly 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 distil-
It consists of hydrocarbons having carbon
lation of natural gas.
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 approxi-
mately 20 °C to 135 °C.)

29.5.2007

EN

Official Journal of the European Union

L 136/219

Substances

Index No

EC No

CAS No

Notes

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
approximately 65 °C to 230 °C.)

Naphtha
naphtha

(petroleum),

full-range

straight-run; Low boiling point

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
approximately - 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 distilla-
tion of crude oil or natural gasoline. It consists predominantly of satu-
rated 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
predominantly in the range of C2 through C7 and boiling in the range
of approximately - 88 °C to 99 °C.)

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 approxi-
mately 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 distilla-
tion of naphtha streams from various refinery processes. It consists of
hydrocarbons having carbon numbers predominantly in the range of
C5 through C12 and boiling in the range of approximately 0 °C to
230 °C.)

L 136/220

EN

Official Journal of the European Union

29.5.2007

Substances

Index No

EC No

CAS No

Notes

Distillates (petroleum),
liser overheads; Low boiling point naphtha

light straight-run gasoline fractionation stabi-

(A complex combination of hydrocarbons having carbon numbers
predominantly in the range of C3 through C6.)

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.)

Naphtha (petroleum), full-range alkylate; Low boiling point modified
naphtha

(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
predominantly 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

(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 predo-
minantly branched chain saturated hydrocarbons having carbon
numbers predominantly in the range of C9 through C12 and boiling in
the range of approximately 150 °C to 220 °C.)

649-272-00-8

272-931-2

68921-08-4

P

649-273-00-3

309-945-6

101631-20-3

P

649-274-00-9

265-066-7

64741-64-6

P

649-275-00-4

265-067-2

64741-65-7

P

Naphtha (petroleum),
naphtha

light alkylate; Low boiling point modified

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
predominantly 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),
naphtha

isomerisation; Low boiling point modified

649-277-00-5

265-073-5

64741-70-4

P

(A complex combination of hydrocarbons obtained from catalytic
isomerisation 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-methylpen-
tane.)

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 hydrocarbons 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

29.5.2007

EN

Official Journal of the European Union

L 136/221

Substances

Index No

EC No

CAS No

Notes

Naphtha (petroleum), solvent-refined heavy; Low boiling point modi-
fied naphtha

(A complex combination of hydrocarbons obtained as the raffinate
from a solvent extraction process.
It consists predominantly of
aliphatic hydrocarbons having carbon numbers predominantly in the
range of C7 through C12 and boiling in the range of approximately
90 °C to 230 °C.)

Raffinates (petroleum), catalytic reformer ethylene glycol-water coun-
tercurrent extracts; 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 predomi-
nantly in the range of C6 through C9.)

Raffinates (petroleum), reformer, Lurgi unit-separated; 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 hydrocarbons with various small amounts of aromatic hydro-
carbons having carbon numbers predominantly in the range of C6
through C8.)

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.)

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.)

Naphtha (petroleum), C4-12 butane-alkylate, isooctane-rich; Low boiling
point modified naphtha

(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 isooc-
tane, 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
hydrotreated 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.)

649-279-00-6

265-095-5

64741-92-0

P

649-280-00-1

270-088-5

68410-71-9

P

649-281-00-7

270-349-3

68425-35-4

P

649-282-00-2

271-267-0

68527-27-5

P

649-283-00-8

295-315-5

91995-53-8

P

649-284-00-3

295-430-0

92045-49-3

P

649-285-00-9

295-436-3

92045-55-1

P

Naphtha (petroleum),
modified naphtha

isomerisation, C6-fraction; Low boiling point

649-286-00-4

295-440-5

92045-58-4

P

(A complex combination of hydrocarbons obtained by distillation of a
gasoline which has been catalytically isomerised. It consists predomi-
nantly of hexane isomers boiling in the range of approximately 60 °C
to 66 °C.)

L 136/222

EN

Official Journal of the European Union

29.5.2007

Substances

Index No

EC No

CAS No

Notes

Hydrocarbons, C6-7, naphtha-cracking, solvent-refined; Low boiling
point modified naphtha

649-287-00-X

295-446-8

92045-64-2

P

(A complex combination of hydrocarbons obtained by the sorption of
benzene from a catalytically fully hydrogenated benzene-rich hydro-
that was distillatively obtained from prehydrogenated
carbon cut
cracked naphtha.
and
naphthenic hydrocarbons having carbon numbers predominantly in
the range of C6 through C7 and boiling in the range of approximately
70 °C to 100 °C.)

consists predominantly of paraffinic

It

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 predo-
minantly of saturated hydrocarbons and boiling in the range of
approximately 65 °C to 70 °C.)

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.)

649-288-00-5

309-871-4

101316-67-0

P

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 hydrocar-
bons 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 hydro-
carbons.)

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 hydrocar-
bons having carbon numbers predominantly in the range of C3
through C11 and boiling in a range approximately up to 204 °C.)

Naphtha (petroleum), catalytic cracked light distilled; 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 hydrocar-
bons having carbon numbers predominantly in the range of C1
through C5.)

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.)

649-291-00-1

270-686-6

68476-46-0

P

649-292-00-7

272-185-8

68783-09-5

P

649-293-00-2

295-311-3

91995-50-5

P

29.5.2007

EN

Official Journal of the European Union

L 136/223

Substances

Index No

EC No

CAS No

Notes

Naphtha (petroleum), heavy catalytic cracked, sweetened; Low boiling
point cat-cracked naphtha

(A complex combination of hydrocarbons obtained by subjecting a
catalytic cracked petroleum distillate to a sweetening process to
convert mercaptans or to remove acidic impurities. It consists predo-
minantly 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),
point cat-cracked naphtha

light catalytic cracked sweetened; Low boiling

(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 predo-
minantly of hydrocarbons boiling in a range of approximately 35 °C to
210 °C.)

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 alka-
line 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.)

649-294-00-8

295-431-6

92045-50-6

P

649-295-00-3

295-441-0

92045-59-5

P

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

649-299-00-5

265-065-1

64741-63-5

P

P

Naphtha (petroleum), light catalytic reformed; Low boiling point cat-
reformed naphtha

(A complex combination of hydrocarbons produced from the distilla-
tion of products from a catalytic reforming process. It consists of
hydrocarbons 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 hydrocarbons. 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 distilla-
tion of products from a catalytic reforming process. It consists of
predominantly aromatic hydrocarbons having numbers predominantly
in the range of C7 through C12 and boiling in the range of approxi-
mately 90 °C to 230 °C.)

649-300-00-9

265-070-9

64741-68-0

P

L 136/224

EN

Official Journal of the European Union

29.5.2007

Substances

Index No

EC No

CAS No

Notes

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.)

649-301-00-4

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

649-303-00-5

270-794-3

68478-15-9

P

P

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.)

Naphtha (petroleum), light catalytic reformed, arom.-free; Low boiling
point cat-reformed naphtha

(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.)

Distillates (petroleum), catalytic reformed straight-run naphtha over-
heads; 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.)

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.)

649-304-00-0

270-993-5

68513-03-1

P

649-305-00-6

271-008-1

68513-63-3

P

649-306-00-1

271-058-4

68514-79-4

P

Naphtha (petroleum,
reformed naphtha

full-range reformed; Low boiling point cat-

649-307-00-7

272-895-8

68919-37-9

P

the products from a catalytic reforming process.

(A complex combination of hydrocarbons produced by the distillation
It consists of
of
hydrocarbons having carbon numbers predominantly in the range of
C5 through C12 and boiling in the range of approximately 35 °C to
230 °C.)

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 hydrocar-
bons 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

29.5.2007

EN

Official Journal of the European Union

L 136/225

Substances

Index No

EC No

CAS No

Notes

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 alkyl-
benzenes 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

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
catalytic dehydrogenation of a predominantly naphthenic naphtha. It
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
nonaromatic 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.)

649-312-00-4

297-458-9

93572-29-3

P

649-313-00-X

297-465-7

93572-35-1

P

Hydrocarbons, C5-11, nonaroms.-rich, reforming light
boiling point cat-reformed naphtha

fraction; Low

649-314-00-5

297-466-2

93572-36-2

P

(A complex combination of hydrocarbons obtained by separation from
the platformate-containing fraction.
It consists predominantly of
nonaromatic 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.)

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.)

L 136/226

EN

Official Journal of the European Union

29.5.2007

Substances

Index No

EC No

CAS No

Notes

Naphtha (petroleum), light thermal cracked; Low boiling point ther-
mally cracked naphtha

(A complex combination of hydrocarbons from distillation of products
from a thermal cracking process. It consists predominantly of unsatu-
rated hydrocarbons having carbon numbers predominantly in the
range of C4 through C8 and boiling in the range of approximately –
10 °C to 130 °C.)

Naphtha (petroleum), heavy thermal cracked; Low boiling point ther-
mally cracked naphtha

(A complex combination of hydrocarbons from distillation of products
from a thermal cracking process. It consists predominantly of unsatu-
rated 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 aromatic; 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.)

649-316-00-6

265-075-6

64741-74-8

P

649-317-00-1

265-085-0

64741-83-9

P

649-318-00-7

267-563-4

67891-79-6

P

Distillates (petroleum),
cracked naphtha

light aromatic; Low boiling point thermally

649-319-00-2

267-565-5

67891-80-9

P

(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 hydrocar-
bons with some unsaturated aliphatic hydrocarbons having a carbon
number predominantly of C5. This stream may contain benzene.)

Distillates (petroleum), naphtha-raffinate pyrolyzate-derived, gasoline-
blending; Low boiling point thermally cracked naphtha

(The complex combination of hydrocarbons obtained by the pyrolysis
fractionation at 816 °C of naphtha and raffinate. It consists predomi-
nantly of hydrocarbons having a carbon number of C9 and boiling at
approximately 204 °C.)

Aromatic hydrocarbons, C6-8, naphtha-raffinate pyrolyzate-derived;
Low boiling point thermally cracked naphtha

(A complex combination of hydrocarbons obtained by the fractiona-
tion pyrolysis at 816 °C of naphtha and raffinate. It consists predomi-
nantly of aromatic hydrocarbons having carbon numbers predomi-
nantly in the range of C6 through C8, including benzene.)

Distillates (petroleum),
boiling point thermally cracked naphtha

thermal cracked naphtha and gas oil; Low

(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.)

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

29.5.2007

EN

Official Journal of the European Union

L 136/227

Substances

Index No

EC No

CAS No

Notes

Distillates (petroleum), thermal cracked naphtha and gas oil, C5-dimer-
contg.; Low boiling point thermally cracked naphtha

thermal cracked naphtha and/or gas oil.

(A complex combination of hydrocarbons produced by the extractive
distillation of
It consists
predominantly 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.)

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
paraffinic 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.)

Distillates (petroleum),
Low boiling point thermally cracked naphtha

light thermal cracked, debutanised aromatic;

(A complex combination of hydrocarbons produced by the distillation
of products from a thermal cracking process. It consists predominantly
of aromatic hydrocarbons, primarily benzene.)

Naphtha (petroleum),
point thermally cracked naphtha

light thermal cracked, sweetened; Low boiling

(A complex combination of hydrocarbons obtained by subjecting a
petroleum 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 hydrocar-
bons 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.)

649-323-00-4

271-632-4

68603-01-0

P

649-324-00-X

271-634-5

68603-03-2

P

649-325-00-5

273-266-0

68955-29-3

P

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

L 136/228

EN

Official Journal of the European Union

29.5.2007

Substances

Index No

EC No

CAS No

Notes

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.)

Distillates (petroleum), hydrotreated middle, intermediate boiling; Low
boiling point hydrogen treated naphtha

(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.)

649-330-00-2

265-185-4

64742-82-1

P

649-331-00-8

270-092-7

68410-96-8

P

Distillates
boiling; Low boiling point hydrogen treated naphtha

light distillate hydrotreating process,

(petroleum),

low-

649-332-00-3

270-093-2

68410-97-9

P

(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.)

Distillates (petroleum), hydrotreated heavy naphtha, deisohexaniser
overheads; 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.)

Solvent naphtha (petroleum),
point hydrogen treated naphtha

light arom., hydrotreated; Low boiling

(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
predominantly in the range of C8 through C10 and boiling in the range
of approximately 135 °C to 210 °C.)

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.)

Naphtha (petroleum), hydrotreated light, cycloalkane-contg.; Low
boiling point hydrogen treated naphtha

(A complex combination of hydrocarbons obtained from the distilla-
tion of a petroleum fraction. It consists predominantly of alkanes and
cycloalkanes boiling in the range of approximately - 20 °C to 190 °C.)

649-333-00-9

270-094-8

68410-98-0

P

649-334-00-4

270-988-8

68512-78-7

P

649-335-00-X

285-511-9

85116-60-5

P

649-336-00-5

285-512-4

85116-61-6

P

29.5.2007

EN

Official Journal of the European Union

L 136/229

Substances

Index No

EC No

CAS No

Notes

Naphtha (petroleum), heavy steam-cracked, hydrogenated; Low boiling
point hydrogen treated naphtha

649-337-00-0

295-432-1

92045-51-7

649-338-00-6

295-433-7

92045-52-8

P

P

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 hydrocar-
bons having carbon numbers predominantly in the range of C4
through C11 and boiling in the range of approximately 30 °C to 250 °
C.)

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 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.)

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 hydro-
carbons 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), light steam-cracked, hydrogenated; Low boiling
point hydrogen treated naphtha

(A complex combination of hydrocarbons produced from the separa-
tion and subsequent hydrogenation of
the products of a steam-
cracking 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 proportion 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.)

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.)

649-339-00-1

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

649-343-00-3

297-852-0

93763-33-8

649-344-00-9

297-853-6

93763-34-9

P

P

L 136/230

EN

Official Journal of the European Union

29.5.2007

Substances

Index No

EC No

CAS No

Notes

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
objectionable 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 predomi-
nantly in the range of C2 to C20. It is a liquid at atmospheric tempera-
ture and pressure.)

Natural gas (petroleum), raw liquid 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

(A complex combination of hydrocarbons from distillation of
the
products from a hydrocracking process. It consists predominantly of
saturated hydrocarbons having carbon numbers predominantly in the
range of C4 through C10, and boiling in the range of approximately –
20 °C to 180 °C.)

Naphtha (petroleum) heavy hydrocracked; Low boiling point naphtha
— unspecified

(A complex combination of hydrocarbons from distillation of
the
products from a hydrocracking process. It consists predominantly of
saturated hydrocarbons having carbon numbers predominantly in the
range of C6 through C12, and boiling in the range of approximately
65 °C to 230 °C.)

Naphtha (petroleum), sweetened; Low boiling point naphtha — unspe-
cified

(A complex combination of hydrocarbons obtained by subjecting a
petroleum 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.)

Naphtha (petroleum), acid-treated; Low boiling point naphtha —
unspecified

(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.)

649-346-00-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

649-351-00-7

265-115-2

64742-15-0

P

29.5.2007

EN

Official Journal of the European Union

L 136/231

Substances

Index No

EC No

CAS No

Notes

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.)

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.)

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 hydro-
carbons having carbon numbers predominantly in the range of C5
through C12 and boiling in the range of approximately 35 °C to 230 °
C.)

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 predomi-
nantly of unsaturated hydrocarbons having carbon numbers predomi-
nantly 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.)

649-352-00-2

265-122-0

64742-22-9

P

649-353-00-8

265-123-6

64742-23-0

P

649-354-00-3

265-170-2

64742-66-1

P

649-355-00-9

265-187-5

64742-83-2

P

Solvent naphtha (petroleum),
naphtha — unspecified

light aromatic; Low boiling point

649-356-00-4

265-199-0

64742-95-6

P

(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.)

Aromatic hydrocarbons, C6-10, acid-treated, neutralised; Low boiling
point naphtha — unspecified

649-357-00-X

268-618-5

68131-49-7

649-358-00-5

270-725-7

68477-34-9

P

P

Distillates (petroleum), C3-5, 2-methyl-2-butene-rich; Low boiling point
naphtha — unspecified

(A complex combination of hydrocarbons from the distillation of
hydrocarbons usually ranging in carbon numbers from C3 through C5,
predominantly isopentane and 3-methyl-1-butene. It consists of satu-
rated 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 distilla-
tion of polymerised steam-cracked petroleum distillate.
It consists
predominantly of hydrocarbons having carbon numbers predominantly
in the range of C5 through C12.)

649-359-00-0

270-735-1

68477-50-9

P

L 136/232

EN

Official Journal of the European Union

29.5.2007

Substances

Index No

EC No

CAS No

Notes

Distillates (petroleum), steam-cracked, C5-12 fraction; Low boiling point
naphtha — unspecified

(A complex combination of organic compounds obtained by the distil-
lation of products from a steam cracking process. It consists of unsatu-
rated hydrocarbons having carbon numbers predominantly in the
range of C5 through C12.)

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

649-362-00-7

270-741-4

68477-61-2

P

P

Extracts (petroleum), cold-acid, C4-6; Low boiling point naphtha —
unspecified

(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
unsaturated hydrocarbons having carbon numbers in the range of C4
through C6, predominantly C5.)

Distillates (petroleum), depentaniser overheads; Low boiling point
naphtha — unspecified

(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.)

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.)

Residual oils (petroleum), deisobutaniser tower; Low boiling point
naphtha — unspecified

(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 unsatu-
rated 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 aromatic; 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.)

649-363-00-2

270-771-8

68477-894-4

P

649-364-00-8

270-791-7

68478-12-6

P

649-365-00-3

270-795-9

68478-16-0

P

649-366-00-9

270-991-4

68513-02-0

P

649-367-00-4

271-138-9

68516-20-1

P

29.5.2007

EN

Official Journal of the European Union

L 136/233

Substances

Index No

EC No

CAS No

Notes

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.)

649-368-00-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), light steam-cracked, debenzenised; Low boiling
point naphtha — unspecified

(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

Naphtha (petroleum), aromatic-containing; Low boiling point naphtha
— unspecified

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 fractiona-
tion of depropaniser bottoms.
It consists of hydrocarbons having
carbon numbers predominantly greater than C5.)

Naphtha (petroleum), light, sweetened; Low boiling point naphtha —
unspecified

(A complex combination of hydrocarbons obtained by subjecting a
petroleum distillate to a sweetening process to convert mercaptans or
to remove acidic impurities. It consists predominantly of saturated and
unsaturated hydrocarbons having carbon numbers predominantly in
the range of C3 through C6 and boiling in the range of approximately
- 20 °C to 100 °C.)

649-373-00-7

271-726-5

68606-10-0

649-374-00-2

272-206-0

68783-66-4

P

P

P

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
pipelines in deeps, scrubbers, etc. It consists predominantly of hydro-
carbons having carbon numbers predominantly in the range of C2
through C8.)

L 136/234

EN

Official Journal of the European Union

29.5.2007

Substances

Index No

EC No

CAS No

Notes

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, aromatic-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 selec-
tive absorption process. It consists predominantly of paraffinic and
cyclic 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
paraffins, 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, distillation resi-
dues; Low boiling point naphtha — unspecified

649-379-00-X

292-698-0

90989-42-7

Hydrocarbons, C4-6, depentaniser
boiling point naphtha — unspecified

lights, arom. hydrotreater; Low

649-380-00-5

295-298-4

91995-38-9

P

P

(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 predominantly in the range of C4 through C6, predominantly
pentanes and pentenes, and boiling in the range of approximately 25 °
C to 40 °C.)

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;
boiling point naphtha — unspecified

low

649-382-00-6

295-331-2

91995-68-5

P

(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 predominantly in the range of C7 through C8 and boiling in
the range of approximately 100 °C to 200 °C.)

Naphtha (petroleum), hydrodesulphurised light, dearomatised;
boiling point naphtha — unspecified

low

649-383-00-1

295-434-2

92045-53-9

P

(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.)

29.5.2007

EN

Official Journal of the European Union

L 136/235

Substances

Index No

EC No

CAS No

Notes

Naphtha (petroleum),
naphtha — unspecified

light, C5-rich, sweetened;

low boiling point

649-384-00-7

295-442-6

92045-60-8

P

(A complex combination of hydrocarbons obtained by subjecting a
petroleum 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.)

Hydrocarbons, C8-11, naphtha-cracking, toluene cut; low boiling point
naphtha — unspecified

(A complex combination of hydrocarbons obtained by distillation
from prehydrogenated cracked naphtha. It consists predominantly of
hydrocarbons having carbon numbers predominantly in the range of
C8 through C11 and boiling in the range of approximately 130 °C to
205 °C.)

Hydrocarbons, C4-11, naphtha-cracking; aromatic-free; low boiling point
naphtha — unspecified

(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
predominantly in the range of C4 through C11 and boiling in the range
of approximately 30 °C to 205 °C.)

649-385-00-2

295-444-7

92045-62-0

P

649-386-00-8

295-445-2

92045-63-1

P

Naphtha (petroleum),
point naphtha — unspecified

light heat-soaked, steam-cracked;

low boiling

649-387-00-3

296-028-8

92201-97-3

P

(A complex combination of hydrocarbons obtained by the fractiona-
tion of steam cracked naphtha after recovery from a heat soaking
It consists predominantly of hydrocarbons having carbon
process.
numbers predominantly in the range of C4 through C6 and boiling in
the range of approximately 0 °C to 80 °C.)

Distillates (petroleum), C6-rich; low boiling point naphtha — unspeci-
fied

(A complex combination of hydrocarbons obtained from the distilla-
tion of a petroleum feedstock. It consists predominantly of hydrocar-
bons 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 — unspe-
cified

(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., distilla-
tion 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
distillates. 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

L 136/236

EN

Official Journal of the European Union

29.5.2007

Substances

Index No

EC No

CAS No

Notes

Extracts (petroleum); heavy naphtha solvent, clay-treated; low boiling
point naphtha — unspecified

(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.)

649-391-00-5

308-261-5

97926-43-7

P

Naphtha (petroleum),
treated; low boiling point naphtha — unspecified

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 predominantly in the range of C7 through C12 and boiling in
the range of approximately 95 °C to 200 °C.)

Naphtha (petroleum),
boiling point naphtha — unspecified

light

steam-cracked,

thermally treated;

low

649-393-00-6

308-714-7

98219-47-7

P

(A complex combination of hydrocarbons obtained by the treatment
and distillation of light steam-cracked petroleum naphtha. It consists
predominantly of hydrocarbons having carbon numbers predominantly
in the range of C5 through C6 and boiling in the range of approxi-
mately 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 raffi-
nation; low boiling point naphtha — unspecified

(A complex combination of hydrocarbons obtained during the sorp-
tion of toluene from a hydrocarbon fraction from cracked gasoline
treated with hydrogen in the presence of a catalyst. It consists predo-
minantly 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.)

Naphtha (petroleum), hydrodesulphurised full-range coker; low boiling
point naphtha — unspecified

(A complex combination of hydrocarbons obtained by fractionation
from hydrodesulphurised coker 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 196 °C.)

Naphtha (petroleum), sweetened light; low boiling point naphtha —
unspecified

(A complex combination of hydrocarbons obtained by subjecting a
petroleum naphtha 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 C5 through C8
and boiling in the range of approximately 20 °C to 130 °C.)

649-394-00-1

309-862-5

101316-56-7

P

649-395-00-7

309-870-9

101316-66-9

P

649-396-00-2

309-879-8

101316-76-1

P

649-397-00-8

309-976-5

101795-01-1

P

29.5.2007

EN

Official Journal of the European Union

L 136/237

Substances

Index No

EC No

CAS No

Notes

Hydrocarbons, C3-6, C5-rich, steam-cracked naphtha; low boiling point
naphtha — unspecified

(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-containing; low boiling point
naphtha — unspecified

(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.)

Residues (petroleum), steam-cracked light, aromatic; low boiling point
naphtha — unspecified

(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 hydrocar-
bons having carbon numbers greater than C5. It consists predomi-
nantly of aromatic hydrocarbons having carbon numbers greater than
C5 and boiling above approximately 40 °C.)

649-398-00-3

310-012-0

102110-14-5

P

649-399-00-9

310-013-6

102110-15-6

P

649-400-00-2

310-057-6

102110-55-4

P

Hydrocarbons, C ≥ 5, C5-6-rich; low boiling point naphtha — unspeci-
fied

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 hydrocar-
bons 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 hydrocar-
bons 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.)

L 136/238

EN

Official Journal of the European Union

29.5.2007

Substances

Index No

EC No

CAS No

Notes

Distillates
Cracked gas oil

(petroleum), hydrodesulphurised light catalytic cracked;

(A complex combination of hydrocarbons obtained by treating light
catalytic 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 relatively large proportion of bicyclic aromatic hydrocar-
bons.)

649-439-00-5

269-781-5

68333-25-5

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 distilla-
tion of products from a steam cracking process. It consists of hydro-
carbons having carbon numbers predominantly in the range of C10
through C18.)

Distillates (petroleum), cracked steam-cracked petroleum distillates;
Cracked gas oil

(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.)

649-441-00-6

270-727-8

68477-38-3

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 hydrocar-
bons having carbon numbers predominantly greater than C9 and
boiling in the range of from approximately 205 °C to 400 °C.)

Distillates (petroleum), hydrodesulphurised thermal cracked middle;
Cracked gas oil

(A complex combination of hydrocarbons obtained by fractionation
from hydrodesulphurised thermal cracker distillate stocks. It consists
predominantly of hydrocarbons having carbon numbers predominantly
in the range of C11 to C25 and boiling in the range of from approxi-
mately 205 °C to 400 °C.)

649-443-00-7

285-505-6

85116-53-6

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 frac-
tion from the distillation of hydrotreated steam-cracked naphtha. It
consists predominantly of hydrocarbons boiling in the range of
approximately 200 °C to 350 °C.)

Residues (petroleum), steam-cracked naphtha distillation; Cracked gas
oil

(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.)

649-445-00-8

295-514-7

92062-00-5

649-446-00-3

295-517-3

92062-04-9

29.5.2007

EN

Official Journal of the European Union

L 136/239

Substances

Index No

EC No

CAS No

Notes

Distillates (petroleum),
Cracked gas oil

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.)

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
phurised; Cracked gas oil

(petroleum),

light vacuum,

thermal-cracked hydrodesul-

649-450-00-5

308-278-8

97926-59-5

(A complex combination of hydrocarbons obtained by catalytic dehy-
drosulphurisation of
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.)

thermal-cracked light vacuum petroleum.

Distillates (petroleum), hydrodesulphurised middle coker; Cracked gas
oil

(A complex combination of hydrocarbons by fractionation from
hydrodesulphurised 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.)

649-451-00-0

309-865-1

101316-59-0

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
It consists predominantly of highly
steam cracking heavy residues.
alkylated heavy aromatic hydrocarbons boiling in the range of approxi-
mately 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
saturated 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 —
unspecified

(A complex combination of hydrocarbons obtained as the raffinate
from a solvent extraction process. It consists predominantly of satu-
rated 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.)

Distillates (petroleum), solvent-refined light paraffinic; Base oil —
unspecified

(A complex combination of hydrocarbons obtained as the raffinate
from a solvent extraction process. It consists predominantly of satu-
rated 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.)

649-454-00-7

265-090-8

64741-88-4

L

649-455-00-2

265-091-3

64741-89-5

L

L 136/240

EN

Official Journal of the European Union

29.5.2007

Substances

Index No

EC No

CAS No

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 —
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 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 carbon numbers predominantly greater than C25 and boiling
above 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 hydrocar-
bons.)

Distillates (petroleum), clay-treated light paraffinic; 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 a relatively large proportion of saturated hydrocar-
bons.)

649-461-00-5

265-138-8

64742-37-6

L

29.5.2007

EN

Official Journal of the European Union

L 136/241

Substances

Index No

EC No

CAS No

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 —
unspecified

(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 — unspe-
cified

(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 —
unspecified

(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 —
unspecified

(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 paraf-
fins.)

Distillates (petroleum), hydrotreated heavy paraffinic; Base oil —
unspecified

(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 hydrocar-
bons.)

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

L 136/242

EN

Official Journal of the European Union

29.5.2007

Substances

Index No

EC No

CAS No

Notes

Distillates (petroleum), hydrotreated light paraffinic; 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
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.)

Distillates (petroleum), solvent-dewaxed light 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 C15 through C30 and produces a finished
oil with a viscosity of less than 19 10-6 m2.s-1 at 40 °C.)

649-468-00-3

265-158-7

64742-55-8

L

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 crys-
tallisation. It consists of hydrocarbons having carbon numbers predo-
minantly 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 paraf-
fins.)

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 visc-
osity of less than 19 10-6 m2.s-1 at 40 °C. It contains relatively few
normal paraffins.)

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.)

649-472-00-5

265-167-6

64742-63-8

L

649-473-00-0

265-168-1

64742-64-9

L

649-474-00-6

265-169-7

64742-65-0

L

29.5.2007

EN

Official Journal of the European Union

L 136/243

Substances

Index No

EC No

CAS No

Notes

649-475-00-1

265-172-3

64742-68-3

L

649-476-00-7

265-173-9

64742-69-4

L

649-477-00-2

265-174-4

64742-70-7

L

649-478-00-8

265-176-5

64742-71-8

L

649-479-00-3

265-179-1

64742-75-2

L

649-480-00-9

265-180-7

64742-76-3

L

649-481-00-4

276-736-3

72623-85-9

L

Naphthenic oils (petroleum), catalytic dewaxed heavy; Base oil —
unspecified

(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 — unspe-
cified

(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.)

Paraffin 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.)

Paraffin oils (petroleum), catalytic dewaxed light; 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 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 —
unspecified

(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 viscosity of at least 19 10-6 m2.s-1 at 40 °C. It contains rela-
tively few normal paraffins.)

Naphthenic oils (petroleum), complex dewaxed light; Base oil —
unspecified

(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.)

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
with dewaxing being carried out between the two stages. It consists
predominantly of hydrocarbons having carbon numbers predominantly
in the range of C20 through C50 and produces a finished oil having a
viscosity of approximately 112 10-6 m2.s-1 at 40 °C. It contains a rela-
tively large proportion of saturated hydrocarbons.)

L 136/244

EN

Official Journal of the European Union

29.5.2007

Substances

Index No

EC No

CAS No

Notes

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), 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 hydro-
carbons having carbon numbers predominantly in the range of C15
through C30 and produces a finished oil having a viscosity of approxi-
mately 15 10-6 m2.s-1 at 40 °C. It contains a relatively large proportion
of saturated hydrocarbons.)

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
predominantly of hydrocarbons having carbon numbers predominantly
in the range of C20 through C50 and produces a finished oil with a visc-
osity of approximately 32 10-6 m2.s-1 at 40 °C. It contains a relatively
large 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
extraction and dewaxing processes. It consists predominantly of satu-
rated 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.)

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
hydrocarbons 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 predominantly in the range of C20 through C50.)

649-485-00-6

292-613-7

90640-91-8

L

649-486-00-1

292-614-2

90640-92-9

L

649-487-00-7

292-616-3

90640-94-1

L

649-488-00-2

292-617-9

90640-95-2

L

29.5.2007

EN

Official Journal of the European Union

L 136/245

Substances

Index No

EC No

CAS No

Notes

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
hydrocarbons 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
catalyst. It consists of hydrocarbons having carbon numbers predomi-
nantly in the range of C15 through C30.)

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

Distillates (petroleum), hydrocracked solvent-refined, dewaxed; Base oil
— unspecified

(A complex combination of liquid hydrocarbons obtained by recrystal-
lisation of dewaxed hydrocracked solvent-refined petroleum distillates.)

649-495-00-0

295-306-6

91995-45-8

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
predominantly of naphthenic hydrocarbons having carbon numbers
predominantly 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

L

Lubricating oils (petroleum) C17-35, solvent-extd., dewaxed, hydro-
treated; Base oil — unspecified

649-497-00-1

295-423-2

92045-42-6

L

L

L

L

L

L

L

L

L 136/246

EN

Official Journal of the European Union

29.5.2007

Substances

Index No

EC No

CAS No

Notes

Lubricating oils (petroleum), hydrocracked nonarom. solvent-deparaf-
fined; Base oil — unspecified

649-498-00-7

295-424-8

92045-43-7

649-499-00-2

295-499-7

92061-86-4

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,
hydrocracked heavy paraffins and boiling approximately above 380 °
C.)

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.)

Lubricating oils (petroleum), base oils, paraffinic; Base oil — unspeci-
fied

(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.)

649-500-00-6

295-810-6

92129-09-4

L

649-501-00-1

297-474-6

93572-43-1

Hydrocarbons, hydrocracked paraffinic distillation 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; hydroge-
nated; Base oil — unspecified

649-504-00-8

305-588-5

94733-08-1

Distillates (petroleum), solvent-refined hydrocracked light; Base oil —
unspecified

(A complex combination of hydrocarbons obtained by solvent dearo-
matisation of the residue of hydrocracked petroleum. It consists predo-
minantly 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.)

649-505-00-3

305-589-0

94733-09-2

Lubricating oils
(petroleum), C18-40,
distillate-based; Base oil — unspecified

solvent-dewaxed hydrocracked

649-506-00-9

305-594-8

94733-15-0

L

(A complex combination of hydrocarbons obtained by solvent deparaf-
fination 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,
raffinate-based; Base oil — unspecified

solvent-dewaxed hydrogenated

649-507-00-4

305-595-3

94733-16-1

L

(A complex combination of hydrocarbons obtained by solvent deparaf-
fination of the hydrogenated raffinate obtained by solvent extraction of
a hydrotreated petroleum distillate. It consists predominantly of hydro-
carbons having carbon numbers predominantly in the range of C18
through C40 and boiling in the range of approximately 370 °C to
550 °C.)

29.5.2007

EN

Official Journal of the European Union

L 136/247

Substances

Index No

EC No

CAS No

Notes

Hydrocarbons, C13-30, aromatic-rich, solvent-extracted naphthenic distil-
late; Base oil — unspecified

649-508-00-X

305-971-7

95371-04-3

Hydrocarbons, C16-32, arom.-rich, solvent-extracted naphthenic distil-
late; Base oil — unspecified

649-509-00-5

305-972-2

95371-05-4

Hydrocarbons, C37-68, dewaxed deasphalted hydrotreated vacuum distil-
lation residues; Base oil — unspecified

649-510-00-0

305-974-3

95371-07-6

Hydrocarbons, C37-65, hydrotreated deasphalted vacuum distillation resi-
dues; Base oil — unspecified

649-511-00-6

305-975-9

95371-08-7

649-512-00-1

307-010-7

97488-73-8

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

649-515-00-8

307-661-7

97675-87-1

Distillates (petroleum), hydrocracked solvent-refined light; Base oil —
unspecified

(A complex combination of hydrocarbons obtained by the solvent
treatment 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 predo-
minantly 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.)

Hydrocarbons, C17-30, hydrotreated solvent-deasphalted atmospheric
distillation residue, distillation 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 deasphalted short residue with hydrogen in the presence of a
catalyst.
It consists predominantly of hydrocarbons having carbon
numbers predominantly 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 viscosity of 4 10-6 m2.s-1 at approximately 100 °C.)

Hydrocarbons, C17-40, hydrotreated solvent-deasphalted distillation
residue, vacuum distillation lights; Base oil — unspecified

(A complex combination of hydrocarbons obtained as first runnings
from the vacuum distillation of effluents from the catalytic hydrotreat-
ment of a solvent deasphalted short residue having a viscosity of 8 10-
6 m2.s-1 at approximately 100 °C. It consists predominantly of hydro-
carbons having carbon numbers predominantly in the range of C17
through C40 and boiling in the range of approximately 300 °C to
500 °C.)

649-516-00-3

307-755-8

97722-06-0

L

L

L

L

L

L

L

L

L 136/248

EN

Official Journal of the European Union

29.5.2007

Substances

Index No

EC No

CAS No

Notes

Hydrocarbons, C13-27, solvent-extracted light naphthenic; Base oil —
unspecified

(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-extracted light naphthenic; Base oil —
unspecified

(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, distillation lights; Base oil
— unspecified

649-520-00-5

308-132-3

97862-82-3

Hydrocarbons, C27-45, naphthenic vacuum distillation; 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

649-525-00-2

309-710-8

100684-37-5

L

L

L

L

L

L

L

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.)

Residual oils (petroleum), clay-treated solvent-dewaxed; Base oil —
unspecified

(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.)

Lubricating oils
dewaxed, hydrogenated; base oil — unspecified

(petroleum) C25,

solvent-extracted, deasphalted,

(A complex combination of hydrocarbons obtained by solvent extrac-
tion and hydrogenation of vacuum distillation residues.
It consists
predominantly of hydrocarbons having carbon numbers predominantly
in the range of greater than C25 and produces a finished oil with a visc-
osity 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-extracted, dewaxed, hydro-
genated; Base oil — unspecified

(A complex combination of hydrocarbons obtained by solvent extrac-
tion and hydrogenation of atmospheric distillation residues. It consists
predominantly of hydrocarbons having carbon numbers predominantly
in the range of C17 through C32 and produces a finished oil with a visc-
osity in the order 17 10-6 m2.s-1 to 23 10-6 m2.s-1 at 40 °C.)

649-526-00-8

309-711-3

100684-38-6

L

649-527-00-3

309-874-0

101316-69-2

L

649-528-00-9

309-875-6

101316-70-5

L

29.5.2007

EN

Official Journal of the European Union

L 136/249

Substances

Index No

EC No

CAS No

Notes

Lubricating oils (petroleum) C20-35, solvent-extracted, dewaxed, hydro-
genated; Base oil — unspecified

(A complex combination of hydrocarbons obtained by solvent extrac-
tion and hydrogenation of atmospheric distillation residues. It consists
predominantly of hydrocarbons having carbon numbers predominantly
in the range of C20 through C35 and produces a finished oil with a visc-
osity 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-extracted, dewaxed, hydro-
genated; Base oil — unspecified

(A complex combination of hydrocarbons obtained by solvent extrac-
tion and hydrogenation of atmospheric distillation residues. It consists
predominantly of hydrocarbons having carbon numbers predominantly
in the range of C24 through C50 and produces a finished oil with a visc-
osity in the order of 16 10-6 m2.s-1 to 75 10-6 m2.s-1 at 40 °C.)

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, aromatic
concentrate; Distillate aromatic extract (treated)

(An aromatic concentrate produced by adding water
naphthenic distillate solvent extract and extraction solvent.)

to heavy

649-531-00-5

272-175-3

68783-00-6

649-532-00-0

272-180-0

68783-04-0

649-533-00-6

272-342-0

68814-89-1

649-534-00-1

292-631-5

90641-07-9

L

L

L

L

649-535-00-7

292-632-0

90641-08-0

L

649-536-00-2

292-633-6

90641-09-1

L

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
predominantly in the range of C20 through C50.)

Extracts (petroleum), heavy paraffinic distillates, solvent-deasphalted;
Distillate aromatic extract (treated)

(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),
Distillate aromatic extract (treated)

light paraffinic distillate solvent, hydrotreated;

(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.)

L 136/250

EN

Official Journal of the European Union

29.5.2007

Substances

Index No

EC No

CAS No

Notes

Extracts (petroleum), hydrotreated paraffinic light distillate solvent;
Distillate 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 predo-
minantly of aromatic hydrocarbons having carbon numbers predomi-
nantly in the range of C16 through C36.)

Extracts (petroleum),
phurised; Distillate aromatic extract (treated)

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 hydrocar-
bons having carbon numbers predominantly in the range of C15
through C30. This stream is likely to contain 5 % wt or more of four-
to six-membered condensed ring aromatic hydrocarbons.)

Extracts (petroleum),
Distillate aromatic extract (treated)

light paraffinic distillate solvent, acid-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),
phurised; Distillate aromatic extract (treated)

light paraffinic distillate solvent, hydrodesul-

(A complex combination of hydrocarbons obtained by solvent extrac-
tion 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 viscosity of greater than 10-5 m2.s-1 at 40 °C.)

Extracts (petroleum), light vacuum gas oil solvent, hydrotreated; Distil-
late aromatic extract (treated)

(A complex combination of hydrocarbons obtained by solvent extrac-
tion 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;
Distillate aromatic extract (treated)

(A complex combination of hydrocarbons resulting from treatment of
a petroleum fraction with natural or modified clay in either a contact
to remove the trace amounts of polar
or percolation process
compounds and impurities present.
It consists predominantly of
aromatic hydrocarbons having carbon numbers predominantly in the
range of C20 through C50. This stream is likely to contain 5 % wt or
more four- to six-membered ring aromatic hydrocarbons.)

649-537-00-8

295-335-4

91995-73-2

L

649-538-00-3

295-338-0

91995-75-4

L

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

29.5.2007

EN

Official Journal of the European Union

L 136/251

Substances

Index No

EC No

CAS No

Notes

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 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.)

649-543-00-0

297-827-4

93763-10-1

L

Extracts
solvent, hydrodesulphurised; Distillate aromatic extract (treated)

solvent-dewaxed heavy paraffinic distillate

(petroleum),

(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.)

Extracts (petroleum), light paraffinic distillate solvent, carbon-treated;
Distillate aromatic extract (treated)

(A complex combination of hydrocarbons obtained as a fraction from
distillation of an extract recovered by solvent extraction of light paraf-
finic top petroleum distillate treated with activated charcoal 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),
Distillate aromatic extract (treated)

light paraffinic distillate solvent, clay-treated;

(A complex combination of hydrocarbons obtained as a fraction from
distillation of an extract recovered by solvent extraction of light paraf-
finic 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),
Distillate aromatic extract (treated)

light vacuum, gas oil solvent, carbon-treated;

(A complex combination of hydrocarbons obtained by solvent extrac-
tion of light vacuum petroleum gas oil treated with activated charcoal
for the removal of trace polar constituents and impurities. It consists
predominantly of aromatic hydrocarbons having carbon numbers
predominantly in the range of C13 through C30.)

Extracts (petroleum), light vacuum, gas oil solvent, clay-treated; Distil-
late aromatic extract (treated)

(A complex combination of hydrocarbons obtained by solvent extrac-
tion of light vacuum petroleum gas oils treated with bleaching earth
for removal of
It consists
predominantly of aromatic hydrocarbons having carbon numbers
predominantly in the range of C13 through C30.)

trace polar constituents and impurities.

649-544-00-6

297-829-5

93763-11-2

L

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 predo-
minantly in the range of C20 through C50.)

L 136/252

EN

Official Journal of the European Union

29.5.2007

Substances

Index No

EC No

CAS No

Notes

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

29.5.2007

EN

Official Journal of the European Union

L 136/253

Appendix 3

Point 29 — Mutagens: category 1

L 136/254

EN

Official Journal of the European Union

29.5.2007

Appendix 4

Point 29 — Mutagens: category 2

Substances

Index No

EC No

CAS No

Notes

Hexamethylphosphoric triamide; hexamethylphosphoramide

015-106-00-2

211-653-8

680-31-9

Diethyl sulphate

Chromium (VI) trioxide

Potassium dichromate

Ammonium dichromate

016-027-00-6

200-589-6

64-67-5

024-001-00-0

215-607-8

1333-82-0

024-002-00-6

231-906-6

7778-50-9

024-003-00-1

232-143-1

7789-09-5

Sodium dichromate anhydrate

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

Cadmium sulphate

024-006-00-8

232-140-5

7789-00-6

024-018-00-3

231-889-5

7775-11-3

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

E

E

E

E

E

E

E

E

E

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]

20-857-2 [2]

75-28-5 [2]

1,3-Butadiene buta-1,3-diene

601-013-00-X

203-450-8

106-99-0

Benzene

601-020-00-8

200-753-7

71-43-2

Benzo[a]pyrene; benzo[d,e,f]chrysene

601-032-00-3

200-028-5

50-32-8

1,2-Dibromo-3-chloropropane

602-021-00-6

202-479-3

96-12-8

Ethylene oxide; oxirane

603-023-00-X

200-849-9

75-21-8

D

E

Propylene oxide; 1,2-epoxypropane; Methyloxirane

603-055-00-4

200-879-2

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

2-Nitrotoluene

609-065-00-5

201-853-3

88-72-2

4,4'-oxydianiline [1] and its salts

p-aminophenyl ether [1]

612-199-00-7

202-977-0 [1]

101-80-4 [1]

Ethyleneimine; aziridine

613-001-00-1

205-793-9

151-56-4

E

E

29.5.2007

EN

Official Journal of the European Union

L 136/255

Substances

Index No

EC No

CAS No

Notes

Carbendazim (ISO)

methyl benzimidazol-2-ylcarbamate

613-048-00-8

234-232-0

10605-21-7

Benomyl (ISO)

613-049-00-3

241-775-7

17804-35-2

methyl 1-(butylcarbamoyl)benzimidazol-2-ylcarbamate

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

Gases (petroleum), catalytic cracked naphtha depropaniser 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

H, K

Gases (petroleum), catalytic cracker; Petroleum gas

649-063-00-1

270-756-6

68477-74-7

H, 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
stabilisation of catalytic polymerised naphtha.
It consists of aliphatic
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.)

649-064-00-7

270-757-1

68477-75-8

H, K

649-065-00-2

270-758-7

68477-76-9

H, K

649-066-00-8

270-760-8

68477-79-2

H, K

649-067-00-3

270-765-5

68477-83-8

H, K

L 136/256

EN

Official Journal of the European Union

29.5.2007

Substances

Index No

EC No

CAS No

Notes

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.)

649-068-00-9

270-767-6

68477-85-0

H, K

Gases (petroleum), deethaniser overheads; Petroleum gas

649-069-00-4

270-768-1

68477-86-1

H, 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

H, 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

H, 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

H, 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 hydrocar-
bons having carbon numbers in the range of C1 through C4, predomi-
nantly propane.)

649-073-00-6

270-777-0

68477-94-1

H, K

Gases (petroleum), Girbatol unit feed; Petroleum gas

649-074-00-1

270-778-6

68477-95-2

H, K

(A complex combination of hydrocarbons that is used as the feed into the
Girbatol unit to remove hydrogen sulfide. It consists of aliphatic hydrocar-
bons 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

H, 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 predomi-
nantly in the range of C1 through C6.)

649-076-00-2

270-802-5

68478-21-7

H, K

29.5.2007

EN

Official Journal of the European Union

L 136/257

Substances

Index No

EC No

CAS No

Notes

Tail gas (petroleum), catalytic cracked naphtha stabilisation absorber; Petro-
leum 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.)

Tail gas (petroleum), catalytic cracker, catalytic reformer and hydrodesul-
phuriser combined fractionater; Petroleum gas

(A complex combination of hydrocarbons obtained from the fractionation
of products from catalytic cracking, catalytic reforming and hydrodesul-
phurising processes treated to remove acidic impurities. It consists predo-
minantly 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 stabiliser
tail gas. It consists predominantly of hydrocarbons having carbon numbers
in the range of C1 through C5, predominantly methane and ethane.)

649-077-00-8

270-803-0

68478-22-8

H, K

649-078-00-3

270-804-6

68478-24-0

H, K

649-079-00-9

270-806-7

68478-26-2

H, K

649-080-00-4

270-813-5

68478-32-0

H, K

649-081-00-X

270-814-0

68478-33-1

H, K

Tail gas (petroleum), vacuum residues thermal cracker; Petroleum gas

649-082-00-5

270-815-6

68478-34-2

H, 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
It consists of hydrocarbons having carbon
condensation of crude oil.
numbers in the range of C3 through C5, predominantly C3 through C4.)

649-083-00-0

270-990-9

68512-91-4

H, 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.)

649-084-00-6

271-000-8

68513-15-5

H, K

L 136/258

EN

Official Journal of the European Union

29.5.2007

Substances

Index No

EC No

CAS No

Notes

(petroleum), hydrocracking depropaniser off, hydrocarbon-rich;

Gases
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.)

649-085-00-1

271-001-3

68513-16-6

H, K

Gases (petroleum), light straight-run naphtha stabiliser off; Petroleum gas

649-086-00-7

271-002-9

68513-17-7

H, 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; Petroleum gas
(A complex combination of hydrocarbons provided by thermal cracking
and absorber operations and by distillation of crude oil. It consists of
hydrocarbons having carbon numbers predominantly in the range of C1
through C4 and boiling in the range of approximately minus 164 °C to
minus 0,5 °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.)

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.)

649-087-00-2

271-010-2

68513-66-6

H, K

649-088-00-8

271-032-2

68514-31-8

H, K

649-089-00-3

271-038-5

68514-36-3

H, K

649-090-00-9

271-259-7

68527-16-2

H, K

Hydrocarbons, C1-4, debutaniser fraction; Petroleum gas

649-091-00-4

271-261-8

68527-19-5

H, K

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

H, K

Hydrocarbons, C2-4; Petroleum gas

649-093-00-5

271-734-9

68606-25-7

H, K

Hydrocarbons, C3; Petroleum gas

649-094-00-0

271-735-4

68606-26-8

H, K

Gases (petroleum), alkylation feed; Petroleum gas

649-095-00-6

271-737-5

68606-27-9

H, K

(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.)

29.5.2007

EN

Official Journal of the European Union

L 136/259

Substances

Index No

EC No

CAS No

Notes

Gases (petroleum), depropaniser bottoms fractionation off; Petroleum gas

649-096-00-1

271-742-2

68606-34-8

H, 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

H, 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.)

Gases (petroleum), catalytic cracking; Petroleum gas

649-098-00-2

272-203-4

68783-64-2

H, 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

H, K

Gases (petroleum), crude oil fractionation off; Petroleum gas

649-100-00-1

272-871-7

68918-99-0

H, 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

H, K

(A complex combination of hydrocarbons obtained by the fractionation of
combined naphtha streams. It consists of saturated aliphatic hydrocarbons
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 hydrocarbons
having carbon numbers predominantly in the range of C1 through C5.)

Gases (petroleum), naphtha unifiner desulphurisation stripper off; Petro-
leum gas

(A complex combination of hydrocarbons produced by a naphtha unifiner
desulphurisation process and stripped from the naphtha product.
It
consists of saturated aliphatic hydrocarbons having carbon numbers predo-
minantly 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.)

649-102-00-2

272-878-5

68919-05-1

H, K

649-103-00-8

272-879-0

68919-06-2

H, K

649-104-00-3

272-882-7

68919-09-5

H, K

L 136/260

EN

Official Journal of the European Union

29.5.2007

Substances

Index No

EC No

CAS No

Notes

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.)

649-105-00-9

272-893-7

68919-20-0

H, K

Gases (petroleum), straight-run stabiliser off; Petroleum gas

649-106-00-4

272-883-2

68919-10-8

H, 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 predo-
minantly 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

H, K

(A complex combination of hydrocarbons obtained from fractionation of
catalytic cracked naphtha.
It consists of hydrocarbons having carbon
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 hydro-
carbons having carbon numbers predominantly in the range of C1 through
C4.)

649-108-00-5

273-170-9

68952-77-2

H, K

Tail gas (petroleum),
absorber; Petroleum gas

thermal-cracked distillate, gas oil and naphtha

649-109-00-0

273-175-6

68952-81-8

H, K

(A complex combination of hydrocarbons obtained from the separation of
thermal-cracked distillates, naphtha and gas oil. It consists predominantly
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
It consists of hydrocarbons having carbon numbers predomi-
process.
nantly in the range of C1 through C6.)

649-110-00-6

273-176-1

68952-82-9

H, K

Gases (petroleum,
gas

light steam-cracked, butadiene concentrate; Petroleum

649-111-00-1

273-265-5

68955-28-2

H, 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
reforming of straight-run naphtha and the fractionation of
the total
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

H, K

29.5.2007

EN

Official Journal of the European Union

L 136/261

Substances

Index No

EC No

CAS No

Notes

Hydrocarbons, C4; Petroleum gas

649-113-00-2

289-339-5

87741-01-3

H, K

Alkanes, C1-4, C3-rich; Petroleum gas

649-114-00-8

292-456-4

90622-55-2

H, K

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

H, K

649-116-00-9

295-405-4

92045-23-3

H, K

649-117-00-4

295-463-0

92045-80-2

H, K, S

Raffinates (petroleum), steam-cracked C4
fraction cuprous ammonium
acetate extraction, C3-5 and C3-5 unsaturated., butadiene-free; Petroleum gas

649-119 -00-5

307-769-4

97722-19-5

H, K

Gases (petroleum), amine system feed; Refinery gas

649-120-00-0

270-746-1

68477-65-6

H, K

(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.)

Gases (petroleum), benzene unit hydrodesulphuriser off; Refinery gas

649-121-00-6

270-747-7

68477-66-7

H, K

(Off gases produced by the benzene unit. It consists primarily of hydrogen.
Carbon monoxide and hydrocarbons having carbon numbers predomi-
nantly 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

H, 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

H, 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.)

L 136/262

EN

Official Journal of the European Union

29.5.2007

Substances

Index No

EC No

CAS No

Notes

Gases (petroleum), catalytic reformed naphtha stripper overheads; Refinery
gas

(A complex combination of hydrocarbons obtained from stabilisation of
catalytic reformed naphtha. It consists of hydrogen and saturated hydrocar-
bons 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-
bons having carbon numbers in the range of C1
through C5 and
hydrogen.)

649-124-00-2

270-759-2

68477-77-0

H, K

649-125-00-8

270-761-3

68477-80-5

H, K

649-126-00-3

270-762-9

68477-81-6

H, K

Gases (petroleum), C6-8 catalytic reformer recycle, hydrogen-rich; Refinery
gas

649-127-00-9

270-763-4

68477-82-7

H, 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

H, K

Gases (petroleum), dry sour, gas-concentration-unit-off; Refinery gas

649-129-00-X

270-774-4

68477-92-9

H, 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 concentration reabsorber distillation; Refinery gas

649-130-00-5

270-776-5

68477-93-0

H, 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

H, K

(A complex combination obtained by absorbing hydrogen from a
hydrogen rich stream. It consists of hydrogen, carbon monoxide, nitrogen,
and methane with small amounts of C2 hydrocarbons.)

Gases (petroleum), hydrogen-rich; Refinery gas

649-132-00-6

270-780-7

68477-97-4

H, 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.)

29.5.2007

EN

Official Journal of the European Union

L 136/263

Substances

Index No

EC No

CAS No

Notes

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

H, K

Gases (petroleum), recycle, hydrogen-rich; Refinery gas

649-134-00-7

270-783-3

68478-00-2

H, 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 hydro-
carbons 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

H, 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

H, 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.)

Gases
Refinery gas

(petroleum),

reforming

hydrotreater,

hydrogen-methane-rich;

649-137-00-3

270-787-5

68478-03-5

H, 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

H, 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 distillation; Refinery gas

649-139-00-4

270-789-6

68478-05-7

H, 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.)

Tail gas (petroleum), catalytic cracker refractionation absorber; Refinery gas

649-140-00-X

270-805-1

68478-25-1

H, K

(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.)

L 136/264

EN

Official Journal of the European Union

29.5.2007

Substances

Index No

EC No

CAS No

Notes

Tail gas (petroleum), catalytic reformed naphtha separator; Refinery gas

649-141-00-5

270-807-2

68478-27-3

H, 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

H, 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

H, 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 hydrodesulphuri-
sation 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.)

Gases (petroleum), reformer effluent high-pressure flash drum off; Refinery
gas

(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.)

649-144-00-1

270-810-9

68478-30-8

H, K

649-145-00-7

270-999-8

68513-14-4

H, K

649-146-00-2

271-003-4

68513-18-8

H, K

649-147-00-8

271-005-5

68513-19-9

H, K

Gases (petroleum), oil refinery gas distillation off; Refinery gas

649-148-00-3

271-258-1

68527-15-1

H, K

(A complex combination separated by distillation of a gas
stream
containing hydrogen, carbon monoxide, carbon dioxide and hydrocarbons
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.)

29.5.2007

EN

Official Journal of the European Union

L 136/265

Substances

Index No

EC No

CAS No

Notes

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 depentanising.
It consists primarily of hydrogen, ethane and propane with 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.)

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.)

649-149-00-9

271-623-5

68602-82-4

H, K

649-150-00-4

271-625-6

68602-84-6

H, K

Petroleum products, refinery gases; Refinery gas

649-151-00 -X

271-750-6

68607-11-4

H, 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

H, K

(A complex combination obtained by the liquid-vapour separation of the
hydrocracking process
It consists predominantly of
hydrogen and saturated hydrocarbons having carbon numbers predomi-
nantly in the range of C1 through C3.)

reactor effluent.

Gases (petroleum), refinery; Refinery gas

649-153-00-0

272-338-9

68814-67-5

H, 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

H, 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.)

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 predomi-
nantly in the range of C4 through C5.)

649-155-00-1

272-775-5

68911-58-0

H, K

Gases (petroleum), hydrotreated sour kerosine flash drum; Refinery gas

649-156-00-7

272-776-0

68911-59-1

H, 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.)

L 136/266

EN

Official Journal of the European Union

29.5.2007

Substances

Index No

EC No

CAS No

Notes

Gases (petroleum), distillate unifiner desulphurisation stripper off; Refinery
gas

(A complex combination stripped from the liquid product of the unifiner
desulphurisation process.
It consists of hydrogen sulphide, methane,
ethane, and propane.)

649-157-00-2

272-873-8

68919-01-7

H, K

Gases (petroleum), fluidised catalytic cracker fractionation off; Refinery gas

649-158-00-8

272-874-3

68919-02-8

H, K

(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.)

Gases (petroleum), fluidised catalytic cracker scrubbing secondary absorber
off; Refinery gas

(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.)

649-159-00-3

272-875-9

68919-03-9

H, K

649-160-00-9

272-876-4

68919-04-0

H, K

(petroleum), platformer

Gases
Refinery gas

stabiliser off,

light ends

fractionation;

649-161-00-4

272-880-6

68919-07-3

H, 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 distillation; Refinery gas

649-162-00-X

272-881-1

68919-08-4

H, K

(A complex combination produced from the first tower used in the distilla-
tion of crude oil. It consists of nitrogen and saturated aliphatic hydrocar-
bons having carbon numbers predominantly in the range of C1 through
C5.)

Gases (petroleum), tar stripper off; Refinery gas

649-163-00-5

272-884-8

68919-11-9

H, 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

H, K

(A combination of hydrogen and methane obtained by fractionation of the
products from the unifiner unit.)

Tail gas
Refinery gas

(petroleum), catalytic hydrodesulphurised naphtha separator;

(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

H, K

29.5.2007

EN

Official Journal of the European Union

L 136/267

Substances

Index No

EC No

CAS No

Notes

Tail gas (petroleum), straight-run naphtha hydrodesulphuriser; Refinery gas

649-166-00-1

273-174-0

68952-80-7

H, K

(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.)

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

H, K

Gases (petroleum), crude distillation and catalytic cracking; Refinery gas

649-168-00-2

273-563-5

68989-88-8

H, 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

H, K

(A complex combination produced by desulphurisation of gas oils with
diethanolamine. It consists predominantly of hydrogen sulphide, hydrogen
and aliphatic hydrocarbons having carbon numbers in the range of C1
through C5.)

Gases (petroleum), gas oil hydrodesulphurisation effluent; Refinery gas

649-170-00-3

295-398-8

92045-16-4

H, 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.)

Gases (petroleum), gas oil hydrodesulphurisation purge; Refinery gas

649-171-00-9

295-399-3

92045-17-5

H, 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

H, 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.)

Gases (petroleum), naphtha steam cracking high-pressure residual; Refinery
gas

(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.)

649-173-00-X

295-401-2

92045-19-7

H, K

L 136/268

EN

Official Journal of the European Union

29.5.2007

Substances

Index No

EC No

CAS No

Notes

Gases (petroleum), residue visbaking off; Refinery gas

649-174-00-5

295-402-8

92045-20-0

H, 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.)

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.)

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.)

Tail gas (petroleum), catalytic polymerisation naphtha fractionation stabi-
liser; 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.)

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.)

649-177-00-1

268-629-5

68131-75-9

H, K

649-178-00-7

269-617-2

68307-98-2

H, K

649-179-00-2

269-618-8

68307-99-3

H, K

649-180-00-8

269-619-3

68308-00-9

H, K

Tail gas (petroleum), cracked distillate hydrotreater stripper; Petroleum gas

649-181-00-3

269-620-9

68308-01-0

H, K

(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.)

649-182-00-9

269-630-3

68308-10-1

H, K

Tail gas (petroleum), gas oil catalytic cracking absorber; Petroleum gas

649-183-00-4

269-623-5

68308-03-2

H, K

(A complex combination of hydrocarbons obtained from the distillation of
products from the catalytic cracking of gas oil. It consists predominantly
of hydrocarbons having carbon numbers predominantly in the range of C1
through C5.)

29.5.2007

EN

Official Journal of the European Union

L 136/269

Substances

Index No

EC No

CAS No

Notes

Tail gas (petroleum), gas recovery plant; Petroleum gas

649-184-00-X

269-624-0

68308-04-3

H, K

(A complex combination of hydrocarbons from the distillation of products
It consists predominantly of
from miscellaneous hydrocarbon streams.
hydrocarbons having carbon numbers predominantly in the range of C1
through C5.)

Tail gas (petroleum), gas recovery plant deethaniser; Petroleum gas

649-185-00-5

269-625-6

68308-05-4

H, K

(A complex combination of hydrocarbons from the distillation of products
from miscellaneous hydrocarbon streams.
It consists of hydrocarbon
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 hydrocar-
bons having carbon numbers predominantly in the range of C1 through
C5.)

Tail gas (petroleum), hydrodesulphurised vacuum gas oil stripper, hydrogen
sulphide-free; Petroleum gas

(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.)

649-186-00-0

269-626-1

68308-06-5

H, K

649-187-00-6

269-627-7

68308-07-6

H, K

Tail gas
light
sulphide-free; Petroleum gas

(petroleum),

straight-run naphtha stabiliser, hydrogen

649-188-00-1

269-629-8

68308-09-8

H, K

(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 hydrocar-
bons 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 hydrocar-
bons having carbon numbers predominantly in the range of C1 through
C6.)

649-189-00-7

269-631-9

68308-11-2

H, K

649-190-00-2

269-632-4

68308-12-3

H, K

Gases (petroleum), catalytic cracked overheads; Petroleum gas

649-191-00-8

270-071-2

68409-99-4

H, 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.)

L 136/270

EN

Official Journal of the European Union

29.5.2007

Substances

Index No

EC No

CAS No

Notes

Alkanes, C1-2; Petroleum gas

649-193-00-9

270-651-5

68475-57-0

H, K

Alkanes, C2-3; Petroleum gas

649-194-00-4

270-652-0

68475-58-1

H, K

Alkanes, C3-4; Petroleum gas

649-195-00-X

270-653-6

68475-59-2

H, K

Alkanes, C4-5; Petroleum gas

649-196-00-5

270-654-1

68475-60-5

H, K

Fuel gases; Petroleum gas

649-197-00-0

270-667-2

68476-26-6

H, K

(A combination of light gases. It consists predominantly of hydrogen and/
or low molecular weight hydrocarbons.)

Fuel gases, crude oil of distillates; Petroleum gas

649-198-00-6

270-670-9

68476-29-9

H, 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

H, K

Hydrocarbons, C4-5; Petroleum gas

649-200-00-5

270-682-4

68476-42-6

H, K

Hydrocarbons, C2-4, C3-rich; Petroleum gas

649-201-00-0

270-689-2

68476-49-3

H, K

Petroleum gases, liquefied; Petroleum gas

649-202-00-6

270-704-2

68476-85-7

H, K, S

(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.)

Petroleum gases, liquefied, sweetened; Petroleum gas

649-203-00-1

270-705-8

68476-86-8

H, K, S

(A complex combination of hydrocarbons obtained by subjecting liquefied
petroleum gas mix to a sweetening process to convert mercaptans or to
It consists of hydrocarbons having carbon
remove acidic impurities.
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 saturated
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 saturated
and unsaturated aliphatic hydrocarbons usually ranging in the carbon
numbers C3 through C6. It consists of saturated and unsaturated hydrocar-
bons having carbon numbers in the range of C3 through C6, predomi-
nantly piperylenes.)

649-204-00-7

270-724-1

68477-33-8

H, K

649-205-00-2

270-726-2

68477-35-0

H, K

29.5.2007

EN

Official Journal of the European Union

L 136/271

Substances

Index No

EC No

CAS No

Notes

Gases (petroleum), butane splitter overheads; Petroleum gas

649-206-00-8

270-750-3

68477-69-0

H, 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.)

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.)

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.)

Tail gas (petroleum), isomerised naphtha fractionation stabiliser; Petroleum
gas

(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.)

649-207-00-3

270-751-9

68477-70-3

H, K

649-208-00-9

270-752-4

68477-71-4

H, K

649-209-00-4

270-754-5

68477-72-5

H, K

649-210-00-X

269-628-2

68308-08-7

H, K

L 136/272

EN

Official Journal of the European Union

29.5.2007

Appendix 5

Point 30 — Toxic to reproduction: category 1

Substances

Index No

EC No

CAS No

Notes

A, E

A, E

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 Constitu-
tion No 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 Constitu-
tion No 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

29.5.2007

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Official Journal of the European Union

L 136/273

Appendix 6

Point 30 — Toxic to reproduction: category 2

Substances

Index No

EC No

CAS No

Notes

Linuron (ISO)
3-(3,4-dichlorophenyl)-1-methoxy-1-methylurea

006-021-00-1

206-356-5

330-55-2

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

—

Potassium dichromate

Ammonium dichromate

Sodium dichromate anhydrate

Sodium dichromate, dihydrate

Sodium chromate

Nickel tetracarbonyl

Cadmium fluoride

Cadmium chloride

Cadmium sulphate

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

024-004-01-4

234-190-3

7789-12-0

024-018-00-3

231-889-5

7775-11-3

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

048-009-00-9

233-331-6

10124-36-4

E

E

E

E

E

E

E

E

E

E

E

Benzo[a]pyrene; benzo[d,e,f]chrysene

601-032-00-3

200-028-5

50-32-8

1-Bromopropane
Propyl bromide
n-Propyl bromide

1,2,3-Trichloropropane

602-019-00-5

203-445-0

106-94-5

602-062-00-X

202-486-1

96-18-4

D

Diphenylether; octabromo derivate

602-094-00-4

251-087-9

32536-52-0

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

1,2-Dimethoxyethane
ethylene glycol dimethyl ether
EGDME

603-031-00-3

203-794-9

110-71-4

2,3-Epoxypropan-1-ol; glycidol oxiranemethanol

603-063-00-8

209-128-3

556-52-5

2-Methoxypropanol

Bis(2-methoxyethyl) ether

R-2,3-epoxy-1-propanol

1,2-Bis(2-methoxyethoxy)ethane
TEGDME;
Triethylene glycol dimethyl ether;
Triglyme

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

603-176-00-2

203-977-3

112-49-2

E

E

L 136/274

EN

Official Journal of the European Union

29.5.2007

Substances

Index No

EC No

CAS No

Notes

4,4'-isobutylethylidenediphenol; 2,2-bis
tane

(4'-hydroxyphenyl)-4-methylpen-

604-024-00-8

401-720-1

6807-17-6

Tetrahydrothiopyran-3-carboxaldehyde

606-062-00-0

407-330-8

61571-06-0

2-Methoxyethyl acetate; ethylene glycol monomethyl ether acetate; methyl-
glycol acetate

607-036-00-1

203-772-9

110-49-6

2-Ethoxyethyl acetate; ethylene glycol monoethyl ether acetate; ethylglycol
acetate

607-037-00-7

203-839-2

111-15-9

2-Ethylhexyl
acetate

3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl methyl

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

Fluazifop-butyl
phenoxy]propionate

(ISO);

butyl

(RS)-2-[4-(5-trifluoromethyl-2-pyridyloxy)

607-304-00-8

274-125-6

69806-50-4

607-251-00-0

274-724-2

70657-70-4

Vinclozolin (ISO); N-3,5-Dichlorophenyl-5-methyl-5-vinyl-1,3-oxazolidine-
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

Bis(2-ethylhexyl) phthalate; di-(2-ethylhexyl) phthalate; DEHP

607-317-00-9

204-211-0

117-81-7

Dibutyl phthalate; DBP

tetrahydrofurfuryl

(+/-)
propionate

(R)-2-[4-(6-chloroquinoxalin-2-yloxy)phenyloxy]

607-373-00-4

414-200-4

119738-06-6

607-318-00-4

201-557-4

84-74-2

1,2-benzenedicarboxylic acid, dipentylester, branched and linear [1]
n-pentyl-isopentylphthalate [2]
di-n-pentyl phthalate [3]
Diisopentylphthalate [4]

607-426-00-1

284-032-2 [1]-[2]
205-017-9 [3]-[4]

84777-06-0 [1]-[2]
131-18-0 [3]
42925-80-4 [4]

Benzyl butyl phthalate
BBP

1,2-Benzenedicarboxylic acid
di-C7-11-branched and linear alkylesters

A mixture of: disodium 4-(3-ethoxycarbonyl-4-(5-(3-ethoxycarbonyl-5-
hydroxy-1-(4-sulfonatophenyl)pyrazol-4-yl)penta-2,4-dienylidene)-4,5-
dihydro-5-oxopyrazol-1-yl)benzenesulfonate;
trisodium 4-(3-ethoxycarbonyl-4-(5-(3-ethoxycarbonyl-5-oxido-1-(4-sulfo-
natophenyl)pyrazol-4-yl)penta-2,4-dienylidene)-4,5-dihydro-5-oxopyrazol-
1-yl)benzenesulfonate

607-430-00-3

201-622-7

85-68-7

607-480-00-6

271-084-6

68515-42-4

607-487-00-4

402-660-9

—

E

E

Dinocap (ISO)

609-023-00-6

254-408-0

39300-45-3

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 elsewhere
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

29.5.2007

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L 136/275

Substances

Index No

EC No

CAS No

Notes

2-[2-hydroxy-3-(2-chlorophenyl)carbamoyl-1-naphthylazo]-7-[2-hydroxy-
3-(3-methylphenyl)carbamoyl-1-naphthylazo]fluoren-9-one

611-131-00-3

420-580-2

—

Azafenidin

611-140-00-2 —

68049-83-2

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

96-45-7

Carbendazim (ISO)
methyl benzimidazol-2-ylcarbamate

Benomyl (ISO)
methyl 1-(butylcarbamoyl)benzimidazol-2-ylcarbamate

613-048-00-8

234-232-0

10605-21-7

613-049-00-3

241-775-7

17804-35-2

Cycloheximide

613-140-00-8

200-636-0

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

3-Ethyl-2-methyl-2-(3-methylbutyl)-1,3-oxazolidine

613-191-00-6

421-150-7

143860-04-2

A mixture of: 1,3,5-tris(3-aminomethylphenyl)-1,3,5-(1H,3H,5H)-triazine-
2,4,6-trione;
a mixture of oligomers of 3,5-bis(3-aminomethylphenyl)-1-poly[3,5-bis(3-
aminomethylphenyl)-2,4,6-trioxo-1,3,5-(1H,3H,5H)-triazin-1-yl]-1,3,5-
(1H,3H,5H)-triazine-2,4,6-trione

613-199-00-X

421-550-1

—

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

L 136/276

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Official Journal of the European Union

29.5.2007

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.

29.5.2007

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L 136/277

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 arti-

cles 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 parti-
culars 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.

L 136/278

EN

Official Journal of the European Union

29.5.2007

Appendix 8

Point 43 — Azocolourants

List of aromatic amines

1.

2.

3.

4.

5.

6.

7.

8.

9.

CAS No

Index No

EC No

Substances

92-67-1

612-072-00-6

202-177-1

biphenyl-4-ylamine

4-aminobiphenyl xenylamine

92-87-5

95-69-2

91-59-8

97-56-3

99-55-8

106-47-8

615-05-4

101-77-9

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

4,4'-bi-o-toluidine

13.

14.

15.

16.

17.

18.

19.

20.

21.

838-88-0

120-71-8

101-14-4

101-80-4

139-65-1

95-53-4

95-80-7

137-17-7

90-04-0

612-085-00-7

212-658-8

4,4'-methylenedi-o-toluidine

204-419-1

6-methoxy-m-toluidine p-cresidine

612-078-00-9

202-918-9

4,4'-methylene-bis-(2-chloro-aniline)

2,2'-dichloro-4,4'-methylene-dianiline

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

29.5.2007

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Official Journal of the European Union

L 136/279

Appendix 9

Point 43 — Azocolourants

List of azodyes

CAS No

Index No

EC No

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
oxidophenylazo)-1-naphtholato)chromate(1-)

bis(6-(4-anisidino)-3-sulfonato-2-(3,5-dinitro-2-

L 136/280

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Official Journal of the European Union

29.5.2007

Appendix 10

Point 43 — Azocolourants

List of testing methods

European
standardisation
organisation (*)

Reference and title of the standard

Reference document

Reference of the
superseded standard

CEN

CEN

CEN

Leather — Chemical
ation of certain azocolorants
leathers

tests — Determin-
in dyed

Textiles — Methods for the determination
of certain aromatic amines derived from
azocolorants — Part 1: Detection of the
use of certain azo colorants accessible
without extraction

Textiles — Methods for determination of
certain aromatic
amines derived from
azocolorants — Part 2: Detection of the
use of certain azo colorants accessible by
extracting the fibres

CEN ISO/TS 17234:2003

NONE

EN 14362-1:2003

NONE

EN 14362-2:2003

NONE

(*) ESO: European standardisation organisations:

CEN: rue de Stassart 36, B-1050 Bruxelles; tel. (32-2) 550 08 11, fax (32-2) 550 08 19. http://www.cenorm.be
CENELEC: rue de Stassart 36, B-1050 Bruxelles; tel. (32-2) 519 68 71, fax (32-2) 519 69 19. http://www.cenelec.org
ETSI: 650, route des Lucioles, F-06921 Sophia Antipolis; tel. (33) 492 94 42 00, fax (33) 493 65 47 16. http://www.etsi.org