22.12.2009

EN

Official Journal of the European Union

L 342/59

REGULATION (EC) No 1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 30 November 2009
on cosmetic products(recast)(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EURO­PEAN UNION,(5)

The environmental concerns that substances used in cos­
metic products may raise are considered through the appli­
cation of Regulation (EC) No 1907/2006 of the European
Parliament and of the Council of 18 December 2006 con­cerning the Registration, Evaluation, Authorisation andRestriction of Chemicals (REACH) and establishing a Euro­pean Chemicals Agency (4), which enables the assessmentof environmental safety in a cross-sectoral manner.

(6)This Regulation relates only to cosmetic products and not
to medicinal products, medical devices or biocidal prod­
ucts. The delimitation follows in particular from thedetailed definition of cosmetic products, which refers bothto their areas of application and to the purposes of their
use.

(7)

The assessment of whether a product is a cosmetic prod­
uct has to be made on the basis of a case-by-case assess­ment, taking into account all characteristics of the product.
Cosmetic products may include creams, emulsions, lotions,gels and oils for the skin, face masks, tinted bases (liquids,
pastes, powders), make-up powders, after-bath powders,hygienic powders, toilet soaps, deodorant soaps, perfumes,
toilet waters and eau de Cologne, bath and shower prepa­
rations (salts, foams, oils, gels), depilatories, deodorants
and anti-perspirants, hair colorants, products for waving,straightening and fixing hair, hair-setting products, haircleansing products (lotions, powders, shampoos), hairconditioning products (lotions, creams, oils), hairdressing
products (lotions, lacquers, brilliantines), shaving products(creams, foams, lotions), make-up and products removing
make-up, products intended for application to the lips,
products for care of the teeth and the mouth, products for
nail care and make-up, products for external intimate
hygiene, sunbathing products, products for tanning with­out sun, skin-whitening products and anti-wrinkle
products.

(8)

The Commission should define the categories of cosmetic
products which are relevant for the application of thisRegulation.

(9)

Cosmetic products should be safe under normal or reason­
ably foreseeable conditions of use. In particular, a riskbenefit reasoning should not justify a risk to human health.

Having regard to the Treaty establishing the European Commu­
nity, and in particular Article 95 thereof,
Having regard to the proposal from the Commission,
Having regard to the opinion of the European Economic andSocial Committee (1),Acting in accordance with the procedure laid down in Article 251of the Treaty (2),Whereas:(1)

Council Directive 76/768/EEC of 27 July 1976 on theapproximation of the laws of the Member States relating tocosmetic products (3) has been significantly amended on
several occasions. Since further amendments are to be
made, in this particular case it should be recast as one
single text in the interests of clarity.

(2)

A Regulation is the appropriate legal instrument as it
imposes clear and detailed rules which do not give roomfor diverging transposition by Member States. Moreover, aRegulation ensures that legal requirements are imple­
mented at the same time throughout the Community.

(3)This Regulation aims at simplifying procedures andstreamlining terminology, thereby reducing administrative
burden and ambiguities. Moreover, it strengthens certain
elements of the regulatory framework for cosmetics, suchas in-market control, with a view to ensuring a high levelof protection of human health.

(4)This Regulation comprehensively harmonises the rules in
the Community in order to achieve an internal market forcosmetic products while ensuring a high level of protec­
tion of human health.

(1) OJ C 27, 3.2.2009, p. 34.
(2) Opinion of the European Parliament of 24 March 2009 (not yet pub­lished in the Official Journal) and Council Decision of 20 November
2009.
(3) OJ L 262, 27.9.1976, p. 169.

(4) OJ L 396, 30.12.2006, p. 1.

L 342/60
(10)

(11)

(12)

(13)

(14)

(15)

(16)

EN

Official Journal of the European Union

The presentation of a cosmetic product and in particular its
form, odour, colour, appearance, packaging, labelling, vol­ume or size should not endanger health and safety of con­sumers due to confusion with foodstuffs, in accordancewith Council Directive 87/357/EEC of 25 June 1987 on
the approximation of the laws of the Member States con­cerning products which, appearing to be other than they
are, endanger the health or safety of consumers (1).

22.12.2009(17)

For the purpose of effective market surveillance, a productinformation file should be made readily accessible, at one
single address within the Community, to the competentauthority of the Member State where the file is located.

(18)

In order to be comparable and of high quality, the resultsof the non-clinical safety studies carried out for the pur­poses of assessing the safety of a cosmetic product should
comply with the relevant Community legislation.

(19)

Ensuring traceability of a cosmetic product throughout thewhole supply chain helps to make market surveillance sim­pler and more efficient. An efficient traceability systemfacilitates market surveillance authorities’ task of tracing
economic operators.

It should be made clear which information is to be madeavailable to the competent authorities. That information
should include all the necessary particulars relating to iden­tity, quality, safety for human health and the effects claimed
for the cosmetic product. In particular, this product infor­
mation should include a cosmetic product safety report
documenting that a safety assessment has been conducted.

(20)

To ensure the uniform application and control of therestrictions for substances, sampling and analysis should
be carried out in a reproducible and standardised manner.

It is necessary to determine under which conditions a dis­tributor is to be considered as the responsible person.

(21)

The term ‘mixture’ as defined in this Regulation shouldhave the same meaning as the term ‘preparation’ previ­
ously used in Community legislation.

(22)

For reasons of effective market surveillance, the competentauthorities should be notified of certain information about
the cosmetic product placed on the market.

(23)

In order to allow for rapid and appropriate medical treat­ment in the event of difficulties, the necessary information
about the product formulation should be submitted to poi­son control centres and assimilated entities, where such
centres have been established by Member States to that
end.

(24)

In order to keep administrative burdens to a minimum, thenotified information for competent authorities, poison
control centres and assimilated entities should be submit­
ted centrally for the Community by way of an electronicinterface.

(25)

In order to ensure a smooth transition to the new elec­
tronic interface, economic operators should be allowed to
notify the information required in accordance with thisRegulation before its date of application.

(26)

The general principle of the responsibility of the manufac­
turer or importer for the safety of the product should be
supported by restrictions of some substances in Annexes II
and III. Moreover, substances which are intended to be
used as colorants, preservatives and UV-filters should belisted in the Annexes IV, V and VI respectively in order tobe allowed for these uses.

In order to establish clear responsibilities, each cosmetic
product should be linked to a responsible person estab­lished within the Community.

All legal or natural persons in the wholesale trade as well
as retailers selling directly to the consumer are covered byreference to the distributor. The obligations of the distribu­
tor should therefore be adapted to the respective role andpart of the activity of each of these operators.

The European cosmetics sector is one of the industrial
activities affected by counterfeiting, which may increaserisks to human health. Member States should pay particu­
lar attention to the implementation of horizontal Commu­
nity legislation and measures regarding counterfeit
products in the field of cosmetic products, for example
Council Regulation (EC) No 1383/2003 of 22 July 2003
concerning customs action against goods suspected of
infringing certain intellectual property rights and the mea­sures to be taken against goods found to have infringed
such rights (2) and Directive 2004/48/EC of the European
parliament and of the Council of 29 April 2004 on theenforcement of intellectual property rights (3). In-market
controls represent a powerful means of identifying prod­
ucts that do not comply with the requirements of thisRegulation.

To ensure their safety, cosmetic products placed on themarket should be produced according to good manufac­
turing practice.

(1) OJ L 192, 11.7.1987, p. 49.
(2) OJ L 196, 2.8.2003, p. 7.
(3) OJ L 157, 30.4.2004, p. 45.

22.12.2009

EN

Official Journal of the European Union(27)

To avoid ambiguities, it should be clarified that the list ofallowed colorants contained in Annex IV includes only
substances which colour through absorption and reflection
and not substances which colour through photolumines­
cence, interference, or chemical reaction.

(28)

To address safety concerns raised, Annex IV, which is cur­rently restricted to skin colorants, should also include haircolorants once the risk assessment of these substances by
the Scientific Committee for Consumer Safety (SCCS) set
up by Commission Decision 2008/721/EC of 5 Septem­
ber 2008 setting up an advisory structure of ScientificCommittees and experts in the field of consumer safety,
public health and the environment (1) has been finalised.
To this end, the Commission should have the possibility toinclude hair colorants in the scope of that Annex by thecomitology procedure.

(29)

(30)

The use of nanomaterials in cosmetic products may
increase with the further development of technology. In
order to ensure a high level of consumer protection, freemovement of goods and legal certainty for manufacturers,
it is necessary to develop a uniform definition for nanoma­
terials at international level. The Community should
endeavour to reach an agreement on a definition in appro­
priate international fora. Should such an agreement bereached, the definition of nanomaterials in this Regulation
should be adapted accordingly.

as CMR 1A or 1B substances, there should be a possibility,
in the exceptional case that these substances comply withfood safety requirements, inter alia as a result of their natu­
rally occurring in food, and that no suitable alternative
substances exist, to use such substances in cosmetic prod­
ucts on the condition that such use has been found safe by
the SCCS. Where such conditions are met, the Commission
should amend the relevant Annexes to this Regulation
within 15 months of classification of substances as CMR
1A or 1B substances under Regulation (EC) No 1272/2008.
Such substances should be continuously reviewed by the
SCCS.

(33)

A safety assessment of substances, particularly those clas­sified as CMR 1A or 1B substances, should consider theoverall exposure to such substances stemming from all
sources. At the same time, for those involved in producing
safety assessments, it is essential that there be a harmon­
ised approach to the development and use of such overall
exposure estimates. In consequence, the Commission, inclose cooperation with the SCCS, the European Chemicals
Agency (ECHA), the European Food Safety Authority(EFSA) and other relevant stakeholders, should, as a matterof urgency, carry out a review and develop guidance
regarding the production and use of overall exposure esti­mates for these substances.

(34)

The assessment by the SCCS of the use of substances clas­sified as CMR 1A and 1B in cosmetic products should also
take into account the exposure to those substances of vul­
nerable population groups, such as children under three
years of age, elderly people, pregnant and breast-feeding
women and persons with compromised immune
responses.

(35)

The SCCS should give opinions where appropriate on thesafety of use of nanomaterials in cosmetic products. These
opinions should be based on full information being madeavailable by the responsible person.

(36)

Action by the Commission and Member States relating to
the protection of human health should be based on the
precautionary principle.

(37)

In order to ensure product safety, prohibited substances
should be acceptable at trace levels only if they are tech­
nologically inevitable with correct manufacturing pro­
cesses and provided that the product is safe.

(38)

The Protocol on protection and welfare of animals annexedto the Treaty provides that the Community and the Mem­
ber States are to pay full regard to the welfare requirementsof animals in the implementation of Community policies,
in particular with regard to the internal market.

At present, there is inadequate information on the risks
associated with nanomaterials. In order to better assess
their safety the SCCS should provide guidance in coopera­tion with relevant bodies on test methodologies which take
into account specific characteristics of nanomaterials.

(31)

The Commission should regularly review the provisions on
nanomaterials in the light of scientific progress.

(32)

Given the hazardous properties of substances classified as
carcinogenic, mutagenic or toxic for reproduction (CMR),
category 1A, 1B and 2, pursuant to Regulation (EC)No 1272/2008 of the European Parliament and of theCouncil of 16 December 2008 on classification, labellingand packaging of substances and mixtures (2), their use incosmetic products should be prohibited. However, as ahazardous property of a substance does not necessarily
always entail a risk, there should be a possibility to allow
the use of substances classified as CMR 2 substances where,
in view of exposure and concentration, they have beenfound safe for use in cosmetic products by the SCCS andare regulated by the Commission in the Annexes to thisRegulation. With regard to substances which are classified(1) OJ L 241, 10.9.2008, p. 21.
(2) OJ L 353, 31.12.2008, p. 1.

L 342/61

L 342/62
(39)

(40)

(41)

(42)

(43)

EN

Official Journal of the European Union

Council Directive 86/609/EEC of 24 November 1986 on
the approximation of laws, regulations and administrative
provisions of the Member States regarding the protectionof animals used for experimental and other scientific pur­poses (1) established common rules for the use of animals
for experimental purposes within the Community and laid
down the conditions under which such experiments must
be carried out in the territory of the Member States. In par­ticular, Article 7 of that Directive requires that animal
experiments be replaced by alternative methods, wheresuch methods exist and are scientifically satisfactory.

The safety of cosmetic products and their ingredients may
be ensured through the use of alternative methods which
are not necessarily applicable to all uses of chemical ingre­
dients. Therefore, the use of such methods by the wholecosmetic industry should be promoted and their adoption
at Community level ensured, where such methods offer anequivalent level of protection to consumers.

The safety of finished cosmetic products can already beensured on the basis of knowledge of the safety of theingredients that they contain. Provisions prohibiting ani­
mal testing of finished cosmetic products should therefore
be laid down. The application, in particular by small andmedium-sized enterprises, of both test methods and assess­ment procedures for relevant available data, including theuse of read-across and weight-of-evidence approaches,
which do not involve the use of animals for assessing thesafety of finished cosmetic products could be facilitated byCommission guidelines.

It will gradually become possible to ensure the safety ofingredients used in cosmetic products by using non-animalalternative methods validated at Community level, or
approved as being scientifically validated, by the European
Centre for the Validation of Alternative Methods (ECVAM)
and with due regard to the development of validation
within the Organisation for Economic Cooperation andDevelopment (OECD). After consulting the SCCS as
regards the applicability of the validated alternative meth­ods to the field of cosmetic products, the Commission
should immediately publish the validated or approved
methods recognised as being applicable to such ingredi­
ents. In order to achieve the highest possible degree of ani­
mal protection, a deadline should be set for the
introduction of a definitive prohibition.

The Commission established timetables of deadlines up
to 11 March 2009 for prohibiting the marketing of cos­
metic products, the final formulation, ingredients or com­binations of ingredients which have been tested onanimals, and for prohibiting each test currently carried out
using animals. In view, however, of tests concerning
repeated-dose toxicity, reproductive toxicity and toxicoki­
netics, it is appropriate for the final deadline for prohibit­
ing the marketing of cosmetic products for which those(1) OJ L 358, 18.12.1986, p. 1.

22.12.2009

tests are used to be 11 March 2013. On the basis of annual
reports, the Commission should be authorised to adapt the
timetables within the abovementioned maximum time
limit.

(44)

Better coordination of resources at Community level willcontribute to increasing the scientific knowledge indis­
pensable for the development of alternative methods. It isessential, for this purpose, that the Community continue
and increase its efforts and take the measures necessary forthe promotion of research and the development of new
non-animal alternative methods, in particular within its
Framework Programmes for research.

(45)

The recognition by third countries of alternative methods
developed in the Community should be encouraged. Inorder to achieve this objective, the Commission and theMember States should take all appropriate steps to facili­tate acceptance of such methods by the OECD. The Com­mission should also endeavour, within the framework ofEuropean Community cooperation agreements, to obtainrecognition of the results of safety tests carried out in theCommunity using alternative methods so as to ensure thatthe export of cosmetic products for which such methods
have been used is not hindered and to prevent or avoid
third countries requiring the repetition of such tests using
animals.

(46)

Transparency is needed regarding the ingredients used incosmetic products. Such transparency should be achievedby indication of the ingredients used in a cosmetic prod­
uct on its packaging. Where for practical reasons it is
impossible to indicate the ingredients on the packaging,such information should be enclosed so that the consumer
has access to this information.

(47)

A glossary of common ingredient names should be com­piled by the Commission to ensure uniform labelling andto facilitate identification of cosmetics ingredients. This
glossary should not be intended to constitute a limitative
list of substances used in cosmetic products.

(48)

In order to inform consumers, cosmetic products shouldbear precise and easily understandable indications con­cerning their durability for use. Given that consumers
should be informed of the date until which the cosmetic
product will continue to fulfil its initial function andremain safe, it is important to know the date of minimum
durability, i.e. the date by which it is best to use the prod­
uct. Where the minimum durability is more than 30
months, the consumer should be informed of the period oftime after opening that the cosmetic product may be usedwithout any harm to the consumer. However, this require­ment should not apply where the concept of the durability
after opening is not relevant, that is to say for single-use
products, products not at risk of deterioration or products
which do not open.

22.12.2009
(49)

EN

Official Journal of the European Union

A number of substances have been identified by the SCCS
as likely to cause allergic reactions and it will be necessary
to restrict their use and/or impose certain conditions con­cerning them. In order to ensure that consumers areadequately informed, the presence of these substances
should be mentioned in the list of ingredients and consum­
ers’ attention should be drawn to the presence of these
ingredients. This information should improve the diagno­
sis of contact allergies among consumers and should
enable them to avoid the use of cosmetic products which
they do not tolerate. For substances which are likely tocause allergy to a significant part of the population, otherrestrictive measures such as a ban or a restriction of con­centration should be considered.

(50)

In the safety assessment of a cosmetic product it should bepossible to take into account results of risk assessmentsthat have been carried out in other relevant areas. The useof such data should be duly substantiated and justified.

(51)

The consumer should be protected from misleading claims
concerning efficacy and other characteristics of cosmetic
products. In particular Directive 2005/29/EC of the Euro­pean Parliament and of the Council of 11 May 2005 con­cerning unfair business-to-consumer commercial practices
in the internal market (1) is applicable. Furthermore, theCommission, in cooperation with Member States, should
define common criteria in relation to specific claims forcosmetic products.

(52)

(53)

(54)

It should be possible to claim on a cosmetic product thatno animal testing was carried out in relation to its devel­
opment. The Commission, in consultation with the Mem­
ber States, has developed guidelines to ensure that
common criteria are applied in the use of claims and thatan aligned understanding of the claims is reached, and inparticular that such claims do not mislead the consumer.
In developing such guidelines, the Commission has also
taken into account the views of the many small andmedium-sized enterprises which make up the majority ofthe ‘non-animal testing’ producers, relevant nongovernmental organisations, and the need for consumers
to be able to make practical distinctions between productson the basis of animal testing criteria.

containing substances which have raised serious doubts interms of safety.
(55)

This Regulation is without prejudice to the possibility for
Member States to regulate, in compliance with Community
law, the notification by health professionals or consumersof serious undesirable effects to the competent authorities
of Member States.

(56)

This Regulation is without prejudice to the possibility for
Member States to regulate, in compliance with Community
law, the establishment of economic operators in the areaof cosmetic products.

(57)

In case of non-compliance with this Regulation, a clear andefficient procedure for the withdrawal and recall of prod­
ucts may be necessary. This procedure should, where pos­sible, build upon existing Community rules for unsafe
goods.

(58)

In order to address cosmetic products which, despite com­plying with the provisions of this Regulation, might endan­
ger human health, a safeguard procedure should be
introduced.

(59)

The Commission should provide indications for the uni­
form interpretation and application of the concept of seri­
ous risks in order to facilitate the consistent
implementation of this Regulation.

(60)

In order to comply with principles of good administrative
practices, any decision by a competent authority in theframework of market surveillance should be duly
substantiated.

(61)

In order to ensure effective in-market control, a highdegree of administrative cooperation amongst the compe­
tent authorities is necessary. This concerns in particularmutual assistance in the verification of product informa­tion files located in another Member State.

(62)

The Commission should be assisted by the SCCS, an inde­
pendent risk assessment body.

(63)

The measures necessary for the implementation of thisRegulation should be adopted in accordance with Council
Decision 1999/468/EC of 28 June 1999 laying down theprocedures for the exercise of implementing powers con­ferred on the Commission (2).

(64)

In particular, power should be conferred on the Commis­
sion to adapt the Annexes to this Regulation to technicalprogress. Since those measures are of general scope and aredesigned to amend non-essential elements of this Regula­tion they must be adopted in accordance with the regula­tory procedure with scrutiny provided for in Article 5a ofDecision 1999/468/EC.

In addition to the labelled information, consumers should
be given the possibility to request certain product-related
information from the responsible person in order to makeinformed product choices.

Effective market surveillance is necessary in order to ensurethat the provisions of this Regulation are respected. To thisend, serious undesirable effects should be notified andcompetent authorities should have a possibility to requestfrom the responsible person a list of cosmetic products(1) OJ L 149, 11.6.2005, p. 22.

L 342/63(2) OJ L 184, 17.7.1999, p. 23.

L 342/64(65)

EN

Official Journal of the European Union

When, on imperative grounds of urgency, the normal timelimits for the regulatory procedure with scrutiny cannot becomplied with, the Commission should be able to apply
the urgency procedure provided for in Article 5a(6) ofDecision 1999/468/EC for the adoption of certain mea­sures relating to CMRs, nanomaterials and potential risks
to human health.

22.12.2009
CHAPTER ISCOPE, DEFINITIONSArticle 1
Scope and objective(66)

Member States should lay down provisions on penalties
applicable to infringements of the provisions of this Regu­
lation and ensure that they are implemented. Those penal­
ties should be effective, proportionate and dissuasive.

This Regulation establishes rules to be complied with by any cos­
metic product made available on the market, in order to ensure
the functioning of the internal market and a high level of protec­
tion of human health.

(67)

Economic operators as well as Member States and theCommission need sufficient time to adapt to the changes
introduced by this Regulation. Therefore it is appropriate
to provide for a sufficient transitional period for that adap­
tation. However, in order to ensure a smooth transition,
economic operators should be allowed to place on themarket cosmetic products which comply with this Regu­
lation before the expiry of that transitional period.

Article 2

(68)

(69)

(70)

(71)

In order to enhance the safety of cosmetic products andstrengthen the market surveillance, cosmetic products
placed on the market after the date of application of thisRegulation should comply with its obligations regarding
safety assessment, the product information file and notifi­
cation, even if similar obligations have already been ful­
filled under Directive 76/768/EEC.
Directive 76/768/EEC should be repealed. However, inorder to ensure appropriate medical treatment in the eventof difficulties and to ensure market surveillance, the infor­
mation received pursuant to Article 7(3) and Article 7a(4)of Directive 76/768/EEC concerning cosmetic products
should be kept by the competent authorities for a certain
period of time and the information kept by the responsible
person should remain available for the same period oftime.
This Regulation should be without prejudice to the obliga­
tions of the Member States relating to the time-limits fortransposition into national law of the Directives set out inPart B of Annex IX.
Since the objective of this Regulation, namely the achieve­
ment of the internal market and a high level of protectionof human health through the compliance of cosmetic
products with the requirements laid down in this Regula­tion, cannot be sufficiently achieved by the Member States
and can therefore, by reason of the scale of the action, bebetter 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 accordancewith the principle of proportionality, as set out in that
Article, this Regulation does not go beyond what is neces­sary in order to achieve that objective,

HAVE ADOPTED THIS REGULATION:

Definitions
1.
For the purposes of this Regulation, the following defini­tions shall apply:(a) ‘cosmetic product’ means any substance or mixture intended
to be placed in contact with the external parts of the humanbody (epidermis, hair system, nails, lips and external genitalorgans) or with the teeth and the mucous membranes of theoral cavity with a view exclusively or mainly to cleaning
them, perfuming them, changing their appearance, protect­
ing them, keeping them in good condition or correcting bodyodours;(b) ‘substance’ means a chemical element and its compounds inthe natural state or obtained by any manufacturing process,including any additive necessary to preserve its stability andany impurity deriving from the process used but excluding
any solvent which may be separated without affecting thestability of the substance or changing its composition;(c) ‘mixture’ means a mixture or solution composed of two or
more substances;(d) ‘manufacturer’ means any natural or legal person who manu­
factures a cosmetic product or has such a product designed
or manufactured, and markets that cosmetic product under
his name or trademark;(e) ‘distributor’ means any natural or legal person in the supply
chain, other than the manufacturer or the importer, whomakes a cosmetic product available on the Community
market;(f) ‘end user’ means either a consumer or professional using thecosmetic product;(g) ‘making available on the market’ means any supply of a cos­
metic product for distribution, consumption or use on theCommunity market in the course of a commercial activity,
whether in return for payment or free of charge;(h) ‘placing on the market’ means the first making available of acosmetic product on the Community market;

22.12.2009

EN

Official Journal of the European Union(i)‘importer’ means any natural or legal person establishedwithin the Community, who places a cosmetic product froma third country on the Community market;(j)‘harmonised standard’ means a standard adopted by one of
the European standardisation bodies listed in Annex I to
Directive 98/34/EC of the European Parliament and of theCouncil of 22 June 1998 laying down a procedure for theprovision of information in the field of technical standards
and regulations and of rules on information society ser­vices (1) on the basis of a request made by the Commissionin accordance with Article 6 of that Directive;(k) ‘nanomaterial’ means an insoluble or biopersistant and inten­
tionally manufactured material with one or more external
dimensions, or an internal structure, on the scale from 1
to 100 nm;(l)

L 342/65

2. For the purposes of point (a) of paragraph 1, a substance or
mixture intended to be ingested, inhaled, injected or implanted
into the human body shall not be considered to be a cosmetic
product.
3.
In view of the various definitions of nanomaterials pub­lished by different bodies and the constant technical and scien­tific developments in the field of nanotechnologies, theCommission shall adjust and adapt point (k) of paragraph 1 totechnical and scientific progress and to definitions subsequently
agreed at international level. That measure, designed to amend
non-essential elements of this Regulation, shall be adopted inaccordance with the regulatory procedure with scrutiny referred
to in Article 32(3).

CHAPTER IISAFETY, RESPONSIBILITY, FREE MOVEMENT‘preservatives’ means substances which are exclusively or
mainly intended to inhibit the development of microorganisms in the cosmetic product;

Article 3
Safety(m) ‘colorants’ means substances which are exclusively or mainly
intended to colour the cosmetic product, the body as a wholeor certain parts thereof, by absorption or reflection of visible
light; in addition, precursors of oxidative hair colorants shallbe deemed colorants;(n) ‘UV-filters’ means substances which are exclusively or mainly
intended to protect the skin against certain UV radiation byabsorbing, reflecting or scattering UV radiation;(o) ‘undesirable effect’ means an adverse reaction for humanhealth attributable to the normal or reasonably foreseeable
use of a cosmetic product;(p) ‘serious undesirable effect’ means an undesirable effect which
results in temporary or permanent functional incapacity, dis­ability, hospitalisation, congenital anomalies or an immedi­
ate vital risk or death;(q) ‘withdrawal’ means any measure aimed at preventing themaking available on the market of a cosmetic product in the
supply chain;(r) ‘recall’ means any measure aimed at achieving the return of acosmetic product that has already been made available to theend user;(s) ‘frame formulation’ means a formulation which lists the cat­egory or function of ingredients and their maximum concen­
tration in the cosmetic product or gives relevant quantitativeand qualitative information whenever a cosmetic product is
not covered or only partially covered by such a formulation.
The Commission shall provide indications for the establish­
ment of the frame formulation and adapt them regularly totechnical and scientific progress.
(1) OJ L 204, 21.7.1998, p. 37.

A cosmetic product made available on the market shall be safe forhuman health when used under normal or reasonably foreseeableconditions of use, taking account, in particular, of the following:(a) presentation
87/357/EEC;

includingconformity

withDirective(b) labelling;(c) instructions for use and disposal;(d) any other indication or information provided by the respon­sible person defined in Article 4.
The provision of warnings shall not exempt persons defined in
Articles 2 and 4 from compliance with the other requirements
laid down in this Regulation.

Article 4
Responsible person
1. Only cosmetic products for which a legal or natural person
is designated within the Community as ‘responsible person’ shallbe placed on the market.
2. For each cosmetic product placed on the market, the respon­sible person shall ensure compliance with the relevant obligations
set out in this Regulation.
3. For a cosmetic product manufactured within the Commu­
nity, and not subsequently exported and imported back into theCommunity, the manufacturer established within the Community
shall be the responsible person.

L 342/66

Official Journal of the European UnionEN

The manufacturer may designate, by written mandate, a person
established within the Community as the responsible person who
shall accept in writing.
Where, for a cosmetic product manufactured within the4.
Community, and not subsequently exported and imported backinto the Community, the manufacturer is established outside theCommunity, he shall designate, by written mandate, a person
established within the Community as the responsible person who
shall accept in writing.
5.
For an imported cosmetic product, each importer shall be
the responsible person for the specific cosmetic product he placeson the market.
The importer may, by written mandate, designate a person estab­lished within the Community as the responsible person who shallaccept in writing.
The distributor shall be the responsible person where he6.
places a cosmetic product on the market under his name or trade­mark or modifies a product already placed on the market in sucha way that compliance with the applicable requirements may beaffected.
The translation of information relating to a cosmetic productalready placed on the market shall not be considered as a modi­
fication of that product of such a nature that compliance with theapplicable requirements of this Regulation may be affected.

Article 522.12.2009

with all the information and documentation necessary to demon­
strate the conformity of specific aspects of the product, in a lan­
guage which can be easily understood by that authority.

Article 6
Obligations of distributors
1.
In the context of their activities, when making a cosmetic
product available on the market, distributors shall act with due
care in relation to applicable requirements.
2. Before making a cosmetic product available on the market
distributors shall verify that:— the labelling information provided for in Article 19(1)(a), (e)and (g) and Article 19(3) and (4) is present,— the language requirements provided for in Article 19(5) are
fulfilled,— the date of minimum durability specified, where applicable
under Article 19(1), has not passed.
3.

Where distributors consider or have reason to believe that:— a cosmetic product is not in conformity with the require­ments laid down in this Regulation, they shall not make theproduct available on the market until it has been brought
into conformity with the applicable requirements,

Obligations of responsible persons
1.
Responsible persons shall ensure compliance with
Articles 3, 8, 10, 11, 12, 13, 14, 15, 16, 17, 18, Article 19(1),(2)and (5), as well as Articles 20, 21, 23 and 24.
2. Responsible persons who consider or have reason to believethat a cosmetic product which they have placed on the market is
not in conformity with this Regulation shall immediately take thecorrective measures necessary to bring that product into confor­
mity, withdraw it or recall it, as appropriate.
Furthermore, where the cosmetic product presents a risk tohuman health, responsible persons shall immediately inform thecompetent national authorities of the Member States in which
they made the product available and of the Member State in which
the product information file is readily accessible, giving details, inparticular, of the non-compliance and of the corrective measurestaken.
3.
Responsible persons shall cooperate with these authorities,
at the request of the latter, on any action to eliminate the risks
posed by cosmetic products which they have made available on
the market. In particular, responsible persons shall, further to areasoned request from a competent national authority, provide it— a cosmetic product which they have made available on themarket is not in conformity with this Regulation, they shallmake sure that the corrective measures necessary to bringthat product into conformity, withdraw it or recall it, as
appropriate, are taken.
Furthermore, where the cosmetic product presents a risk tohuman health, distributors shall immediately inform the respon­sible person and the competent national authorities of the Mem­
ber States in which they made the product available, giving details,
in particular, of the non-compliance and of the corrective mea­sures taken.
4. Distributors shall ensure that, while a product is under their
responsibility, storage or transport conditions do not jeopardiseits compliance with the requirements set out in this Regulation.
5. Distributors shall cooperate with competent authorities, at
the request of the latter, on any action to eliminate the risks posedby products which they have made available on the market. In
particular, distributors shall, further to a reasoned request from acompetent national authority, provide it with all the informationand documentation necessary to demonstrate the conformity ofthe product with the requirements listed under paragraph 2, in alanguage which can be easily understood by that authority.

22.12.2009

Official Journal of the European Union

EN

Article 7
Identification within the supply chain
At the request of a competent authority:— responsible persons shall identify the distributors to whomthey supply the cosmetic product,— the distributor shall identify the distributor or the responsible
person from whom, and the distributors to whom, the cos­
metic product was supplied.
This obligation shall apply for a period of three years following
the date on which the batch of the cosmetic product was madeavailable to the distributor.

L 342/67(b) an appropriate weight-of-evidence approach is used in thesafety assessment for reviewing data from all existing sources;(c) the cosmetic product safety report is kept up to date in viewof additional relevant information generated subsequent toplacing the product on the market.
The first subparagraph shall also apply to cosmetic products thathave been notified under Directive 76/768/EEC.
The Commission, in close cooperation with all stakeholders, shalladopt appropriate guidelines to enable undertakings, in particu­
lar small and medium-sized enterprises, to comply with therequirements laid down in Annex I. Those guidelines shall be
adopted in accordance with the regulatory procedure referred toin Article 32(2).

Article 8
Good manufacturing practice1.
The manufacture of cosmetic products shall comply withgood manufacturing practice with a view to ensuring the objec­
tives of Article 1.
2.
Compliance with good manufacturing practice shall be pre­sumed where the manufacture is in accordance with the relevant
harmonised standards, the references of which have been pub­lished in the Official Journal of the European Union.
Article 9Free movement
Member States shall not, for reasons related to the requirements
laid down in this Regulation, refuse, prohibit or restrict the mak­ing available on the market of cosmetic products which comply
with the requirements of this Regulation.
CHAPTER III
SAFETY ASSESSMENT, PRODUCT INFORMATION FILE,NOTIFICATION

2. The cosmetic product safety assessment, as set out in Part B
of Annex I shall be carried out by a person in possession of a
diploma or other evidence of formal qualifications awarded oncompletion of a university course of theoretical and practical
study in pharmacy, toxicology, medicine or a similar discipline, ora course recognised as equivalent by a Member State.
3.
Non-clinical safety studies referred to in the safety assess­ment according to paragraph 1 and carried out after 30 June
1988 for the purpose of assessing the safety of a cosmetic prod­
uct shall comply with Community legislation on the principles ofgood laboratory practice, as applicable at the time of performanceof the study, or with other international standards recognised as
being equivalent by the Commission or the ECHA.

Article 11
Product information file
1. When a cosmetic product is placed on the market, theresponsible person shall keep a product information file for it.
The product information file shall be kept for a period of ten years
following the date on which the last batch of the cosmetic prod­
uct was placed on the market.

Article 10
Safety assessment

2.
The product information file shall contain the following
information and data which shall be updated as necessary:

1. In order to demonstrate that a cosmetic product complies
with Article 3, the responsible person shall, prior to placing a cos­
metic product on the market, ensure that the cosmetic producthas undergone a safety assessment on the basis of the relevant
information and that a cosmetic product safety report is set up inaccordance with Annex I.

(a) a description of the cosmetic product which enables the
product information file to be clearly attributed to the cos­
metic product;

The responsible person shall ensure that:(a) the intended use of the cosmetic product and the anticipatedsystemic exposure to individual ingredients in a final formu­
lation are taken into account in the safety assessment;(b) the cosmetic product safety report referred to in Article 10(1);(c) a description of the method of manufacturing and a state­ment on compliance with good manufacturing practicereferred to in Article 8;L 342/68

Official Journal of the European Union

EN(d) where justified by the nature or the effect of the cosmetic
product, proof of the effect claimed for the cosmetic product;(e) data on any animal testing performed by the manufacturer,
his agents or suppliers, relating to the development or safetyassessment of the cosmetic product or its ingredients, includ­ing any animal testing performed to meet the legislative or
regulatory requirements of third countries.

22.12.2009(f) the presence of substances in the form of nanomaterials and:(i)their identification including the chemical name (IUPAC)
and other descriptors as specified in point 2 of the Pre­
amble to Annexes II to VI to this Regulation;(ii) the reasonably foreseeable exposure conditions;3.
The responsible person shall make the product information
file readily accessible in electronic or other format at his address
indicated on the label to the competent authority of the Member
State in which the file is kept.

(g) the name and the Chemicals Abstracts Service (CAS) or EC
number of substances classified as carcinogenic, mutagenic
or toxic for reproduction (CMR), of category 1A or 1B, underPart 3 of Annex VI to Regulation (EC) No 1272/2008;

The information contained in the product information file shallbe available in a language which can be easily understood by thecompetent authorities of the Member State.

(h) the frame formulation allowing for prompt and appropriate
medical treatment in the event of difficulties.

4.
The requirements provided in paragraphs 1 to 3 of this
Article shall also apply to cosmetic products that have been noti­
fied under Directive 76/768/EEC.

Article 12
Sampling and analysis
1.
Sampling and analysis of cosmetic products shall be per­formed in a reliable and reproducible manner.
2.
In the absence of any applicable Community legislation,
reliability and reproducibility shall be presumed if the method
used is in accordance with the relevant harmonised standards, thereferences of which have been published in the Official Journal of
the European Union.

Article 13
Notification
1.
Prior to placing the cosmetic product on the market the
responsible person shall submit, by electronic means, the follow­
ing information to the Commission:(a) the category of cosmetic product and its name or names,
enabling its specific identification;(b) the name and address of the responsible person where theproduct information file is made readily accessible;

The first subparagraph shall also apply to cosmetic products noti­
fied under Directive 76/768/EEC.
2.
When the cosmetic product is placed on the market, theresponsible person shall notify to the Commission the originallabelling, and, where reasonably legible, a photograph of the cor­
responding packaging.
3. As from 11 July 2013, a distributor who makes available ina Member State a cosmetic product already placed on the market
in another Member State and translates, on his own initiative, anyelement of the labelling of that product in order to comply withnational law, shall submit, by electronic means, the following
information to the Commission:(a) the category of cosmetic product, its name in the Member
State of dispatch and its name in the Member State in which
it is made available, enabling its specific identification;(b) the Member State in which the cosmetic product is madeavailable;(c) his name and address;(d) the name and address of the responsible person where theproduct information file is made readily accessible..
4. Where a cosmetic product has been placed on the market
before 11 July 2013 but is no longer placed on the market as
from that date, and a distributor introduces that product in a
Member State after that date, that distributor shall communicate
the following to the responsible person:(c) the country of origin in the case of import;(d) the Member State in which the cosmetic product is to beplaced on the market;(a) the category of cosmetic product, its name in the Member
State of dispatch and its name in the Member State in which
it is made available, enabling its specific identification;(e) the contact details of a physical person to contact in the caseof necessity;(b) the Member State in which the cosmetic product is madeavailable;

22.12.2009

Official Journal of the European UnionEN(c) his name and address.

L 342/69(c) colorants

On the basis of that communication, the responsible person shallsubmit to the Commission, by electronic means, the informationreferred to in paragraph 1 of this Article, where notifications
according to Article 7(3) and Article 7a (4) of Directive
76/768/EEC have not been carried out in the Member State inwhich the cosmetic product is made available.
5. The Commission shall, without delay, make the informationreferred to in points (a) to (g) of paragraph 1, and in paragraphs 2
and 3 available electronically to all competent authorities.
That information may be used by competent authorities only forthe purposes of market surveillance, market analysis, evaluationand consumer information in the context of Articles 25, 26
and 27.
6. The Commission shall, without delay, make the informationreferred to in paragraphs 1, 2 and 3 available electronically to poi­son centres or similar bodies, where such centres or bodies havebeen established by Member States.
That information may be used by those bodies only for the pur­poses of medical treatment.

(i)colorants other than those listed in Annex IV and colo­rants which are listed there but not used in accordancewith the conditions laid down in that Annex, except forhair colouring products referred to in paragraph 2;(ii) without prejudice to points (b), (d)(i) and (e)(i), sub­stances which are listed in Annex IV but which are notintended to be used as colorants, and which are not usedin accordance with the conditions laid down in that
Annex;(d) preservatives(i)preservatives other than those listed in Annex V and pre­servatives which are listed there but not used in accor­
dance with the conditions laid down in that Annex;(ii) without prejudice to points (b), (c)(i) and (e)(i), sub­stances listed in Annex V but which are not intended to
be used as preservatives, and which are not used inaccordance with the conditions laid down in that Annex;(e) UV-filters

7.
Where any of the information set out in paragraphs 1, 3
and 4 changes, the responsible person or the distributor shall pro­vide an update without delay.

(i)

8.
The Commission may, taking into account technical andscientific progress and specific needs related to market surveil­
lance, amend paragraphs 1 to 7 by adding requirements.

(ii) without prejudice to points (b), (c)(i) and (d)(i), sub­stances listed in Annex VI but which are not intended to
be used as UV-filters and which are not used in accor­
dance with the conditions laid down in that Annex.

Those measures, designed to amend non-essential elements of thisRegulation, shall be adopted in accordance with the regulatory
procedure with scrutiny referred to in Article 32(3).

CHAPTER IV
RESTRICTIONS FOR CERTAIN SUBSTANCES

Article 14
Restrictions for substances listed in the Annexes
1. Without prejudice to Article 3, cosmetic products shall notcontain any of the following:(a) prohibited substances— prohibited substances listed in Annex II;(b) restricted substances— restricted substances which are not used in accordancewith the restrictions laid down in Annex III;UV-filters other than those listed in Annex VI and
UV-filters which are listed there but not used in accor­
dance with the conditions laid down in that Annex;

2. Subject to a decision of the Commission to extend the scopeof Annex IV to hair colouring products, such products shall notcontain colorants intended to colour the hair, other than thoselisted in Annex IV and colorants intended to colour the hair which
are listed there but not used in accordance with the conditions
laid down in that Annex.
The decision of the Commission referred to in the first subpara­graph, designed to amend non-essential elements of this Regula­tion, shall be adopted in accordance with the regulatory procedure
with scrutiny referred to in Article 32(3).
Article 15
Substances classified as CMR substances1.
The use in cosmetic products of substances classified as
CMR substances, of category 2, under Part 3 of Annex VI to Regu­
lation (EC) No 1272/2008 shall be prohibited. However, a sub­stance classified in category 2 may be used in cosmetic products
where the substance has been evaluated by the SCCS and foundsafe for use in cosmetic products. To these ends the Commission
shall adopt the necessary measures in accordance with the regu­
latory procedure with scrutiny referred to in Article 32(3) of thisRegulation.

L 342/70

EN

Official Journal of the European Union

2.
The use in cosmetic products of substances classified as
CMR substances, of category 1A or 1B under Part 3 of Annex VI
to Regulation (EC) No 1272/2008 shall be prohibited.
However, such substances may be used in cosmetic products by
way of exception where, subsequent to their classification as CMR
substances of category 1A or 1B under Part 3 of Annex VI to
Regulation (EC) No 1272/2008, all of the following conditions
are fulfilled:

22.12.2009

ECHA, the EFSA and other relevant stakeholders, drawing, as
appropriate, on relevant best practice.
4.
When Community or internationally agreed criteria for
identifying substances with endocrine-disrupting properties areavailable, or at the latest on 11 January 2015, the Commission
shall review this Regulation with regard to substances withendocrine-disrupting properties.

Article 16(a) they comply with the food safety requirements as defined inRegulation (EC) No 178/2002 of the European Parliamentand of the Council of 28 January 2002 laying down the gen­eral principles and requirements of food law, establishing theEuropean Food Safety Authority and laying down proceduresin matters of food safety (1);

1. For every cosmetic product that contains nanomaterials, ahigh level of protection of human health shall be ensured.

(b) there are no suitable alternative substances available, as docu­
mented in an analysis of alternatives;

2. The provisions of this Article do not apply to nanomateri­als used as colorants, UV-filters or preservatives regulated under
Article 14, unless expressly specified.

(c) the application is made for a particular use of the productcategory with a known exposure; and(d) they have been evaluated and found safe by the SCCS for use
in cosmetic products, in particular in view of exposure tothese products and taking into consideration the overall
exposure from other sources, taking particular account ofvulnerable population groups.
Specific labelling in order to avoid misuse of the cosmetic prod­
uct shall be provided in accordance with Article 3 of this Regu­
lation, taking into account possible risks linked to the presence of
hazardous substances and the routes of exposure.
In order to implement this paragraph, the Commission shallamend the Annexes to this Regulation in accordance with theregulatory procedure with scrutiny referred to in Article 32(3) ofthis Regulation within 15 months of the inclusion of the sub­stances concerned in Part 3 of Annex VI to Regulation (EC)No 1272/2008.
On imperative grounds of urgency, the Commission may use theurgency procedure referred to in Article 32(4) of this Regulation.
The Commission shall mandate the SCCS to re-evaluate those
substances as soon as safety concerns arise, and at the latest five
years after their inclusion in Annexes III to VI to this Regulation,
and at least every subsequent five years.

Nanomaterials

3. In addition to the notification under Article 13, cosmetic
products containing nanomaterials shall be notified to the Com­mission by the responsible person by electronic means six months
prior to being placed on the market, except where they havealready been placed on the market by the same responsible per­son before 11 January 2013.
In the latter case, cosmetic products containing nanomaterials
placed on the market shall be notified to the Commission by the
responsible person between 11 January 2013 and 11 July 2013by electronic means, in addition to the notification in Article 13.
The first and the second subparagraphs shall not apply to cos­
metic products containing nanomaterials that are in conformity
with the requirements set out in Annex III.
The information notified to the Commission shall contain at least
the following:(a) the identification of the nanomaterial including its chemicalname (IUPAC) and other descriptors as specified in point 2of the Preamble to Annexes II to VI;(b) the specification of the nanomaterial including size of par­ticles, physical and chemical properties;(c) an estimate of the quantity of nanomaterial contained in cos­
metic products intended to be placed on the market per year;3.
By 11 January 2012, the Commission shall ensure thatappropriate guidance is developed with the aim of enabling a har­monised approach to the development and use of overall expo­
sure estimates in assessing the safe use of CMR substances. This
guidance shall be developed in consultation with the SCCS, the(d) the toxicological profile of the nanomaterial;(1) OJ L 31, 1.2.2002, p. 1.

(f) the reasonably foreseeable exposure conditions.

(e) the safety data of the nanomaterial relating to the category ofcosmetic product, as used in such products;

22.12.2009

EN

Official Journal of the European Union

The responsible person may designate another legal or natural
person by written mandate for the notification of nanomaterials
and shall inform the Commission thereof.
The Commission shall provide a reference number for the sub­mission of the toxicological profile, which may substitute theinformation to be notified under point (d).
4.
In the event that the Commission has concerns regarding
the safety of a nanomaterial, the Commission shall, without delay,
request the SCCS to give its opinion on the safety of such nano­material for use in the relevant categories of cosmetic products
and on the reasonably foreseeable exposure conditions. The Com­mission shall make this information public. The SCCS shall deliver
its opinion within six months of the Commission’s request. Where
the SCCS finds that any necessary data is lacking, the Commis­
sion shall request the responsible person to provide such data
within an explicitly stated reasonable time, which shall not be
extended. The SCCS shall deliver its final opinion within six
months of submission of additional data. The opinion of the SCCS
shall be made publicly available.
5.
The Commission may, at any time, invoke the procedure inparagraph 4 where it has any safety concerns, for example due to
new information supplied by a third party.
6.
Taking into account the opinion of the SCCS, and where
there is a potential risk to human health, including when there isinsufficient data, the Commission may amend Annexes II and III.

L 342/71

cosmetic products within the Community, including thoseused as colorants, UV-filters and preservatives in a separate
section. The first report shall be presented by 11 July 2014
The report update shall summarise, in particular, the newnanomaterials in new categories of cosmetic products, thenumber of notifications, the progress made in developing
nano-specific assessment methods and safety assessment
guides, and information on international cooperation
programmes.
11.
The Commission shall regularly review the provisions of
this Regulation concerning nanomaterials in the light of scientificprogress and shall, where necessary, propose suitable amend­
ments to those provisions.
The first review shall be undertaken by 11 July 2018.

Article 17
Traces of prohibited substances
The non-intended presence of a small quantity of a prohibited
substance, stemming from impurities of natural or synthetic
ingredients, the manufacturing process, storage, migration frompackaging, which is technically unavoidable in good manufactur­
ing practice, shall be permitted provided that such presence is inconformity with Article 3.

CHAPTER V
ANIMAL TESTINGThe Commission may, taking into account technical and7.
scientific progress, amend paragraph 3 by adding requirements.
Article 18
8.
The measures, referred to in paragraphs 6 and 7, designed
to amend non-essential elements of this Regulation, shall be
adopted in accordance with the regulatory procedure with scru­
tiny referred to in Article 32(3).
9.
On imperative grounds of urgency the Commission may
use the procedure referred to in Article 32(4).
10.
The following information shall be made available by theCommission:

Animal testing
1. Without prejudice to the general obligations deriving from
Article 3, the following shall be prohibited:(a) the placing on the market of cosmetic products where thefinal formulation, in order to meet the requirements of thisRegulation, has been the subject of animal testing using amethod other than an alternative method after such alterna­
tive method has been validated and adopted at Community
level with due regard to the development of validation within
the OECD;(a) By 11 January 2014, the Commission shall make available acatalogue of all nanomaterials used in cosmetic products
placed on the market, including those used as colorants,
UV-filters and preservatives in a separate section, indicating
the categories of cosmetic products and the reasonably fore­
seeable exposure conditions. This catalogue shall be regularly
updated thereafter and be made publicly available.

(b) the placing on the market of cosmetic products containing
ingredients or combinations of ingredients which, in order tomeet the requirements of this Regulation, have been the sub­ject of animal testing using a method other than an alterna­
tive method after such alternative method has been validated
and adopted at Community level with due regard to thedevelopment of validation within the OECD;(b) The Commission shall submit to the European Parliament
and the Council an annual status report, which will giveinformation on developments in the use of nanomaterials in(c) the performance within the Community of animal testing offinished cosmetic products in order to meet the requirementsof this Regulation;

L 342/72

EN

Official Journal of the European Union(d) the performance within the Community of animal testing ofingredients or combinations of ingredients in order to meetthe requirements of this Regulation, after the date on whichsuch tests are required to be replaced by one or more vali­
dated alternative methods listed in Commission Regulation(EC) No 440/2008 of 30 May 2008 laying down test meth­ods pursuant to Regulation (EC) No 1907/2006 of the Euro­pean Parliament and of the Council on the Registration,
Evaluation, Authorisation and Restriction of Chemicals(REACH) (1) or in Annex VIII to this Regulation.
2. The Commission, after consulting the SCCS and the Euro­pean Centre for the Validation of Alternative Methods (ECVAM)
and with due regard to the development of validation within theOECD, has established timetables for the implementation of theprovisions under points (a), (b) and (d) of paragraph 1, including
deadlines for the phasing-out of the various tests. The timetables
were made available to the public on 1 October 2004 and sent to
the European Parliament and the Council. The period for imple­
mentation was limited to 11 March 2009 in relation to points (a),(b) and (d) of paragraph 1.
In relation to the tests concerning repeated-dose toxicity, repro­
ductive toxicity and toxicokinetics, for which there are no alter­
natives yet under consideration, the period for implementation ofparagraph 1(a) and (b) shall be limited to 11 March 2013.
The Commission shall study possible technical difficulties in com­plying with the ban in relation to tests, in particular those con­cerning repeated-dose toxicity, reproductive toxicity andtoxicokinetics, for which there are no alternatives yet under con­sideration. Information about the provisional and final results ofthese studies forms part of the yearly reports presented pursuant
to Article 35.
On the basis of these annual reports, the timetables established as
referred to in the first subparagraph, could be adapted up
to 11 March 2009 in relation to the first subparagraph and may
be adapted up to 11 March 2013 in relation to the second sub­paragraph and after consultation of the entities referred to in thefirst subparagraph.

22.12.2009

paragraph 1. The request shall contain an evaluation of the situ­
ation and indicate the measures necessary. On this basis, theCommission may, after consulting the SCCS and by means of areasoned decision, authorise the derogation. That authorisation
shall lay down the conditions associated with this derogation interms of specific objectives, duration and reporting of the results.
A derogation shall be granted only where:(a) the ingredient is in wide use and cannot be replaced byanother ingredient capable of performing a similar function;(b) the specific human health problem is substantiated and theneed to conduct animal tests is justified and is supported bya detailed research protocol proposed as the basis for theevaluation.
The decision on the authorisation, the conditions associated with
it and the final result achieved shall be part of the annual reportpresented by the Commission in accordance with Article 35.
The measures referred to in the sixth subparagraph, designed toamend non-essential elements of this Regulation, shall be adopted
in accordance with the regulatory procedure with scrutiny
referred to in Article 32(3).
3.

For the purposes of this Article and Article 20:(a) ‘finished cosmetic product’ means the cosmetic product in its
final formulation, as placed on the market and made avail­able to the end user, or its prototype;(b) ‘prototype’ means a first model or design that has not been
produced in batches, and from which the finished cosmetic
product is copied or finally developed.

CHAPTER VI
CONSUMER INFORMATIONThe Commission shall study progress and compliance with thedeadlines as well as possible technical difficulties in complying
with the ban. Information about the provisional and final resultsof the Commission studies forms part of the yearly reports pre­sented pursuant to Article 35. If these studies conclude, at the lat­
est two years prior to the end of the maximum period referred toin the second subparagraph, that for technical reasons one ormore tests referred to in that subparagraph will not be developed
and validated before the expiry of the period referred to therein it
shall inform the European Parliament and the Council and shallput forward a legislative proposal in accordance with Article 251of the Treaty.
In exceptional circumstances, where serious concerns arise as
regards the safety of an existing cosmetic ingredient, a Member
State may request the Commission to grant a derogation from
(1) OJ L 142, 31.5.2008, p. 1.

Article 19
Labelling1.
Without prejudice to other provisions in this Article, cos­
metic products shall be made available on the market only where
the container and packaging of cosmetic products bear the fol­lowing information in indelible, easily legible and visible lettering:(a) the name or registered name and the address of the respon­sible person. Such information may be abbreviated in so far
as the abbreviation makes it possible to identify that person
and his address. If several addresses are indicated, the one
where the responsible person makes readily available theproduct information file shall be highlighted. The country oforigin shall be specified for imported cosmetic products;

22.12.2009

EN

Official Journal of the European Union(b) the nominal content at the time of packaging, given byweight or by volume, except in the case of packaging con­taining less than five grams or five millilitres, free samples
and single-application packs; for pre-packages normally soldas a number of items, for which details of weight or volume
are not significant, the content need not be given provided
the number of items appears on the packaging. This infor­
mation need not be given if the number of items is easy tosee from the outside or if the product is normally only soldindividually;(c) the date until which the cosmetic product, stored underappropriate conditions, will continue to fulfil its initial func­tion and, in particular, will remain in conformity with
Article 3 (‘date of minimum durability’).

The date itself or details of where it appears on the packag­
ing shall be preceded by the symbol shown in point 3 ofAnnex VII or the words: ‘best used before the end of’.

The date of minimum durability shall be clearly expressedand shall consist of either the month and year or the day,month and year, in that order. If necessary, this information
shall be supplemented by an indication of the conditions
which must be satisfied to guarantee the stated durability.

Indication of the date of minimum durability shall not be
mandatory for cosmetic products with a minimum durabil­
ity of more than 30 months. For such products, there shallbe an indication of the period of time after opening for which
the product is safe and can be used without any harm to theconsumer. This information shall be indicated, except where
the concept of durability after opening is not relevant, by thesymbol shown in point 2 of Annex VII followed by the period(in months and/or years);(d) particular precautions to be observed in use, and at least
those listed in Annexes III to VI and any special precaution­ary information on cosmetic products for professional use;(e) the batch number of manufacture or the reference for iden­
tifying the cosmetic product. Where this is impossible forpractical reasons because the cosmetic products are too
small, such information need appear only on the packaging;(f) the function of the cosmetic product, unless it is clear fromits presentation;(g) a list of ingredients. This information may be indicated on the
packaging alone. The list shall be preceded by the term
‘ingredients’.

L 342/73

For the purpose of this Article, an ingredient means any sub­stance or mixture intentionally used in the cosmetic productduring the process of manufacturing. The following shall not,however, be regarded as ingredients:(i)

impurities in the raw materials used;(ii) subsidiary technical materials used in the mixture but
not present in the final product.
Perfume and aromatic compositions and their raw materials
shall be referred to by the terms ‘parfum’ or ‘aroma’. More­over, the presence of substances, the mention of which is
required under the column ‘Other’ in Annex III, shall be indi­cated in the list of ingredients in addition to the terms par­fum or aroma.
The list of ingredients shall be established in descending orderof weight of the ingredients at the time they are added to thecosmetic product. Ingredients in concentrations of less than
1 % may be listed in any order after those in concentrationsof more than 1 %.
All ingredients present in the form of nanomaterials shall beclearly indicated in the list of ingredients. The names of suchingredients shall be followed by the word ‘nano’ in brackets.
Colorants other than colorants intended to colour the hair
may be listed in any order after the other cosmetic ingredi­
ents. For decorative cosmetic products marketed in several
colour shades, all colorants other than colorants intended tocolour the hair used in the range may be listed, provided thatthe words ‘may contain’ or the symbol ‘+/-’ are added. The CI(Colour Index) nomenclature shall be used, where applicable.
2. Where it is impossible for practical reasons to label theinformation mentioned in points (d) and (g) of paragraph 1 asprovided, the following applies:— the information shall be mentioned on an enclosed or
attached leaflet, label, tape, tag or card;— unless impracticable, this information shall be referred to byabbreviated information or the symbol given in point 1 ofAnnex VII, which must appear on the container or packag­
ing for the information referred in point (d) of paragraph 1
and on packaging for the information referred in point (g) ofparagraph 1.
3.
In the case of soap, bath balls and other small products
where it is impossible for practical reasons for the informationreferred to in point (g) of paragraph 1 to appear on a label, tag,tape or card or in an enclosed leaflet, this information shall appear
on a notice in immediate proximity to the container in which thecosmetic product is exposed for sale.

L 342/74

Official Journal of the European Union

EN

22.12.2009

Article 21

4.
For cosmetic products that are not pre-packaged, are pack­aged at the point of sale at the purchaser’s request, or are prepackaged for immediate sale, Member States shall adopt detailed
rules for indication of the information referred to in paragraph 1.

Access to information for the public

5.
The language of the information mentioned in points (b),(c), (d) and (f) of paragraph 1 and in paragraphs (2), (3) and (4)shall be determined by the law of the Member States in which the
product is made available to the end user.

Without prejudice to the protection, in particular, of commercial
secrecy and of intellectual property rights, the responsible person
shall ensure that the qualitative and quantitative composition of
the cosmetic product and, in the case of perfume and aromaticcompositions, the name and code number of the composition
and the identity of the supplier, as well as existing data on unde­sirable effects and serious undesirable effects resulting from use of
the cosmetic product are made easily accessible to the public by
any appropriate means.

6. The information mentioned in point (g) of paragraph 1 shallbe expressed by using the common ingredient name set out in theglossary provided for in Article 33. In the absence of a common
ingredient name, a term as contained in a generally accepted
nomenclature shall be used.

Article 20
Product claims

The quantitative information regarding composition of the cos­
metic product required to be made publicly accessible shall belimited to hazardous substances in accordance with Article 3 ofRegulation (EC) No 1272/2008.

CHAPTER VII
MARKET SURVEILLANCE

Article 221.
In the labelling, making available on the market and adver­
tising of cosmetic products, text, names, trade marks, pictures andfigurative or other signs shall not be used to imply that theseproducts have characteristics or functions which they do not have.

2.
The Commission shall, in cooperation with Member States,
establish an action plan regarding claims used and fix priorities
for determining common criteria justifying the use of a claim.

After consulting the SCCS or other relevant authorities, the Com­mission shall adopt a list of common criteria for claims which
may be used in respect of cosmetic products, in accordance withthe regulatory procedure with scrutiny referred to in Article 32(3)of this Regulation, taking into account the provisions of Directive
2005/29/EC.

By 11 July 2016, the Commission shall submit to the European
Parliament and the Council a report regarding the use of claimson the basis of the common criteria adopted under the second
subparagraph. If the report concludes that claims used in respectof cosmetic products are not in conformity with the common cri­
teria, the Commission shall take appropriate measures to ensurecompliance in cooperation with the Member States.

In-market control
Member States shall monitor compliance with this Regulation via
in-market controls of the cosmetic products made available on
the market. They shall perform appropriate checks of cosmetic
products and checks on the economic operators on an adequate
scale, through the product information file and, where appropri­
ate, physical and laboratory checks on the basis of adequate
samples.
Member States shall also monitor compliance with the principles
of good manufacturing practices.
Member States shall entrust to market surveillance authorities thenecessary powers, resources and knowledge in order for thoseauthorities to properly perform their tasks.
Member States shall periodically review and assess the function­
ing of their surveillance activities. Such reviews and assessments
shall be carried out at least every four years and the results thereof
shall be communicated to the other Member States and the Com­mission and be made available to the public, by way of electronic
communication and, where appropriate, by other means.
Article 23
Communication of serious undesirable effects

3.
The responsible person may refer, on the product packag­
ing or in any document, notice, label, ring or collar accompany­
ing or referring to the cosmetic product, to the fact that no animal
tests have been carried out only if the manufacturer and his sup­pliers have not carried out or commissioned any animal tests on
the finished cosmetic product, or its prototype, or any of theingredients contained in it, or used any ingredients that have beentested on animals by others for the purpose of developing newcosmetic products.

1.
In the event of serious undesirable effects, the responsible
person and distributors shall without delay notify the following to
the competent authority of the Member State where the serious
undesirable effect occurred:(a) all serious undesirable effects which are known to him or
which may reasonably be expected to be known to him;

22.12.2009

Official Journal of the European UnionEN(b) the name of the cosmetic product concerned, enabling its
specific identification;(c) the corrective measures taken by him, if any.

L 342/75

into conformity, the withdrawal of the product from the market
or its recall, within an expressly mentioned time limit, commen­
surate with the nature of the risk, where there is non-compliancewith any of the following:(a) the good manufacturing practice referred to in Article 8;

Where the responsible person reports serious undesirable2.
effects to the competent authority of the Member State where theeffect occurred, that competent authority shall immediately trans­
mit the information referred to in paragraph 1 to the competentauthorities of the other Member States.

(b) the safety assessment referred to in Article 10;(c) the requirements for the product information file referred toin Article 11;3.
Where distributors report serious undesirable effects to thecompetent authority of the Member State where the effectoccurred, that competent authority shall immediately transmit the
information referred to in paragraph 1 to the competent authori­ties of the other Member States and to the responsible person.

(d) the provisions on sampling and analysis referred to in
Article 12;

Where end users or health professionals report serious
4.
undesirable effects to the competent authority of the Member
State where the effect occurred, that competent authority shallimmediately transmit the information on the cosmetic productconcerned to the competent authorities of the other Member
States and to the responsible person.

(f) the restrictions for substances referred to in Articles 14, 15
and 17;5.
Competent authorities may use the information referred toin this Article for the purposes of in-market surveillance, market
analysis, evaluation and consumer information in the context ofArticles 25, 26 and 27.

(e) the notification requirements referred to in Articles 13
and 16;(g) the animal testing requirements referred to in Article 18;(h) the labelling requirements referred to in Article 19(1), (2), (5)and (6);(i)the requirements related to product claims set out in
Article 20;(j)

the access to information for the public referred to in
Article 21;

Article 24
Information on substances
In the event of serious doubt regarding the safety of any substancecontained in cosmetic products, the competent authority of a
Member State in which a product containing such a substance ismade available on the market may by reasoned request require theresponsible person to submit a list of all cosmetic products forwhich he is responsible and which contain this substance. The list
shall indicate the concentration of this substance in the cosmetic
products.
Competent authorities may use the information referred to in this
Article for the purposes of in-market surveillance, market analy­
sis, evaluation and consumer information in the context ofArticles 25, 26 and 27.

CHAPTER VIIINON-COMPLIANCE, SAFEGUARD CLAUSE

Article 25
Non-compliance by the responsible person
1.
Without prejudice to paragraph 4, competent authorities
shall require the responsible person to take all appropriate mea­sures, including corrective actions bringing the cosmetic product(k) the communication of serious undesirable effects referred toin Article 23;(l)the information requirements on substances referred to in
Article 24.

2.
Where applicable, a competent authority shall inform thecompetent authority of the Member State in which the respon­sible person is established of the measures which it has required
the responsible person to take.
3.
The responsible person shall ensure that the measuresreferred to in paragraph 1 are taken in respect of all the products
concerned which are made available on the market throughout
the Community.
4. In the case of serious risks to human health, where the com­
petent authority considers that the non-compliance is not limited
to the territory of the Member State in which the cosmetic prod­
uct is made available on the market, it shall inform the Commis­
sion and the competent authorities of the other Member States ofthe measures which it has required the responsible person to take.
5. The competent authority shall take all appropriate measures
to prohibit or restrict the making available on the market of thecosmetic product or to withdraw the product from the market or
to recall it in the following cases:(a) where an immediate action is necessary in the event of seri­
ous risk to human health; orL 342/76

Official Journal of the European Union

EN

22.12.2009(b) where the responsible person does not take all appropriate
measures within the time limit referred to in paragraph 1.

For the purposes of the first subparagraph, the informationexchange system provided for in Article 12(1) of Directive
2001/95/EC shall be used.

In the event of serious risks to human health, that competentauthority shall inform the Commission and the competentauthorities of the other Member States, without delay, of the mea­sures taken.

Article 12(2), (3) and (4) of Directive 2001/95/EC shall apply.

6.
In the absence of a serious risk to human health, in theevent that the responsible person does not take all appropriate
measures, the competent authority shall without delay inform thecompetent authority of the Member State in which the respon­sible person is established of the measures taken.
7.
For the purposes of paragraphs 4 and 5 of this Article, theinformation exchange system provided for in Article 12(1) of
Directive 2001/95/EC of the European Parliament and of theCouncil of 3 December 2001 on general product safety (1) shallbe used.
Article 12(2), (3) and (4) of Directive 2001/95/EC and Article 23
of Regulation (EC) No 765/2008 of the European Parliament andof the Council of 9 July 2008 setting out the requirements foraccreditation and market surveillance relating to the marketing ofproducts (2) shall also apply.

3.
The Commission shall determine, as soon as possible,
whether the provisional measures referred to in paragraph 1 are
justified or not. For that purpose it shall, whenever possible, con­sult the interested parties, the Member States and the SCCS.
4. Where the provisional measures are justified, Article 31(1)shall apply.
5.
Where the provisional measures are not justified the Com­mission shall inform the Member States thereof and the compe­
tent authority concerned shall repeal the provisional measures inquestion.
Article 28
Good administrative practices
1.
Any decision taken pursuant to Articles 25 and 27 shallstate the exact grounds on which it is based. It shall be notified by
the competent authority without delay to the responsible person,
who shall at the same time be informed of the remedies available
to him under the law of the Member State concerned and of thetime limits to which remedies are subject.

Article 26
Non-compliance by distributors
Competent authorities shall require distributors to take all appro­
priate measures, including corrective actions bringing the cos­
metic product into conformity, the withdrawal of the productfrom the market or its recall, within a given reasonable time limit,
commensurate with the nature of the risk, where there is noncompliance with obligations laid down in Article 6.

2. Except in the case where immediate action is necessary forreasons of serious risk to human health, the responsible person
shall have the opportunity to put forward his viewpoint before
any decision is taken.
3.
Where applicable, the provisions mentioned in para­graphs 1 and 2 shall apply with regard to the distributor for any
decisions taken pursuant to Articles 26 and 27.
CHAPTER IX

Article 27

ADMINISTRATIVE COOPERATION

Safeguard clause
Article 29
1.
In the case of products meeting the requirements listed in
Article 25(1), where a competent authority ascertains, or has rea­
sonable grounds for concern, that a cosmetic product or products
made available on the market present or could present a serious
risk to human health, it shall take all appropriate provisional mea­sures in order to ensure that the product or products concerned
are withdrawn, recalled or their availability is otherwise restricted.

Cooperation between competent authorities
1. The competent authorities of the Member States shall coop­erate with each other and with the Commission to ensure theproper application and due enforcement of this Regulation andshall transmit to each other all information necessary with a viewto applying this Regulation uniformly.

2. The competent authority shall immediately communicate to
the Commission and the competent authorities of the other Mem­
ber States the measures taken and any supporting data.

The Commission shall provide for the organisation of an
2.
exchange of experience between the competent authorities inorder to coordinate the uniform application of this Regulation.

(1) OJ L 11, 15.1.2002, p. 4.
(2) OJ L 218, 13.8.2008, p. 30.

Cooperation may be part of initiatives developed at inter­3.
national level.

22.12.2009

Official Journal of the European Union

EN

Article 30
Cooperation regarding verification of product information
files
The competent authority of any Member State where the cosmetic
product is made available may request the competent authority of
the Member State where the product information file is madereadily accessible to verify whether the product information filesatisfies the requirements referred to in Article 11(2) and whether
the information set out therein provides evidence of the safety of
the cosmetic product.
The requesting competent authority shall provide a motivation
for the request.
Upon that request, the competent authority requested shall, with­out undue delay and taking into account the degree of urgency,
carry out the verification and shall inform the requesting compe­
tent authority of its findings.
CHAPTER X
IMPLEMENTING MEASURES, FINAL PROVISIONS

Article 31
Amendment of the Annexes
1.
Where there is a potential risk to human health, arisingfrom the use of substances in cosmetic products, which needs tobe addressed on a Community-wide basis, the Commission may,after consulting the SCCS, amend Annexes II to VI accordingly.
Those measures, designed to amend non-essential elements of thisRegulation, shall be adopted in accordance with the regulatory
procedure with scrutiny referred to in Article 32(3).
On imperative grounds of urgency, the Commission may use theurgency procedure referred to in Article 32(4).
2.
The Commission may, after consulting the SCCS, amend
Annexes III to VI and VIII for the purposes of adapting them totechnical and scientific progress.
Those measures, designed to amend non-essential elements of thisRegulation, shall be adopted in accordance with the regulatory
procedure with scrutiny referred to in Article 32(3).
3. Where it appears necessary, in order to ensure the safety ofcosmetic products placed on the market, the Commission may,after consulting the SCCS, amend Annex I.
Those measures, designed to amend non-essential elements of thisRegulation, shall be adopted in accordance with the regulatory
procedure with scrutiny referred to in Article 32(3).
Article 32
Committee procedure
1.
The Commission shall be assisted by the Standing Commit­
tee on Cosmetic Products.

L 342/77

2. 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.
3. 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.
4. Where reference is made to this paragraph, Article 5a(1), (2),(4) and (6) and Article 7 of Decision 1999/468/EC shall apply
having regard to the provisions of Article 8 thereof.
Article 33
Glossary of common ingredient names
The Commission shall compile and update a glossary of common
ingredient names. To this end, the Commission shall take accountof internationally recognised nomenclatures including the Inter­national Nomenclature of Cosmetic Ingredients (INCI). That glos­sary shall not constitute a list of the substances authorised for use
in cosmetic products.
The common ingredient name shall be applied for the purpose oflabelling cosmetic products placed on the market at the latest
twelve months after publication of the glossary in the Official Jour­nal of the European Union.
Article 34
Competent authorities, poison control centres orassimilated entities
1. Member States shall designate their national competentauthorities.
2. Member States shall communicate the details of authorities
referred to in paragraph 1 and of the poison centres and similar
bodies referred to in Article 13(6) to the Commission. They shallcommunicate an update of these details as necessary.
3. The Commission shall compile and update a list of theauthorities and bodies referred to in paragraph 2 and make itavailable to the public.
Article 35
Annual report on animal testing
Every year the Commission shall present a report to the European
Parliament and the Council on:(1) progress made in the development, validation and legal
acceptance of alternative methods. The report shall containprecise data on the number and type of experiments relating
to cosmetic products carried out on animals. The Member
States shall be obliged to collect that information in addition
to collecting statistics as laid down by Directive 86/609/EEC.
The Commission shall in particular ensure the development,
validation and legal acceptance of alternative test methods
which do not use live animals;

L 342/78

Official Journal of the European UnionEN(2) progress made by the Commission in its efforts to obtainacceptance by the OECD of alternative methods validated atCommunity level and recognition by third countries of theresults of the safety tests carried out in the Community using
alternative methods, in particular within the framework ofcooperation agreements between the Community and thesecountries;(3) the manner in which the specific needs of small and mediumsized enterprises have been taken into account.
Article 36
Formal objection against harmonised standards
1.
When a Member State or the Commission considers that a
harmonised standard does not entirely satisfy the requirements set
out in the relevant provisions of this Regulation, the Commission
or the Member State concerned shall bring the matter before theCommittee set up by Article 5 of Directive 98/34/EC, giving its
arguments. The Committee shall deliver its opinion without delay.
2.
In the light of the Committee’s opinion, the Commission
shall decide to publish, not to publish, to publish with restriction,
to maintain, to maintain with restriction or to withdraw the ref­erences to the harmonised standard concerned in the Official Jour­nal of the European Union.
3.
The Commission shall inform the Member States and theEuropean standardisation body concerned. It shall, if necessary,request the revision of the harmonised standards concerned.

22.12.2009

Article 38
RepealDirective 76/768/EEC is repealed with effect from 11 July 2013,
with the exception of Article 4b which is repealed with effectfrom 1 December 2010.
References to the repealed Directive shall be understood as refer­ences to this Regulation.
This Regulation shall be without prejudice to the obligations of
the Member States relating to the time-limits for transposition
into national law of the Directives set out in Part B of Annex IX.
However, the competent authorities shall continue to keep avail­able the information received pursuant to Article 7(3) and
Article 7a(4) of Directive 76/768/EEC and responsible persons
shall continue to keep readily accessible the information collectedpursuant to Article 7a of that Directive until 11 July 2020.
Article 39
Transitional provisions
By way of derogation from Directive 76/768/EEC, cosmetic prod­
ucts which comply with this Regulation may be placed on themarket before 11 July 2013.
As from 11 January 2012, by way of derogation from Directive
76/768/EEC, notification carried out in accordance with
Article 13 of this Regulation shall be considered to comply with
Article 7(3) and Article 7a(4) of that Directive.
Article 40
Entry into force and date of application

Article 37

1. This Regulation shall enter into force on the [twentieth day
after its publication in the Official Journal of the European Union

Penalties
Member States shall lay down the provisions on penalties appli­
cable for infringement of the provisions of this Regulation andshall take all measures necessary to ensure that they are imple­
mented. The penalties provided for must be effective, proportion­
ate and dissuasive. The Member States shall notify those
provisions to the Commission by 11 July 2013 and shall notify it
without delay of any subsequent amendment affecting them.

2.

It shall apply from 11 July 2013, with the exception of:— Article 15(1) and (2) which shall apply from 1 December
2010, as well as Articles 14, 31 and 32 to the extent thatthey are necessary to apply Article 15(1) and (2); and— Article 16(3) second subparagraph, which shall apply from
11 January 2013.

This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 30 November 2009.
For the European Parliament
The President

For the Council
The President

J. BUZEKB. ASK22.12.2009

EN

Official Journal of the European Union

ANNEX ICOSMETIC PRODUCT SAFETY REPORTThe cosmetic product safety report shall, as a minimum, contain the following:

PART A – Cosmetic product safety information
1.

Quantitative and qualitative composition of the cosmetic product
The qualitative and quantitative composition of the cosmetic product, including chemical identity of the substances(incl. chemical name, INCI, CAS, EINECS/ELINCS, where possible) and their intended function. In the case of perfume
and aromatic compositions, description of the name and code number of the composition and the identity of the
supplier.

2.

Physical/chemical characteristics and stability of the cosmetic product
The physical and chemical characteristics of the substances or mixtures, as well as the cosmetic product.
The stability of the cosmetics product under reasonably foreseeable storage conditions.

3.

Microbiological quality
The microbiological specifications of the substance or mixture and the cosmetic product. Particular attention shall be
paid to cosmetics used around the eyes, on mucous membranes in general, on damaged skin, on children under three
years of age, on elderly people and persons showing compromised immune responses.
Results of preservation challenge test.

4.

Impurities, traces, information about the packaging material
The purity of the substances and mixtures.
In the case of traces of prohibited substances, evidence for their technical unavoidability.
The relevant characteristics of packaging material, in particular purity and stability.

5.

Normal and reasonably foreseeable use
The normal and reasonably foreseeable use of the product. The reasoning shall be justified in particular in the light ofwarnings and other explanations in the product labelling.

6.

Exposure to the cosmetic product
Data on the exposure to cosmetic product taking into consideration the findings under Section 5 in relation to
1)

The site(s) of application;

2)

The surface area(s) of application;

3)

The amount of product applied;4)

The duration and frequency of use;

5)

The normal and reasonably foreseeable exposure route(s);6)

The targeted (or exposed) population(s). Potential exposure of a specific population shall also be taken into
account.

L 342/79

L 342/80

EN

Official Journal of the European Union

The calculation of the exposure shall also take into consideration the toxicological effects to be considered (e.g. expo­
sure might need to be calculated per unit area of skin or per unit of body weight). The possibility of secondary expo­
sure by routes other than those resulting from direct application should also be considered (e.g. non-intended inhalationof sprays, non-intended ingestion of lip products, etc.).
Particular consideration shall be given to any possible impacts on exposure due to particle sizes.
7.

Exposure to the substances
Data on the exposure to the substances contained in the cosmetic product for the relevant toxicological endpoints tak­ing into account the information under Section 6.

8.

Toxicological profile of the substances
Without prejudice to Article 18, the toxicological profile of substance contained in the cosmetic product for all rel­evant toxicological endpoints. A particular focus on local toxicity evaluation (skin and eye irritation), skin sensitisa­
tion, and in the case of UV absorption photo-induced toxicity shall be made.
All significant toxicological routes of absorption shall be considered as well as the systemic effects and margin of safety(MoS) based on a no observed adverse effects level (NOAEL) shall be calculated. The absence of these considerations
shall be duly justified.
Particular consideration shall be given to any possible impacts on the toxicological profile due to—particle sizes, including nanomaterials,—

impurities of the substances and raw material used, and—interaction of substances.

Any read-across shall be duly substantiated and justified.
The source of information shall be clearly identified.
9.

Undesirable effects and serious undesirable effects
All available data on the undesirable effects and serious undesirable effects to the cosmetic product or, where relevant,other cosmetic products. This includes statistical data.

10. Information on the cosmetic product
Other relevant information, e.g. existing studies from human volunteers or the duly confirmed and substantiated find­ings of risk assessments carried out in other relevant areas.

PART B – Cosmetic product safety assessment
1.

Assessment conclusion
Statement on the safety of the cosmetic product in relation to Article 3.

2.

Labelled warnings and instructions of use
Statement on the need to label any particular warnings and instructions of use in accordance with Article 19(1)(d).

3.

Reasoning
Explanation of the scientific reasoning leading to the assessment conclusion set out under Section 1 and the statement
set out under Section 2. This explanation shall be based on the descriptions set out under Part A. Where relevant, mar­gins of safety shall be assessed and discussed.

22.12.2009

22.12.2009

EN

Official Journal of the European Union

There shall be inter alia a specific assessment for cosmetic products intended for use on children under the age of threeand for cosmetic products intended exclusively for use in external intimate hygiene.
Possible interactions of the substances contained in the cosmetic product shall be assessed.
The consideration and non-consideration of the different toxicological profiles shall be duly justified.
Impacts of the stability on the safety of the cosmetic product shall be duly considered.
4.

Assessor’s credentials and approval of part B
Name and address of the safety assessor.
Proof of qualification of safety assessor.
Date and signature of safety assessor.

L 342/81

L 342/82

Official Journal of the European Union

EN

Preamble to Annexes II to VI(1) For the purposes of the Annexes II to VI:(a)‘Rinse-off product’ means a cosmetic product which is intended to be removed after application on the skin, thehair or the mucous membranes;(b) ‘Leave-on product’ means a cosmetic product which is intended to stay in prolonged contact with the skin, thehair or the mucous membranes;(c)‘Hair product’ means a cosmetic product which is intended to be applied on the hair of head or face, except eyelashes;(d) ‘Skin product’ means a cosmetic product which is intended to be applied on the skin;(e)‘Lip product’ means a cosmetic product which is intended to be applied on the lips;(f)‘Face product’ means a cosmetic product which is intended to be applied on the skin of the face;(g)‘Nail product’ means a cosmetic product which is intended to be applied on nails;(h) ‘Oral product’ means a cosmetic product which is intended to be applied on teeth or the mucous membranes ofthe oral cavity;
(i)

(j)

‘Product applied on mucous membranes’ means a cosmetic product which is intended to be applied on the mucous
membranes—of the oral cavity,—on the rim of the eyes,—

or of the external genital organs;‘Eye product’ means a cosmetic product which is intended to be applied in the vicinity of the eyes;(k) ‘Professional use’ means the application and use of cosmetic products by persons in the exercise of their profes­
sional activity.
(2) In order to facilitate substance identification, the following descriptors are used:—

The Non-proprietary Names (INN) for pharmaceutical products, WHO, Geneva, August 1975;—

The Chemical Abstracts Service numbers (CAS);—

The EC number which correspond to either the European Inventory of Existing Commercial chemical Substances(EINECS) numbers or the European List of Notified Chemical Substances (ELINCS) numbers or the registration
number given under Regulation (EC) No 1907/2006;—

The XAN which is the name approved by specific country (X), e.g. USAN which correspond to the United State
approved name;—

The name in the glossary of common ingredient names referred to in Article 33 of this Regulation.

(3) Substances listed in Annexes III to VI do not cover nanomaterials, except where specifically mentioned.

22.12.2009

22.12.2009

Official Journal of the European Union

EN

L 342/83

ANNEX II
LIST OF SUBSTANCES PROHIBITED IN COSMETIC PRODUCTS

Substance identification

Reference
numberChemical name/INN

CAS number

EC number

a

b

c

d

1

N-(5-Chlorobenzoxazol-2-yl)acetamide

35783-57-4

2(2-Acetoxyethyl)trimethylammonium hydroxide (Acetylcholine) and its
salts

51-84-3

200-128-93

Deanol aceglumate (INN)3342-61-8

222-085-5

4

Spironolactone (INN)

52-01-7200-133-6

5[4-(4-Hydroxy-3-iodophenoxy)-3,5-diiodophenyl]acetic acid (Tiratricol(INN)) and its salts

51-24-1

200-086-1

6

Methotrexate (INN)

59-05-2

200-413-8

7

Aminocaproic acid (INN) and its salts

60-32-2

200-469-3

8

Cinchophen (INN), its salts, derivatives and salts of these derivatives

132-60-5

205-067-1

9

Thyropropic acid (INN) and its salts

51-26-3

10

Trichloroacetic acid76-03-9

200-927-2

11

Aconitum napellus L. (leaves, roots and galenical preparations)84603-50-9

283-252-6

12

Aconitine (principal alkaloid of Aconitum napellus L.) and its salts

302-27-2

206-121-7

13

Adonis vernalis L. and its preparations

84649-73-0

283-458-6

14

Epinephrine (INN)

51-43-4200-098-7

15

Rauwolfia serpentina L., alkaloids and their salts

90106-13-1

290-234-1

16

Alkyne alcohols, their esters, ethers and salts

17

Isoprenaline (INN)7683-59-2

231-687-7

18

Allyl isothiocyanate

57-06-7

200-309-2

19

Alloclamide (INN) and its salts

5486-77-1

20

Nalorphine (INN), its salts and ethers

62-67-9200-546-1

21

Sympathicomimetic amines acting on the central nervous system: any
substance contained in the first list of medicaments which are subject
to medical prescription and are referred to in resolution AP (69) 2 of
the Council of Europe

300-62-9

206-096-2

22

Aniline, its salts and its halogenated and sulphonated derivatives

62-53-3

200-539-3

23

Betoxycaine (INN) and its salts

3818-62-0

24

Zoxazolamine (INN)

61-80-3

200-519-4

25

Procainamide (INN), its salts and derivatives

51-06-9200-078-8

26

Benzidine

92-87-5

202-199-1

27

Tuaminoheptane (INN), its isomers and salts

123-82-0

204-655-5

28

Octodrine (INN) and its salts

543-82-8

208-851-1

29

2-Amino-1,2-bis(4-methoxyphenyl)ethanol and its salts

530-34-7

30

1,3-Dimethylpentylamine and its salts

105-41-9

203-296-1

31

4-Aminosalicylic acid and its salts

65-49-6

200-613-5

32

Toluidines, their isomers, salts and halogenated and sulphonatedderivatives

26915-12-8

248-105-2

L 342/84

Official Journal of the European Union

EN

22.12.2009

Substance identification

Referencen u mb er

Chem ical n ame /I NN

CAS n u mb er

E C n u mb er

a

b

c

d

33

Xylidines, their isomers, salts and halogenated and sulphonatedderivatives

1300-73-8

215-091-4

34

Imperatorin (9-(3-methylbut-2-enyloxy)furo[3,2-g]chromen-7-one)

482-44-0

207-581-1

35

Ammi majus L. and its galenical preparations

90320-46-0

291-072-4

36

2,3-Dichloro-2-methylbutane

507-45-937

Substances with androgenic effect38

Anthracene oil

39

Antibiotics

40

120-12-7

204-371-1

Antimony and its compounds

7440-36-0

231-146-5

41

Apocynum cannabinum L. and its preparations

84603-51-0

283-253-1

42

Apomorphine ((R)
5,6,6a,7-tetrahydro-6-methyl-4H-dibenzo[de,g]quinoline-10,11-diol)and its salts

58-00-4

200-360-0

43

Arsenic and its compounds

7440-38-2

231-148-6

44

Atropa belladonna L. and its preparations

8007-93-0

232-365-945

Atropine, its salts and derivatives

51-55-8200-104-8

46

Barium salts, with the exception of barium sulphide under theconditions laid down in Annex III, and of barium sulfate, lakes, salts
and pigments prepared from colouring agents when listed in Annex IV

47

Benzene71-43-2

200-753-7

48

Benzimidazol-2(3H)-one

615-16-7

210-412-4

49

Benzazepines and benzodiazepines

12794-10-4

50

1-Dimethylaminomethyl-1-methylpropyl benzoate (amylocaine) andits salts

644-26-8

51

2,2,6-Trimethyl-4-piperidyl benzoate (eucaine) and its salts

500-34-552

Isocarboxazid (INN)

59-63-2

200-438-4

53

Bendroflumethiazide (INN) and its derivatives

73-48-3

200-800-1

54

Beryllium and its compounds

7440-41-7

231-150-7

55

Bromine, elemental

7726-95-6

231-778-1

56

Bretylium tosilate (INN)

61-75-6

200-516-8

57

Carbromal (INN)

77-65-6

201-046-6

58

Bromisoval (INN)

496-67-3

207-825-7

59

Brompheniramine (INN) and its salts

86-22-6

201-657-8

60

Benzilonium bromide (INN)

1050-48-2

213-885-5

61

Tetrylammonium bromide (INN)

71-91-0200-769-4

62

Brucine357-57-3

206-614-7

63

Tetracaine (INN) and its salts

94-24-6

202-316-6

64

Mofebutazone (INN)

2210-63-1

218-641-1

65

Tolbutamide (INN)

64-77-7

200-594-3

66

Carbutamide (INN)

339-43-5

206-424-4

67

Phenylbutazone (INN)

50-33-9200-029-0

68

Cadmium and its compounds

7440-43-9

231-152-8

69

Cantharides, Cantharis vesicatoria

92457-17-5

296-298-7

70

Cantharidine

56-25-7200-263-3

211-411-1

22.12.2009

Official Journal of the European Union

EN

L 342/85

Substance identification

Referencen u mb er

Chem ical n ame /I NN

CAS n u mb er

E C n u mb er

a

b

c

d

71

Phenprobamate (INN)

673-31-4

211-606-1

72

Nitroderivatives of carbazole

73

Carbon disulphide75-15-0200-843-6

74

Catalase

9001-05-2

232-577-1

75

Cephaeline and its salts

483-17-0

207-591-6

76

Chenopodium ambrosioides L. (essential oil)

8006-99-3

77

2,2,2-Trichloroethane-1,1-diol

302-17-0

206-117-5

78

Chlorine

7782-50-5

231-959-5

79

Chlorpropamide (INN)

94-20-2

202-314-5

80

Moved or deleted

81

4-Phenylazophenylene-1,3-diamine citrate hydrochloride (chrysoidine
citrate hydrochloride)5909-04-6

82

Chlorzoxazone (INN)

95-25-0

202-403-983

2-Chloro-6-methylpyrimidin-4-yldimethylamine (crimidine-ISO)

535-89-7

208-622-6

84

Chlorprothixene (INN) and its salts

113-59-7

204-032-8

85

Clofenamide (INN)

671-95-4

211-588-5

86N,N-bis(2-chloroethyl)methylamine N-oxide and its salts

126-85-2

87

Chlormethine (INN) and its salts

51-75-2

200-120-5

88

Cyclophosphamide (INN) and its salts

50-18-0

200-015-4

89

Mannomustine (INN) and its salts

576-68-1

209-404-3

90

Butanilicaine (INN) and its salts

3785-21-5

91

Chlormezanone (INN)

80-77-3

201-307-4

92

Triparanol (INN)

78-41-1

201-115-093

2-[2(4-Chlorophenyl)-2-phenylacetyl]indane-1,3-dione(chlorophacinone-ISO)

3691-35-8

223-003-0

94

Chlorphenoxamine (INN)

77-38-3

95

Phenaglycodol (INN)

79-93-6

201-235-3

96

Chloroethane

75-00-3

200-830-597

Chromium; chromic acid and its salts

7440-47-3

231-157-5

98

Claviceps purpurea Tul., its alkaloids and galenical preparations

84775-56-4

283-885-8

99

Conium maculatum L. (fruit, powder, galenical preparations)85116-75-2

285-527-6

100

Glycyclamide (INN)

664-95-9

211-557-6

101

Cobalt benzenesulphonate

23384-69-2

102

Colchicine, its salts and derivatives

64-86-8

200-598-5

103

Colchicoside and its derivatives

477-29-2

207-513-0

104

Colchicum autumnale L. and its galenical preparations

84696-03-7

283-623-2

105

Convallatoxin

508-75-8

208-086-3

106

Anamirta cocculus L. (fruit)

107

Croton tiglium L. (oil)8001-28-3

108

1-Butyl-3-(N-crotonoylsulphanilyl)urea

52964-42-8

L 342/86

Official Journal of the European Union

EN

22.12.2009

Substance identification

Referencen u mb er

Chem ical n ame /I NN

CAS n u mb er

E C n u mb er

a

b

c

d

109

Curare and curarine

8063-06-7/
22260-42-0

232-511-1/
244-880-6110Synthetic curarizants

111

Hydrogen cyanide and its salts

74-90-8

200-821-6

112

Feclemine (INN);
2-(alpha-Cyclohexylbenzyl)-N,N,N’,N’-tetraethyl-1,3-propanediamine

3590-16-7

113

Cyclomenol (INN) and its salts

5591-47-9

114

Sodium hexacyclonate (INN)

7009-49-6

115

Hexapropymate (INN)

358-52-1

116

Moved or deleted

117

O,O’-Diacetyl-N-allyl-N-normorphine

2748-74-5

118

Pipazetate (INN) and its salts

2167-85-3

218-508-8119

5-(α,β-Dibromophenethyl)-5-methylhydantoin

511-75-1

208-133-8

120

N,N’-Pentamethylenebis(trimethylammonium) salts, e. g.
pentamethonium bromide (INN)

541-20-8

208-771-7

121

N,N’-[(Methylimino)diethylene]bis(ethyldimethylammonium) salts, e. g.
azamethonium bromide (INN)

306-53-6

206-186-1

122

Cyclarbamate (INN)5779-54-4

227-302-7

123

Clofenotane (INN); DDT (ISO)50-29-3200-024-3

124

N,N’-Hexamethylenebis(trimethylammonium) salts, e. g.
hexamethonium bromide (INN)

55-97-0200-249-7

125Dichloroethanes (ethylene chlorides) e.g. 1,2-Dichloroethane

107-06-2

203-458-1

126

Dichloroethylenes (acetylene chlorides) e.g. Vinylidene chloride(1,1-Dichloroethylene)

75-35-4

200-864-0

127

Lysergide (INN) (LSD) and its salts

50-37-3200-033-2

128

2-Diethylaminoethyl 3-hydroxy-4-phenylbenzoate and its salts

3572-52-9

222-686-2

129

Cinchocaine (INN) and its salts

85-79-0

201-632-1

130

3-Diethylaminopropyl cinnamate

538-66-9

131

O,O’-Diethyl-O-4-nitrophenyl phosphorothioate (Parathion - ISO)56-38-2

200-271-7

132[Oxalylbis(iminoethylene)]bis[(o-chlorobenzyl)diethylammonium] salts,
e. g. ambenonium chloride (INN)

115-79-7

204-107-5

133

Methyprylon (INN) and its salts

125-64-4

204-745-4

134

Digitaline and all heterosides of Digitalis purpurea L.

752-61-4

212-036-6

135

7-[2-Hydroxy-3-(2-hydroxyethyl-N-methylamino)propyl]theophylline(xanthinol)

2530-97-4

136

Dioxethedrin (INN) and its salts

497-75-6

207-849-8

137

Piprocurarium iodide (INN)3562-55-8

222-627-0

138

Propyphenazone (INN)

479-92-5

207-539-2

139

Tetrabenazine (INN) and its salts

58-46-8200-383-6

140

Captodiame (INN)

486-17-9

207-629-1

141

Mefeclorazine (INN) and its salts

1243-33-0

142

Dimethylamine

124-40-3

204-697-4

143

1,1-Bis(dimethylaminomethyl)propyl benzoate (amydricaine, alypine)
and its salts

963-07-5

213-512-6

144

Methapyrilene (INN) and its salts

91-80-5

202-099-8

227-002-6

206-618-9

22.12.2009

Official Journal of the European Union

EN

L 342/87

Substance identification

Referencen u mb er

Chem ical n ame /I NN

CAS n u mb er

E C n u mb er

a

b

c

d

145

Metamfepramone (INN) and its salts

15351-09-4

239-384-1

146

Amitriptyline (INN) and its salts

50-48-6200-041-6

147

Metformin (INN) and its salts

657-24-9

211-517-8

148

Isosorbide dinitrate (INN)

87-33-2

201-740-9

149

Malononitrile

109-77-3

203-703-2

150

Succinonitrile

110-61-2

203-783-9

151

Dinitrophenol isomers

51-28-5/
329-71-5/
573-56-8/
25550-58-7

200-087-7/
206-348-1/
209-357-9/
247-096-2

152

Inproquone (INN)

436-40-8

153

Dimevamide (INN) and its salts

60-46-8

200-479-8

154

Diphenylpyraline (INN) and its salts

147-20-6

205-686-7

155

Sulfinpyrazone (INN)

57-96-5

200-357-4

156

N-(3-Carbamoyl-3,3-diphenylpropyl)-N,N-diisopropylmethylammonium salts, e. g. isopropamide iodide (INN)

71-81-8

200-766-8

157

Benactyzine (INN)

302-40-9

206-123-8

158

Benzatropine (INN) and its salts

86-13-5

159

Cyclizine (INN) and its salts

82-92-8

201-445-5

160

5,5-Diphenyl-4-imidazolidone (Doxenitoin (INN))

3254-93-1

221-851-6

161

Probenecid (INN)

57-66-9200-344-3

162

Disulfiram (INN); thiram (INN)

97-77-8/
137-26-8

202-607-8/
205-286-2

163

Emetine, its salts and derivatives

483-18-1

207-592-1

164

Ephedrine and its salts

299-42-3

206-080-5

165

Oxanamide (INN) and its derivatives

126-93-2

166

Eserine or physostigmine and its salts

57-47-6

200-332-8

167

Esters of 4-aminobenzoic acid, with the free amino group, with the
exception of that given in Annex VI

168

Choline salts and their esters, e. g. choline chloride (INN)

67-48-1

200-655-4

169

Caramiphen (INN) and its salts

77-22-5

201-013-6

170

Diethyl 4-nitrophenyl phosphate (Paraoxon - ISO)

311-45-5

206-221-0

171

Metethoheptazine (INN) and its salts

509-84-2

172

Oxpheneridine (INN) and its salts

546-32-7

173

Ethoheptazine (INN) and its salts

77-15-6

174

Metheptazine (INN) and its salts

469-78-3

175

Methylphenidate (INN) and its salts

113-45-1

204-028-6

176

Doxylamine (INN) and its salts

469-21-6

207-414-2

177

Tolboxane (INN)

2430-46-8

178

4-Benzyloxyphenol and 4-ethoxyphenol

103-16-2/
622-62-8

203-083-3/
210-748-1

179

Parethoxycaine (INN) and its salts

94-23-5

205-246-4

180

Fenozolone (INN)

15302-16-6

239-339-6

181

Glutethimide (INN) and its salts

77-21-4

201-012-0

201-007-3

L 342/88

Official Journal of the European Union

EN

22.12.2009

Substance identification

Referencen u mb er

Chem ical n ame /I NN

CAS n u mb er

E C n u mb er

a

b

c

d

182

Ethylene oxide75-21-8

200-849-9

183

Bemegride (INN) and its salts

64-65-3

200-588-0

184

Valnoctamide (INN)

4171-13-5

224-033-7

185

Haloperidol (INN)

52-86-8200-155-6

186

Paramethasone (INN)

53-33-8200-169-2

187

Fluanisone (INN)

1480-19-9

216-038-8

188

Trifluperidol (INN)

749-13-3

189

Fluoresone (INN)

2924-67-6

220-889-0

190

Fluorouracil (INN)

51-21-8200-085-6

191

Hydrofluoric acid, its normal salts, its complexes and hydrofluorides
with the exception of those given in Annex III

7664-39-3

231-634-8

192

Furfuryltrimethylammonium salts, e. g. furtrethonium iodide (INN)

541-64-0

208-789-5

193

Galantamine (INN)

357-70-0

194

Progestogens

195

1,2,3,4,5,6-Hexachlorocyclohexane (BHC-ISO)

58-89-9200-401-2

196(1R,4S,5R,8S)-1,2,3,4,10,10-Hexachloro-6,7-epoxy-1,4,4a,5,6,7,8,
8a-octahydro-1,4:5,8-dimethano-naphthalene (endrin-ISO)

72-20-8

200-775-7

197

Hexachloroethane

67-72-1

200-666-4

198(1R,4S,5R,8S)-1,2,3,4,10,10-Hexachloro-1,4,4a,5,8,8a-hexahydro-1,
4:5,8-dimethanonaphthalene (isodrin-ISO)

465-73-6

207-366-2

199

Hydrastine, hydrastinine and their salts

118-08-1/
6592-85-4

204-233-0/
229-533-9

200

Hydrazides and their salts e.g. Isoniazid (INN)

54-85-3

200-214-6

201

Hydrazine, its derivatives and their salts

302-01-2

206-114-9

202

Octamoxin (INN) and its salts

4684-87-1

203

Warfarin (INN) and its salts

81-81-2

201-377-6

204

Ethyl bis(4-hydroxy-2-oxo-1-benzopyran-3-yl)acetate and salts of theacid

548-00-5

208-940-5

205

Methocarbamol (INN)

532-03-6

208-524-3

206

Propatylnitrate (INN)

2921-92-8

220-866-5

207

4,4’-Dihydroxy-3,3’-(3-methylthiopropylidene) dicoumarin

208

Fenadiazole (INN)

1008-65-7

209

Nitroxoline (INN) and its salts

4008-48-4

223-662-4

210

Hyoscyamine, its salts and derivatives

101-31-5

202-933-0

211

Hyoscyamus niger L. (leaves, seeds, powder and galenical preparations)84603-65-6

283-265-7

212

Pemoline (INN) and its salts

2152-34-3

218-438-8

213

Iodine7553-56-2

231-442-4

214

Decamethylenebis(trimethylammonium) salts, e. g. decamethonium
bromide (INN)

541-22-0

208-772-2

215

Ipecacuanha (Cephaelis ipecacuanha Brot. and related species) (roots,
powder and galenical preparations)8012-96-2

232-385-8

216(2-Isopropylpent4-enoyl)urea (apronalide)528-92-7

208-443-3

217

α-Santonin[(3S,5aR,9bS)-3,3a,4,5,5a,9b-hexahydro-3,5a,9-trimethylnaphto[1,2-b] furan-2,8-dione]

481-06-1

207-560-7

218

Lobelia inflata L. and its galenical preparations

84696-23-1

283-642-6

22.12.2009

Official Journal of the European Union

EN

L 342/89

Substance identification

Referencen u mb er

Chem ical n ame /I NN

CAS n u mb er

E C n u mb er

a

b

c

d

219

Lobeline (INN) and its salts

90-69-7

202-012-3

220

Barbiturates

221

Mercury and its compounds, except those special cases included in
Annex V7439-97-6

231-106-7

222

3,4,5-Trimethoxyphenethylamine (Mescaline) and its salts

54-04-6

200-190-7

223

Metaldehyde

9002-91-9

224

2-(4-Allyl-2-methoxyphenoxy)-N,N-diethylacetamide and its salts

305-13-5

225

Coumetarol (INN)

4366-18-1

224-455-1

226

Dextromethorphan (INN) and its salts

125-71-3

204-752-2

227

2-Methylheptylamine and its salts

540-43-2

228

Isometheptene (INN) and its salts

503-01-5

207-959-6

229

Mecamylamine (INN)

60-40-2

200-476-1

230

Guaifenesin (INN)

93-14-1

202-222-5

231

Dicoumarol (INN)

66-76-2

200-632-9

232

Phenmetrazine (INN), its derivatives and salts

134-49-6

205-143-4

233

Thiamazole (INN)

60-56-0200-482-4

234

3,4-Dihydro-2-methoxy-2-methyl-4-phenyl-2H,5H-pyrano [3,2-c]-[1]benzopyran-5-one (cyclocoumarol)

518-20-7

208-248-3

235

Carisoprodol (INN)

78-44-4

201-118-7

236

Meprobamate (INN)

57-53-4

200-337-5

237

Tefazoline (INN) and its salts

1082-56-0

238

Arecoline

63-75-2

200-565-5

239

Poldine metilsulfate (INN)

545-80-2

208-894-6

240

Hydroxyzine (INN)

68-88-2

200-693-1

241

2-Naphthol

135-19-3

205-182-7

242

1-and 2-Naphthylamines and their salts

134-32-7/
91-59-8

205-138-7/
202-080-4

243

3-(1-Naphthyl)-4-hydroxycoumarin

39923-41-6

244

Naphazoline (INN) and its salts

835-31-4

212-641-5

245

Neostigmine and its salts e. g. neostigmine bromide (INN)

114-80-7

204-054-8

246

Nicotine and its salts

54-11-5

200-193-3

247

Amyl nitrites

110-46-3

203-770-8

248

Inorganic nitrites, with the exception of sodium nitrite

14797-65-0

249

Nitrobenzene

98-95-3250

Nitrocresols and their alkali metal salts

12167-20-3

251

Nitrofurantoin (INN)

67-20-9

200-646-5

252

Furazolidone (INN)

67-45-8

200-653-3

253

Nitroglycerin; Propane-1,2,3-triyl trinitrate

55-63-0200-240-8

254

Acenocoumarol (INN)

152-72-7

205-807-3

255

Alkali pentacyanonitrosylferrate (2-) e.g.

14402-89-2/
13755-38-9

238-373-9 / -256

Nitrostilbenes, their homologues and their derivatives

257

Noradrenaline and its salts

51-41-2

200-096-6

202-716-0

L 342/90

Official Journal of the European Union

EN

22.12.2009

Substance identification

Referencen u mb er

Chem ical n ame /I NN

CAS n u mb er

E C n u mb er

a

b

c

d

258

Noscapine (INN) and its salts

128-62-1

204-899-2

259

Guanethidine (INN) and its salts

55-65-2

200-241-3

260

Oestrogens

261

Oleandrin465-16-7

207-361-5

262

Chlortalidone (INN)

77-36-1

201-022-5

263

Pelletierine and its salts

2858-66-4/
4396-01-4

220-673-6/
224-523-0

264

Pentachloroethane76-01-7

200-925-1

265

Pentaerithrityl tetranitrate (INN)

78-11-5

201-084-3

266

Petrichloral (INN)

78-12-6267

Octamylamine (INN) and its salts

502-59-0

207-947-0

268

Picric acid

88-89-1

201-865-9

269

Phenacemide (INN)

63-98-9200-570-2

270

Difencloxazine (INN)

5617-26-5

271

2-Phenylindan-1,3-dione (phenindione (INN))

83-12-5

201-454-4

272

Ethylphenacemide (pheneturide (INN))

90-49-3

201-998-2

273

Phenprocoumon (INN)

435-97-2

207-108-9274

Fenyramidol (INN)

553-69-5

209-044-7

275

Triamterene (INN) and its salts

396-01-0

206-904-3

276

Tetraethyl pyrophosphate (TEPP - ISO)107-49-3

203-495-3

277

Tritolyl phosphate

1330-78-5

215-548-8

278

Psilocybine (INN)

520-52-5

208-294-4

279

Phosphorus and metal phosphides

7723-14-0

231-768-7

280

Thalidomide (INN) and its salts

50-35-1

200-031-1

281

Physostigma venenosum Balf.

89958-15-6

289-638-0

282

Picrotoxin

124-87-8

204-716-6

283

Pilocarpine and its salts

92-13-7

202-128-4

284

α-Piperidin-2-ylbenzyl acetate, laevorotatory threoform(levofacetoperane (INN)) and its salts

24558-01-8

285

Pipradrol (INN) and its salts

467-60-7

207-394-5

286

Azacyclonol (INN) and its salts

115-46-8

204-092-5

287

Bietamiverine (INN)

479-81-2

207-538-7

288

Butopiprine (INN) and its salts

55837-15-5

259-848-7

289

Lead and its compounds

7439-92-1

231-100-4

290

Coniine458-88-8

207-282-6

291

Prunus laurocerasus L. (‘cherry laurel water’)89997-54-6

289-689-9

292

Metyrapone (INN)

54-36-4

200-206-2

293

Radioactive substances, as defined by Directive 96/29/Euratom (1)laying down basic safety standards for the protection of the health ofworkers and the general public against the dangers arising fromionising radiation

294

Juniperus sabina L. (leaves, essential oil and galenical preparations)

90046-04-1

289-971-1

22.12.2009

Official Journal of the European Union

EN

L 342/91

Substance identification

Referencen u mb er

Chem ical n ame /I NN

CAS n u mb er

E C n u mb er

a

b

c

d

295

Hyoscine, its salts and derivatives

296Gold salts

51-34-3200-090-3297

Selenium and its compounds with the exception of selenium
disulphide under the conditions set out under reference No 49 inAnnex III7782-49-2

231-957-4

298

Solanum nigrum L. and its galenical preparations

84929-77-1

284-555-6

299

Sparteine (INN) and its salts

90-39-1

201-988-8300

Glucocorticoids (Corticosteroids)

301

Datura stramonium L. and its galenical preparations

84696-08-2

283-627-4

302

Strophantines, their aglucones and their respective derivatives

11005-63-3

234-239-9

303

Strophantus species and their galenical preparations

304

Strychnine and its salts

57-24-9200-319-7

305

Strychnos species and their galenical preparations

306

Narcotics, natural and synthetic: All substances listed in Tables I and II
of the single Convention on narcotic drugs signed in New York on
30 March 1961

307

Sulphonamides (sulphanilamide and its derivatives obtained bysubstitution of one or more H-atoms of the -NH2 groups) and their
salts

308

Sultiame (INN)

61-56-3

200-511-0309

Neodymium and its salts

7440-00-8

231-109-3

310

Thiotepa (INN)

52-24-4

200-135-7

311

Pilocarpus jaborandi Holmes and its galenical preparations

84696-42-4

283-649-4

312

Tellurium and its compounds

13494-80-9

236-813-4

313

Xylometazoline (INN) and its salts

526-36-3

208-390-6

314

Tetrachloroethylene

127-18-4

204-825-9

315

Carbon tetrachloride

56-23-5

200-262-8

316

Hexaethyl tetraphosphate757-58-4

212-057-0

317

Thallium and its compounds

7440-28-0

231-138-1

318

Thevetia neriifolia Juss., glycoside extract

90147-54-9

290-446-4

319

Ethionamide (INN)

536-33-4

208-628-9

320

Phenothiazine (INN) and its compounds

92-84-2

202-196-5

321

Thiourea and its derivatives, with the exception of the one listed in
Annex III62-56-6

200-543-5

322

Mephenesin (INN) and its esters

59-47-2

200-427-4

323

Vaccines, toxins or serums defined as immunological medicinal
products pursuant to Article 1(4) of Directive 2001/83/EC

324

Tranylcypromine (INN) and its salts

155-09-9

205-841-9

325

Trichloronitromethane (chloropicrine)

76-06-2

200-930-9326

2,2,2-Tribromoethanol (tribromoethyl alcohol)

75-80-9

200-903-1

327

Trichlormethine (INN) and its salts

817-09-4

212-442-3

328

Tretamine (INN)

51-18-3200-083-5

329

Gallamine triethiodide (INN)

65-29-2

200-605-1

330

Urginea scilla Steinh. and its galenical preparations

84650-62-4

283-520-2

331

Veratrine, its salts and galenical preparations

8051-02-3

613-062-00-4

332

Schoenocaulon officinale Lind (seeds and galenical preparations)

84604-18-2

283-296-6

L 342/92

Official Journal of the European Union

EN

22.12.2009

Substance identification

Referencen u mb er

Chem ical n ame /I NN

CAS n u mb er

E C n u mb er

a

b

c

d

333

Veratrum spp. and their preparations

90131-91-2

290-407-1

334

Vinyl chloride monomer

75-01-4

200-831-0

335

Ergocalciferol (INN) and cholecalciferol (vitamins D2 and D3)

50-14-6/
67-97-0

200-014-9/
200-673-2

336

Salts of O-alkyldithiocarbonic acids (xanthates)

337

Yohimbine and its salts

146-48-5

205-672-0

338

Dimethyl sulfoxide (INN)

67-68-5

200-664-3

339

Diphenhydramine (INN) and its salts

58-73-1

200-396-7

340

4-tert-Butylphenol

98-54-4

202-679-0

341

4-tert-Butylpyrocatechol

98-29-3

202-653-9

342

Dihydrotachysterol (INN)

67-96-9

200-672-7

343

Dioxane123-91-1

204-661-8

344

Morpholine and its salts

110-91-8

203-815-1

345.

Pyrethrum album L. and its galenical preparations346

2-[4-Methoxybenzyl-N-(2-pyridyl)amino]ethyldimethylamine maleate(Mepyramine maleate; pyrilamine maleate)59-33-6

200-422-7

347

Tripelennamine (INN)

91-81-6

202-100-1

348

Tetrachlorosalicylanilides

7426-07-5

349

Dichlorosalicylanilides

1147-98-4

350

Tetrabromosalicylanilides351

Dibromosalicylanilides

352

Bithionol (INN)

97-18-7

202-565-0

353

Thiuram monosulphides

97-74-5

202-605-7

354

Moved or deleted

355

Dimethylformamide (N,N-Dimethylformamide)

68-12-2

200-679-5356

4-Phenylbut-3-en-2-one (Benzylidene acetone)

122-57-6

204-555-1

357

Benzoates of 4-hydroxy-3-methoxycinnamyl alcohol (coniferyl
alcohol) except for normal content in natural essences used

358

Furocoumarines (e. g. trioxysalen (INN), 8-methoxypsoralen,
5-methoxypsoralen) except for normal content in natural essencesused.

3902-71-4/
298-81-7/
484-20-8

223-459-0/
206-066-9/
207-604-5

In sun protection and in bronzing products, furocoumarines shall be
below 1 mg/kg
359

Oil from the seeds of Laurus nobilis L.

84603-73-6

283-272-5

360

Safrole except for normal content in the natural essences used andprovided the concentration does not exceed:

94-59-7

202-345-4

100 ppm in the finished product, 50 ppm in products for dental andoral hygiene, and provided that Safrole is not present in toothpastes
intended specifically for children361

5,5’-Di-isopropyl-2,2’-dimethylbiphenyl-4,4’-diyl dihypoiodite (thymol
iodide)552-22-7

209-007-5362

3’-Ethyl-5’,6’,7’,8’-tetrahydro-5’,5’,8’,8’-tetramethyl-2’-acetonaphthoneor 7-acetyl-6-ethyl-1,1,4,4-tetramethyl-1,2,3,4-tetrahydronaphtalen(AETT; Versalide)88-29-9

201-817-7363

o-Phenylenediamine and its salts

95-54-5

202-430-6

22.12.2009

Official Journal of the European Union

EN

L 342/93

Substance identification

Referencen u mb er

Chemi cal n ame /I NN

CAS n u mb er

E C n u mb er

a

b

c

d

364

4-Methyl-m-phenylenediamine (Toluene-2,4-diamine) and its salts

95-80-7

202-453-1

365

Aristolochic acid and its salts; Aristolochia spp. and their preparations

475-80-9/
313-67-7/
15918-62-4

202-499-6/
206-238-3/-

366

Chloroform

67-66-3

200-663-8

367

2,3,7,8-Tetrachlorodibenzo-p-dioxin (TCDD)

1746-01-6

217-122-7

368

2,6-Dimethyl-1,3-dioxan-4-yl acetate (Dimethoxane)

828-00-2

212-579-9

369

Pyrithione sodium (INNM) ( )3811-73-2

223-296-5

370

N-(Trichloromethylthio)-4-cyclohexene-1,2-dicarboximide (Captan ISO)

133-06-2

205-087-0371

2,2’-Dihydroxy-3,3’,5,5’,6,6’-hexachlorodiphenylmethane(Hexachlorophene (INN))

70-30-4

200-733-8

372

6-(Piperidinyl)-2,4-pyrimidinediamine 3-oxide (Minoxidil (INN)) and its
salts

38304-91-5

253-874-2

373

3,4’,5-Tribromosalicylanilide (Tribromsalan (INN))

87-10-5

201-723-6

374

Phytolacca spp. and their preparations

65497-07-6/
60820-94-2

375

Tretinoin (INN) (retinoic acid and its salts)

302-79-4

206-129-0

376

1-Methoxy-2,4-diaminobenzene (2,4-diaminoanisole - CI 76050) andits salts

615-05-4

210-406-1

377

1-Methoxy-2,5-diaminobenzene (2,5-diaminoanisole) and its salts

5307-02-8

226-161-9

378

Colouring agent CI 12140

3118-97-6

221-490-4

379

Colouring agent CI 26105 (Solvent Red 24)

85-83-6

201-635-8

380

Colouring agent CI 42555 (Basic Violet 3)548-62-9

208-953-6

Colouring agent CI 42555:1

467-63-0

207-396-6

2

Colouring agent CI 42555:2
381

Amyl 4-dimethylaminobenzoate, mixed isomers (Padimate A (INN))

14779-78-3

238-849-6

383

2-Amino-4-nitrophenol

99-57-0

202-767-9

384

2-Amino-5-nitrophenol

121-88-0

204-503-8385

11-α-Hydroxypregn-4-ene-3,20-dione and its esters

80-75-1

201-306-9

386

Colouring agent CI 42640 ([4-[[4-(Dimethylamino)phenyl][4-[ethyl(3sulphonatobenzyl)amino]phenyl]methylene]cyclohexa-2,5-dien-1ylidene](ethyl)(3-sulphonatobenzyl)ammonium, sodium salt)

1694-09-3

216-901-9

387

Colouring agent CI 13065

587-98-4

209-608-2

388

Colouring agent CI 42535 (Basic Violet 1)

8004-87-3

389

Colouring agent CI 61554 (Solvent Blue 35)17354-14-2

241-379-4

390

Anti-androgens of steroidal structure391

Zirconium and its compounds, with the exception of the substances
listed under reference number 50 in Annex III, and the zirconium
lakes, pigments or salts of the colouring agents when listed in
Annex IV

7440-67-7

231-176-9

392

Moved or deleted

393

Acetonitrile

75-05-8

200-835-2

394

Tetrahydrozoline (Tetryzoline (INN)) and its salts

84-22-0

201-522-3

L 342/94

Official Journal of the European Union

EN

22.12.2009

Substance identification

Referencen u mb er

Chemi cal n ame /I NN

CAS n u mb er

E C n u mb er

a

b

c

d

395

Hydroxy-8-quinoline and its sulphate, except for the uses provided forin No 51 in Annex III

148-24-3/
134-31-6

205-711-1/
205-137-1

396

Dithio-2,2-bispyridine-dioxide 1,1’ (additive with trihydrated
magnesium sulphate) - (pyrithione disulphide + magnesium sulphate)

43143-11-9

256-115-3

397

Colouring agent CI 12075 (Pigment Orange 5) and its lakes, pigments
and salts

3468-63-1

222-429-4

398

Colouring agent CI 45170 and CI 45170:1 (Basic Violet 10)

81-88-9/509-34-2

201-383-9/
208-096-8

399

Lidocaine (INN)

137-58-6

205-302-8

400

1,2-Epoxybutane

106-88-7

203-438-2

401

Colouring agent CI 15585

5160-02-1/
2092-56-0

225-935-3/
218-248-5402

Strontium lactate

29870-99-3

249-915-9403

Strontium nitrate

10042-76-9

233-131-9404

Strontium polycarboxylate

405

Pramocaine (INN)

140-65-8

205-425-7406

4-Ethoxy-m-phenylenediamine and its salts

5862-77-1

407

2,4-Diaminophenylethanol and its salts

14572-93-1

408

Pyrocatechol (Catechol)

120-80-9

204-427-5

409

Pyrogallol

87-66-1

201-762-9

410

Nitrosamines e.g. Dimethylnitrosoamine; Nitrosodipropylamine;
2,2’-Nitrosoimino)bisethanol

62-75-9/621-64-7/
1116-54-7

200-549-8/
210-698-0/
214-237-4

411

Secondary alkyl- and alkanolamines and their salts

412

4-Amino-2-nitrophenol

119-34-6

204-316-1

413

2-Methyl-m-phenylenediamine (Toluene-2,6-diamine)

823-40-5

212-513-9414

4-tert.-Butyl-3-methoxy-2,6-dinitrotoluene (Musk Ambrette)

83-66-9

201-493-7

415

Moved or deleted

416

Cells, tissues or products of human origin

417

3,3-Bis(4-hydroxyphenyl)phthalide (Phenolphthalein (INN))

77-09-8

201-004-7

418

3-Imidazol-4-ylacrylic acid (Urocanic acid) and its ethyl ester

104-98-3/
27538-35-8

203-258-4/
248-515-1

419

Category 1 material and Category 2 material as defined in Articles 4
and 5 respectively of Regulation (EC) No 1774/2002 of the European
Parliament and of the Council (3), and ingredients derived therefrom

420

Crude and refined coal tars

8007-45-2

232-361-7

421

1,1,3,3,5-Pentamethyl-4,6-dinitroindane (Moskene)

116-66-5

204-149-4

422

5-tert.-Butyl-1,2,3-trimethyl-4,6-dinitrobenzene (Musk Tibetene)145-39-1

205-651-6

423

Alanroot oil (Inula helenium L.), when used as a fragrance ingredient

97676-35-2

424

Benzyl cyanide, when used as a fragrance ingredient140-29-4

205-410-5425

Cyclamen alcohol, when used as a fragrance ingredient4756-19-8

225-289-2

426

Diethyl maleate, when used as a fragrance ingredient141-05-9

205-451-9

427

3,4-Dihydrocoumarin, when used as a fragrance ingredient119-84-6

204-354-9

428

2,4-Dihydroxy-3-methylbenzaldehyde, when used as a fragrance
ingredient6248-20-0

228-369-5

22.12.2009

Official Journal of the European Union

EN

L 342/95

Substance identification

Referencen u mb er

Chem ical n ame /I NN

CAS n u mb er

E C n u mb er

a

b

c

d

429

3,7-Dimethyl-2-octen-1-ol (6,7-Dihydrogeraniol), when used as afragrance ingredient40607-48-5

254-999-5

430

4,6-Dimethyl-8-tert-butylcoumarin, when used as a fragrance
ingredient

17874-34-9

241-827-9

431

Dimethyl citraconate, when used as a fragrance ingredient617-54-9

432

7,11-Dimethyl-4,6,10-dodecatrien-3-one (Pseudomethylionone), whenused as a fragrance ingredient26651-96-7

247-878-3

433

6,10-Dimethyl-3,5,9-undecatrien-2-one (Pseudoionone)(, when used asa fragrance ingredient141-10-6

205-457-1

434

Diphenylamine, when used as a fragrance ingredient122-39-4

204-539-4

435

Ethyl acrylate, when used as a fragrance ingredient140-88-5

205-438-8

436

Fig leaf absolute (Ficus carica L.), when used as a fragrance ingredient68916-52-9

437trans-2-Heptenal, when used as a fragrance ingredient

18829-55-5

242-608-0

438trans-2-Hexenal diethyl acetal, when used as a fragrance ingredient67746-30-9

266-989-8

439trans-2-Hexenal dimethyl acetal, when used as a fragrance ingredient

18318-83-7

242-204-4

440

Hydroabietyl alcohol, when used as a fragrance ingredient13393-93-6

236-476-3

441

6-Isopropyl-2-decahydronaphthalenol, when used as a fragrance
ingredient34131-99-2

251-841-7

442

7-Methoxycoumarin, when used as a fragrance ingredient531-59-9

208-513-3443

4-(4-Methoxyphenyl)-3-butene-2-one (Anisylidene acetone), when used
as a fragrance ingredient943-88-4

213-404-9444

1-(4-Methoxyphenyl)-1-penten-3-one(alpha-Methylanisylideneacetone), when used as a fragrance ingredient104-27-8

203-190-5

445

Methyl trans-2-butenoate, when used as a fragrance ingredient623-43-8

210-793-7

446

7-Methylcoumarin, when used as a fragrance ingredient2445-83-2

219-499-3

447

5-Methyl-2,3-hexanedione (Acetyl isovaleryl), when used as a fragrance
ingredient

13706-86-0

237-241-8

448

2-Pentylidenecyclohexanone, when used as a fragrance ingredient

25677-40-1

247-178-8

449

3,6,10-Trimethyl-3,5,9-undecatrien-2-one (Pseudo-Isomethyl ionone),when used as a fragrance ingredient1117-41-5

214-245-8

450

Verbena oil (Lippia citriodora Kunth.), when used as a fragrance
ingredient8024-12-2

451

Moved or deleted452

6-(2-Chloroethyl)-6-(2-methoxyethoxy)-2,5,7,10-tetraoxa6-silaundecane

37894-46-5

253-704-7

453

Cobalt dichloride

7646-79-9

231-589-4

454

Cobalt sulphate

10124-43-3

233-334-2

455

Nickel monoxide

1313-99-1

215-215-7

456

Dinickel trioxide

1314-06-3

215-217-8

457

Nickel dioxide

12035-36-8

234-823-3

458

Trinickel disulphide12035-72-2

234-829-6

459

Tetracarbonylnickel

13463-39-3

236-669-2

460

Nickel sulphide

16812-54-7

240-841-2

461

Potassium bromate

7758-01-2

231-829-8

462

Carbon monoxide

630-08-0

211-128-3

463

Buta-1,3-diene, see also entries 464-611

106-99-0

203-450-8

L 342/96

EN

Official Journal of the European Union

22.12.2009

Substance identification

Referencen u mb er

Chem ical n ame /I NN

CAS n u mb er

E C n u mb er

a

b

c

d

464

Isobutane, if it contains ≥ 0,1 % w/w Butadiene75-28-5

200-857-2

465

Butane, if it contains ≥ 0,1 % w/w Butadiene106-97-8

203-448-7

466

Gases (petroleum), C3-4, if they contain > 0,1 % w/w Butadiene

68131-75-9

268-629-5

467

Tail gas (petroleum), catalytic cracked distillate and catalytic cracked
naphtha fractionation absorber, if it contains > 0,1 % w/w Butadiene

68307-98-2

269-617-2

468

Tail gas (petroleum), catalytic polymn. naphtha fractionation stabiliser,
if it contains > 0,1 % w/w Butadiene

68307-99-3

269-618-8

469

Tail gas (petroleum), catalytic reformed naphtha fractionation
stabiliser, hydrogen sulfide-free, if it contains > 0,1 % w/w Butadiene

68308-00-9

269-619-3

470

Tail gas (petroleum), cracked distillate hydrotreater stripper, if it
contains > 0,1 % w/w Butadiene

68308-01-0

269-620-9

471

Tail gas (petroleum), gas oil catalytic cracking absorber, if it contains> 0,1 % w/w Butadiene

68308-03-2

269-623-5

472

Tail gas (petroleum), gas recovery plant, if it contains > 0,1 % w/w
Butadiene

68308-04-3

269-624-0

473

Tail gas (petroleum), gas recovery plant deethaniser, if it contains> 0,1 % w/w Butadiene

68308-05-4

269-625-6

474

Tail gas (petroleum), hydrodesulfurised distillate and hydrodesulfurised
naphtha fractionator, acid-free, if it contains > 0,1 % w/w Butadiene

68308-06-5

269-626-1

475

Tail gas (petroleum), hydrodesulfurised vacuum gas oil stripper,hydrogen sulfide-free, if it contains > 0,1 % w/w Butadiene

68308-07-6

269-627-7

476

Tail gas (petroleum), isomerised naphtha fractionation stabiliser, if it
contains > 0,1 % w/w Butadiene

68308-08-7

269-628-2

477

Tail gas (petroleum), light straight-run naphtha stabiliser, hydrogensulfide-free, if it contains > 0,1 % w/w Butadiene

68308-09-8

269-629-8

478

Tail gas (petroleum), straight-run distillate hydrodesulfurised, hydrogensulfide-free, if it contains > 0,1 % w/w Butadiene

68308-10-1

269-630-3

479

Tail gas (petroleum), propane-propylene alkylation feed prep
deethaniser, if it contains > 0,1 % w/w Butadiene

68308-11-2

269-631-9

480

Tail gas (petroleum), vacuum gas oil hydrodesulfurised, hydrogensulfide-free, if it contains > 0,1 % w/w Butadiene

68308-12-3

269-632-4

481

Gases (petroleum), catalytic cracked overheads, if they contain > 0,1 %w/w Butadiene

68409-99-4

270-071-2

482

Alkanes, C1-2, if they contain > 0,1 % w/w Butadiene

68475-57-0

270-651-5

483

Alkanes, C2-3, if they contain > 0,1 % w/w Butadiene

68475-58-1

270-652-0

484

Alkanes, C3-4, if they contain > 0,1 % w/w Butadiene

68475-59-2

270-653-6

485

Alkanes, C4-5, if they contain > 0,1 % w/w Butadiene

68475-60-5

270-654-1

486

Fuel-gases, if they contain > 0,1 % w/w Butadiene

68476-26-6

270-667-2

487

Fuel gases, crude oil distillates, if they contain > 0,1 % w/w Butadiene

68476-29-9

270-670-9

488

Hydrocarbons, C3-4, if they contain > 0,1 % w/w Butadiene

68476-40-4

270-681-9

489

Hydrocarbons, C4-5, if they contain > 0,1 % w/w Butadiene

68476-42-6

270-682-4

490

Hydrocarbons, C2-4, C3-rich, if they contain > 0,1 % w/w Butadiene

68476-49-3

270-689-2

22.12.2009

EN

Official Journal of the European Union

L 342/97

Substance identification

Referencen u mb er

Chem ical n ame /I NN

CAS n u mb er

E C n u mb er

a

b

c

d

491

Petroleum gases, liquefied, if they contain > 0,1 % w/w Butadiene

68476-85-7

270-704-2

492

Petroleum gases, liquefied, sweetened, if they contain > 0,1 % w/w
Butadiene

68476-86-8

270-705-8

493

Gases (petroleum), C3-4, isobutane-rich if they contain > 0,1 % w/w
Butadiene

68477-33-8

270-724-1

494

Distillates (petroleum), C3-6, piperylene-rich, if they contain > 0,1 %w/w Butadiene

68477-35-0

270-726-2

495

Gases (petroleum), amine system feed, if they contain > 0,1 % w/w
Butadiene

68477-65-6

270-746-1

496

Gases (petroleum), benzene unit hydrodesulfurised off, if they contain> 0,1 % w/w Butadiene

68477-66-7

270-747-7

497

Gases (petroleum), benzene unit recycle, hydrogen-rich, if they contain> 0,1 % w/w Butadiene

68477-67-8

270-748-2

498

Gases (petroleum), blend oil, hydrogen-nitrogen-rich, if they contain> 0,1 % w/w Butadiene

68477-68-9

270-749-8

499

Gases (petroleum), butane splitter overheads, if they contain > 0,1 %w/w Butadiene

68477-69-0

270-750-3

500

Gases (petroleum), C2-3, if they contain > 0,1 % w/w Butadiene

68477-70-3

270-751-9

501

Gases (petroleum), catalytic-cracked gas oil depropaniser bottoms,
C4-rich acid-free, if they contain > 0,1 % w/w Butadiene

68477-71-4

270-752-4

502

Gases (petroleum), catalytic-cracked naphtha debutaniser bottoms,
C3-5-rich, if they contain > 0,1 % w/w Butadiene

68477-72-5

270-754-5

503

Gases (petroleum), catalytic cracked naphtha depropaniser overhead,C3-rich acid-free, if they contain > 0,1 % w/w Butadiene

68477-73-6

270-755-0

504

Gases (petroleum), catalytic cracker, if they contain > 0,1 % w/w
Butadiene

68477-74-7

270-756-6

505

Gases (petroleum), catalytic cracker, C1-5-rich, if they contain > 0,1 %w/w Butadiene

68477-75-8

270-757-1

506

Gases (petroleum), catalytic polymd. naphtha stabiliser overhead,C2-4-rich, if they contain > 0,1 % w/w Butadiene

68477-76-9

270-758-7

507

Gases (petroleum), catalytic reformed naphtha stripper overheads, if
they contain > 0,1 % w/w Butadiene

68477-77-0

270-759-2

508

Gases (petroleum), catalytic reformer, C1-4-rich, if they contain > 0,1 %w/w Butadiene

68477-79-2

270-760-8

509

Gases (petroleum), C6-8 catalytic reformer recycle, if they contain> 0,1 % w/w Butadiene

68477-80-5

270-761-3

510

Gases (petroleum), C6-8 catalytic reformer, if they contain > 0,1 % w/w
Butadiene

68477-81-6

270-762-9

511

Gases (petroleum), C6-8 catalytic reformer recycle, hydrogen-rich, ifthey contain > 0,1 % w/w Butadiene

68477-82-7

270-763-4

512

Gases (petroleum), C3-5 olefinic-paraffinic alkylation feed, if they
contain > 0,1 % w/w Butadiene

68477-83-8

270-765-5

513

Gases (petroleum), C2-return stream, if they contain > 0,1 % w/w
Butadiene

68477-84-9

270-766-0

514

Gases (petroleum), C4-rich, if they contain > 0,1 % w/w Butadiene

68477-85-0

270-767-6

515

Gases (petroleum), deethaniser overheads, if they contain > 0,1 % w/w
Butadiene

68477-86-1

270-768-1

516

Gases (petroleum), deisobutaniser tower overheads, if they contain> 0,1 % w/w Butadiene

68477-87-2

270-769-7

517

Gases (petroleum), depropaniser dry, propene-rich, if they contain> 0,1 % w/w Butadiene

68477-90-7

270-772-3

L 342/98

EN

Official Journal of the European Union

22.12.2009

Substance identification

Referencen u mb er

Chem ical n ame /I NN

CAS n u mb er

E C n u mb er

a

b

c

d

518

Gases (petroleum), depropaniser overheads, if they contain > 0,1 %w/w Butadiene

68477-91-8

270-773-9

519

Gases (petroleum), dry sour, gas-concn. -unit-off, if they contain> 0,1 % w/w Butadiene

68477-92-9

270-774-4

520

Gases (petroleum), gas concn. reabsorber distn., if they contain> 0,1 % w/w Butadiene

68477-93-0

270-776-5

521

Gases (petroleum), gas recovery plant depropaniser overheads, if they
contain > 0,1 % w/w Butadiene

68477-94-1

270-777-0

522

Gases (petroleum), Girbatol unit feed, if they contain > 0,1 % w/w
Butadiene

68477-95-2

270-778-6

523

Gases (petroleum), hydrogen absorber off, if they contain > 0,1 % w/w
Butadiene

68477-96-3

270-779-1

524

Gases (petroleum), hydrogen-rich, if they contain > 0,1 % w/w
Butadiene

68477-97-4

270-780-7

525

Gases (petroleum), hydrotreater blend oil recycle,hydrogen-nitrogen-rich, if they contain > 0,1 % w/w Butadiene

68477-98-5

270-781-2

526

Gases (petroleum), isomerised naphtha fractionator, C4-rich, hydrogensulfide-free, if they contain > 0,1 % w/w Butadiene

68477-99-6

270-782-8

527

Gases (petroleum), recycle, hydrogen-rich, if they contain > 0,1 % w/w
Butadiene

68478-00-2

270-783-3

528

Gases (petroleum), reformer make-up, hydrogen-rich, if they contain> 0,1 % w/w Butadiene

68478-01-3

270-784-9

529

Gases (petroleum), reforming hydrotreater, if they contain > 0,1 %w/w Butadiene

68478-02-4

270-785-4

530

Gases (petroleum), reforming hydrotreater, hydrogen-methane-rich, ifthey contain > 0,1 % w/w Butadiene

68478-03-5

270-787-5

531

Gases (petroleum), reforming hydrotreater make-up, hydrogen-rich, ifthey contain > 0,1 % w/w Butadiene

68478-04-6

270-788-0

532

Gases (petroleum), thermal cracking distn., if they contain > 0,1 %w/w Butadiene

68478-05-7

270-789-6

533

Tail gas (petroleum), catalytic cracked clarified oil and thermal cracked
vacuum residue fractionation reflux drum, if it contains > 0,1 % w/w
Butadiene

68478-21-7

270-802-5

534

Tail gas (petroleum), catalytic cracked naphtha stabilisation absorber, if
it contains > 0,1 % w/w Butadiene

68478-22-8

270-803-0

535

Tail gas (petroleum), catalytic cracker, catalytic reformer andhydrodesulfurised combined fractionater, if it contains > 0,1 % w/w
Butadiene

68478-24-0

270-804-6

536

Tail gas (petroleum), catalytic cracker refractionation absorber, if it
contains > 0,1 % w/w Butadiene

68478-25-1

270-805-1

537

Tail gas (petroleum), catalytic reformed naphtha fractionation
stabiliser, if it contains > 0,1 % w/w Butadiene

68478-26-2

270-806-7

538

Tail gas (petroleum), catalytic reformed naphtha separator, if it
contains > 0,1 % w/w Butadiene

68478-27-3

270-807-2

539

Tail gas (petroleum), catalytic reformed naphtha stabiliser, if it
contains > 0,1 % w/w Butadiene

68478-28-4

270-808-8

540

Tail gas (petroleum), cracked distillate hydrotreater separator, if it
contains > 0,1 % w/w Butadiene

68478-29-5

270-809-3

541

Tail gas (petroleum), hydrodesulfurised straight-run naphtha separator,
if it contains > 0,1 % w/w Butadiene

68478-30-8

270-810-9

22.12.2009

EN

Official Journal of the European Union

L 342/99

Substance identification

Referencen u mb er

Chem ical n ame /I NN

CAS n u mb er

E C n u mb er

a

b

c

d

542

Tail gas (petroleum), saturate gas plant mixed stream, C4-rich, if it
contains > 0,1 % w/w Butadiene

68478-32-0

270-813-5

543

Tail gas (petroleum), saturate gas recovery plant, C1-2-rich, if it
contains > 0,1 % w/w Butadiene

68478-33-1

270-814-0

544

Tail gas (petroleum), vacuum residues thermal cracker, if it contains> 0,1 % w/w Butadiene

68478-34-2

270-815-6

545

Hydrocarbons, C3-4-rich, petroleum distillate, if they contain > 0,1 %w/w Butadiene

68512-91-4

270-990-9

546

Gases (petroleum), catalytic reformed straight-run naphtha stabiliser
overheads, if they contain > 0,1 % w/w Butadiene

68513-14-4

270-999-8

547

Gases (petroleum), full-range straight-run naphtha dehexaniser off, if
they contain > 0,1 % w/w Butadiene

68513-15-5

271-000-8

548

Gases (petroleum), hydrocracking depropaniser off, hydrocarbon-rich,
if they contain > 0,1 % w/w Butadiene

68513-16-6

271-001-3

549

Gases (petroleum), light straight-run naphtha stabiliser off, if they
contain > 0,1 % w/w Butadiene

68513-17-7

271-002-9

550

Gases (petroleum), reformer effluent high-pressure flash drum off, if
they contain > 0,1 % w/w Butadiene

68513-18-8

271-003-4

551

Gases (petroleum), reformer effluent low-pressure flash drum off, if
they contain > 0,1 % w/w Butadiene

68513-19-9

271-005-5

552

Residues (petroleum), alkylation splitter, C4-rich, if they contain> 0,1 % w/w Butadiene

68513-66-6

271-010-2

553

Hydrocarbons, C1-4, if they contain > 0,1 % w/w Butadiene

68514-31-8

271-032-2

554

Hydrocarbons, C1-4, sweetened, if they contain > 0,1 % w/w Butadiene

68514-36-3

271-038-5

555

Gases (petroleum), oil refinery gas distn. off, if they contain > 0,1 %w/w Butadiene

68527-15-1

271-258-1

556

Hydrocarbons, C1-3, if they contain > 0,1 % w/w Butadiene

68527-16-2

271-259-7

557

Hydrocarbons, C1-4, debutaniser fraction, if they contain > 0,1 % w/w
Butadiene

68527-19-5

271-261-8

558

Gases (petroleum), benzene unit hydrotreater depentaniser overheads,
if they contain > 0,1 % w/w Butadiene

68602-82-4

271-623-5

559

Gases (petroleum), C1-5, wet, if they contain > 0,1 % w/w Butadiene

68602-83-5

271-624-0

560

Gases (petroleum), secondary absorber off, fluidised catalytic cracker
overheads fractionator, if they contain > 0,1 % w/w Butadiene

68602-84-6

271-625-6

561

Hydrocarbons, C2-4, if they contain > 0,1 % w/w Butadiene

68606-25-7

271-734-9

562

Hydrocarbons, C3, if they contain > 0,1 % w/w Butadiene

68606-26-8

271-735-4

563

Gases (petroleum), alkylation feed, if they contain > 0,1 % w/w
Butadiene

68606-27-9

271-737-5

564

Gases (petroleum), depropaniser bottoms fractionation off, if they
contain > 0,1 % w/w Butadiene

68606-34-8

271-742-2

565

Petroleum products, refinery gases, if they contain > 0,1 % w/w
Butadiene

68607-11-4

271-750-6

566

Gases (petroleum), hydrocracking low-pressure separator, if they
contain > 0,1 % w/w Butadiene

68783-06-2

272-182-1

567

Gases (petroleum), refinery blend, if they contain > 0,1 % w/w
Butadiene

68783-07-3

272-183-7

568

Gases (petroleum), catalytic cracking, if they contain > 0,1 % w/w
Butadiene

68783-64-2

272-203-4

L 342/100

EN

Official Journal of the European Union

22.12.2009

Substance identification

Referencen u mb er

Chem ical n ame /I NN

CAS n u mb er

E C n u mb er

a

b

c

d

569

Gases (petroleum), C2-4, sweetened, if they contain > 0,1 % w/w
Butadiene

68783-65-3

272-205-5

570

Gases (petroleum), refinery, if they contain > 0,1 % w/w Butadiene

68814-67-5

272-338-9

571

Gases (petroleum), platformer products separator off, if they contain> 0,1 % w/w Butadiene

68814-90-4

272-343-6

572

Gases (petroleum), hydrotreated sour kerosine depentaniser stabiliser
off, if they contain > 0,1 % w/w Butadiene

68911-58-0

272-775-5

573

Gases (petroleum), hydrotreated sour kerosine flash drum, if they
contain > 0,1 % w/w Butadiene

68911-59-1

272-776-0

574

Gases (petroleum), crude oil fractionation off, if they contain > 0,1 %w/w Butadiene

68918-99-0

272-871-7

575

Gases (petroleum), dehexaniser off, if they contain > 0,1 % w/w
Butadiene

68919-00-6

272-872-2

576

Gases (petroleum), distillate unifiner desulfurisation stripper off, if they
contain > 0,1 % w/w Butadiene

68919-01-7

272-873-8

577

Gases (petroleum), fluidised catalytic cracker fractionation off if they
contain > 0,1 % w/w Butadiene

68919-02-8

272-874-3

578

Gases (petroleum), fluidised catalytic cracker scrubbing secondary
absorber off, if they contain > 0,1 % w/w Butadiene

68919-03-9

272-875-9

579

Gases (petroleum), heavy distillate hydrotreater desulfurisation stripper
off, if they contain > 0,1 % w/w Butadiene

68919-04-0

272-876-4

580

Gases (petroleum), light straight run gasoline fractionation stabiliser
off, if they contain > 0,1 % w/w Butadiene

68919-05-1

272-878-5

581

Gases (petroleum), naphtha unifiner desulfurisation stripper off, if they
contain > 0,1 % w/w Butadiene

68919-06-2

272-879-0

582

Gases (petroleum), platformer stabiliser off, light ends fractionation, if
they contain > 0,1 % w/w Butadiene

68919-07-3

272-880-6

583

Gases (petroleum), preflash tower off, crude distn., if they contain> 0,1 % w/w Butadiene

68919-08-4

272-881-1

584

Gases (petroleum), straight-run naphtha catalytic reforming off, if they
contain > 0,1 % w/w Butadiene

68919-09-5

272-882-7

585

Gases (petroleum), straight-run stabiliser off, if they contain > 0,1 %w/w Butadiene

68919-10-8

272-883-2

586

Gases (petroleum), tar stripper off, if they contain > 0,1 % w/w
Butadiene

68919-11-9

272-884-8

587

Gases (petroleum), unifiner stripper off, if they contain > 0,1 % w/w
Butadiene

68919-12-0

272-885-3

588

Gases (petroleum), fluidised catalytic cracker splitter overheads, if they
contain > 0,1 % w/w Butadiene

68919-20-0

272-893-7

589

Gases (petroleum), catalytic cracked naphtha debutaniser, if they
contain > 0,1 % w/w Butadiene

68952-76-1

273-169-3

590

Tail gas (petroleum), catalytic cracked distillate and naphtha stabiliser,
if it contains > 0,1 % w/w Butadiene

68952-77-2

273-170-9

591

Tail gas (petroleum), catalytic hydrodesulfurised naphtha separator, if
it contains > 0,1 % w/w Butadiene

68952-79-4

273-173-5

592

Tail gas (petroleum), straight-run naphtha hydrodesulfurised, if it
contains > 0,1 % w/w Butadiene

68952-80-7

273-174-0

593

Tail gas (petroleum), thermal-cracked distillate, gas oil and naphtha
absorber, if it contains > 0,1 % w/w Butadiene

68952-81-8

273-175-6

22.12.2009

Official Journal of the European Union

EN

L 342/101

Substance identification

Referencen u mb er

Chem ical n ame /I NN

CAS n u mb er

E C n u mb er

a

b

c

d

594

Tail gas (petroleum), thermal cracked hydrocarbon fractionation
stabiliser, petroleum coking, if it contains > 0,1 % w/w Butadiene

68952-82-9

273-176-1

595

Gases (petroleum), light steam-cracked, butadiene conc., if they
contain > 0,1 % w/w Butadiene

68955-28-2

273-265-5

596

Gases (petroleum), sponge absorber off, fluidised catalytic cracker andgas oil desulfuriser overhead fractionation, if they contain > 0,1 % w/w
Butadiene

68955-33-9

273-269-7

597

Gases (petroleum), straight-run naphtha catalytic reformer stabiliser
overhead, if they contain > 0,1 % w/w Butadiene

68955-34-0

273-270-2

598

Gases (petroleum), crude distn. and catalytic cracking, if they contain >0,1 % w/w Butadiene

68989-88-8

273-563-5

599

Hydrocarbons, C4, if they contain > 0,1 % w/w Butadiene87741-01-3

289-339-5

600

Alkanes, C1-4, C3-rich, if they contain > 0,1 % w/w Butadiene

90622-55-2

292-456-4

601

Gases (petroleum), gas oil diethanolamine scrubber off, if they contain> 0,1 % w/w Butadiene92045-15-3

295-397-2

602

Gases (petroleum), gas oil hydrodesulfurisation effluent, if they contain> 0,1 % w/w Butadiene92045-16-4

295-398-8

603

Gases (petroleum), gas oil hydrodesulfurisation purge, if they contain> 0,1 % w/w Butadiene92045-17-5

295-399-3

604

Gases (petroleum), hydrogenator effluent flash drum off, if they
contain > 0,1 % w/w Butadiene92045-18-6

295-400-7

605

Gases (petroleum), naphtha steam cracking high-pressure residual, if
they contain > 0,1 % w/w Butadiene92045-19-7

295-401-2

606

Gases (petroleum), residue visbreaking off, if they contain > 0,1 % w/w
Butadiene

92045-20-0

295-402-8

607

Gases (petroleum), steam-cracker C3-rich, if they contain > 0,1 % w/w
Butadiene

92045-22-2

295-404-9

608

Hydrocarbons, C4, steam-cracker distillate, if they contain > 0,1 % w/w
Butadiene

92045-23-3

295-405-4

609

Petroleum gases, liquefied, sweetened, C4 fraction, if they contain> 0,1 % w/w Butadiene92045-80-2

295-463-0

610

Hydrocarbons, C4, 1,3-butadiene- and isobutene-free, if they contain> 0,1 % w/w Butadiene95465-89-7

306-004-1

611

Raffinates (petroleum), steam-cracked C4 fraction cuprous ammonium
acetate extn., C3-5 and C3-5 unsatd., butadiene-free, if they contain> 0,1 % w/w Butadiene

97722-19-5

307-769-4

612

Benzo[def]chrysene (benzo[a]pyrene)50-32-8200-028-5

613

Pitch, coal tar-petroleum, if it contains > 0,005 % w/w benzo[a]pyrene

68187-57-5

269-109-0

614

Distillates (coal-petroleum), condensed-ring arom., if they contain> 0,005 % w/w benzo[a]pyrene

68188-48-7

269-159-3

615

Moved or deleted

616

Moved or deleted

617

Creosote oil, acenaphthene fraction, acenaphthene-free, if it contains> 0,005 % w/w benzo[a]pyrene

90640-85-0

292-606-9

618

Pitch, coal tar, low-temp., if it contains > 0,005 % w/w
benzo[a]pyrene

90669-57-1

292-651-4

619

Pitch, coal tar, low-temp., heat-treated, if it contains > 0,005 % w/w
benzo[a]pyrene

90669-58-2

292-653-5

L 342/102

Official Journal of the European Union

EN

22.12.2009

Substance identification

Referencen u mb er

Chem ical n ame /I NN

CAS n u mb er

E C n u mb er

a

b

c

d

620

Pitch, coal tar, low-temp., oxidised, if it contains > 0,005 % w/w
benzo[a]pyrene

90669-59-3

292-654-0

621

Extract residues (coal), brown, if they contain > 0,005 % w/w
benzo[a]pyrene

91697-23-3

294-285-0622

Paraffin waxes (coal), brown-coal high-temp. tar, if they contain> 0,005 % w/w benzo[a]pyrene

92045-71-1

295-454-1

623

Paraffin waxes (coal), brown-coal high-temp. tar, hydrotreated, if they
contain > 0,005 % w/w benzo[a]pyrene

92045-72-2

295-455-7

624

Waste solids, coal-tar pitch coking, if they contain > 0,005 % w/w
benzo[a]pyrene

92062-34-5

295-549-8

625

Pitch, coal tar, high-temp., secondary, if it contains > 0,005 % w/w
benzo[a]pyrene

94114-13-3

302-650-3

626

Residues (coal), liq. solvent extn., if they contain > 0,005 % w/w
benzo[a]pyrene

94114-46-2

302-681-2

627

Coal liquids, liq. solvent extn. soln., if they contain > 0,005 % w/w
benzo[a]pyrene

94114-47-3

302-682-8

628

Coal liquids, liq. solvent extn., if they contain > 0,005 % w/w
benzo[a]pyrene

94114-48-4

302-683-3

629

Paraffin waxes (coal), brown-coal high-temp. tar, carbon-treated, if
they contain > 0,005 % w/w benzo[a]pyrene

97926-76-6

308-296-6

630

Paraffin waxes (coal), brown-coal high-temp tar, clay-treated, if they
contain > 0,005 % w/w benzo[a]pyrene

97926-77-7

308-297-1

631

Paraffin waxes (coal), brown-coal high-temp tar, silicic acid-treated, if
they contain > 0,005 % w/w benzo[a]pyrene

97926-78-8

308-298-7

632

Absorption oils, bicyclo arom. and heterocylic hydrocarbon fraction, if
they contain > 0,005 % w/w benzo[a]pyrene

101316-45-4

309-851-5

633

Aromatic hydrocarbons, C20-28, polycyclic, mixed coal-tar
pitch-polyethylene polypropylene pyrolysis-derived, if they contain> 0,005 % w/w benzo[a]pyrene

101794-74-5

309-956-6

634

Aromatic hydrocarbons, C20-28, polycyclic, mixed coal-tar
pitch-polyethylene pyrolysis-derived, if they contain > 0,005 % w/w
benzo[a]pyrene

101794-75-6

309-957-1

635

Aromatic hydrocarbons, C20-28, polycyclic, mixed coal-tar
pitch-polystyrene pyrolysis-derived, if they contain > 0,005 % w/w
benzo[a]pyrene

101794-76-7

309-958-7

636

Pitch, coal tar, high-temp., heat-treated, if it contains > 0,005 % w/w
benzo[a]pyrene

121575-60-8

310-162-7

637

Dibenz[a,h]anthracene

53-70-3

200-181-8

638

Benz[a]anthracene

56-55-3

200-280-6

639

Benzo[e]pyrene

192-97-2

205-892-7

640

Benzo[j]fluoranthene205-82-3

205-910-3641

Benz(e)acephenanthrylene

205-99-2

205-911-9

642

Benzo(k)fluoranthene

207-08-9

205-916-6

643

Chrysene

218-01-9

205-923-4

644

2-Bromopropane

75-26-3

200-855-1

645

Trichloroethylene

79-01-6

201-167-4

646

1,2-Dibromo-3-chloropropane

96-12-8

202-479-3

22.12.2009

Official Journal of the European Union

EN

L 342/103

Substance identification

Referencen u mb er

Chem ical n ame /I NN

CAS n u mb er

E C n u mb er

a

b

c

d

647

2,3-Dibromopropan-1-ol

96-13-9

202-480-9

648

1,3-Dichloropropan-2-ol

96-23-1

202-491-9649

α,α,α-Trichlorotoluene

98-07-7

202-634-5

650

α-Chlorotoluene (Benzyl chloride)

100-44-7

202-853-6

651

1,2-Dibromoethane

106-93-4

203-444-5

652

Hexachlorobenzene

118-74-1

204-273-9

653

Bromoethylene (Vinyl bromide)593-60-2

209-800-6

654

1,4-Dichlorobut-2-ene

764-41-0

212-121-8

655

Methyloxirane (Propylene oxide)

75-56-9

200-879-2

656(Epoxyethyl)benzene (Styrene oxide)

96-09-3

202-476-7

657

1-Chloro-2,3-epoxypropane (Epichlorohydrin)

106-89-8

203-439-8

658

R-1-Chloro-2,3-epoxypropane

51594-55-9

424-280-2

659

1,2-Epoxy-3-phenoxypropane (Phenylglycidyl ether)122-60-1

204-557-2

660

2,3-Epoxypropan-1-ol (Glycidol)

556-52-5

209-128-3

661

R-2,3-Epoxy-1-propanol

57044-25-4

404-660-4

662

2,2′-Bioxirane (1,2:3,4-Diepoxybutane)1464-53-5

215-979-1

663(2RS,3RS)-3-(2-Chlorophenyl)-2-(4-fluorophenyl)-[1H-1,2,4-triazol-1-yl) 133855-98-8
methyl]oxirane; Epoxiconazole

406-850-2

664

Chloromethyl methyl ether

107-30-2

203-480-1

665

2-Methoxyethanol and its acetate (2-Methoxyethyl acetate)109-86-4/
110-49-6

203-713-7/
203-772-9

666

2-Ethoxyethanol and its acetate (2-Ethoxyethyl acetate)110-80-5/
111-15-9

203-804-1/
203-839-2

667

Oxybis[chloromethane], bis (Chloromethyl) ether

542-88-1

208-832-8

668

2-Methoxypropanol

1589-47-5

216-455-5

669

Propiolactone

57-57-8200-340-1

670

Dimethylcarbamoyl chloride

79-44-7

201-208-6

671

Urethane (Ethyl carbamate)

51-79-6

200-123-1

672

Moved or deleted

673

Moved or deleted

674

Methoxyacetic acid625-45-6

210-894-6

675

Dibutyl phthalate

84-74-2

201-557-4

676

bis(2-Methoxyethyl) ether (Dimethoxydiglycol)

111-96-6

203-924-4

677

bis(2-Ethylhexyl) phthalate (Diethylhexyl phthalate)

117-81-7

204-211-0

678

bis(2-Methoxyethyl) phthalate

117-82-8

204-212-6

679

2-Methoxypropyl acetate

70657-70-4

274-724-2

680

2-Ethylhexyl[[[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl]thio]acetate

80387-97-9

279-452-8

681

Acrylamide, unless regulated elsewhere in this Regulation

79-06-1

201-173-7

682

Acrylonitrile

107-13-1

203-466-5

683

2-Nitropropane

79-46-9201-209-1

L 342/104

Official Journal of the European Union

EN

22.12.2009

Substance identification

Referencen u mb er

Chem ical n ame /I NN

CAS n u mb er

E C n u mb er

a

b

c

d

684

Dinoseb, its salts and esters with the exception of those specified
elsewhere in this list

88-85-7

201-861-7

685

2-Nitroanisole

91-23-6

202-052-1

686

4-Nitrobiphenyl

92-93-3

202-204-7

687

2,4-Dinitrotoluene;121-14-2/
25321-14-6

204-450-0/
246-836-1

Dinitrotoluene, technical grade
688

Binapacryl

485-31-4

207-612-9

689

2-Nitronaphthalene581-89-5

209-474-5

690

2,3-Dinitrotoluene602-01-7

210-013-5

691

5-Nitroacenaphthene602-87-9

210-025-0

692

2,6-Dinitrotoluene606-20-2

210-106-0

693

3,4-Dinitrotoluene610-39-9

210-222-1

694

3,5-Dinitrotoluene618-85-9

210-566-2

695

2,5-Dinitrotoluene619-15-8

210-581-4

696

Dinoterb, its salts and esters

1420-07-1

215-813-8

697

Nitrofen

1836-75-5

217-406-0

698

Moved or deleted

699

Diazomethane334-88-3

206-382-7

700

1,4,5,8-Tetraaminoanthraquinone (Disperse Blue 1)

2475-45-8

219-603-7

701

Moved or deleted

702

1-Methyl-3-nitro-1-nitrosoguanidine

70-25-7

200-730-1

703

Moved or deleted

704

Moved or deleted

705

4,4′-Methylenedianiline

101-77-9

202-974-4

706

4,4′-(4-Iminocyclohexa-2,5-dienylidenemethylene) dianiline hydrochlo­ride

569-61-9

209-321-2

707

4,4′-Methylenedi-o-toluidine

838-88-0

212-658-8

708

o-Anisidine

90-04-0

201-963-1

709

3,3′-Dimethoxybenzidine (ortho-Dianisidine) and its salts

119-90-4

204-355-4

710

Moved or deleted

711

o-Dianisidine based azo dyes

712

3,3′-Dichlorobenzidine

91-94-1

202-109-0

713

Benzidine dihydrochloride

531-85-1

208-519-6

714[[1,1′-Biphenyl]-4,4′-diyl]diammonium sulphate

531-86-2

208-520-1

715

3,3′-Dichlorobenzidine dihydrochloride

612-83-9

210-323-0

716

Benzidine sulphate21136-70-9

244-236-4

717

Benzidine acetate

36341-27-2

252-984-8

718

3,3′-Dichlorobenzidine dihydrogen bis(sulphate)

64969-34-2

265-293-1

719

3,3′-Dichlorobenzidine sulphate

74332-73-3

277-822-3

720

Benzidine based azo dyes

721

4,4′-Bi-o-toluidine (ortho-Tolidine)

119-93-7

204-358-0

722

4,4′-Bi-o-toluidine dihydrochloride

612-82-8

210-322-5

723[3,3′-Dimethyl[1,1′-biphenyl]-4,4′-diyl]diammonium bis(hydrogensulphate)

64969-36-4

265-294-7

22.12.2009

Official Journal of the European Union

EN

L 342/105

Substance identification

Referencen u mb er

Chem ical n ame /I NN

CAS n u mb er

E C n u mb er

a

b

c

d

724

4,4′-Bi-o-toluidine sulphate74753-18-7

277-985-0725

o-Tolidine based dyes

726

Biphenyl-4-ylamine (4-Aminobiphenyl) and its salts

92-67-1

202-177-1

727

Azobenzene

103-33-3

203-102-5

728(Methyl-ONN-azoxy)methyl acetate592-62-1

209-765-7

729

Cycloheximide

66-81-9

200-636-0

730

2-Methylaziridine

75-55-8

200-878-7

731

Imidazolidine-2-thione (Ethylene thiourea)

96-45-7

202-506-9

732

Furan

110-00-9

203-727-3

733

Aziridine151-56-4

205-793-9

734

Captafol2425-06-1

219-363-3

735

Carbadox

6804-07-5

229-879-0

736

Flumioxazin

103361-09-7

613-166-00-X

737

Tridemorph

24602-86-6

246-347-3

738

Vinclozolin

50471-44-8

256-599-6

739

Fluazifop-butyl69806-50-4

274-125-6

740

Flusilazole

85509-19-9

014-017-00-6

741

1,3,5-Tris(oxiranylmethyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione(TGIC)

2451-62-9

219-514-3

742

Thioacetamide

62-55-5

200-541-4

743

Moved or deleted

744

Formamide75-12-7

200-842-0

745

N-Methylacetamide

79-16-3

201-182-6

746

N-Methylformamide

123-39-7

204-624-6

747

N,N-Dimethylacetamide

127-19-5

204-826-4

748

Hexamethylphosphoric-triamide

680-31-9

211-653-8

749

Diethyl sulphate

64-67-5

200-589-6

750

Dimethyl sulphate

77-78-1

201-058-1

751

1,3-Propanesultone

1120-71-4

214-317-9752

Dimethylsulphamoyl-chloride

13360-57-1

236-412-4

753

Sulfallate

95-06-7

202-388-9

754

A mixture of:
4-[[bis-(4-Fluorophenyl)methylsilyl]methyl]-4H-1,2,4-triazoleand 1-[[bis-(4-fluorophenyl)methylsilyl]methyl]-1H-1,2,4-triazole

755(+/–)-Tetrahydrofurfuryl–(R)-2-[4-(6-chloroquinoxalin-2-yloxy)phenyloxy]propionate

119738-06-6

607-373-00-4

756

6-Hydroxy-1-(3-Isopropoxypropyl)-4-methyl-2-oxo-5-[4-(phenylazo)
phenylazo]-1,2-dihydro-3-pyridinecarbonitrile

85136-74-9­

4 0-3400-3

757(6-(4-Hydroxy-3-(2-methoxyphenylazo)-2-sulfonato-7-naphthylamino)1,3,5-triazine-2,4-diyl)bis[(amino-1-methylethyl)ammonium] formate

108225-03-2

402-060-7758

Trisodium[4′-(8-acetylamino-3,6-disulfonato-2-naphthylazo)-4″-(6-benzoylamino3-Sulfonato-2-naphthylazo)-biphenyl-1,3′,3″,1‴-tetraolato-O,O′,O″,O‴]
copper(II)611-030-00-4

403-250-2

413-590-3

L 342/106

Official Journal of the European Union

EN

22.12.2009

Substance identification

Referencen u mb er

Chem ical n ame /I NN

CAS n u mb er

E C n u mb er

a

b

c

d

759

A mixture of:N-[3-Hydroxy-2-(2-methylacryloylaminomethoxy)propoxymethyl]2-methylacrylamide andN-[2,3-bis-(2-Methylacryloylaminomethoxy)propoxymethyl]2-methylacrylamide and methacrylamide
and 2-methyl-N-(2-methylacryloylaminomethoxymethyl)-acrylamide
and N-(2,3-dihydroxypropoxymethyl)-2-methylacrylamide

412-790-8760

1,3,5-tris-[(2Sand 2R)-2,3-Epoxypropyl]-1,3,5-triazine-2,4,6-(1H,3H,5H)-trione(Teroxirone)

59653-74-6

616-091-00-0761Erionite

12510-42-8

650-012-00-0

762

Asbestos

12001-28-4

650-013-00-6

763

Petroleum8002-05-9

232-298-5

764

Distillates (petroleum), heavy hydrocracked, if they contain > 3 % w/w
DMSO extract

64741-76-0

265-077-7

765

Distillates (petroleum), solvent-refined heavy paraffinic, if they contain> 3 % w/w DMSO extract

64741-88-4

265-090-8

766

Distillates (petroleum), solvent-refined light paraffinic, if they contain> 3 % w/w DMSO extract

64741-89-5

265-091-3

767

Residual oils (petroleum), solvent deasphalted, if they contain > 3 %w/w DMSO extract

64741-95-3

265-096-0

768

Distillates (petroleum), solvent-refined heavy naphthenic, if they
contain > 3 % w/w DMSO extract

64741-96-4

265-097-6

769

Distillates (petroleum), solvent-refined light naphthenic, if they contain> 3 % w/w DMSO extract

64741-97-5

265-098-1

770

Residual oils (petroleum), solvent-refined, if they contain > 3 % w/w
DMSO extract

64742-01-4

265-101-6

771

Distillates (petroleum), clay-treated heavy paraffinic, if they contain> 3 % w/w DMSO extract

64742-36-5

265-137-2

772

Distillates (petroleum), clay-treated light paraffinic, if they contain> 3 % w/w DMSO extract

64742-37-6

265-138-8

773

Residual oils (petroleum), clay-treated, if they contain > 3 % w/w
DMSO extract

64742-41-2

265-143-5

774

Distillates (petroleum), clay-treated heavy naphthenic, if they contain> 3 % w/w DMSO extract

64742-44-5

265-146-1

775

Distillates (petroleum), clay-treated light naphthenic, if they contain> 3 % w/w DMSO extract

64742-45-6

265-147-7

776

Distillates (petroleum), hydrotreated heavy naphthenic, if they contain> 3 % w/w DMSO extract

64742-52-5

265-155-0

777

Distillates (petroleum), hydrotreated light naphthenic, if they contain> 3 % w/w DMSO extract

64742-53-6

265-156-6

778

Distillates (petroleum), hydrotreated heavy paraffinic, if they contain> 3 % w/w DMSO extract

64742-54-7

265-157-1

779

Distillates (petroleum), hydrotreated light paraffinic, if they contain> 3 % w/w DMSO extract

64742-55-8

265-158-7

780

Distillates (petroleum), solvent-dewaxed light paraffinic, if they contain> 3 % w/w DMSO extract

64742-56-9

265-159-2

781

Residual oils (petroleum), hydrotreated, if they contain > 3 % w/w
DMSO extract

64742-57-0

265-160-8

782

Residual oils (petroleum), solvent-dewaxed, if they contain > 3 % w/w
DMSO extract

64742-62-7

265-166-0

22.12.2009

EN

Official Journal of the European Union

L 342/107

Substance identification

Referencen u mb er

Chem ical n ame /I NN

CAS n u mb er

E C n u mb er

a

b

c

d

783

Distillates (petroleum), solvent-dewaxed heavy naphthenic, if they
contain > 3 % w/w DMSO extract

64742-63-8

265-167-6

784

Distillates (petroleum), solvent-dewaxed light naphthenic, if they
contain > 3 % w/w DMSO extract

64742-64-9

265-168-1

785

Distillates (petroleum), solvent-dewaxed heavy paraffinic, if they
contain > 3 % w/w DMSO extract

64742-65-0

265-169-7

786

Foots oil (petroleum), if it contains > 3 % w/w DMSO extract

64742-67-2

265-171-8

787

Naphthenic oils (petroleum), catalytic dewaxed heavy, if they contain> 3 % w/w DMSO extract

64742-68-3

265-172-3

788

Naphthenic oils (petroleum), catalytic dewaxed light, if they contain> 3 % w/w DMSO extract

64742-69-4

265-173-9

789

Paraffin oils (petroleum), catalytic dewaxed heavy, if they contain> 3 % w/w DMSO extract

64742-70-7

265-174-4

790

Paraffin oils (petroleum), catalytic dewaxed light, if they contain > 3 %w/w DMSO extract

64742-71-8

265-176-5

791

Naphthenic oils (petroleum), complex dewaxed heavy, if they contain> 3 % w/w DMSO extract

64742-75-2

265-179-1

792

Naphthenic oils (petroleum), complex dewaxed light, if they contain> 3 % w/w DMSO extract

64742-76-3

265-180-7

793

Extracts (petroleum), heavy naphthenic distillate solvent, arom. Conc.,
if they contain > 3 % w/w DMSO extract

68783-00-6

272-175-3

794

Extracts (petroleum), solvent-refined heavy paraffinic distillate solvent,if they contain > 3 % w/w DMSO extract

68783-04-0

272-180-0795

Extracts (petroleum), heavy paraffinic distillates, solvent-deasphalted, if
they contain > 3 % w/w DMSO extract

68814-89-1

272-342-0

796

Lubricating oils (petroleum), C20-50, hydrotreated neutral oil-based,
high-viscosity, if they contain > 3 % w/w DMSO extract

72623-85-9

276-736-3

797

Lubricating oils (petroleum), C15-30, hydrotreated neutral oil-based, if
they contain > 3 % w/w DMSO extract

72623- 86-0

276-737-9

798

Lubricating oils (petroleum), C20-50, hydrotreated neutral oil-based, if
they contain > 3 % w/w DMSO extract

72623- 87-1

276-738-4

799

Lubricating oils, if they contain > 3 % w/w DMSO extract

74869-22-0

278-012-2

800

Distillates (petroleum), complex dewaxed heavy paraffinic, if they
contain > 3 % w/w DMSO extract

90640-91-8

292-613-7

801

Distillates (petroleum), complex dewaxed light paraffinic, if they
contain > 3 % w/w DMSO extract

90640-92-9

292-614-2

802

Distillates (petroleum), solvent dewaxed heavy paraffinic, clay-treated,
if they contain > 3 % w/w DMSO extract

90640-94-1

292-616-3

803

Hydrocarbons, C20-50, solvent dewaxed heavy paraffinic, hydrotreated,
if they contain > 3 % w/w DMSO extract

90640-95-2

292-617-9804

Distillates (petroleum), solvent dewaxed light paraffinic, clay-treated, if
they contain > 3 % w/w DMSO extract

90640-96-3

292-618-4

805

Distillates (petroleum), solvent dewaxed light paraffinic, hydrotreated,
if they contain > 3 % w/w DMSO extract

90640-97-4

292-620-5806

Extracts (petroleum), heavy naphthenic distillate solvent, hydrotreated,
if they contain > 3 % w/w DMSO extract

90641-07-9

292-631-5

L 342/108

EN

Official Journal of the European Union

22.12.2009

Substance identification

Referencen u mb er

Chem ical n ame /I NN

CAS n u mb er

E C n u mb er

a

b

c

d

807

Extracts (petroleum), heavy paraffinic distillate solvent, hydrotreated, if
they contain > 3 % w/w DMSO extract

90641-08-0

292-632-0

808

Extracts (petroleum), light paraffinic distillate solvent, hydrotreated, if
they contain > 3 % w/w DMSO extract

90641-09-1

292-633-6

809

Residual oils (petroleum), hydrotreated solvent dewaxed, if they
contain > 3 % w/w DMSO extract90669-74-2

292-656-1

810

Residual oils (petroleum), catalytic dewaxed, if they contain > 3 % w/w
DMSO extract

91770-57-9

294-843-3

811

Distillates (petroleum), dewaxed heavy paraffinic, hydrotreated, if they
contain > 3 % w/w DMSO extract

91995-39-0

295-300-3

812

Distillates (petroleum), dewaxed light paraffinic, hydrotreated, if they
contain > 3 % w/w DMSO extract

91995-40-3

295-301-9

813

Distillates (petroleum), hydrocracked solvent-refined, dewaxed, if they
contain > 3 % w/w DMSO extract

91995-45-8

295-306-6

814

Distillates (petroleum), solvent-refined light naphthenic, hydrotreated,
if they contain > 3 % w/w DMSO extract

91995-54-9

295-316-0

815

Extracts (petroleum), hydrotreated light paraffinic distillate solvent, if
they contain > 3 % w/w DMSO extract

91995- 73-2

295-335-4

816

Extracts (petroleum), light naphthenic distillate solvent,hydrodesulfurised, if they contain > 3 % w/w DMSO extract

91995-75-4

295-338-0

817

Extracts (petroleum), light paraffinic distillate solvent, acid-treated, if
they contain > 3 % w/w DMSO extract

91995-76-5

295-339-6

818

Extracts (petroleum), light paraffinic distillate solvent,hydrodesulfurised, if they contain > 3 % w/w DMSO extract

91995-77-6

295-340-1

819

Extracts (petroleum), light vacuum gas oil solvent, hydrotreated, if they
contain > 3 % w/w DMSO extract

91995-79-8

295-342-2

820

Foots oil (petroleum), hydrotreated, if it contains > 3 % w/w DMSO
extract

92045-12-0

295-394-6

821

Lubricating oils (petroleum), C17-35, solvent-extd., dewaxed,hydrotreated, if they contain > 3 % w/w DMSO extract

92045-42-6

295-423-2

822

Lubricating oils (petroleum), hydrocracked nonarom
solvent-deparaffined, if they contain > 3 % w/w DMSO extract

92045-43-7

295-424-8

823

Residual oils (petroleum), hydrocracked acid-treated solvent-dewaxed,
if they contain > 3 % w/w DMSO extract

92061-86-4

295-499-7

824

Paraffin oils (petroleum), solvent-refined dewaxed heavy, if they
contain > 3 % w/w DMSO extract

92129-09-4

295-810-6

825

Extracts (petroleum), heavy paraffinic distillate solvent, clay-treated, if
they contain > 3 % w/w DMSO extract

92704-08-0

296-437-1

826

Lubricating oils (petroleum), base oils, paraffinic, if they contain > 3 %w/w DMSO extract

93572-43-1

297-474-6

827

Extracts (petroleum), heavy naphthenic distillate solvent,hydrodesulfurised, if they contain > 3 % w/w DMSO extract

93763-10-1

297-827-4

828

Extracts (petroleum), solvent-dewaxed heavy paraffinic distillate
solvent, hydrodesulfurised, if they contain > 3 % w/w DMSO extract

93763-11-2

297-829-5

22.12.2009

EN

Official Journal of the European Union

L 342/109

Substance identification

Referencen u mb er

Chem ical n ame /I NN

CAS n u mb er

E C n u mb er

a

b

c

d

829

Hydrocarbons, hydrocracked paraffinic distn. residues,
solvent-dewaxed, if they contain > 3 % w/w DMSO extract

93763-38-3

297-857-8

830

Foots oil (petroleum), acid-treated, if it contains > 3 % w/w DMSO
extract

93924-31-3

300-225-7

831

Foots oil (petroleum), clay-treated, if it contains > 3 % w/w DMSO
extract

93924-32-4

300-226-2

832

Hydrocarbons, C20-50, residual oil hydrogenation vacuum distillate, ifthey contain > 3 % w/w DMSO extract

93924-61-9

300-257-1

833

Distillates (petroleum), solvent-refined hydrotreated heavy,hydrogenated, if they contain > 3 % w/w DMSO extract

94733-08-1

305-588-5

834

Distillates (petroleum), solvent-refined hydrocracked light, if they
contain > 3 % w/w DMSO extract

94733-09-2

305-589-0

835

Lubricating oils (petroleum), C18-40, solvent-dewaxed hydrocracked
distillate-based, if they contain > 3 % w/w DMSO extract

94733-15-0

305-594-8

836

Lubricating oils (petroleum), C18-40, solvent-dewaxed hydrogenatedraffinate-based, if they contain > 3 % w/w DMSO extract

94733-16-1

305-595-3

837

Hydrocarbons, C13-30, arom. -rich, solvent-extd. naphthenic distillate,
if they contain > 3 % w/w DMSO extract

95371-04-3

305-971-7

838

Hydrocarbons, C16-32, arom. rich, solvent-extd. naphthenic distillate, ifthey contain > 3 % w/w DMSO extract

95371-05-4

305-972-2

839

Hydrocarbons, C37-68, dewaxed deasphalted hydrotreated vacuum
distn. Residues, if they contain > 3 % w/w DMSO extract

95371-07-6

305-974-3

840

Hydrocarbons, C37-65, hydrotreated deasphalted vacuum distn.
Residues, if they contain > 3 % w/w DMSO extract

95371-08-7

305-975-9

841

Distillates (petroleum), hydrocracked solvent-refined light, if they
contain > 3 % w/w DMSO extract

97488-73-8

307-010-7

842

Distillates (petroleum), solvent-refined hydrogenated heavy, if they
contain > 3 % w/w DMSO extract

97488-74-9

307-011-2

843

Lubricating oils (petroleum), C18-27, hydrocracked solvent-dewaxed, if
they contain > 3 % w/w DMSO extract

97488-95-4

307-034-8

844

Hydrocarbons, C17-30, hydrotreated solvent-deasphalted atm. distn.
residue, distn. lights, if they contain > 3 % w/w DMSO extract

97675-87-1

307-661-7

845

Hydrocarbons, C17-40, hydrotreated solvent-deasphalted distn. residue,
vacuum distn. lights, if they contain > 3 % w/w DMSO extract

97722-06-0

307-755-8

846

Hydrocarbons, C13-27, solvent-extd. light naphthenic, if they contain> 3 % w/w DMSO extract

97722-09-3

307-758-4

847

Hydrocarbons, C14-29, solvent-extd. light naphthenic, if they contain> 3 % w/w DMSO extract

97722-10-6

307-760-5

848

Foots oil (petroleum), carbon-treated, if it contains > 3 % w/w DMSO
extract

97862-76-5

308-126-0

849

Foots oil (petroleum), silicic acid-treated, if it contains > 3 % w/w
DMSO extract

97862-77-6

308-127-6

L 342/110

EN

Official Journal of the European Union

22.12.2009

Substance identification

Referencen u mb er

Chem ical n ame /I NN

CAS n u mb er

E C n u mb er

a

b

c

d

850

Hydrocarbons, C27-42, dearomatised, if they contain > 3 % w/w DMSO
extract

97862-81-2

308-131-8

851

Hydrocarbons, C17-30, hydrotreated distillates, distn. Lights, if they
contain > 3 % w/w DMSO extract

97862-82-3

308-132-3

852

Hydrocarbons, C27-45, naphthenic vacuum distn., if they contain > 3 %w/w DMSO extract

97862-83-4

308-133-9853

Hydrocarbons, C27-45, dearomatised, if they contain > 3 % w/w DMSO
extract

97926-68-6

308-287-7

854

Hydrocarbons, C20-58, hydrotreated, if they contain > 3 % w/w DMSO
extract

97926-70-0

308-289-8

855

Hydrocarbons, C27-42, naphthenic, if they contain > 3 % w/w DMSO
extract

97926-71-1

308-290-3

856

Extracts (petroleum), light paraffinic distillate solvent, carbon-treated, if
they contain > 3 % w/w DMSO extract

100684-02-4

309-672-2

857

Extracts (petroleum), light paraffinic distillate solvent, clay-treated, if
they contain > 3 % w/w DMSO extract

100684- 03-5

309-673-8

858

Extracts (petroleum), light vacuum, gas oil solvent, carbon-treated, if
they contain > 3 % w/w DMSO extract

100684-04-6

309-674-3

859

Extracts (petroleum), light vacuum gas oil solvent, clay-treated, if they
contain > 3 % w/w DMSO extract

100684-05-7

309-675-9

860

Residual oils (petroleum), carbon-treated solvent-dewaxed, if they
contain > 3 % w/w DMSO extract

100684-37-5

309-710-8

861

Residual oils (petroleum), clay-treated solvent-dewaxed, if they contain> 3 % w/w DMSO extract

100684-38-6

309-711-3

862

Lubricating oils (petroleum), C>25, solvent-extd., deasphalted, dewaxed,hydrogenated, if they contain > 3 % w/w DMSO extract

101316-69-2

309-874-0

863

Lubricating oils (petroleum), C17-32, solvent-extd., dewaxed,hydrogenated, if they contain > 3 % w/w DMSO extract

101316-70-5

309-875-6

864

Lubricating oils (petroleum), C20-35, solvent-extd., dewaxed,hydrogenated, if they contain > 3 % w/w DMSO extract

101316-71-6

309-876-1

865

Lubricating oils (petroleum), C24-50, solvent-extd., dewaxed,hydrogenated, if they contain > 3 % w/w DMSO extract

101316-72-7

309-877-7

866

Distillates (petroleum), sweetened middle, except if the full refining
history is known and it can be shown that the substance from which
it is produced is not a carcinogen

64741-86-2

265-088-7

867

Gas oils (petroleum), solvent-refined, except if the full refining history
is known and it can be shown that the substance from which it isproduced is not a carcinogen

64741-90-8

265-092-9

868

Distillates (petroleum), solvent-refined middle, except if the fullrefining history is known and it can be shown that the substance fromwhich it is produced is not a carcinogen

64741-91-9

265-093-4

869

Gas oils (petroleum), acid-treated, except if the full refining history is
known and it can be shown that the substance from which it isproduced is not a carcinogen

64742-12-7

265-112-6

870

Distillates (petroleum), acid-treated middle, except if the full refining
history is known and it can be shown that the substance from which
it is produced is not a carcinogen

64742-13-8

265-113-1

871

Distillates (petroleum), acid-treated light, except if the full refining
history is known and it can be shown that the substance from which
it is produced is not a carcinogen

64742-14-9

265-114-7

22.12.2009

EN

Official Journal of the European Union

L 342/111

Substance identification

Referencen u mb er

Chem ical n ame /I NN

CAS n u mb er

E C n u mb er

a

b

c

d

872

Gas oils (petroleum), chemically neutralised, except if the full refining
history is known and it can be shown that the substance from which
it is produced is not a carcinogen

64742-29-6

265-129-9

873

Distillates (petroleum), chemically neutralised middle, except if the fullrefining history is known and it can be shown that the substance fromwhich it is produced is not a carcinogen

64742-30-9

265-130-4

874

Distillates (petroleum), clay-treated middle, except if the full refining
history is known and it can be shown that the substance from which
it is produced is not a carcinogen

64742-38-7

265-139-3

875

Distillates (petroleum), hydrotreated middle, except if the full refining
history is known and it can be shown that the substance from which
it is produced is not a carcinogen

64742-46-7

265-148-2

876

Gas oils (petroleum), hydrodesulfurised, except if the full refining
history is known and it can be shown that the substance from which
it is produced is not a carcinogen

64742-79-6

265-182-8

877

Distillates (petroleum), hydrodesulfurised middle, except if the fullrefining history is known and it can be shown that the substance fromwhich it is produced is not a carcinogen

64742-80-9

265-183-3

878

Distillates (petroleum), catalytic reformer fractionator residue,
high-boiling, except if the full refining history is known and it can beshown that the substance from which it is produced is not a
carcinogen

68477-29-2

270-719-4

879

Distillates (petroleum), catalytic reformer fractionator residue,
intermediate-boiling, except if the full refining history is known and it
can be shown that the substance from which it is produced is not a
carcinogen

68477-30-5

270-721-5

880

Distillates (petroleum), catalytic reformer fractionator residue,
low-boiling, except if the full refining history is known and it can beshown that the substance from which it is produced is not a
carcinogen

68477-31-6

270-722-0

881

Alkanes, C12-26, branched and linear, except if the full refining history
is known and it can be shown that the substance from which it isproduced is not a carcinogen

90622-53-0

292-454-3

882

Distillates (petroleum), highly refined middle, except if the full refining
history is known and it can be shown that the substance from which
it is produced is not a carcinogen

90640-93-0

292-615-8

883

Distillates (petroleum), catalytic reformer, heavy arom. conc., except if
the full refining history is known and it can be shown that thesubstance from which it is produced is not a carcinogen91995-34-5

295-294-2

884

Gas oils, paraffinic, except if the full refining history is known and it
can be shown that the substance from which it is produced is not a
carcinogen

93924-33-5

300-227-8

885

Naphtha (petroleum), solvent-refined hydrodesulfurised heavy, except
if the full refining history is known and it can be shown that thesubstance from which it is produced is not a carcinogen

97488-96-5

307-035-3

886

Hydrocarbons, C16-20, hydrotreated middle distillate, distn. Lights,
except if the full refining history is known and it can be shown thatthe substance from which it is produced is not a carcinogen

97675- 85-9

307-659-6

887

Hydrocarbons, C12-20, hydrotreated paraffinic, distn. lights, except if
the full refining history is known and it can be shown that thesubstance from which it is produced is not a carcinogen

97675-86-0

307-660-1

888

Hydrocarbons, C11-17, solvent-extd. light naphthenic, except if the fullrefining history is known and it can be shown that the substance fromwhich it is produced is not a carcinogen

97722-08-2

307-757-9

L 342/112

EN

Official Journal of the European Union

22.12.2009

Substance identification

Referencen u mb er

Chem ical n ame /I NN

CAS n u mb er

E C n u mb er

a

b

c

d

889

Gas oils, hydrotreated, except if the full refining history is known andit can be shown that the substance from which it is produced is not a
carcinogen97862-78-7

308-128-1

890

Distillates (petroleum), carbon-treated light paraffinic, except if the fullrefining history is known and it can be shown that the substance fromwhich it is produced is not a carcinogen

100683-97-4

309-667-5

891

Distillates (petroleum), intermediate paraffinic, carbon-treated, except if
the full refining history is known and it can be shown that thesubstance from which it is produced is not a carcinogen

100683-98-5

309-668-0

892

Distillates (petroleum), intermediate paraffinic, clay-treated, except if
the full refining history is known and it can be shown that thesubstance from which it is produced is not a carcinogen

100683-99-6

309-669-6

893

Lubricating greases, except if the full refining history is known and it
can be shown that the substance from which it is produced is not a
carcinogen74869-21-9

278-011-7

894

Slack wax (petroleum), except if the full refining history is known andit can be shown that the substance from which it is produced is not a
carcinogen

64742-61-6

265-165-5

895

Slack wax (petroleum), acid-treated, except if the full refining history is
known and it can be shown that the substance from which it isproduced is not a carcinogen90669-77-5

292-659-8

896

Slack wax (petroleum), clay-treated, except if the full refining history is
known and it can be shown that the substance from which it isproduced is not a carcinogen90669-78-6

292-660-3

897

Slack wax (petroleum), hydrotreated, except if the full refining history
is known and it can be shown that the substance from which it isproduced is not a carcinogen

92062-09-4

295-523-6

898

Slack wax (petroleum), low-melting, except if the full refining history
is known and it can be shown that the substance from which it isproduced is not a carcinogen

92062-10-7

295-524-1

899

Slack wax (petroleum), low-melting, hydrotreated, except if the fullrefining history is known and it can be shown that the substance fromwhich it is produced is not a carcinogen

92062-11-8

295-525-7

900

Slack wax (petroleum), low-melting, carbon-treated, except if the fullrefining history is known and it can be shown that the substance fromwhich it is produced is not a carcinogen97863-04-2

308-155-9

901

Slack wax (petroleum), low-melting, clay-treated, except if the fullrefining history is known and it can be shown that the substance fromwhich it is produced is not a carcinogen97863-05-3

308-156-4

902

Slack wax (petroleum), low-melting, silicic acid-treated, except if thefull refining history is known and it can be shown that the substancefrom which it is produced is not a carcinogen97863-06-4

308-158-5

903

Slack wax (petroleum), carbon-treated, except if the full refining
history is known and it can be shown that the substance from which
it is produced is not a carcinogen

100684-49-9

309-723-9

904

Petrolatum, except if the full refining history is known and it can beshown that the substance from which it is produced is not a
carcinogen8009-03-8

232-373-2

905

Petrolatum (petroleum), oxidised, except if the full refining history is
known and it can be shown that the substance from which it isproduced is not a carcinogen64743-01-7

265-206-7

906

Petrolatum (petroleum), alumina-treated, except if the full refining
history is known and it can be shown that the substance from which
it is produced is not a carcinogen

85029-74-9

285-098-5

22.12.2009

EN

Official Journal of the European Union

L 342/113

Substance identification

Referencen u mb er

Chem ical n ame /I NN

CAS n u mb er

E C n u mb er

a

b

c

d

907

Petrolatum (petroleum), hydrotreated, except if the full refining history
is known and it can be shown that the substance from which it isproduced is not a carcinogen

92045-77-7

295-459-9

908

Petrolatum (petroleum), carbon-treated, except if the full refining
history is known and it can be shown that the substance from which
it is produced is not a carcinogen97862-97-0

308-149-6

909

Petrolatum (petroleum), silicic acid-treated, except if the full refining
history is known and it can be shown that the substance from which
it is produced is not a carcinogen97862-98-1

308-150-1

910

Petrolatum (petroleum), clay-treated, except if the full refining history
is known and it can be shown that the substance from which it isproduced is not a carcinogen

100684-33-1

309-706-6

911

Distillates (petroleum), light catalytic cracked

64741-59-9

265-060-4

912

Distillates (petroleum), intermediate catalytic cracked

64741-60-2

265-062-5

913

Distillates (petroleum), light thermal cracked

64741-82-8

265-084-5

914

Distillates (petroleum), hydrodesulfurised light catalytic cracked

68333-25-5

269-781-5

915

Distillates (petroleum), light steam-cracked naphtha

68475-80-9

270-662-5

916

Distillates (petroleum), cracked steam-cracked petroleum distillates

68477-38-3

270-727-8917

Gas oils (petroleum), steam-cracked

68527-18-4

271-260-2

918

Distillates (petroleum), hydrodesulfurised thermal cracked middle

85116-53-6

285-505-6

919

Gas oils (petroleum), thermal-cracked, hydrodesulfurised

92045-29-9

295-411-7

920

Residues (petroleum), hydrogenated steam-cracked naphtha

92062-00-5

295-514-7

921

Residues (petroleum), steam-cracked naphtha distn.

92062-04-9

295-517-3

922

Distillates (petroleum), light catalytic cracked, thermally degraded

92201-60-0

295-991-1

923

Residues (petroleum), steam-cracked heat-soaked naphtha

93763-85-0

297-905-8

924

Gas oils (petroleum), light vacuum, thermal-cracked hydrodesulfurised97926-59-5

308-278-8

925

Distillates (petroleum), hydrodesulfurised middle coker

101316-59-0

309-865-1

926

Distillates (petroleum), heavy steam-cracked

101631-14-5

309-939-3

927

Residues (petroleum), atm. Tower

64741-45-3

265-045-2

928

Gas oils (petroleum), heavy vacuum

64741-57-7

265-058-3

929

Distillates (petroleum), heavy catalytic cracked

64741-61-3

265-063-0

930

Clarified oils (petroleum), catalytic cracked

64741-62-4

265-064-6

931

Residues (petroleum), catalytic reformer fractionator

64741-67-9

265-069-3

932

Residues (petroleum), hydrocracked

64741-75-9

265-076-1

933

Residues (petroleum), thermal cracked

64741-80-6

265-081-9

934

Distillates (petroleum), heavy thermal cracked

64741-81-7

265-082-4

935

Gas oils (petroleum), hydrotreated vacuum

64742-59-2

265-162-9

936

Residues (petroleum), hydrodesulfurised atmospheric tower

64742-78-5

265-181-2

937

Gas oils (petroleum), hydrodesulfurised heavy vacuum

64742-86-5

265-189-6

938

Residues (petroleum), steam-cracked

64742-90-1

265-193-8

939

Residues (petroleum), atmospheric

68333-22-2

269-777-3

940

Clarified oils (petroleum), hydrodesulfurised catalytic cracked

68333-26-6

269-782-0

941

Distillates (petroleum), hydrodesulfurised intermediate catalytic cracked

68333-27-7

269-783-6

942

Distillates (petroleum), hydrodesulfurised heavy catalytic cracked

68333-28-8

269-784-1

L 342/114

Official Journal of the European Union

EN

22.12.2009

Substance identification

Referencen u mb er

Chem ical n ame /I NN

CAS n u mb er

E C n u mb er

a

b

c

d

943

Fuel oil, residues-straight-run gas oils, high-sulfur

68476-32-4

270-674-0

944

Fuel oil, residual

68476-33-5

270-675-6

945

Residues (petroleum), catalytic reformer fractionator residue distn.

68478-13-7

270-792-2

946

Residues (petroleum), heavy coker gas oil and vacuum gas oil

68478-17-1

270-796-4

947

Residues (petroleum), heavy coker and light vacuum

68512-61-8

270-983-0

948

Residues (petroleum), light vacuum

68512-62-9

270-984-6

949

Residues (petroleum), steam-cracked light

68513-69-9

271-013-9

950

Fuel oil, No 668553-00-4

271-384-7

951

Residues (petroleum), topping plant, low-sulfur

68607-30-7

271-763-7

952

Gas oils (petroleum), heavy atmospheric

68783-08-4

272-184-2

953

Residues (petroleum), coker scrubber, condensed-ring-arom. -contg

68783-13-1

272-187-9

954

Distillates (petroleum), petroleum residues vacuum

68955-27-1

273-263-4

955

Residues (petroleum), steam-cracked, resinous

68955-36-2

273-272-3

956

Distillates (petroleum), intermediate vacuum

70592-76-6

274-683-0

957

Distillates (petroleum), light vacuum

70592-77-7

274-684-6

958

Distillates (petroleum), vacuum

70592-78-8

274-685-1

959

Gas oils (petroleum), hydrodesulfurised coker heavy vacuum

85117-03-9

285-555-9

960

Residues (petroleum), steam-cracked, distillates

90669-75-3

292-657-7

961

Residues (petroleum), vacuum, light90669-76-4

292-658-2

962

Fuel oil, heavy, high-sulfur

92045-14-2

295-396-7

963

Residues (petroleum), catalytic cracking

92061-97-7

295-511-0964

Distillates (petroleum), intermediate catalytic cracked, thermallydegraded

92201-59-7

295-990-6

965

Residual oils (petroleum)

93821-66-0

298-754-0

966

Residues, steam cracked, thermally treated98219-64-8

308-733-0

967

Distillates (petroleum), hydrodesulfurised full-range middle

101316-57-8

309-863-0

968

Distillates (petroleum), light paraffinic

64741-50-0

265-051-5

969

Distillates (petroleum), heavy paraffinic

64741-51-1

265-052-0970

Distillates (petroleum), light naphthenic

64741-52-2

265-053-6

971

Distillates (petroleum), heavy naphthenic

64741-53-3

265-054-1

972

Distillates (petroleum), acid-treated heavy naphthenic

64742-18-3

265-117-3

973

Distillates (petroleum), acid-treated light naphthenic

64742-19-4

265-118-9974

Distillates (petroleum), acid-treated heavy paraffinic

64742-20-7

265-119-4

975

Distillates (petroleum), acid-treated light paraffinic

64742-21-8

265-121-5

976

Distillates (petroleum), chemically neutralised heavy paraffinic

64742-27-4

265-127-8

977

Distillates (petroleum), chemically neutralised light paraffinic

64742-28-5

265-128-3

978Distillates (petroleum), chemically neutralised heavy naphthenic

64742-34-3

265-135-1

979

Distillates (petroleum), chemically neutralised light naphthenic

64742-35-4

265-136-7

980

Extracts (petroleum), light naphthenic distillate solvent

64742-03-6

265-102-1

981

Extracts (petroleum), heavy paraffinic distillate solvent

64742-04-7

265-103-7

22.12.2009

Official Journal of the European Union

EN

L 342/115

Substance identification

Referencen u mb er

Chemi cal n ame /I NN

CAS n u mb er

E C n u mb er

a

b

c

d

982

Extracts (petroleum), light paraffinic distillate solvent

64742-05-8

265-104-2

983

Extracts (petroleum), heavy naphthenic distillate solvent

64742-11-6

265-111-0

984

Extracts (petroleum), light vacuum gas oil solvent

91995-78-7

295-341-7

985

Hydrocarbons, C26-55, arom. rich97722-04-8

307-753-7

986

Disodium3,3′-[[1,1′-biphenyl]-4,4′-diylbis(azo)]bis(4-aminonaphthalene1-sulphonate)573-58-0

209-358-4

987

Disodium 4-amino-3-[[4′-[(2,4-diaminophenyl)azo][1,1′-biphenyl]-4-yl]azo]-5-hydroxy-6-(phenylazo)naphthalene2,7-disulphonate

1937-37-7

217-710-3

988

Tetrasodium 3,3′-[[1,1′-biphenyl]-4,4′-diylbis(azo)]bis[5-amino4-hydroxynaphthalene-2,7-disulphonate]2602-46-2

220-012-1

989

4-o-Tolylazo-o-toluidine

97-56-3

202-591-2

990

4-Aminoazobenzene

60-09-3

200-453-6

991

Disodium[5-[[4′-[[2,6-dihydroxy-3-[(2-hydroxy-5-sulphophenyl)azo]phenyl]azo][1,1′-biphenyl]-4-yl]azo]salicylato(4-)]cuprate(2-)

16071-86-6

240-221-1

992

Resorcinol diglycidyl ether

101-90-6

202-987-5

993

1,3-Diphenylguanidine

102-06-7

203-002-1

994

Heptachlor-epoxide1024-57-3

213-831-0

995

4-Nitrosophenol

104-91-6

203-251-6

996

Carbendazim

10605-21-7

234-232-0997

Allyl glycidyl ether

106-92-3

203-442-4

998

Chloroacetaldehyde

107-20-0

203-472-8

999

Hexane110-54-3

203-777-61000

2-(2-Methoxyethoxy)ethanol (Diethylene glycol monomethyl ether;
DEGME)

111-77-3

203-906-6

1001(+/–)-2-(2,4-Dichlorophenyl)-3-(1H-1,2,4-triazol-1-yl)propyl-1,1,2,
2-tetrafluoroethylether (Tetraconazole - ISO)112281-77-3

407-760-6

1002

4-[4-(1,3-Dihydroxyprop-2-yl)phenylamino]-1,8-dihydroxy5-nitroanthraquinone

114565-66-1

406-057-1

1003

5,6,12,13-Tetrachloroanthra(2,1,9-def:6,5,10-d’e’f’)diisoquinoline-1,3,
8,10(2H,9H)-tetrone

115662-06-1

405-100-1

1004

tris(2-Chloroethyl) phosphate

115-96-8

204-118-5

1005

4′-Ethoxy-2-benzimidazoleanilide

120187-29-3

407-600-5

1006

Nickel dihydroxide

12054-48-7

235-008-5

1007

N,N-Dimethylaniline

121-69-7

204-493-5

1008

Simazine

122-34-9

204-535-2

1009

bis(Cyclopentadienyl)-bis(2,6-difluoro-3-(pyrrol-1-yl)-phenyl)titanium

125051-32-3

412-000-1

1010

N,N,N′,N′-Tetraglycidyl-4,4′-diamino-3,3′-diethyldiphenylmethane

130728-76-6

410-060-3

1011

Divanadium pentaoxide

1314-62-1

215-239-8

1012

Pentachlorophenol and its alkali salts

87-86-5/
131-52-2/
7778-73-6

201-778-6/
205-025-2/
231-911-3

L 342/116

Official Journal of the European Union

EN

22.12.2009

Substance identification

Referencen u mb er

Chem ical n ame /I NN

CAS n u mb er

E C n u mb er

a

b

c

d

1013

Phosphamidon

13171-21-6

236-116-5

1014

N-(Trichloromethylthio)phthalimide (Folpet - ISO)

133-07-3

205-088-6

1015

N-2-Naphthylaniline

135-88-6

205-223-9

1016

Ziram

137-30-4

205-288-3

1017

1-Bromo-3,4,5-trifluorobenzene

138526-69-9

418-480-9

1018

Propazine

139-40-2

205-359-9

1019

3-(4-Chlorophenyl)-1,1-dimethyluronium trichloroacetate;monuron-TCA

140-41-0

006-043-00-1

1020

Isoxaflutole

141112-29-0

606-054-00-7

1021

Kresoxim-methyl

143390-89-0

607-310-00-0

1022

Chlordecone143-50-0

205-601-3

1023

9-Vinylcarbazole1484-13-5

216-055-0

1024

2-Ethylhexanoic acid149-57-5

205-743-6

1025

Monuron150-68-5

205-766-1

1026

Morpholine-4-carbonyl chloride

15159-40-7

239-213-0

1027

Daminozide

1596-84-5

216-485-9

1028

Alachlor (ISO)15972-60-8

240-110-8

1029

UVCB condensation product of: tetrakis-hydroxymethylphosphonium
chloride, urea and distilled hydrogenated C16-18 tallow alkylamine

166242-53-1

422-720-8

1030

Ioxynil and Ioxynil octanoate (ISO)1689-83-4/
3861-47-0

216-881-1/
223-375-4

1031

Bromoxynil (ISO) (3,5-Dibromo-4-hydroxybenzonitrile) andBromoxynil heptanoate (ISO)1689-84-5/
56634-95-8

216-882-7/
260-300-4

1032

2,6-Dibromo-4-cyanophenyl octanoate

1689-99-2

216-885-3

1033

Moved or deleted

1034

5-Chloro-1,3-dihydro-2H-indol-2-one

17630-75-0

412-200-91035

Benomyl

17804-35-2

241-775-7

1036

Chlorothalonil

1897-45-6

217-588-1

1037

N′-(4-Chloro-o-tolyl)-N,N-dimethylformamidine monohydrochloride

19750-95-9

243-269-1

1038

4,4′-Methylenebis(2-ethylaniline)

19900-65-3

243-420-1

1039

Valinamide

20108-78-5

402-840-7

1040[(p-Tolyloxy)methyl]oxirane

2186-24-5

218-574-8

1041[(m-Tolyloxy)methyl]oxirane

2186-25-6

218-575-3

1042

2,3-Epoxypropyl o-tolyl ether

2210-79-9

218-645-3

1043[(Tolyloxy)methyl]oxirane, cresyl glycidyl ether

26447-14-3

247-711-4

1044

Di-allate2303-16-4

218-961-1

1045

Benzyl 2,4-dibromobutanoate

23085-60-1

420-710-8

1046

Trifluoroiodomethane2314-97-8

219-014-5

1047

Thiophanate-methyl

23564-05-8

245-740-7

2,6

3,9 5,81048

Dodecachloropentacyclo[5.2.1.0 .0 0 ]decane (Mirex)

2385-85-5

219-196-6

1049

Propyzamide

23950-58-5

245-951-4

1050

Butyl glycidyl ether

2426-08-6

219-376-4

1051

2,3,4-Trichlorobut-1-ene

2431-50-7

219-397-9

22.12.2009

Official Journal of the European Union

EN

L 342/117

Substance identification

Referencen u mb er

Chem ical n ame /I NN

CAS n u mb er

E C n u mb er

a

b

c

d

1052

Chinomethionate

2439-01-2

219-455-3

1053(R)-α-Phenylethylammonium (-)-(1R,2S)-(1,2-epoxypropyl)phosphonate
monohydrate

25383-07-7

418-570-8

1054

5-Ethoxy-3-trichloromethyl-1,2,4-thiadiazole (Etridiazole - ISO)2593-15-9

219-991-8

1055

Disperse Yellow 32832-40-8

220-600-81056

1,2,4-Triazole

288-88-0

206-022-9

1057

Aldrin (ISO)309-00-2

206-215-8

1058

Diuron (ISO)330-54-1

206-354-4

1059

Linuron (ISO)330-55-2

206-356-5

1060

Nickel carbonate

3333-67-3

222-068-2

1061

3-(4-Isopropylphenyl)-1,1-dimethylurea (Isoproturon - ISO)

34123-59-6

251-835-4

1062

Iprodione

36734-19-7

253-178-9

1063

Moved or deleted1064

5-(2,4-Dioxo-1,2,3,4-tetrahydropyrimidine)-3-fluoro2-hydroxymethyltetrahydrofuran

41107-56-6

415-360-8

1065

Crotonaldehyde

4170-30-3

224-030-0

1066

Hexahydrocyclopenta(c)pyrrole-1-(1H)-ammonium
N-ethoxycarbonyl-N-(p-tolylsulfonyl)azanide

1067

4,4′-Carbonimidoylbis[N,N-dimethylaniline] and its salts

492-80-8

207-762-5

1068

DNOC (ISO)534-52-1

208-601-1

1069

Toluidinium chloride

540-23-8

208-740-8

1070

Toluidine sulphate (1:1)

540-25-0

208-741-3

1071

2-(4-tert.-Butylphenyl)ethanol

5406-86-0

410-020-5

1072

Fenthion

55-38-9200-231-9

1073

Chlordane, pur

57-74-9200-349-0

1074

Hexan-2-one (Methyl butyl ketone)

591-78-6

209-731-1

1075

Fenarimol

60168-88-9

262-095-7

1076

Acetamide60-35-5

200-473-5

1077

N-Cyclohexyl-N-methoxy-2,5-dimethyl-3-furamide (Furmecyclox ISO)60568-05-0

262-302-0

1078

Dieldrin

60-57-1

200-484-5

1079

4,4′-Isobutylethylidenediphenol

6807-17-6

401-720-1

1080

Chlordimeform

6164-98-3

228-200-5

1081

Amitrole

61-82-5

200-521-5

1082

Carbaryl

63-25-2

200-555-0

1083

Distillates (petroleum), light hydrocracked

64741-77-1

265-078-2

1084

1-Ethyl-1-methylmorpholinium bromide65756-41-4

612-182-00-4

1085(3-Chlorophenyl)-(4-methoxy-3-nitrophenyl)methanone

66938-41-8

423-290-4

1086

Fuels, diesel, except if the full refining history is known and it can beshown that the substance from which it is produced is not a
carcinogen68334-30-5

269-822-7

1087

Fuel oil, no. 2

68476-30-2

270-671-4

1088

Fuel oil, no. 4

68476-31-3

270-673-5

1089

Fuels, diesel, no. 2

68476-34-6

270-676-1

418-350-1

L 342/118

Official Journal of the European Union

EN

22.12.2009

Substance identification

Referencen u mb er

Chem ical n ame /I NN

CAS n u mb er

E C n u mb er

a

b

c

d

1090

2,2-Dibromo-2-nitroethanol

69094-18-4

412-380-91091

1-Ethyl-1-methylpyrrolidinium bromide

69227-51-6

612-183-00-X

1092

Monocrotophos

6923-22-4

230-042-7

1093

Nickel

7440-02-0

231-111-4

1094

Bromomethane (Methyl bromide - ISO)74-83-9

200-813-2

1095

Chloromethane (Methyl chloride)

74-87-3

200-817-4

1096

Iodomethane (Methyl iodide)74-88-4

200-819-5

1097

Bromoethane (Ethyl bromide)

74-96-4

200-825-8

1098

Heptachlor

76-44-8

200-962-3

1099

Fentin hydroxide

76-87-9

200-990-6

1100

Nickel sulphate

7786-81-4

232-104-9

1101

3,5,5-Trimethylcyclohex-2-enone (Isophorone)

78-59-1

201-126-0

1102

2,3-Dichloropropene

78-88-6

201-153-8

1103

Fluazifop-P-butyl (ISO)79241-46-6

607-305-00-3

1104(S)-2,3-Dihydro-1H-indole-carboxylic acid79815-20-6

410-860-2

1105

Toxaphene

8001-35-2

232-283-3

1106(4-Hydrazinophenyl)-N-methylmethanesulfonamide hydrochloride

81880-96-8

406-090-1

1107

CI Solvent Yellow 14

842-07-9

212-668-2

1108

Chlozolinate

84332-86-5

282-714-4

1109

Alkanes, C10-13, monochloro85535-84-8

287-476-5

1110

Moved or deleted

1111

2,4,6-Trichlorophenol

88-06-2

201-795-9

1112

Diethylcarbamoyl-chloride

88-10-8

201-798-5

1113

1-Vinyl-2-pyrrolidone

88-12-0

201-800-4

1114

Myclobutanil (ISO)(2-(4-chlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)hexanenitrile)

88671-89-0

410-400-0

1115

Fentin acetate

900-95-8

212-984-01116

Biphenyl-2-ylamine

90-41-5

201-990-91117

Trans-4-cyclohexyl-L-proline monohydro-chloride

90657-55-9

419-160-1

1118

2-Methyl-m-phenylene diisocyanate (Toluene 2,6-diisocyanate)91-08-7

202-039-0

1119

4-Methyl-m-phenylene diisocyanate (Toluene 2,4-diisocyanate)584-84-9

209-544-5

1120

m-Tolylidene diisocyanate (Toluene diisocyanate)26471-62-5

247-722-4

1121

Fuels, jet aircraft, coal solvent extn., hydrocracked hydrogenated94114-58-6

302-694-3

1122

Fuels, diesel, coal solvent extn., hydrocracked hydrogenated94114-59-7

302-695-9

1123

Pitch, if it contains > 0,005 % w/w benzo[a]pyrene

61789-60-4

263-072-4

1124

2-Butanone oxime

96-29-7

202-496-6

1125

Hydrocarbons, C16-20, solvent-dewaxed hydrocracked paraffinic distn.
Residue

97675-88-2

307-662-2

1126

α,α-Dichlorotoluene

98-87-3

202-709-2

22.12.2009

Official Journal of the European Union

EN

L 342/119

Substance identification

Referencen u mb er

Chem ical n ame /I NN

CAS n u mb er

E C n u mb er

a

b

c

d

1127

Mineral wool, with the exception of those specified elsewhere in thisAnnex; [Man-made vitreous (silicate)fibres with random orientation
with alkaline oxide and alkali earth oxide (Na2O + K2O + CaO + MgO+ BaO) content greater than 18 % by weight]

1128

Reaction product of acetophenone, formaldehyde, cyclohexylamine,
methanol and acetic acid1129

Moved or deleted

1130

Moved or deleted

1131

Trisodium bis(7-acetamido-2-(4-nitro-2-oxidophenylazo)-3-sulfonato1-naphtholato)chromate(1-)

400-810-81132

A mixture of: 4-allyl-2,6-bis(2,3-epoxypropyl)phenol,
4-allyl-6-(3-(6-(3-(6-(3-(4-allyl-2,6-bis(2,3-epoxypropyl)-phenoxy)2-hydroxypropyl)-4-allyl-2-(2,3-epoxypropyl)phenoxy)2-hydroxypropyl)-4-allyl-2-(2,3-epoxypropyl)-phenoxy2-hydroxypropyl-2-(2,3-epoxypropyl)phenol,
4-allyl-6-(3-(4-allyl-2,6-bis(2,3-epoxypropyl)phenoxy)-2hydroxypropyl)-2-(2,3-epoxypropyl)phenoxy)phenol
and 4-allyl-6-(3-(6-(3-(4-allyl-2,6-bis(2,3-epoxypropyl)-phenoxy)2-hydroxypropyl)-4-allyl-2-(2,3-epoxypropyl)phenoxy)2-hydroxypropyl)-2-(2,3-epoxypropyl)phenol

417-470-1

1133

Costus root oil (Saussurea lappa Clarke), when used as a fragrance
ingredient8023-88-91134

7-Ethoxy-4-methylcoumarin, when used as a fragrance ingredient87-05-8

201-721-5

1135

Hexahydrocoumarin, when used as a fragrance ingredient700-82-3

211-851-4

1136

Peru balsam (INCI name: Myroxylon pereirae), when used as afragrance ingredient8007-00-9

232-352-8

1137

Isobutyl nitrite542-56-2

208-819-7

1138

Isoprene (stabilized); (2-methyl-1,3-butadiene)

78-79-5

201-143-3

1139

1-Bromopropane; n-Propyl bromide

106-94-5

203-445-0

1140

Chloroprene (stabilized); (2-Chlorobuta-1,3-diene)

126-99-8

204-818-0

1141

1,2,3-Trichloropropane

96-18-4

202-486-1

1142

Ethylene glycol dimethyl ether (EGDME)

110-71-4

203-794-9

1143

Dinocap (ISO)39300-45-3

254-408-0

1144

Diaminotoluene, technical product -mixture of [4-methyl-mphenylenediamine] (4) and [2-methyl-m-phenylenediamine] (5)25376-45-8

246-910-3

406-230-1

Methyl-phenylenediamine
1145

p-Chlorobenzotrichloride

5216-25-1

226-009-1

1146

Diphenylether; octabromo derivate

32536-52-0

251-087-9

1147

1,2-bis(2-Methoxyethoxy)ethane; Triethylene glycol dimethyl ether(TEGDME)

112-49-2

203-977-3

1148

Tetrahydrothiopyran-3-carboxaldehyde

61571-06-0

407-330-8

1149

4,4′-bis(Dimethylamino)benzophenone (Michler’s ketone)

90-94-8

202-027-5

1150

Oxiranemethanol, 4-methylbenzene-sulfonate, (S)-70987-78-9

417-210-7

1151

1,2-Benzenedicarboxylic acid, dipentylester, branched and linear [1]84777-06-0 [1]284-032-2

n-Pentyl-isopentylphthalate [2]­[2]di-n-Pentyl phthalate [3]131-18-0 [3]

205-017-9

Diisopentylphthalate [4]605-50-5 [4]210-088-4

L 342/120

Official Journal of the European Union

EN

22.12.2009

Substance identification

Referencen u mb er

Chemi cal n ame /I NN

CAS n u mb er

E C n u mb er

a

b

c

d

1152

Benzyl butyl phthalate (BBP)

85-68-7

201-622-7

1153

1,2-Benzenedicarboxylic acid, di-C7-11, branched and linear alkyl esters

68515-42-4

271-084-6

1154

A mixture of: disodium 4-(3-ethoxycarbonyl-4-(5-(3-ethoxycarbonyl5-hydroxy-1-(4-sulfonatophenyl)
pyrazol-4-yl)penta-2,4-dienylidene)-4,5-dihydro5-oxopyrazol-1-yl)benzenesulfonate and trisodium
4-(3-ethoxycarbonyl-4-(5-(3-ethoxycarbonyl-5-oxido1-(4-sulfonatophenyl)pyrazol-4-yl)penta-2,4-dienylidene)-4,5-dihydro5-oxopyrazol-1-yl)benzenesulfonate402-660-9

1155(Methylenebis(4,1-phenylenazo(1-(3-(dimethylamino)propyl)-1,2-dihydro-6-hydroxy-4-methyl-2-oxopyridine-5,3-diyl)))-1,1′-dipyridinium dichloride dihydrochloride

401-500-51156

2-[2-Hydroxy-3-(2-chlorophenyl)carbamoyl-1-naphthylazo]-7-[2-hydroxy-3-(3-methylphenyl)carbamoyl-1-naphthylazo]
fluoren-9-one

420-580-2

1157

Azafenidin

68049-83-2

1158

2,4,5-Trimethylaniline [1]137-17-7 [1]2,4,5-Trimethylaniline hydrochloride [2]21436-97-5 [2]1159

4,4′-Thiodianiline and its salts

139-65-1

205-370-9

1160

4,4′-Oxydianiline (p-Aminophenyl ether) and its salts

101-80-4

202-977-0

1161

N,N,N′,N′-Tetramethyl-4,4′-methylenedianiline

101-61-1

202-959-2

1162

6-Methoxy-m-toluidine; (p-Cresidine)120-71-8

204-419-1

1163

3-Ethyl-2-methyl-2-(3-methylbutyl)-1,3-oxazolidine

143860-04-2

421-150-7

1164

A mixture of:
1,3,5-tris(3-aminomethylphenyl)-1,3,5-(1H,3H,5H)-triazine-2,4,6-trione
and 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)-triazin1-yl]-1,3,5-(1H,3H,5H)-triazine-2,4,6-trione

1165

2-Nitrotoluene

88-72-2

201-853-3

1166

Tributyl phosphate126-73-8

204-800-2

1167

Naphthalene

91-20-3

202-049-5

1168

Nonylphenol [1]25154-52-3 [1]246-672-0

205-282-0

421-550-1

4-Nonylphenol, branched [2]84852-15-3 [2]284-325-5

1169

1,1,2-Trichloroethane79-00-5

201-166-9

1170

Moved or deleted

1171

Moved or deleted

1172

allyl chloride; (3-Chloropropene)

107-05-1

203-457-6

1173

1,4-Dichlorobenzene; (p-Dichlorobenzene)

106-46-7

203-400-51174

bis(2-Chloroethyl) ether

111-44-4

203-870-1

1175

Phenol108-95-2

203-632-7

1176

Bisphenol A (4,4′-Isopropylidenediphenol)

80-05-7

201-245-8

1177

Trioxymethylene (1,3,5-Trioxan)

110-88-3

203-812-5

1178

Propargite (ISO)2312-35-8

219-006-1

1179

1-Chloro-4-nitrobenzene

100-00-5

202-809-6

1180

Molinate (ISO)2212-67-1

218-661-067564-91-4

266-719-9

624-83-9

210-866-3

1181

Fenpropimorph (ISO)1182

Moved or deleted

1183

Methyl isocyanate22.12.2009

Official Journal of the European Union

EN

L 342/121

Substance identification

Referencen u mb er

Chem ical n ame /I NN

CAS n u mb er

E C n u mb er

a

b

c

d

1184

N,N-Dimethylanilinium tetrakis(pentafluorophenyl)borate

1185

O,O′-(Ethenylmethylsilylene) di[(4-methylpentan-2-one) oxime]

118612-00-3

422-050-6

1186

A 2:1 mixture of:
4-(7-hydroxy-2,4,4-trimethyl-2-chromanyl)resorcinol-4-yl-tris(6-diazo-5,6-dihydro-5-oxonaphthalen-1-sulfonate)
and 4-(7-hydroxy-2,4,4-trimethyl-2-chromanyl)resorcinolbis(6-diazo-5,6-dihydro-5-oxonaphthalen-1-sulfonate)

1187

A mixture of: reaction product of
4,4′-methylenebis[2-(4-hydroxybenzyl)-3,6-dimethylphenol]and 6-diazo-5,6-dihydro-5-oxo-naphthalenesulfonate (1:2) andreaction product of
4,4′-methylenebis[2-(4-hydroxybenzyl)-3,6-dimethylphenol]and 6-diazo-5,6-dihydro-5-oxonaphthalenesulfonate (1:3)

1188

Malachite green hydrochloride [1]569-64-2 [1]209-322-8

Malachite green oxalate [2]18015-76-4 [2]241-922-51189

1-(4-Chlorophenyl)-4,4-dimethyl-3-(1,2,4-triazol-1-ylmethyl)
pentan-3-ol

107534-96-3

403-640-2

1190

5-(3-Butyryl-2,4,6-trimethylphenyl)-2-[1-(ethoxyimino)propyl]3-hydroxycyclohex-2-en-1-one

138164-12-2

414-790-3

1191

trans-4-Phenyl-L-proline

96314-26-0

416-020-1

1192

Moved or deleted

1193

A mixture of: 5-[(4-[(7-amino-1-hydroxy-3-sulfo-2-naphthyl)azo]2,5-diethoxyphenyl)azo]-2-[(3-phosphonophenyl)azo]benzoic acidand 5-[(4-[(7-amino-1-hydroxy-3-sulfo-2-naphthyl)azo]2,5-diethoxyphenyl)azo]-3-[(3-phosphonophenyl)azo]benzoic acid

163879-69-4

418-230-91194

2-{]4-(2-Ammoniopropylamino)-6-[}4-hydroxy-3-(5-methyl2-methoxy-4-sulfamoylphenylazo)-2-sulfonatonaphth-7-ylamino{]-1,3,5-triazin-2-ylamino[}-2-aminopropyl formate

1195

5-Nitro-o-toluidine [1]99-55-8 [1]

202-765-8

5-Nitro-o-toluidine hydrochloride [2]51085-52-0 [2]256-960-8

1196

1-(1-Naphthylmethyl)quinolinium chloride

65322-65-8

406-220-7

1197(R)-5-Bromo-3-(1-methyl-2-pyrrolidinylmethyl)-1H-indole

143322-57-0

422-390-5

1198

Pymetrozine (ISO)123312-89-0

613-202-00-4

1199

Oxadiargyl (ISO)39807-15-3

254-637-6

1200

Chlorotoluron (3-(3-chloro-p-tolyl)-1,1-dimethylurea)

15545-48-9

239-592-2

1201

N-[2-(3-Acetyl-5-nitrothiophen-2-ylazo)-5-diethylaminophenyl]
acetamide1202

1,3-bis(Vinylsulfonylacetamido)propane

93629-90-4

428-350-3

421-870-1
140698-96-0

414-770-4

417-980-4

424-260-3

416-860-91203

p-Phenetidine (4-Ethoxyaniline)

156-43-4

205-855-5

1204

m-Phenylenediamine and its salts

108-45-2

203-584-7

1205

Residues (coal tar), creosote oil distn., if it contains > 0,005 % w/w
benzo[a]pyrene

92061-93-3

295-506-3

1206

Creosote oil, acenaphthene fraction, wash oil, if it contains > 0,005 %w/w benzo[a]pyrene

90640-84-9

292-605-3

1207

Creosote oil, if it contains > 0,005 % w/w benzo[a]pyrene

61789-28-4

263-047-8

1208

Creosote, if it contains > 0,005 % w/w benzo[a]pyrene

8001-58-9

232-287-5

1209

Creosote oil, high-boiling distillate, wash oil, if it contains > 0,005 %w/w benzo[a]pyrene

70321-79-8

274-565-9

1210

Extract residues (coal), creosote oil acid, wash oil extract residue, if it
contains > 0,005 % w/w benzo[a]pyrene

122384-77-4

310-189-4

1211

Creosote oil, low-boiling distillate, wash oil, if it contains > 0,005 %w/w benzo[a]pyrene

70321-80-1

274-566-4

L 342/122

Official Journal of the European Union

EN

22.12.2009

Substance identification

Referencen u mb er

Chem ical n ame /I NN

CAS n u mb er

E C n u mb er

a

b

c

d

1212

6-Methoxy-2,3-Pyridinediamine and its HCl salt, when used as a
substance in hair dye products

94166-62-8

303-358-9

1213

2,3-Naphthalenediol, when used as a substance in hair dye products

92-44-4

202-156-7

1214

2,4-Diaminodiphenylamine, when used as a substance in hair dye
products

136-17-4

1215

2,6-Bis(2-Hydroxyethoxy)-3,5-Pyridinediamine and its HCl salt, whenused as a substance in hair dye products

117907-42-3

1216

2-Methoxymethyl-p-Aminophenol and its HCl salt, when used as a
substance in hair dye products

135043-65-1/
29785-47-5

1217

4,5-Diamino-1-Methylpyrazole and its HCl salt, when used as a
substance in hair dye products

20055-01-0/
21616-59-1

1218

4,5-Diamino-1-((4-Chlorophenyl)Methyl)-1H-Pyrazole Sulfate, whenused as a substance in hair dye products

163183-00-4

1219

4-Chloro-2-Aminophenol, when used as a substance in hair dye
products

95-85-2

202-458-9

1220

4-Hydroxyindole, when used as a substance in hair dye products

2380-94-1

219-177-2

1221

4-Methoxytoluene-2,5-Diamine and its HCl salt, when used as a
substance in hair dye products

56496-88-9

1222

5-Amino-4-Fluoro-2-Methylphenol Sulfate, when used as a substancein hair dye products

163183-01-5

1223

N,N-Diethyl-m-Aminophenol, when used as a substance in hair dye
products

91-68-9/68239-84-9

1224

N,N-Dimethyl-2,6-Pyridinediamine and its HCl salt, when used as a
substance in hair dye products

—

1225

N-Cyclopentyl-m-Aminophenol, when used as a substance in hair dye
products

104903-49-3

1226

N-(2-Methoxyethyl)-p-phenylenediamine and its HCl salt, when used asa substance in hair dye products

72584-59-9/
66566-48-1

1227

2,4-Diamino-5-methylphenetol and its HCl salt, when used as a
substance in hair dye products

113715-25-6

1228

1,7-Naphthalenediol, when used as a substance in hair dye products575-38-2

209-383-0

1229

3,4-Diaminobenzoic acid, when used as a substance in hair dye
products

619-05-6

210-577-2

1230

2-Aminomethyl-p-aminophenol and its HCl salt, when used as a
substance in hair dye products

79352-72-0

1231

Solvent Red 1 (CI 12150), when used as a substance in hair dye
products

1229-55-6

214-968-9

1232

Acid Orange 24 (CI 20170), when used as a substance in hair dye
products

1320-07-6

215-296-9

1233

Acid Red 73 (CI 27290), when used as a substance in hair dye
products

5413-75-2

226-502-1

1234

PEG-3,2′,2′-di-p-Phenylenediamine

144644-13-3

1235

6-Nitro-o-Toluidine

570-24-1

1236

HC Yellow No 1173388-54-2

1237

HC Orange No 381612-54-6

1238

HC Green No 1

52136-25-1

257-687-7

1239

HC Red No 8 and its salts

13556-29-1/
97404-14-3- / 306-778-0

1240

Tetrahydro-6-nitroquinoxaline and its salts

158006-54-3/
41959-35-7/
73855-45-5

202-090-9/
269-478-8

276-723-2

209-329-6

22.12.2009

Official Journal of the European Union

EN

L 342/123

Substance identification

Referencen u mb er

Chem ical n ame /I NN

CAS n u mb er

E C n u mb er

a

b

c

d

1241

Disperse Red 15, except as impurity in Disperse Violet 1

116-85-8

204-163-0

1242

4-Amino-3-fluorophenol

399-95-1

402-230-0

1243

N,N′-dihexadecyl-N,N′-bis(2-hydroxyethyl)propanediamide

149591-38-8

422-560-9

Bishydroxyethyl Biscetyl Malonamide
1244

1-Methyl-2,4,5-trihydroxybenzene and its salts, when used as a sub­stance in hair dye products1124-09-0

214-390-7

1245

2,6-Dihydroxy-4-methylpyridine and its salts, when used as a sub­stance in hair dye products4664-16-8

225-108-7

1246

5-Hydroxy-1,4-benzodioxane and its salts, when used as a substance inhair dye products

10288-36-5

233-639-0

1247

3,4-Methylenedioxyphenol and its salts, when used as a substance inhair dye products533-31-3

208-561-5

1248

3,4-Methylenedioxyaniline and its salts, when used as a substance inhair dye products

14268-66-7

238-161-6

1249

Hydroxypyridinone and its salts, when used as a substance in hair dye
products

822-89-9

212-506-0

1250

3-Nitro-4-aminophenoxyethanol and its salts, when used as a sub­stance in hair dye products

50982-74-6

1251

2-methoxy-4-nitrophenol (4-Nitroguaiacol) and its salts, when used asa substance in hair dye products

3251-56-7

1252

CI Acid Black 131 and its salts, when used as a substance in hair dye
products

12219-01-1

1253

1,3,5-Trihydroxybenzene (Phloroglucinol) and its salts, when used as a
substance in hair dye products

108-73-6

203-611-2

1254

1,2,4-Benzenetriacetate and its salts, when used as a substance in hairdye products

613-03-6

210-327-2

1255

Ethanol, 2,2’-iminobis-, reaction products with epichlorohydrin and 2nitro-1,4-benzenediamine (HC Blue No. 5) and its salts, when used as a
substance in hair dye products

68478-64-8/
158571-58-5

1256

N-Methyl-1,4-diaminoanthraquinone, reaction products with epichlo­rohydrin and monoethanolamine (HC Blue No. 4) and its salts, whenused as a substance in hair dye products

158571-57-4

1257

4-Aminobenzenesulfonic acid (Sulfanilic acid) and its salts, when used
as a substance in hair dye products

121-57-3/
515-74-2

204-482-5/
208-208-5

1258

3,3’-(Sulfonylbis(2-nitro-4,1-phenylene)imino)bis(6-(phenylamino))
benzenesulfonic acid and its salts, when used as a substance in hair dye
products

6373-79-1

228-922-0

1259

3(or5)-((4-(Benzylmethylamino)phenyl)azo)-1,2-(or1,4)-dimethyl-1H1,2,4-triazolium and its salts, when used as a substance in hair dye
products

89959-98-8/
12221-69-1

289-660-0

1260

2,2’-((3-Chloro-4-((2,6-dichloro-4nitrophenyl)azo)phenyl)imino)bisethanol (Disperse Brown 1) and its
salts, when used as a substance in hair dye products

23355-64-8

245-604-7

1261

Benzothiazolium, 2-[[4-[ethyl(2-hydroxyethyl)amino]phenyl]azo]-6methoxy-3-methyl-, and its salts, when used as a substance in hair dye
products

12270-13-2

235-546-0

1262

2-[(4-Chloro-2-nitrophenyl)azo]-N-(2-methoxyphenyl)-3oxobutanamide (Pigment Yellow 73) and its salts, when used as a sub­stance in hair dye products

13515-40-7

236-852-7

221-839-0

L 342/124

EN

Official Journal of the European Union

22.12.2009

Substance identification

Referencen u mb er

Chem ical n ame /I NN

CAS n u mb er

E C n u mb er

a

b

c

d

1263

2,2’-[(3,3’-Dichloro[1,1’-biphenyl]-4,4’-diyl)bis(azo)]bis[3-oxoN-phenylbutanamide] (Pigment Yellow 12) and its salts, when used asa substance in hair dye products

6358-85-6

228-787-8

1264

2,2’-(1,2-Ethenediyl)bis[5-((4-ethoxyphenyl)azo]benzenesulfonic acid)and its salts, when used as a substance in hair dye products

2870-32-8

220-698-2

1265

2,3-Dihydro-2,2-dimethyl-6-[(4-(phenylazo)-1-naphthalenyl)azo]1H-pyrimidine (Solvent Black 3) and its salts, when used as a
substance in hair dye products

4197-25-5

224-087-1

1266

3(or5)-[[4-[(7-amino-1-hydroxy-3-sulphonato-2-naphthyl)azo]1-naphthyl]azo]salicylic acid and its salts, when used as a substance inhair dye products3442-21-5/
34977-63-4

222-351-0/
252-305-5

1267

2-Naphthalenesulfonic acid,7-(benzoylamino)-4-hydroxy-3-[[4-[(4-sulfophenyl)azo]phenyl]azo]-,
and its salts, when used as a substance in hair dye products

2610-11-9

220-028-91268(μ-((7,7’-Iminobis(4-hydroxy-3-((2-hydroxy-5-(N-methylsulphamoyl)
phenyl)azo)naphthalene-2-sulphonato))(6-)))dicuprate(2-) and its salts,
when used as a substance in hair dye products

37279-54-2

253-441-8

1269

3-[(4-(Acetylamino)phenyl)azo]-4-hydroxy-7-[[[[5-hydroxy6-(phenylazo)-7-sulfo-2-naphthalenyl]amino]carbonyl]amino]2-naphthalenesulfonic acid and its salts, when used as a substance inhair dye products

3441-14-3

222-348-4

1270

2-Naphthalenesulfonic acid,
7,7’-(carbonyldiimino)bis(4-hydroxy-3-[[2-sulfo-4-[(4-sulfophenyl)azo]phenyl]azo]-, and its salts, when used as a substance in hair dye
products

2610-10-8/25188-41-4

220-027-3

1271

Ethanaminium, N-(4-[bis[4-(diethylamino)phenyl]methylene]-2,5cyclohexadien-1-ylidene)-N-ethyl-, and its salts, when used as a
substance in hair dye products

2390-59-2

219-231-5

1272

3H-Indolium, 2-[[(4-methoxyphenyl)methylhydrazono]methyl]-1,3,3trimethyl-, and its salts, when used as a substance in hair dye products

54060-92-3

258-946-7

1273

3H-Indolium,
2-(2-((2,4-dimethoxyphenyl)amino)ethenyl)-1,3,3-trimethyl-, and its
salts, when used as a substance in hair dye products

4208-80-4

224-132-5

1274

Nigrosine spirit soluble (Solvent Black 5), when used as a substance inhair dye products

11099-03-9

1275

Phenoxazin-5-ium, 3,7-bis(diethylamino)-, and its salts, when used as a
substance in hair dye products

47367-75-9/33203-82-6

251-403-5

1276

Benzo[a]phenoxazin-7-ium, 9-(dimethylamino)-, and its salts, whenused as a substance in hair dye products

7057-57-0/
966-62-1

230-338-6/
213-524-1

1277

6-Amino-2-(2,4-dimethylphenyl)-1H-benz[de]isoquinoline-1,3(2H)dione (Solvent Yellow 44) and its salts, when used as a substance inhair dye products

2478-20-8

219-607-9

1278

1-Amino-4-[[4-[(dimethylamino)methyl]phenyl]amino]anthraquinone
and its salts, when used as a substance in hair dye products

67905-56-0/
12217-43-5

267-677-4/
235-398-7

1279

Laccaic Acid (CI Natural Red 25) and its salts, when used as a
substance in hair dye products

60687-93-6

1280

Benzenesulfonic acid, 5-[(2,4-dinitrophenyl)amino]-2-(phenylamino)-,and its salts, when used as a substance in hair dye products6373-74-6/
15347-52-1

228-921-5/
239-377-3

1281

4-[(4-Nitrophenyl)azo]aniline (Disperse Orange 3) and its salts, whenused as a substance in hair dye products

730-40-5/70170-61-5

211-984-8

1282

4-Nitro-m-phenylenediamine and its salts, when used as a substance inhair dye products

5131-58-8

225-876-3

22.12.2009

EN

Official Journal of the European Union

L 342/125

Substance identification

Referencen u mb er

Chem ical n ame /I NN

CAS n u mb er

E C n u mb er

a

b

c

d

1283

1-Amino-4-(methylamino)-9,10-anthracenedione (Disperse Violet 4)
and its salts, when used as a substance in hair dye products

1220-94-6

214-944-8

1284

N-Methyl-3-nitro-p-phenylenediamine and its salts, when used as a
substance in hair dye products2973-21-9

221-014-51285

N1-(2-Hydroxyethyl)-4-nitro-o-phenylenediamine (HC Yellow No. 5)
and its salts, when used as a substance in hair dye products

56932-44-6

260-450-01286

N1-(Tris(hydroxymethyl))methyl-4-nitro-1,2-phenylenediamine (HCYellow No. 3) and its salts, when used as a substance in hair dye
products

56932-45-7

260-451-6

1287

2-Nitro-N-hydroxyethyl-p-anisidine and its salts, when used as a
substance in hair dye products

57524-53-5

1288

N,N’-Dimethyl-N-Hydroxyethyl-3-nitro-p-phenylenediamine and its
salts, when used as a substance in hair dye products

10228-03-2

233-549-1

1289

3-(N-Methyl-N-(4-methylamino-3-nitrophenyl)amino)propane-1,2-dioland its salts, when used as a substance in hair dye products

93633-79-5

403-440-5

1290

4-Ethylamino-3-nitrobenzoic acid (N-Ethyl-3-Nitro PABA) and its salts,
when used as a substance in hair dye products

2788-74-1

412-090-2

1291(8-[(4-Amino-2-nitrophenyl)azo]-7-hydroxy-2-naphthyl)
trimethylammonium and its salts, except Basic Red 118 (CAS71134-97-9) as impurity in Basic Brown 17, when used as a
substance in hair dye products

71134-97-9

275-216-3

1292

5-((4-(Dimethylamino)phenyl)azo)-1,4-dimethyl-1H-1,2,4-triazolium
and its salts, when used as a substance in hair dye products

12221-52-2

1293

m-Phenylenediamine, 4-(phenylazo)-, and its salts, when used as a
substance in hair dye products495-54-5

207-803-7

1294

1,3-Benzenediamine, 4-methyl-6-(phenylazo)- and its salts, when used
as a substance in hair dye products

4438-16-8

224-654-3

1295

2,7-Naphthalenedisulfonic acid,5-(acetylamino)-4-hydroxy-3-((2-methylphenyl)azo)-, and its salts,
when used as a substance in hair dye products

6441-93-6

229-231-7

1296

4,4’-[(4-Methyl-1,3-phenylene)bis(azo)]bis[6-methyl-1,
3-benzenediamine] (Basic Brown 4) and its salts, when used as a
substance in hair dye products4482-25-1

224-764-1

1297

Benzenaminium,
3-[[4-[[diamino(phenylazo)phenyl]azo]-2-methylphenyl]azo]N,N,N-trimethyl-, and its salts, when used as a substance in hair dye
products

83803-99-0

280-920-91298

Benzenaminium,
3-[[4-[[diamino(phenylazo)phenyl]azo]-1-naphthalenyl]azo]N,N,N-trimethyl-, and its salts, when used as a substance in hair dye
products

83803-98-9

280-919-3

1299

Ethanaminium,
N-[4-[(4-(diethylamino)phenyl)phenylmethylene]-2,5-cyclohexadien1-ylidene]-N-ethyl- and its salts, when used as a substance in hair dye
products

633-03-4

211-190-1

1300

9,10-Anthracenedione, 1-[(2-hydroxyethyl)amino]-4-(methylamino)-,and its derivatives and salts, when used as a substance in hair dye
products

2475-46-9/
86722-66-9

219-604-2/
289-276-3

1301

1,4-Diamino-2-methoxy-9,10-anthracenedione (Disperse Red 11) andits salts, when used as a substance in hair dye products2872-48-2

220-703-8

1302

1,4-Dihydroxy-5,8-bis[(2-hydroxyethyl)amino]anthraquinone (Disperse
Blue 7) and its salts, when used as a substance in hair dye products3179-90-6

221-666-0

L 342/126

EN

Official Journal of the European Union

22.12.2009

Substance identification

Referencen u mb er

Chem ical n ame /I NN

CAS n u mb er

E C n u mb er

a

b

c

d

1303

1-[(3-Aminopropyl)amino]-4-(methylamino)anthraquinone and its
salts, when used as a substance in hair dye products

22366-99-0

244-938-0

1304

N-[6-[(2-Chloro-4-hydroxyphenyl)imino]-4-methoxy-3-oxo1,4-cyclohexadien-1-yl]acetamide (HC Yellow No. 8) and its salts,
when used as a substance in hair dye products

66612-11-1

266-424-51305[6-[[3-Chloro-4-(methylamino)phenyl]imino]-4-methyl-3oxocyclohexa-1,4-dien-1-yl]urea (HC Red No. 9) and its salts, whenused as a substance in hair dye products

56330-88-2

260-116-4

1306

Phenothiazin-5-ium, 3,7-bis(dimethylamino)-, and its salts, when used
as a substance in hair dye products

61-73-4

200-515-2

1307

4,6-Bis(2-Hydroxyethoxy)-m-Phenylenediamine and its salts, whenused as a substance in hair dye products

94082-85-6

1308

5-Amino-2,6-Dimethoxy-3-Hydroxypyridine and its salts, when used
as a substance in hair dye products

104333-03-1

1309

4,4’-Diaminodiphenylamine and its salts, when used as a substance inhair dye products537-65-5

208-673-4

1310

4-Diethylamino-o-toluidine and its salts, when used as a substance inhair dye products

148-71-0/24828-38-4/
2051-79-8

205-722-1/
246-484-9/
218-130-3

1311

N,N-Diethyl-p-phenylenediamine and its salts, when used as a
substance in hair dye products

93-05-0/6065-27-6/
6283-63-2

202-214-1/
227-995-6/
228-500-6

1312

N,N-Dimethyl-p-phenylenediamine and its salts, when used as a
substance in hair dye products

99-98-9/6219-73-4

202-807-5/
228-292-7

1313

Toluene-3,4-Diamine and its salts, when used as a substance in hairdye products496-72-0

207-826-2

1314

2,4-Diamino-5-methylphenoxyethanol and its salts, when used as a
substance in hair dye products

141614-05-3/
113715-27-8

1315

6-Amino-o-cresol and its salts, when used as a substance in hair dye
products

17672-22-9

1316

Hydroxyethylaminomethyl-p-aminophenol and its salts, when used asa substance in hair dye products

110952-46-0/
135043-63-9

1317

2-Amino-3-nitrophenol and its salts, when used as a substance in hairdye products603-85-0

210-060-1

1318

2-Chloro-5-nitro-N-hydroxyethyl-p-phenylenediamine and its salts,
when used as a substance in hair dye products

50610-28-1

256-652-3

1319

2-Nitro-p-phenylenediamine and its salts, when used as a substance inhair dye products

5307-14-2/
18266-52-9

226-164-5/
242-144-9

1320

Hydroxyethyl-2,6-dinitro-p-anisidine and its salts, when used as a
substance in hair dye products

122252-11-3

1321

6-Nitro-2,5-pyridinediamine and its salts, when used as a substance inhair dye products

69825-83-8

1322

Phenazinium, 3,7-diamino-2,8-dimethyl-5-phenyl-, and its salts, whenused as a substance in hair dye products477-73-6

1323

3-Hydroxy-4-[(2-hydroxynaphthyl)azo]-7-nitronaphthalene-1-sulphonic 16279-54-2/
5610-64-0
acid and its salts, when used as a substance in hair dye products207-518-8
240-379-1/
227-029-3

22.12.2009

EN

Official Journal of the European Union

L 342/127

Substance identification

Referencen u mb er

Chem ical n ame /I NN

CAS n u mb er

E C n u mb er

a

b

c

d

1324

3-[(2-nitro-4-(trifluoromethyl)phenyl)amino]propane-1,2-diol (HCYellow No. 6) and its salts, when used as a substance in hair dye
products

104333-00-81325

2-[(4-chloro-2-nitrophenyl)amino]ethanol (HC Yellow No. 12) and its
salts, when used as a substance in hair dye products

59320-13-7

1326

3-[[4-[(2-Hydroxyethyl)Methylamino]-2-Nitrophenyl]Amino]-1,2-Propanediol and its salts, when used as a substance in hair dye
products

173994-75-7/
102767-27-1

1327

3-[[4-[Ethyl(2-Hydroxyethyl)Amino]-2-Nitrophenyl]Amino]-1,2-Propanediol and its salts, when used as a substance in hair dye
products

114087-41-1/
114087-42-2

1328

Ethanaminium,
N-[4-[[4-(diethylamino)phenyl][4-(ethylamino)-1-naphthalenyl]
methylene]-2,5-cyclohexadien-1-ylidene]-N-ethyl-, and its salts, whenused as a substance in hair dye products

2390-60-5(1) OJ L 159, 29.6.1996, p. 1
(2) Modified INNM-name.
(3) OJ L 273, 10.10.2002, p. 1.
(4) for the individual ingredient see reference number 364 in Annex II.
(5) for the individual ingredient see reference number 413 in Annex II.

219-232-0

L 342/128

ANNEX III
LIST OF SUBSTANCES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS LAID DOWN

Substance identification

Restrictions

Chemical name/INN

N ame of Com mon
Ingredients Glossary

CAS number

EC number

Product type, body parts

Maximum concentration inready for use preparation

O therWording of conditions ofuse and warnings

a

b

c

d

e

f

g

h

i

10043-35-3/
11113-50-1

233-139-2/
234-343-4(a) 5 % (as boric acid)(a) Not to be used in
products for children under 3 yearsof age(a) Not to be used forchildren under 3
years of age

1aBoric acid, borates
Boric acidand tetraborates withthe exception ofsubstance No 1184 in
Annex II(a) Talc(b) Oral products(c) Other products(excluding bathproducts and hairwaving products)(b) 0,1 % (as boricacid)(b) Not to be used in
products for chil­dren under 3 yearsof age(b) Not to be swallowed(c) 3 % (as boric acid)(c) Not to be used in
products for children under 3 yearsof age(c) Not to be used forchildren under 3
years of age

Not to be used on
peeling or irritatedskin if the concentration of freesoluble borates
exceeds 1,5 % (asboric acid)
1b

Tetraborates, see also
1a)

Not to be used on
peeling or irritatedskin

Not to be used forchildren under 3
years of age

Official Journal of the European Union

Not to be used on
peeling or irritatedskin if the concentration of freesoluble borates
exceeds 1,5 % (asboric acid)

EN

Referencen u mb er

Not to be used on
peeling or irritatedskin(a) 18 % (as boric acid) (a) Not to be used in
products for children under 3 yearsof age(a) Not to be used forchildren under 3
years of age(b) Hair products(b) 8 % (as boric acid)(b) Rinse well22.12.2009(a) Bath products

Restrictions

Chemical name/INN

N ame of Com mon
Ingredients Glossary

CAS number

EC number

Product type, body parts

Maximum concentration inready for use preparation

O therWording of conditions ofuse and warnings

a

b

c

d

e

f

g

h

i

2a

Thioglycolic acid68-11-1

200-677-4(a) Hair products

8%

General use

Conditions of use:

ready for use pH 7
to 9,5(a) (b) (c)EN

Thioglycolic acid andits salts

22.12.2009

Substance identification

Referencen u mb er

Avoid contact with eyes
In the event of contact
with eyes, rinse immedi­
ately with plenty ofwater and seek medical
adviceProfessional use
ready for use pH 7
to 9,5

Wear suitable gloves
Warnings:(a) (b) (c)Contains thioglycolate
Follow the instructions
Keep out of reach ofchildren(b) Depilatories

5%

ready for use pH 7
to 12,7

L 342/129(c) Hair rinse-off prod­ 2 %ready for use pH 7
ucts
to 9,5The abovementioned
percentages are calcu­
lated as thioglycolic acid(a) For professional use
only

Official Journal of the European Union(a) (c)11 %Restrictions

Chemical name/INN

N ame of Com mon
Ingredients Glossary

CAS number

EC number

Product type, body parts

Maximum concentration inready for use preparation

O therWording of conditions ofuse and warnings

a

b

c

d

e

f

g

h

i

2b

Hair waving or
straightening products(a) 8 %

General use

Conditions of use:

ready for use pH 6
to 9,5(a) (b)EN

Thioglycolic acid
esters

L 342/130

Substance identification

Referencen u mb er

May cause sensitizationin the event of skin con­tact
Avoid contact with eyes

Wear suitable gloves
Warnings:
Contains thioglycolate
Follow the instructions
Keep out of reach ofchildren(b) 11 %The abovemen­tioned percentages
are calculated as
thioglycolic acid

Oxalic acid, its esters
and alkaline salts

Oxalic acid144-62-7

205-634-3

4

Ammonia

Ammonia

7664-41-7/
1336-21-6

231-635-3/
215-647-6

Hair products

5%

6 % (as NH3)

ready for use pH 6
to 9,5

Professional use(b) For professional use
only

For professional use only

Above 2 %: Contains
ammonia22.12.20093

Professional use

Official Journal of the European Union

In the event of contact
with eyes, rinse immedi­
ately with plenty ofwater and seek medical
adviceRestrictions

Chemical name/INN

N ame of Com mon
Ingredients Glossary

CAS number

EC number

Product type, body parts

Maximum concentration inready for use preparation

O therWording of conditions ofuse and warnings

a

b

c

d

e

f

g

h

i

Tosylchloramide
sodium (INN)

Chloramine-T

127-65-1

204-854-7

6

Chlorates of alkali
metalsSodium chlorate

7775-09-9

231-887-4

0,2 %
EN

5

22.12.2009

Substance identification

Referencen u mb er

3811-04-9

223-289-7

Dichloromethane75-09-2

200-838-9

106-50-3

203-404-7

7

Dichloromethane8

p-Phenylenediamine, p-Phenylenediamine
its N-substituted
derivatives and its
salts; N-substituted
derivatives ofo-Phenylenediamine (1), with the
exception of thosederivatives listed else­
where in this Annex
and under reference
numbers 1309, 1311,
and 1312 in Annex II(a) 5 %(b) Other products(b) 3 %

35 % (when mixed with 0,2 % as maximum
1,1,1-trichloro-ethane, impurity content
total concentrationmust not exceed 35 %)Oxidising colouring
agents for hair dyeing

6 % (as free base)(a) General use
Not to be used oneyebrows(a) Can cause an allergic
reactionContains phenylene­
diamines

Official Journal of the European Union

Potassium chlorate(a) Toothpaste

Do not use to dyeeyelashes or eye­brows(b) Professional use(b) For professional use
only
Contains phenylene­
diamines

Wear suitable gloves

L 342/131

Can cause an aller­
gic reaction

Restrictions

Chemical name/INN

N ame of Com mon
Ingredients Glossary

CAS number

EC number

Product type, body parts

Maximum concentration inready for use preparation

O therWording of conditions ofuse and warnings

a

b

c

d

e

f

g

h

i

9

95-70-5

202-442-1

Oxidising colouring
agents for hair dyeing

10 % (as free base)(a) General use
Not to be used oneyebrows(a) Can cause an allergic
reactionContains phenylenediamines
Do not use to dyeeyelashes or eye­brows(b) For professional use
only
Contains phenylenediamines
Can cause an aller­
gic reaction
Wear suitable gloves

Diaminophenols (1)Oxidising colouring
agents for hair dyeing

10 % (as free base)(a) General use
Not to be used oneyebrows(b) Professional use(a) Can cause an allergic
reaction

Official Journal of the European Union(b) Professional use

10

EN

MethylphenyleneToluene-2,5-diamine
diamines, theirN-substituted
derivatives (1) andtheir salts with the
exception ofsubstances underreference
numbers 364, 413,
1144, 1310
and 1313 in Annex II

L 342/132

Substance identification

Referencen u mb er

Do not use to dyeeyelashes or eye­brows(b) For professional use
only
Can cause an aller­
gic reaction
Wear suitable gloves

Dichlorophen

Dichlorophen

97-23-4

202-567-1

0,5 %Contains Dichlorophen

22.12.200911

Restrictions

Chemical name/INN

N ame of Com mon
Ingredients Glossary

CAS number

EC number

Product type, body parts

Maximum concentration inready for use preparation

O therWording of conditions ofuse and warnings

a

b

c

d

e

f

g

h

i

7722-84-1

231-765-0

12

Hydroquinone (4)Formaldehyde

Hydroquinone(b) Skin- products

50-00-0

123-31-9

200-001-8

204-617-8

12 % H2O2 (40 vol­umes), present or
released(a) Wear suitable gloves

4 % H2O2, present or
released

Avoid contact with eyes(c) Nail hardening
products

2 % of H2O2, present or
released(d) Oral products

0,1 % of H2O2, present
or released

Nail hardening products 5 % (as formaldehyde)(a) Oxidising colouring 0,3 %agent for hair dye­ing(a) (b) (c):Contains hydrogen per­oxide

Rinse eyes immediately if
product comes into con­tact with them

For purposes other thaninhibiting the develop­
ment of microorganisms in the
product. This purpose
has to be apparent fromthe presentation of the
product

Protect cuticles withgrease or oil

General use

Do not use to dye eye­lashes or eyebrowsNot to be used on eye­browsContains formalde­
hyde (3)

Official Journal of the European Union

14

Formaldehyde (2)(a) Hair- productsEN

13

Hydrogen peroxide,
Hydrogen peroxide
and other compounds
or mixtures that
release hydrogen
peroxide, including
carbamide peroxideand zinc peroxide22.12.2009

Substance identification

Referencen u mb er

Rinse eyes immediately if
the product comes into
contact with themContains Hydroquinone

Professional use

For professional use only

Rinse eyes immediately if
product comes into con­tact with them

L 342/133

Contains hydroquinone

Restrictions

Chemical name/INN

N ame of Com mon
Ingredients Glossary

CAS number

EC number

Product type, body parts

Maximum concentration inready for use preparation

O therWording of conditions ofuse and warnings

a

b

c

d

e

f

g

h

i

0,02 % (after mixing for Professional useuse)(b) For professional use
only
Avoid skin contact

EN(b) Artificial nail sys­tems

L 342/134

Substance identification

Referencen u mb er

Read directions foruse carefully

15aPotassium or sodiumhydroxide

Potassiumhydroxide/sodiumhydroxide

1310-58-3/
1310-73-2

215-181-3/
215-185-5(a) Nail cuticle solvent(a) 5 % (5)(a) Contains alkali

Can cause blindness
Keep out of reach ofchildren(b) Hair straightener

2 % (5)General use

Contains alkali
Avoid contact with eyes
Can cause blindness
Keep out of reach ofchildren

4,5 % (5)For professional use only
Avoid contact with eyes
Can cause blindness(c) pH adjuster for
depilatories(c) pH < 12,7(c) Keep out of reach ofchildren
Avoid contact witheyes(d) Other uses as pH
adjuster(d) pH < 11

22.12.2009

Professional use

Official Journal of the European Union

Avoid contact witheyes

Restrictions

Chemical name/INN

N ame of Com mon
Ingredients Glossary

CAS number

EC number

Product type, body parts

a

b

c

d

e

f

1310-65-2

215-183-4

15b

Lithium hydroxide

Lithium hydroxide(a) Hair straighteners

Maximum concentration inready for use preparation

O therWording of conditions ofuse and warnings

g

h

i

2%( )
6

General use

22.12.2009

Substance identification

Referencen u mb er(a) Contains alkali
EN

Avoid contact witheyes
Can cause blindness
Keep out of reach ofchildrenProfessional use

Avoid contact with eyes
Can cause blindness(b) pH adjuster for
depilatories

pH < 12,7

Official Journal of the European Union

4,5 % (6)(b) Contains alkali
Keep out of reach ofchildren
Avoid contact witheyes

pH < 11

L 342/135(c) Other uses as pH
adjuster (for rinseoff products only)

Restrictions

Chemical name/INN

N ame of Com mon
Ingredients Glossary

CAS number

EC number

Product type, body parts

Maximum concentration inready for use preparation

O therWording of conditions ofuse and warnings

a

b

c

d

e

f

g

h

i

1305-62-0

215-137-3

15c

Calcium hydroxide

Calcium hydroxide(a) Contains alkali
Avoid contact with
eyes

EN

(a) Hair straighteners(a) 7 % (as calcium
containing twohydroxide)components: cal­cium hydroxide anda guanidine salt

L 342/136

Substance identification

Referencen u mb er

Keep out of reach ofchildrenCan cause blindness(b) pH adjuster for
depilatories(b) pH < 12,7(b) Contains alkali

Avoid contact witheyes(c) Other uses (e.g. pH
adjuster, processing
aid)(c) pH < 11

1-Naphthol and its
salts

1-Naphtol

90-15-3

201-969-4

Oxidising colouring
agents for hair dyeing

2,0 %In combination with
Can cause an allergichydrogen peroxide the reaction
maximum use concen­
tration upon applicationis 1,0 %17

Sodium nitrite

Sodium nitrite

7632-00-0

231-555-9

Rust inhibitor

0,2 %Not to be used withsecondary and/or ter­tiary amines or othersubstances forming nit­
rosamines

18

Nitromethane

Nitromethane

75-52-5

200-876-6

Rust inhibitor

0,3 %

19

Moved or deleted

20

Moved or deleted

22.12.2009

16

Official Journal of the European Union

Keep out of reach ofchildrenRestrictions

Chemical name/INN

N ame of Com mon
Ingredients Glossary

CAS number

EC number

Product type, body parts

Maximum concentration inready for use preparation

O therWording of conditions ofuse and warnings

a

b

c

d

e

f

g

h

i

21

130-95-0

205-003-2(a) Hair rinse-off prod­ (a) 0,5 % (as quinine
ucts
base)

EN

Cinchonan-9-ol,
Quinine6’-methoxy-, (8.alpha.,9R)- and its salts

22.12.2009

Substance identification

Referencen u mb er(b) Hair leave-on prod­ (b) 0,2 % (as quinine
ucts
base)
22

Resorcinol (4)Resorcinol

108-46-3

203-585-2(a) Oxidising colouring 5 %agent for hair dye­ing

General use

Contains resorcinol

Not to be used on eye­browsRinse hair well after
application

Rinse eyes immediately if
product comes into con­tact with them
Professional use

For professional use only
Contains resorcinol
Rinse eyes immediately if
product comes into con­tact with them2324(b) Hair lotions andshampoos0,5 %(a) Alkali sulphides(a) Depilatories(a) 2 % (as sulphur)(b) Alkaline earth
sulphides(b) Depilatories(b) 6 % (as sulphur)pH ≤ 12,7(a) (b) Keep out of reachof children
Avoid contact
with eyes

1 % (as zinc)

L 342/137

Water-soluble zinc
Zinc acetate, zincsalts with the excep­ chloride, zinc glucon­tion of zincate, zinc glutamate
4-hydroxybenzenesulphonate(entry 25) and zinc
pyrithione (entry 101
and Annex V, entry 8)

Contains resorcinol

Official Journal of the European Union

Do not use to dye eye­lashes or eyebrowsRestrictions

Chemical name/INN

N ame of Com mon
Ingredients Glossary

CAS number

EC number

Product type, body parts

Maximum concentration inready for use preparation

O therWording of conditions ofuse and warnings

a

b

c

d

e

f

g

h

i

Zinc
4-hydroxybenzene
sulphonate

Zinc phenolsulfonate

127-82-2

26

AmmoniumAmmonium
20859-38-5/
monofluorophosphate monofluorophosphate 66115-19-3

204-867-8

Deodorants,
antiperspirants andastringent lotions

6 % (as % anhydrous
substance)

Avoid contact with eyes

Oral products

0,15 % (as F). Whenmixed with otherfluorine compounds
permitted under thisAnnex, total F
concentration must notexceed 0,15 %Contains ammonium
monofluorophosphate

EN

25

Disodium fluorophos­ Sodium monofluoro­
phatephosphate

10163-15-2/
7631-97-2

233-433-0/
231-552-2

Oral products

0,15 % (as F). Whenmixed with other fluo­rine compounds permit­
ted under this Annex,
total F concentrationmust not exceed 0,15 %Official Journal of the European Union

For any toothpaste con­taining 0,1 to 0,15 %fluoride unless it isalready labelled ascontra-indicated for chil­dren (e.g. ‘for adult use
only’) the following
labelling is obligatory:‘Children of 6 years andyounger: Use a pea sizedamount for supervised
brushing to minimize
swallowing. In case of
intake of fluoride fromother sources consult adentist or doctor’27

L 342/138

Substance identification

Referencen u mb er

Contains sodium monof­
luorophosphate

22.12.2009

For any toothpaste con­taining 0,1 to 0,15 %fluoride unless it isalready labelled ascontra-indicated for chil­dren (e.g. ‘for adult use
only’) the following
labelling is obligatory:

Restrictions

Chemical name/INN

N ame of Com mon
Ingredients Glossary

CAS number

EC number

Product type, body parts

Maximum concentration inready for use preparation

O therWording of conditions ofuse and warnings

a

b

c

d

e

f

g

h

i

Dipotassium fluoro­
phosphate

Potassium monofluo­
rophosphate14104-28-0

237-957-0

Oral products

0,15 % (as F). Whenmixed with other fluo­rine compounds permit­
ted under this Annex,
total F concentrationmust not exceed 0,15 %Contains potassium
monofluorophosphate
For any toothpaste con­taining 0,1 to 0,15 %fluoride unless it isalready labelled ascontra-indicated for chil­dren (e.g. ‘for adult use
only’) the following
labelling is obligatory:‘Children of 6 years andyounger: Use a pea sizedamount for supervised
brushing to minimize
swallowing. In case of
intake of fluoride fromother sources consult adentist or doctor’29

Calcium fluorophos­
phate

Calcium monofluoro­ 7789-74-4
phosphate232-187-1

Oral productsContains calcium
monofluorophosphate

L 342/139

0,15 % (as F). Whenmixed with other fluo­rine compounds permit­
ted under this Annex,
total F concentrationmust not exceed 0,15 %Official Journal of the European Union

28

EN‘Children of 6 years andyounger: Use a pea sizedamount for supervised
brushing to minimize
swallowing. In case of
intake of fluoride fromother sources consult adentist or doctor’

22.12.2009

Substance identification

Referencen u mb er

Restrictions

Chemical name/INN

N ame of Com mon
Ingredients Glossary

CAS number

EC number

Product type, body parts

Maximum concentration inready for use preparation

O therWording of conditions ofuse and warnings

a

b

c

d

e

f

g

h

i

30

Calcium fluoride

Calcium fluoride

7789-75-5

232-188-7

Oral products

0,15 % (as F). Whenmixed with other fluo­rine compounds permit­
ted under this Annex,
total F concentrationmust not exceed 0,15 %Contains calcium fluo­
ride

Official Journal of the European Union‘Children of 6 years andyounger: Use a pea sizedamount for supervised
brushing to minimize
swallowing. In case of
intake of fluoride fromother sources consult adentist or doctor’EN

For any toothpaste con­taining 0,1 to 0,15 %fluoride unless it isalready labelled ascontra-indicated for chil­dren (e.g. ‘for adult use
only’) the following
labelling is obligatory:

L 342/140

Substance identification

Referencen u mb er

For any toothpaste con­taining 0,1 to 0,15 %fluoride unless it isalready labelled ascontra-indicated for chil­dren (e.g. ‘for adult use
only’) the following
labelling is obligatory:

22.12.2009‘Children of 6 years andyounger: Use a pea sizedamount for supervised
brushing to minimize
swallowing. In case of
intake of fluoride fromother sources consult adentist or doctor’Restrictions

Chemical name/INN

N ame of Com mon
Ingredients Glossary

CAS number

EC number

Product type, body parts

Maximum concentration inready for use preparation

O therWording of conditions ofuse and warnings

a

b

c

d

e

f

g

h

i

7681-49-4

231-667-8

Oral products

31

Sodium fluoride

Sodium fluoride

Contains sodium fluoride
For any toothpaste con­taining 0,1 to 0,15 %fluoride unless it isalready labelled ascontra-indicated for chil­dren (e.g. ‘for adult use
only’) the following
labelling is obligatory:

32

Potassium fluoride

Potassium fluoride

7789-23-3

232-151-5

Oral products

0,15 % (as F). Whenmixed with other fluo­rine compounds permit­
ted under this Annex,
total F concentrationmust not exceed 0,15 %Contains potassium fluo­
ride

Official Journal of the European Union‘Children of 6 years andyounger: Use a pea sizedamount for supervised
brushing to minimize
swallowing. In case of
intake of fluoride fromother sources consult adentist or doctor’EN

0,15 % (as F). Whenmixed with otherfluorine compounds
permitted under thisAnnex, total F
concentration must notexceed 0,15 %22.12.2009

Substance identification

Referencen u mb er

For any toothpaste con­taining 0,1 to 0,15 %fluoride unless it isalready labelled ascontra-indicated for chil­dren (e.g. ‘for adult use
only’) the following
labelling is obligatory:

L 342/141‘Children of 6 years andyounger: Use a pea sizedamount for supervised
brushing to minimize
swallowing. In case of
intake of fluoride fromother sources consult adentist or doctor’Restrictions

Chemical name/INN

N ame of Com mon
Ingredients Glossary

CAS number

EC number

Product type, body parts

Maximum concentration inready for use preparation

O therWording of conditions ofuse and warnings

a

b

c

d

e

f

g

h

i

Ammonium fluoride

Ammonium fluoride

12125-01-8

235-185-9

Oral products

33

Contains ammonium
fluoride
For any toothpaste con­taining 0,1 to 0,15 %fluoride unless it isalready labelled ascontra-indicated for chil­dren (e.g. ‘for adult use
only’) the following
labelling is obligatory:

34

Aluminium fluoride

Aluminium fluoride

7784-18-1

232-051-1

Oral products

0,15 % (as F). Whenmixed with other fluo­rine compounds permit­
ted under this Annex,
total F concentrationmust not exceed 0,15 %Contains aluminiumfluoride

Official Journal of the European Union‘Children of 6 years andyounger: Use a pea sizedamount for supervised
brushing to minimize
swallowing. In case of
intake of fluoride fromother sources consult adentist or doctor’EN

0,15 % (as F). Whenmixed with otherfluorine compounds
permitted under thisAnnex, total F
concentration must notexceed 0,15 %L 342/142

Substance identification

Referencen u mb er

For any toothpaste con­taining 0,1 to 0,15 %fluoride unless it isalready labelled ascontra-indicated for chil­dren (e.g. ‘for adult use
only’) the following
labelling is obligatory:

22.12.2009‘Children of 6 years andyounger: Use a pea sizedamount for supervised
brushing to minimize
swallowing. In case of
intake of fluoride fromother sources consult adentist or doctor’Restrictions

Chemical name/INN

N ame of Com mon
Ingredients Glossary

CAS number

EC number

Product type, body parts

Maximum concentration inready for use preparation

O therWording of conditions ofuse and warnings

a

b

c

d

e

f

g

h

i

7783-47-3

231-999-3

Oral products

35

Tin difluoride

Stannous fluoride

Contains stannous fluo­
ride
For any toothpaste con­taining 0,1 to 0,15 %fluoride unless it isalready labelled ascontra-indicated for chil­dren (e.g. ‘for adult use
only’) the following
labelling is obligatory:

36

Hexadecyl ammonium Cetylamine hydrofluo­ 3151-59-5
fluorideride

221-588-7

Oral products

0,15 % (as F). Whenmixed with other fluo­rine compounds permit­
ted under this Annex,
total F concentrationmust not exceed 0,15 %Contains Cetylaminehydrofluoride

Official Journal of the European Union‘Children of 6 years andyounger: Use a pea sizedamount for supervised
brushing to minimize
swallowing. In case of
intake of fluoride fromother sources consult adentist or doctor’EN

0,15 % (as F). Whenmixed with otherfluorine compounds
permitted under thisAnnex, total F
concentration must notexceed 0,15 %22.12.2009

Substance identification

Referencen u mb er

For any toothpaste con­taining 0,1 to 0,15 %fluoride unless it isalready labelled ascontra-indicated for chil­dren (e.g. ‘for adult use
only’) the following
labelling is obligatory:

L 342/143‘Children of 6 years andyounger: Use a pea sizedamount for supervised
brushing to minimize
swallowing. In case of
intake of fluoride fromother sources consult adentist or doctor’Restrictions

Chemical name/INN

N ame of Com mon
Ingredients Glossary

CAS number

EC number

Product type, body parts

Maximum concentration inready for use preparation

O therWording of conditions ofuse and warnings

a

b

c

d

e

f

g

h

i

37

—

—

Oral products

0,15 % (as F). Whenmixed with otherfluorine compounds
permitted under thisAnnex, total F
concentration must notexceed 0,15 %Contains 3-(NHexadecyl-N-2hydroxyethylammonio)
propylbis(2-hydroxyethyl) ammo­nium difluoride‘Children of 6 years andyounger: Use a pea sizedamount for supervised
brushing to minimize
swallowing. In case of
intake of fluoride fromother sources consult adentist or doctor’

38

N,N’,N’Tris(polyoxyethylene)N-hexadecylpropylenediamine
dihydrofluoride——

Oral products

0,15 % (as F). Whenmixed with other fluo­rine compounds permit­
ted under this Annex,
total F concentrationmust not exceed 0,15 %Official Journal of the European Union

For any toothpaste con­taining 0,1 to 0,15 %fluoride unless it isalready labelled ascontra-indicated for chil­dren (e.g. ‘for adult use
only’) the following
labelling is obligatory:EN

3-(N-HexadecylN-2-hydroxyethylammonio)
propylbis(2-hydroxyethyl)ammonium difluoride

L 342/144

Substance identification

Referencen u mb er

Contains N,N’,N’Tris(polyoxyethylene)-Nhexadecylpropylenediamine
dihydrofluoride

22.12.2009

For any toothpaste con­taining 0,1 to 0,15 %fluoride unless it isalready labelled ascontra-indicated for chil­dren (e.g. ‘for adult use
only’) the following
labelling is obligatory:

Restrictions

Chemical name/INN

N ame of Com mon
Ingredients Glossary

CAS number

EC number

Product type, body parts

Maximum concentration inready for use preparation

O therWording of conditions ofuse and warnings

a

b

c

d

e

f

g

h

i

9-Octadecenamine,hydrofluoride

Octadecenylammonium fluoride

2782-81-2—

Oral products

0,15 % (as F). Whenmixed with other fluo­rine compounds permit­
ted under this Annex,
total F concentrationmust not exceed 0,15 %Contains octadecenylammonium fluoride
For any toothpaste con­taining 0,1 to 0,15 %fluoride unless it isalready labelled ascontra-indicated for chil­dren (e.g. ‘for adult use
only’) the following
labelling is obligatory:‘Children of 6 years andyounger: Use a pea sizedamount for supervised
brushing to minimize
swallowing. In case of
intake of fluoride fromother sources consult adentist or doctor’

40

Disodium hexafluoro­ Sodium fluorosilicate
silicate

16893-85-9

240-934-8

Oral productsContains sodium fluoro­
silicate

L 342/145

0,15 % (as F). Whenmixed with other fluo­rine compounds permit­
ted under this Annex,
total F concentrationmust not exceed 0,15 %Official Journal of the European Union

39

EN‘Children of 6 years andyounger: Use a pea sizedamount for supervised
brushing to minimize
swallowing. In case of
intake of fluoride fromother sources consult adentist or doctor’

22.12.2009

Substance identification

Referencen u mb er

Restrictions

Chemical name/INN

N ame of Com mon
Ingredients Glossary

CAS number

EC number

Product type, body parts

Maximum concentration inready for use preparation

O therWording of conditions ofuse and warnings

a

b

c

d

e

f

g

h

i

41

Dipotassium
hexafluorosilicate

Potassium fluorosili­
cate

16871-90-2

240-896-2

Oral products

0,15 % (as F). Whenmixed with other fluo­rine compounds permit­
ted under this Annex,
total F concentrationmust not exceed 0,15 %Contains potassium fluo­
rosilicate

Official Journal of the European Union‘Children of 6 years andyounger: Use a pea sizedamount for supervised
brushing to minimize
swallowing. In case of
intake of fluoride fromother sources consult adentist or doctor’EN

For any toothpaste con­taining 0,1 to 0,15 %fluoride unless it isalready labelled ascontra-indicated for chil­dren (e.g. ‘for adult use
only’) the following
labelling is obligatory:

L 342/146

Substance identification

Referencen u mb er

For any toothpaste con­taining 0,1 to 0,15 %fluoride unless it isalready labelled ascontra-indicated for chil­dren (e.g. ‘for adult use
only’) the following
labelling is obligatory:

22.12.2009‘Children of 6 years andyounger: Use a pea sizedamount for supervised
brushing to minimize
swallowing. In case of
intake of fluoride fromother sources consult adentist or doctor’Restrictions

N ame of Com mon
Ingredients Glossary

CAS number

EC number

Product type, body parts

Maximum concentration inready for use preparation

O therWording of conditions ofuse and warnings

a

b

c

d

e

f

g

h

i

Ammoniumfluorosilicate

16919-19-0

240-968-3

Oral products

42

Ammoniumhexafluorosilicate

0,15 % (as F). Whenmixed with otherfluorine compounds
permitted under thisAnnex, total F
concentration must notexceed 0,15 %Contains ammonium
fluorosilicate
For any toothpaste con­taining 0,1 to 0,15 %fluoride unless it isalready labelled ascontra-indicated for chil­dren (e.g. ‘for adult use
only’) the following
labelling is obligatory:

43

Magnesium hexafluo­
rosilicate

Magnesium fluorosili­ 16949-65-8
cate241-022-2

Oral products

0,15 % (as F). Whenmixed with other fluo­rine compounds permit­
ted under this Annex,
total F concentrationmust not exceed 0,15 %Contains magnesium
fluorosilicate

Official Journal of the European Union‘Children of 6 years andyounger: Use a pea sizedamount for supervised
brushing to minimize
swallowing. In case of
intake of fluoride fromother sources consult adentist or doctor’ENChemical name/INN

22.12.2009

Substance identification

Referencen u mb er

For any toothpaste con­taining 0,1 to 0,15 %fluoride unless it isalready labelled ascontra-indicated for chil­dren (e.g. ‘for adult use
only’) the following
labelling is obligatory:

L 342/147‘Children of 6 years andyounger: Use a pea sizedamount for supervised
brushing to minimize
swallowing. In case of
intake of fluoride fromother sources consult adentist or doctor’Restrictions

Chemical name/INN

N ame of Com mon
Ingredients Glossary

CAS number

EC number

Product type, body parts

Maximum concentration inready for use preparation

O therWording of conditions ofuse and warnings

a

b

c

d

e

f

g

h

i

15534-95-9

239-579-1

44

Dimethylol ethylene
thiourea(a) Hair- products(a) 2 %(a) Not to be used inaerosol dispensers(sprays)(b) Nail- products(b) 2 %(b) pH < 4

Benzyl alcohol (7)Benzyl alcohol

100-51-6

202-859-9

Solvents, perfumes andflavourings

For purposes other thaninhibiting the develop­
ment of microorganisms in the
product. This purpose
has to be apparent fromthe presentation of the
product

46

6-Methylcoumarin

6-Methylcoumarin

92-48-8

202-158-8

Oral products

0,003 %

47

3-Pyridinemethanol,hydrofluoride

Nicomethanol hydrof­ 62756-44-9
luoride—Oral products

0,15 % (as F). Whenmixed with other fluo­rine compounds permit­
ted under this Annex,
total F concentrationmust not exceed 0,15 %Contains nicomethanolhydrofluoride
For any toothpaste con­taining 0,1 to 0,15 %fluoride unless it isalready labelled ascontra-indicated for chil­dren (e.g. ‘for adult use
only’) the following
labelling is obligatory:

Official Journal of the European Union

45

Contains Dimethylol
ethylene thiourea

EN

1,3-Bis(hydroxymethyl)
imidazolidine2-thione

L 342/148

Substance identification

Referencen u mb er‘Children of 6 years andyounger: Use a pea sizedamount for supervised
brushing to minimize
swallowing. In case of
intake of fluoride fromother sources consult adentist or doctor’Silver nitrate

Silver nitrate

7761-88-8

231-853-9

Only for colouring eye­lashes and eyebrows4%

Contains silver nitrate
Rinse eyes immediately if
product comes into con­tact with them

22.12.200948

Restrictions

Chemical name/INN

N ame of Com mon
Ingredients Glossary

CAS number

EC number

Product type, body parts

Maximum concentration inready for use preparation

O therWording of conditions ofuse and warnings

a

b

c

d

e

f

g

h

i

7488-56-4

231-303-8

49

Selenium sulfide

Selenium disulphide

Antidandruff shampoos 1 %Avoid contact with eyes
or damaged skin50

Aluminium zirconium
chloride hydroxide
complexes

Anti-perspirants

5,4 % (as zirconium)

1. The ratio of thenumber of alu­
minium atoms tothat of zirconium
atoms must be
between 2 and 10
2. The ratio of thenumber of (Al + Zr)
atoms to that ofchlorine atoms must
be between 0,9and 2,1
3. Not to be used inaerosol dispensers(sprays)51

Methanol

Methyl alcohol148-24-3/134-31-6

67-56-1

205-711-1/
205-137-1

200-659-6

Stabilizer for hydrogen
peroxide in rinse-off
hair- products

0,3 % (as base)Stabilizer for hydrogen
peroxide in leave-on
hair products

0,03 % (as base)

Denaturant for ethanol
and isopropyl alcohol

5 % (as a % ethanol andisopropyl alcohol)

L 342/149

52

Quinolin-8-ol and bis Oxyquinoline and(8-hydroxyoxyquinoline sulfate
quinolium) sulphate

Do not apply to irritatedor damaged skin

Official Journal of the European Union

AlxZr(OH)yClz and thealuminium zirconium
chloride hydroxide
glycine complexes

20 % (as anhydrous
aluminium zirconium
chloride hydroxide)EN

Contains selenium disul­phide

22.12.2009

Substance identification

Referencen u mb er

Restrictions

Chemical name/INN

N ame of Com mon
Ingredients Glossary

CAS number

EC number

Product type, body parts

Maximum concentration inready for use preparation

O therWording of conditions ofuse and warnings

a

b

c

d

e

f

g

h

i

2809-21-4

220-552-8

53

1-Phenoxypropan-2ol (8)Phenoxyisopropanol(a) Hair- product1,5 % (as etidronic acid)(b) Soap

0,2 % (as etidronic acid)Use only in rinse-off
products

2%

EN

54

(1-Hydroxyethylidene- Etidronic acid
diphosphonic acid)and its salts

770-35-4

212-222-7

Moved or deleted

56

Magnesium fluoride

Magnesium fluoride

7783-40-6

231-995-1

Oral products

0,15 % (as F). Whenmixed with other fluo­rine compounds permit­
ted under this Annex,
total F concentrationmust not exceed 0,15 %For purposes other thaninhibiting the develop­
ment of microorganisms in the
product. This purpose
has to be apparent fromthe presentation of the
product

Contains magnesium
fluoride

Official Journal of the European Union

Not to be used in oral
products

55

L 342/150

Substance identification

Referencen u mb er

For any toothpaste con­taining 0,1 to 0,15 %fluoride unless it isalready labelled ascontra-indicated for chil­dren (e.g. ‘for adult use
only’) the following
labelling is obligatory:

22.12.2009‘Children of 6 years andyounger: Use a pea sizedamount for supervised
brushing to minimize
swallowing. In case of
intake of fluoride fromother sources consult adentist or doctor’Restrictions

Chemical name/INN

N ame of Com mon
Ingredients Glossary

CAS number

EC number

Product type, body parts

Maximum concentration inready for use preparation

O therWording of conditions ofuse and warnings

a

b

c

d

e

f

g

h

i

10476-85-4

233-971-6

57

Talc

543-94-2

14807-96-6

208-854-8

238-877-9

3,5 % (as strontium).
When mixed with otherpermitted strontium
compounds the total
strontium content must
not exceed 3,5 %(b) Shampoo and face
products

2,1 % (as strontium).
When mixed with otherpermitted strontium
compounds the total
strontium content must
not exceed 2,1 %Oral products

3,5 % (as strontium).
When mixed with otherpermitted strontium
compounds the total
strontium content must
not exceed 3,5 %(a) Powdery products
intended to be used
for children under3 years of age(b) Other productsContains strontium chlo­ride
Frequent use by children
is not advisable

Contains strontium
acetateFrequent use by children
is not advisable(a) Keep powder awayfrom children’s noseand mouth

L 342/151

Talc: Hydrated mag­nesium silicate

Strontium acetate(a) Oral products

Official Journal of the European Union

59

Strontium acetatehemihydrate

Strontium chloride

EN

58

Strontium chloride
hexahydrate

22.12.2009

Substance identification

Referencen u mb er

Restrictions

Chemical name/INN

N ame of Com mon
Ingredients Glossary

CAS number

EC number

Product type, body parts

Maximum concentration inready for use preparation

O therWording of conditions ofuse and warnings

a

b

c

d

e

f

g

h

i

60

Maximum secondaryamine content: 0,5 %—Not to be usedwith nitrosating
systems—

Maximum second­ary amine content:
5 % (applies to raw
materials)—

Maximum nitro­samine content:
50 μg/kg—

Keep in nitrite-freecontainers—

Not to be usedwith nitrosating
systems- Minimum
purity: 99 %—Maximum second­ary amine content:
0,5 % (applies to
raw materials)—

Maximum nitro­samine content:
50 μg/kg—

Keep in nitrite-freecontainers

Official Journal of the European Union

Monoalkylamines,
monoalkanolamines
and their salts

Maximum secondaryamine content: 0,5 %EN

61

Fatty acid
dialkylamides anddialkanolamides

L 342/152

Substance identification

Referencen u mb er

22.12.2009

Restrictions

Chemical name/INN

N ame of Com mon
Ingredients Glossary

CAS number

EC number

Product type, body parts

Maximum concentration inready for use preparation

O therWording of conditions ofuse and warnings

a

b

c

d

e

f

g

h

i

62

(a) 2,5 %(b) Rinse-off products

Strontium hydroxide

18480-07-4

242-367-1

pH adjuster for depila­
tories

3,5 % (as strontium)(a) (b)— Not to be usedwith nitrosating
systems—

Minimum purity:
99 %—Maximum second­ary amine content:
0,5 % (applies to
raw materials)—

Maximum nitro­samine content:
50 μg/kg—

Keep in nitrite-freecontainers

pH ≤ 12,7

Keep out of reach ofchildren

Official Journal of the European Union

Strontium hydroxide(a) Leave-on products

EN

63

Trialkylamines,
trialkanolamines andtheir salts

22.12.2009

Substance identification

Referencen u mb er

Avoid contact with eyes

64

Strontium peroxide

Strontium peroxide

1314-18-7

215-224-6

Rinse-off hair products

4,5 % (as strontium)

For professional use only
Wear suitable gloves

L 342/153

All products must meet Avoid contact with eyes
the hydrogen peroxide
Rinse eyes immediately if
release requirements
product comes into con­Professional use
tact with them

Restrictions

Chemical name/INN

N ame of Com mon
Ingredients Glossary

CAS number

EC number

Product type, body parts

Maximum concentration inready for use preparation

O therWording of conditions ofuse and warnings

a

b

c

d

e

f

g

h

i

91080-29-4

293-522-5

6563449-41-2/
68391-01-5/
68424-85-1/
85409-22-9

264-151-6/
269-919-4/
270-325-2/
287-089-1

Benzalkonium
saccharinate

68989-01-5

273-545-7

Polyacrylamides

2-Benzylideneheptanal Amyl cinnamal

122-40-7

204-541-5

3 % (as benzalkonium
chloride)

In the final products the Avoid contact with eyes
concentrations ofbenzalkonium chloride,bromide andsaccharinate with analkyl chain of C14, orless must not exceed
0,1 % (as benzalkonium
chloride)
For purposes other thaninhibiting thedevelopment of
micro-organisms in the
product. This purpose
has to be apparent fromthe presentation of the
product(a) Body- leave-on
products(a) Maximum residual
acrylamide content
0,1 mg/kg(b) Other products(b) Maximum residual
acrylamide content
0,5 mg/kg

Official Journal of the European Union

67

Benzalkonium
chloride

Rinse-off hair (head)products

EN

66

Benzalkonium
Benzalkonium
chloride, bromide and bromide
saccharinate (9)L 342/154

Substance identification

Referencen u mb er

The presence of thesubstance must be indi­cated in the list of ingre­
dients referred to in
Article 19(1)(g) when its
concentration exceeds:
0,001 % inleave-on products—

0,01 % in rinse-off
products

22.12.2009—

Restrictions

Chemical name/INN

N ame of Com mon
Ingredients Glossary

CAS number

EC number

Product type, body parts

Maximum concentration inready for use preparation

O therWording of conditions ofuse and warnings

a

b

c

d

e

f

g

h

i

100-51-6

202-859-9

The presence of thesubstance must be indi­cated in the list of ingre­
dients referred to in
Article 19(1)(g) when its
concentration exceeds:— 0,001 % inleave-on products— 0,01 % in rinse-off
products

69

Cinnamyl alcohol

Cinnamyl alcohol

104-54-1

203-212-3

The presence of thesubstance must be indi­cated in the list of ingre­
dients referred to in
Article 19(1)(g) when its
concentration exceeds:— 0,001 % inleave-on products— 0,01 % in rinse-off
products

70

3,7-Dimethyl-2,6octadienal

Citral5392-40-5

226-394-6

The presence of thesubstance must be indi­cated in the list of ingre­
dients referred to in
Article 19(1)(g) when its
concentration exceeds:— 0,001 % inleave-on products— 0,01 % in rinse-off
products

L 342/155

Benzyl alcohol

Official Journal of the European Union

Benzyl alcoholEN68

22.12.2009

Substance identification

Referencen u mb er

Restrictions

Chemical name/INN

N ame of Com mon
Ingredients Glossary

CAS number

EC number

Product type, body parts

Maximum concentration inready for use preparation

O therWording of conditions ofuse and warnings

a

b

c

d

e

f

g

h

i

97-53-0

202-589-1

The presence of thesubstance must be indi­cated in the list of ingre­
dients referred to in
Article 19(1)(g) when its
concentration exceeds:— 0,001 % inleave-on products— 0,01 % in rinse-off
products

72

7-Hydroxycitronellal

Hydroxycitronellal

107-75-5

203-518-7

The presence of thesubstance must be indi­cated in the list of ingre­
dients referred to in
Article 19(1)(g) when its
concentration exceeds:— 0,001 % inleave-on products— 0,01 % in rinse-off
products

73

Phenol, 2-methoxy-4- Isoeugenol(1-propenyl)-97-54-1

202-590-7

The presence of thesubstance must be indi­cated in the list of ingre­
dients referred to in
Article 19(1)(g) when its
concentration exceeds:— 0,001 % inleave-on products— 0,01 % in rinse-off
products

22.12.2009

Eugenol

Official Journal of the European Union

Phenol, 2-methoxy4-(2-propenyl)EN71

L 342/156

Substance identification

Referencen u mb er

Restrictions

Chemical name/INN

N ame of Com mon
Ingredients Glossary

CAS number

EC number

Product type, body parts

Maximum concentration inready for use preparation

O therWording of conditions ofuse and warnings

a

b

c

d

e

f

g

h

i

101-85-9

202-982-8

The presence of thesubstance must be indi­cated in the list of ingre­
dients referred to in
Article 19(1)(g) when its
concentration exceeds:— 0,001 % inleave-on products— 0,01 % in rinse-off
products

75

Benzyl salicylate

Benzyl salicylate

118-58-1

204-262-9

The presence of thesubstance must be indi­cated in the list of ingre­
dients referred to in
Article 19(1)(g) when its
concentration exceeds:— 0,001 % inleave-on products— 0,01 % in rinse-off
products

762-Propenal, 3-phenyl- Cinnamal

104-55-2

203-213-9

The presence of thesubstance must be indi­cated in the list of ingre­
dients referred to in
Article 19(1)(g) when its
concentration exceeds:— 0,001 % inleave-on products— 0,01 % in rinse-off
products

L 342/157

Amylcinnamyl
alcohol

Official Journal of the European Union

2-Pentyl3-phenylprop2-en-1-ol

EN74

22.12.2009

Substance identification

Referencen u mb er

Restrictions

Chemical name/INN

N ame of Com mon
Ingredients Glossary

CAS number

EC number

Product type, body parts

Maximum concentration inready for use preparation

O therWording of conditions ofuse and warnings

a

b

c

d

e

f

g

h

i

91-64-5

202-086-7

The presence of thesubstance must be indi­cated in the list of ingre­
dients referred to in
Article 19(1)(g) when its
concentration exceeds:— 0,001 % inleave-on products— 0,01 % in rinse-off
products

78

2,6-Octadien-1-ol,
3,7-dimethyl-, (2E)-

Geraniol

106-24-1

203-377-1

The presence of thesubstance must be indi­cated in the list of ingre­
dients referred to in
Article 19(1)(g) when its
concentration exceeds:— 0,001 % inleave-on products— 0,01 % in rinse-off
products

79

3 and 4-(4-Hydroxy4-methylpentyl)
cyclohex-3-ene-1carbaldehyde

Hydroxyisohexyl
51414-25-6/3-cyclohexene carbox­ 31906-04-4
aldehyde257-187-9/
250-863-4

The presence of thesubstance must be indi­cated in the list of ingre­
dients referred to in
Article 19(1)(g) when its
concentration exceeds:— 0,001 % inleave-on products— 0,01 % in rinse-off
products

22.12.2009

Coumarin

Official Journal of the European Union

2H-1-Benzopyran2-one

EN77

L 342/158

Substance identification

Referencen u mb er

Restrictions

Chemical name/INN

N ame of Com mon
Ingredients Glossary

CAS number

EC number

Product type, body parts

Maximum concentration inready for use preparation

O therWording of conditions ofuse and warnings

a

b

c

d

e

f

g

h

i

105-13-5

203-273-6

The presence of thesubstance must be indi­cated in the list of ingre­
dients referred to in
Article 19(1)(g) when its
concentration exceeds:— 0,001 % inleave-on products— 0,01 % in rinse-off
products

81

2-Propenoic acid,3-phenyl-, phenylm­
ethyl ester

Benzyl cinnamate

103-41-3

203-109-3

The presence of thesubstance must be indi­cated in the list of ingre­
dients referred to in
Article 19(1)(g) when its
concentration exceeds:— 0,001 % inleave-on products— 0,01 % in rinse-off
products

82

2,6,10-Dodecatrien-1- Farnesolol, 3,7,11-trimethyl-4602-84-0

225-004-1

The presence of thesubstance must be indi­cated in the list of ingre­
dients referred to in
Article 19(1)(g) when its
concentration exceeds:— 0,001 % inleave-on products— 0,01 % in rinse-off
products

L 342/159

Anise alcohol

Official Journal of the European Union

4-Methoxybenzyl
alcoholEN

80

22.12.2009

Substance identification

Referencen u mb er

Restrictions

Chemical name/INN

N ame of Com mon
Ingredients Glossary

CAS number

EC number

Product type, body parts

Maximum concentration inready for use preparation

O therWording of conditions ofuse and warnings

a

b

c

d

e

f

g

h

i

80-54-6

201-289-8

The presence of thesubstance must be indi­cated in the list of ingre­
dients referred to in
Article 19(1)(g) when its
concentration exceeds:— 0,001 % inleave-on products— 0,01 % in rinse-off
products

84

1,6-Octadien-3-ol,
3,7-dimethyl-

Linalool

78-70-6

201-134-4

The presence of thesubstance must be indi­cated in the list of ingre­
dients referred to in
Article 19(1)(g) when its
concentration exceeds:— 0,001 % inleave-on products— 0,01 % in rinse-off
products

85

Benzyl benzoate

Benzyl benzoate

120-51-4

204-402-9

The presence of thesubstance must be indi­cated in the list of ingre­
dients referred to in
Article 19(1)(g) when its
concentration exceeds:— 0,001 % inleave-on products— 0,01 % in rinse-off
products

22.12.2009

Butylphenyl
methylpropional

Official Journal of the European Union

2-(4-tert-Butylbenzyl)
propionaldehydeEN83

L 342/160

Substance identification

Referencen u mb er

Restrictions

Chemical name/INN

N ame of Com mon
Ingredients Glossary

CAS number

EC number

Product type, body parts

Maximum concentration inready for use preparation

O therWording of conditions ofuse and warnings

a

b

c

d

e

f

g

h

i

106-22-9/26489-01-0

203-375-0/
247-737-6

The presence of thesubstance must be indi­cated in the list of ingre­
dients referred to in
Article 19(1)(g) when its
concentration exceeds:— 0,001 % inleave-on products— 0,01 % in rinse-off
products

87

2-Benzylideneoctanal

Hexyl cinnamal

101-86-0

202-983-3

The presence of thesubstance must be indi­cated in the list of ingre­
dients referred to in
Article 19(1)(g) when its
concentration exceeds:— 0,001 % inleave-on products— 0,01 % in rinse-off
products

88(4R)-1-Methyl-4-(1methylethenyl)cyclo­
hexeneLimonene

5989-27-5

227-813-5

The presence of thesubstance must be indi­cated in the list of ingre­
dients referred to in
Article 19(1)(g) when its
concentration exceeds:— 0,001 % inleave-on products— 0,01 % in rinse-off
products

L 342/161

Citronellol

Official Journal of the European Union

Citronellol/(±)-3,7-dimethyloct6-en-1-ol

EN86

22.12.2009

Substance identification

Referencen u mb er

Restrictions

Chemical name/INN

N ame of Com mon
Ingredients Glossary

CAS number

EC number

Product type, body parts

Maximum concentration inready for use preparation

O therWording of conditions ofuse and warnings

a

b

c

d

e

f

g

h

i

111-12-6

203-836-6

The presence of thesubstance must be indi­cated in the list of ingre­
dients referred to in
Article 19(1)(g) when its
concentration exceeds:— 0,001 % inleave-on products— 0,01 % in rinse-off
products

90

3-Methyl-4-(2,6,6trimethyl-2cyclohexen-1-yl)-3buten-2-one

alpha-Isomethyl ion­one

127-51-5

204-846-3

The presence of thesubstance must be indi­cated in the list of ingre­
dients referred to in
Article 19(1)(g) when its
concentration exceeds:— 0,001 % inleave-on products— 0,01 % in rinse-off
products

91

Oak moss extract

Evernia prunastri
extract

90028-68-5

289-861-3

The presence of thesubstance must be indi­cated in the list of ingre­
dients referred to in
Article 19(1)(g) when its
concentration exceeds:— 0,001 % inleave-on products— 0,01 % in rinse-off
products

22.12.2009

Methyl 2-octynoate

Official Journal of the European Union

Methyl heptin
carbonateEN89

L 342/162

Substance identification

Referencen u mb er

Restrictions

Chemical name/INN

N ame of Com mon
Ingredients Glossary

CAS number

EC number

Product type, body parts

Maximum concentration inready for use preparation

O therWording of conditions ofuse and warnings

a

b

c

d

e

f

g

h

i

90028-67-4

289-860-8

92

Treemoss extract

The presence of thesubstance must be indi­cated in the list of ingre­
dients referred to in
Article 19(1)(g) when its
concentration exceeds:

2,4Pyrimidinediamine,
3-oxideDiaminopyrimidine
oxide74638-76-9—

Hair products

1,5 %

94

Dibenzoyl peroxide

Benzoyl peroxide

94-36-0

202-327-6

Artificial nail systems

0,7 % (after mixing foruse)

0,001 % inleave-on products—

0,01 % in rinse-off
products

Professional use

For professional use only
Avoid skin contact
Read directions for use
carefully

95

Hydroquinone
p-Hydroxyanisol
methylether/Mequinol

150-76-5

205-769-8

Artificial nail systems

0,02 % (after mixing for Professional use
use)

Official Journal of the European Union

93

—

EN

Evernia furfuracea
extract

22.12.2009

Substance identification

Referencen u mb er

For professional use only
Avoid skin contact
Read directions for use
carefully

96

5-tert-Butyl-2,4,6trinitro-m-xylene

Musk xylene

81-15-2

201-329-4

All cosmetic products,
with the exception oforal products(a) 1,0 % in fine fra­
grance(c) 0,03 % in otherproducts

L 342/163(b) 0,4 % in eau detoilette

Restrictions

Chemical name/INN

N ame of Com mon
Ingredients Glossary

CAS number

EC number

Product type, body parts

Maximum concentration inready for use preparation

O therWording of conditions ofuse and warnings

a

b

c

d

e

f

g

h

i

97

Musk ketone

81-14-1

201-328-9

All cosmetic products,
with the exception oforal products(a) 1,4 % in fine fra­
granceEN

4’-tert-Butyl-2’,6’dimethyl-3’,5’dinitroacetophenone

L 342/164

Substance identification

Referencen u mb er(b) 0,56 % in eau detoilette(c) 0,042 % in otherproducts

98

Salicylic acid

69-72-7

200-712-3(a) Rinse-off hair prod­ (a) 3,0 %ucts(b) 2,0 %(b) Other products

Not to be used in prepa­ Not to be used for chil­rations for children
dren under 3 years ofunder 3 years of age,age (11)
except for shampoos
For purposes other thaninhibiting the develop­
ment of microorganisms in the
product. This purpose
has to be apparent fromthe presentation of the
product

99

Inorganic sulfites andbisulfites (12)(a) Oxidative hair dye
products(b) Hair straightening
products(a) 0,67 % (as free SO2) For purposes other thaninhibiting the develop­
ment of microorganisms in the
product. This purpose
has to be apparent from(b) 6,7 % (as free SO2) the presentation of the
product(c) 0,45 % (as free SO2)(d) Other self-tanning
products(d) 0,40 % (as freeSO2)

22.12.2009(c) Self-tanning prod­
ucts for the face

Official Journal of the European Union

Benzoic acid,
2-hydroxy- (10)Restrictions

Chemical name/INN

N ame of Com mon
Ingredients Glossary

CAS number

EC number

Product type, body parts

Maximum concentration inready for use preparation

O therWording of conditions ofuse and warnings

a

b

c

d

e

f

g

h

i

100

101-20-2

202-924-1

Rinse-off products

1,5 %Purity criteria:
3,3’,4,4’Tetrachloroazobenzene≤ 1 ppmEN

1-(4-Chlorophenyl)-3- Triclocarban(3,4-dichlorophenyl)
urea (13)22.12.2009

Substance identification

Referencen u mb er

3,3’,4,4’Tetrachloroazoxyben­
zene ≤ 1 ppm

101

Pyrithione zinc (14)Zinc pyrithione

13463-41-7

236-671-3

Leave-on hair products

0,1 %

102

1,2-Dimethoxy-4-(2propenyl)-benzene

Methyl eugenol

93-15-2

202-223-0

Fine fragrance

0,01 %

Eau de toilette

0,004 %

Fragrance cream

0,002 %

Rinse-off products

0,001 %

L 342/165

Other leave-on products 0,0002 %and oral products

For purposes other thaninhibiting the develop­
ment of microorganisms in the
product. This purpose
has to be apparent fromthe presentation of the
product

Official Journal of the European Union

For purposes other thaninhibiting the develop­
ment of microorganisms in the
product. This purpose
has to be apparent fromthe presentation of the
product

Restrictions

Chemical name/INN

N ame of Com mon
Ingredients Glossary

CAS number

EC number

Product type, body parts

Maximum concentration inready for use preparation

O therWording of conditions ofuse and warnings

a

b

c

d

e

f

g

h

i

215

Naphthalene-2,7-diol582-17-2

210-236-8

209-478-7(a) Oxidising colouring (a) 3,0 %agents for hair dye­ing(b) Non-oxidisingcolouring agentsfor hair dyeing(b) 3,0 %Oxidising colouring
agents for hair dyeing

1,0 %In combination with(a) (b) Can cause aller­hydrogen peroxide thegic reaction
maximum use concen­
tration upon applicationis 1,5 %Not to be used after
31.12.2009

In combination withhydrogen peroxide themaximum use concen­
tration upon application
is 0,5 %Not to be used after
31.12.2009

217

m-Aminophenol andits salts

3-Aminophenol

591-27-5

209-711-2

Oxidising colouring
agents for hair dyeing

2,0 %In combination with
Can cause allergic reac­hydrogen peroxide the tion
maximum use concen­
tration upon applicationis 1,0 %Official Journal of the European Union

2,7-Naphthalenediol
and its salts

4-Amino-3-nitrophenol 610-81-1

EN

216

4-Amino3-nitrophenol and its
salts

L 342/166

Substance identification

Referencen u mb er

Not to be used after
31.12.2009

218

2,6-Dihydroxy-3,4dimethylpyridine andits salts

2,6-Dihydroxy-3,4dimethylpyridine

84540-47-6

283-141-2

Oxidising colouring
agents for hair dyeing

2,0 %Not to be used after
31.12.2009

22.12.2009

In combination withhydrogen peroxide themaximum use concen­
tration upon applicationis 1,0 %Restrictions

Chemical name/INN

N ame of Com mon
Ingredients Glossary

CAS number

EC number

Product type, body parts

Maximum concentration inready for use preparation

O therWording of conditions ofuse and warnings

a

b

c

d

e

f

g

h

i

92952-81-3

406-305-9

219

4-Hydroxypropylamino3-nitrophenol(a) Oxidising colouring (a) 5,2 %agents for hair dye­ing(b) Non-oxidisingcolouring agentsfor hair dyeing

1-[(2’-Methoxyethyl)amino]-2-nitro-4-[di(2’-hydroxyethyl)amino]benzene andits salts

HC Blue No 1123920-15-2

459-980-7(a) Oxidising colouring (a) 3,0 %agents for hair dye­ing(b) Non-oxidisingcolouring agentsfor hair dyeing

221

1-Methyl-3-nitro-4Hydroxyethyl-2-nitro- 100418-33-5(.beta.-hydroxyethyl) p-toluidine
aminobenzene and its
salts

408-090-7(a) Oxidising colouring (a) 2,0 %agents for hair dye­ing(b) Non-oxidisingcolouring agentsfor hair dyeing

222

1-Hydroxy-2-.beta.hydroxyethylamino4,6-dinitrobenzene
and its salts

2-Hydroxyethylpicramic acid

99610-72-7

412-520-9(b) 2,0 %(b) 1,0 %(a) Oxidising colouring (a) 3,0 %agents for hair dye­ing(b) 2,0 %In combination with(a) (b) Can cause aller­hydrogen peroxide thegic reaction
maximum use concen­
tration upon applicationis 1,5 %Not to be used after
31.12.2009

In combination with(a) (b) Can cause aller­hydrogen peroxide thegic reaction
maximum use concen­
tration upon applicationis 1,0 %Not to be used after
31.12.2009

In combination with(a) (b) Can cause aller­hydrogen peroxide thegic reaction
maximum use concen­
tration upon applicationis 1,5 %Not to be used after
31.12.2009

L 342/167(b) Non-oxidisingcolouring agentsfor hair dyeing

Not to be used after
31.12.2009

Official Journal of the European Union

220(b) 2,6 %In combination with(a) (b) Can cause aller­hydrogen peroxide thegic reaction
maximum use concen­
tration upon applicationis 2,6 %EN

1-Hydroxy-3-nitro4-(3-hydroxypro
pylamino)benzene
and its salts

22.12.2009

Substance identification

Referencen u mb er

Restrictions

Chemical name/INN

N ame of Com mon
Ingredients Glossary

CAS number

EC number

Product type, body parts

Maximum concentration inready for use preparation

O therWording of conditions ofuse and warnings

a

b

c

d

e

f

g

h

i

223

205-768-2

Oxidising colouring
agent for hair dyeing

3,0 %In combination with
Can cause allergic reac­hydrogen peroxide the tion
maximum use concen­
tration upon applicationis 1,5 %EN

4-Methylaminophenol p-Methylaminophenol 150-75-4
and its salts

L 342/168

Substance identification

Referencen u mb er

Not to be used after
31.12.2009
1-(3-HydroxyHC Violet No 2
propylamino)-2-nitro4-bis(2hydroxyethylamino)
benzene and its salts

104226-19-9

410-910-3

Non-oxidising colouring 2,0 %agent for hair dyeing

Not to be used after
31.12.2009

225

1-(.beta.HC Blue No 12
Hydroxyethyl)amino-2-nitro-4-Nethyl-N-(.beta.hydroxyethyl)aminobenzene and its
salts

104516-93-0

407-020-2(a) Oxidising colouring (a) 1,5 %agents for hair dye­ing

In combination with(a) (b) Can cause aller­hydrogen peroxide thegic reaction
maximum use concen­
tration upon application
is 0,75 %(b) Non-oxidisingcolouring agentsfor hair dyeing(b) 1,5 %Not to be used after
31.12.2009

Oxidising colouring
agents for hair dyeing

2,0 %In combination with
Can cause allergic reac­hydrogen peroxide the tion
maximum use concen­
tration upon applicationis 1,0 %226

4,4’-[1,3Propanediylbis(oxy)]bis-, benzene1,3-diamine and its
salts

1,3-Bis-(2,481892-72-0
diaminophenoxy)pro­pane

279-845-4

Official Journal of the European Union

224

Not to be used after
31.12.2009

227

3-Amino-2,4dichlorophenol andits salts

3-Amino-2,4dichlorophenol

61693-43-4

262-909-0

Oxidising colouring
agents for hair dyeing

2,0 %Not to be used after
31.12.2009

22.12.2009

In combination with
Can cause allergic reac­hydrogen peroxide the tion
maximum use concen­
tration upon applicationis 1,0 %Restrictions

Chemical name/INN

N ame of Com mon
Ingredients Glossary

CAS number

EC number

Product type, body parts

Maximum concentration inready for use preparation

O therWording of conditions ofuse and warnings

a

b

c

d

e

f

g

h

i

228

Phenyl methyl
pyrazolone

89-25-8

201-891-0

Oxidising colouring
agents for hair dyeing

0,5 %In combination withhydrogen peroxide themaximum use concen­
tration upon application
is 0,25 %EN

3-Methyl-1-phenyl5-pyrazolone and its
salts

22.12.2009

Substance identification

Referencen u mb er

Not to be used after
31.12.2009229

2-Methyl-5hydroxyethylami­
nophenol

55302-96-0

259-583-7

Oxidising colouring
agents for hair dyeing

2,0 %In combination with
Can cause allergic reac­hydrogen peroxide the tion
maximum use concen­
tration upon applicationis 1,0 %Not to be used after
31.12.2009230

3,4-Dihydro-2H-1,4benzoxazin-6-ol andits salts

Hydroxybenzomor­
pholine26021-57-8

247-415-5

Oxidising colouring
agents for hair dyeing

2,0 %In combination with
Can cause allergic reac­hydrogen peroxide the tion
maximum use concen­
tration upon applicationis 1,0 %Not to be used after
31.12.2009

1,5-bis(.beta.HC Yellow No 10
Hydroxyethyl)amino-2-nitro-4chlorobenzene and its
salts

109023-83-8

416-940-3

Non-oxidising colouring 0,2 %agents for hair dyeing

Not to be used after
31.12.2009232

3,5-Diamino-2,6dimethoxypyridine
and its salts

85679-78-3/
56216-28-5- / 260-062-1

Oxidising colouring
agents for hair dyeing

In combination with
Can cause allergic reac­hydrogen peroxide the tion
maximum use concen­
tration upon application
is 0,25 %2,6-Dimethoxy-3,5pyridinediamine HCl

0,5 %Not to be used after
31.12.2009

L 342/169

231

Official Journal of the European Union

5-[(2-Hydroxyethyl)amino]-o-cresol andits salts

Restrictions

Chemical name/INN

N ame of Com mon
Ingredients Glossary

CAS number

EC number

Product type, body parts

Maximum concentration inready for use preparation

O therWording of conditions ofuse and warnings

a

b

c

d

e

f

g

h

i

HC Orange No 285765-48-6

416-410-1

Non-oxidising colouring 1,0 %agents for hair dyeing

Not to be used after
31.12.2009234

Ethanol, 2-[(4-amino- HC Violet No 1
2-methyl5-nitrophenyl)amino]-and its salts

82576-75-8

417-600-7(a) Oxidising colouring (a) 0,5 %agents for hair dye­ing

In combination withhydrogen peroxide themaximum use concen­
tration upon application
is 0,25 %(b) Non-oxidisingcolouring agentsfor hair dyeing(b) 0,5 %Not to be used after
31.12.2009

235

2-[3-(Methylamino)-4- 3-Methylamino-459820-63-2
nitrophenoxy]
nitro-phenoxyethanol
ethanol and its salts

261-940-7

Non-oxidising colouring 1,0 %agents for hair dyeing

Not to be used after
31.12.2009236

2-[(2-Methoxy-42-Hydroxynitrophenyl)amino]et­ ethylamino-5-nitrohanol and its salts
anisole66095-81-6

266-138-0

Non-oxidising colouring 1,0 %agents for hair dyeing

Not to be used after
31.12.2009237

2,2’-[(4-Amino-3nitrophenyl)imino­]bisethanolhydrochloride andother salts

94158-13-1

303-083-4(a) Oxidising colouring (a) 2,5 %agents for hair dye­ing

In combination withhydrogen peroxide themaximum use concen­
tration upon applicationis 1,25 %Naphthalene-1,5-dioland its salts

1,5-Naphthalenediol

83-56-7

201-487-4(b) Non-oxidisingcolouring agentsfor hair dyeing(b) 2,5 %Oxidising colouring
agents for hair dyeing

1,0 %Not to be used after
31.12.2009

Not to be used after
31.12.2009

22.12.2009

238

HC Red No 13

Official Journal of the European Union

1-(2-Aminoethyl)amino-4(2-hydroxyethyl)oxy2-nitrobenzene andits salts

EN233

L 342/170

Substance identification

Referencen u mb er

Restrictions

Chemical name/INN

N ame of Com mon
Ingredients Glossary

CAS number

EC number

Product type, body parts

Maximum concentration inready for use preparation

O therWording of conditions ofuse and warnings

a

b

c

d

e

f

g

h

i

239

Hydroxypropyl
128729-30-6bis(N-hydroxyethylp-phenyldiamine) HCl

416-320-2

Oxidising colouring
agents for hair dyeing

3,0 %In combination with
Can cause allergic reac­hydrogen peroxide the tion
maximum use concen­
tration upon applicationis 1,5 %ENHydroxypropylbis(N-hydroxyethylp-phenylenediamine)
and its salts

22.12.2009

Substance identification

Referencen u mb er

Not to be used after
31.12.2009

o-Aminophenol andits saltso-Aminophenol

95-55-6

202-431-1

Oxidising colouring
agents for hair dyeing

2,0 %In combination withhydrogen peroxide themaximum use concen­
tration upon applicationis 1,0 %Not to be used after
31.12.2009

241

5-Amino-o-cresol and 4-Amino-2its saltshydroxytoluene2835-95-2

220-618-6

Oxidising colouring
agents for hair dyeing

3,0 %In combination withhydrogen peroxide themaximum use concen­
tration upon applicationis 1,5 %Official Journal of the European Union

240

Not to be used after
31.12.2009

242

2,42,466422-95-5
Diaminophenoxyetha­ Diaminophenoxyetha­
nol and its salts
nol HCl

266-357-1

Oxidising colouring
agents for hair dyeing

4,0 %Not to be used after
31.12.2009

L 342/171

In combination withhydrogen peroxide themaximum use concen­
tration upon applicationis 2,0 %Restrictions

Chemical name/INN

N ame of Com mon
Ingredients Glossary

CAS number

EC number

Product type, body parts

Maximum concentration inready for use preparation

O therWording of conditions ofuse and warnings

a

b

c

d

e

f

g

h

i

243

2-Methylresorcinol

608-25-3

210-155-8

Oxidising colouring
agents for hair dyeing

2,0 %In combination withhydrogen peroxide themaximum use concen­
tration upon applicationis 1,0 %EN

1,3-Benzenediol,
2-methyl-, and its
salts -

L 342/172

Substance identification

Referencen u mb er

Not to be used after
31.12.2009244

4-Amino-m-cresoland its salts

4-Amino-m-cresol

2835-99-6

220-621-2

Oxidising colouring
agents for hair dyeing

3,0 %Not to be used after
31.12.2009245

2-[(3-amino-4methoxyphenyl)ami­no]ethanol and its
salts

2-Amino-4hydroxyethylami­
noanisole

83763-47-7

280-733-2

Oxidising colouring
agents for hair dyeing

3,0 %In combination withhydrogen peroxide themaximum use concen­
tration upon applicationis 1,5 %Not to be used after
31.12.2009

246

247

Hydroxyethyl-3,4Hydroxyethyl-3,481329-90-0
methylenedioxyaniline methylenedioxyaniline
2-(1,3-benzodioxol-5- HCI
ylamino)ethanolhydrochloride andother salts

303-085-5

2,2’-[[4-[(2Hydroxyethyl)amino]-3nitrophenyl]imino­]bisethanol. and its
salts

251-410-3

HC Blue No 233229-34-4

Oxidising colouring
agents for hair dyeing

3,0 %Official Journal of the European Union

In combination withhydrogen peroxide themaximum use concen­
tration upon applicationis 1,5 %In combination withhydrogen peroxide themaximum use concen­
tration upon applicationis 1,5 %Not to be used after
31.12.2009

Not to be used after
31.12.2009

22.12.2009

Non-oxidising colouring 2,8 %agents for hair dyeingRestrictions

Chemical name/INN

N ame of Com mon
Ingredients Glossary

CAS number

EC number

Product type, body parts

Maximum concentration inready for use preparation

O therWording of conditions ofuse and warnings

a

b

c

d

e

f

g

h

i

65235-31-6

265-648-0

248

251

4-Nitrophenyl amino­ 27080-42-8ethylurea

HC Red No 10
1-amino-2-nitro-4(2’,3’and HC Red No 11
dihydroxypropyl)
amino-5chlorobenzene
and 1,4-bis-(2’,3’dihydroxypropyl)
amino-2-nitro-5chlorobenzene and its
salts

95576-89-9
and 95576-92-4

Phenol, 2-chloro-6(ethylamino)-4-nitroand its salts

131657-78-8

2-Chloro-6ethylamino-4nitrophenol

410-700-1—

In combination withhydrogen peroxide themaximum use concen­
tration upon applicationis 3,0 %(b) Non-oxidisingcolouring agentsfor hair dyeing

Not to be used after
31.12.2009(a) Oxidising colouring (a) 0,5 %agents for hair dye­ing

In combination withhydrogen peroxide themaximum use concen­
tration upon application
is 0,25 %(b) Non-oxidisingcolouring agentsfor hair dyeing

Not to be used after
31.12.2009(b) 0,5 %(a) Oxidising colouring (a) 2,0 %agents for hair dye­ing(b) Non-oxidisingcolouring agentsfor hair dyeing

411-440-1(b) 6,0 %(b) 1,0 %In combination withhydrogen peroxide themaximum use concen­
tration upon applicationis 1,0 %Not to be used after
31.12.2009

In combination withhydrogen peroxide themaximum use concen­
tration upon applicationis 1,5 %(b) Non-oxidisingcolouring agentsfor hair dyeing

Not to be used after
31.12.2009

L 342/173(a) Oxidising colouring (a) 3,0 %agents for hair dye­ing(b) 3,0 %Official Journal of the European Union250

1-(.beta.-Ureidoethy­l)amino-4-nitroben­
zene and its salts(a) Oxidising colouring (a) 6,0 %agents for hair dye­
ing

EN

249

4-[(2-Hydroxyethyl)
3-Nitro-p-hydroxyeamino]-3-nitrophenol thylaminophenol
and its salts

22.12.2009

Substance identification

Referencen u mb er

Restrictions

Chemical name/INN

N ame of Com mon
Ingredients Glossary

CAS number

EC number

Product type, body parts

Maximum concentration inready for use preparation

O therWording of conditions ofuse and warnings

a

b

c

d

e

f

g

h

i

6358-09-4

228-762-1

252

2-Amino-6-chloro4-nitrophenol(a) Oxidising colouring (a) 2,0 %agents for hair dye­ing(b) Non-oxidisingcolouring agentsfor hair dyeing

2580-56-5(a) Oxidising colouring (a) 0,5 %agents for hair dye­
ing

254

Disodium 5-amino-4- Acid Red 33 (CIhydroxy-317200)(phenylazo)
naphthalene-2,7disulphonate (CI17200) and othersalts

3567-66-6

222-656-9

Non-oxidising colouring 2,0 %agents for hair dyeing

Not to be used after
31.12.2009255

Disodium 3-[(2,4dimethyl-5sulphonatophenyl)azo]-4hydroxynaphthalene1-sulphonate (CI14700) and othersalts

4548-53-2

224-909-9

Non-oxidising colouring 2,0 %agents for hair dyeing

Not to be used after
31.12.2009(b) Non-oxidisingcolouring agentsfor hair dyeing(b) 0,5 %In combination withhydrogen peroxide themaximum use concen­
tration upon application
is 0,25 %Not to be used after
31.12.2009

22.12.2009[4-[[4-Anilino-1Basic Blue 26 (CInaphthyl][444045)(dimethylamino)
phenyl]methylene]
cyclohexa-2,5-dien-1ylidene]
dimethylammonium
chloride (CI 44045)
and other salts

Ponceau SX (CI14700)

219-943-6

Not to be used after
31.12.2009

Official Journal of the European Union

253(b) 2,0 %In combination withhydrogen peroxide themaximum use concen­
tration upon applicationis 1,0 %EN

2-Amino-6-chloro4-nitrophenol and its
salts

L 342/174

Substance identification

Referencen u mb er

Restrictions

Chemical name/INN

N ame of Com mon
Ingredients Glossary

CAS number

EC number

Product type, body parts

Maximum concentration inready for use preparation

O therWording of conditions ofuse and warnings

a

b

c

d

e

f

g

h

i

256

Basic Violet 14(CI 42510)

632-99-5

211-189-6(a) Oxidising colouring (a) 0,3 %agents for hair dye­ing(b) Non-oxidisingcolouring agentsfor hair dyeing(b) 0,3 %In combination withhydrogen peroxide themaximum use concen­
tration upon application
is 0,15 %EN(4-(4-Aminophenyl)(4-iminocyclohexa2,5-dienylidene)
methyl)2-methylanilinehydrochloride(CI 42510) and othersalts

22.12.2009

Substance identification

Referencen u mb er

Not to be used after
31.12.2009(1) These substances may be used singly or in combination provided that the sum of the ratios of the levels of each of them in the cosmetic product expressed with reference to the maximum level authorised for each of them does not exceed 1.
(2) For use as a preservative, see Annex V, No. 5.
(3) Only if the concentration exceeds 0,05 %.
(5) The quantity of sodium, potassium or lithium hydroxide is expressed as weight of sodium hydroxide. In cases of mixtures, the sum should not exceed the limits given in column g.
(6) The concentration of sodium, potassium or lithium hydroxide is expressed as weight of sodium hydroxide. In case of mixtures, the sum should not exceed the limits given in column g.
(7) For use as a preservative, see Annex V, No. 34.
(8) For use as a preservative, see Annex V, No 43.
(9) For use as a preservative, see Annex V, No. 54.
(10) For use as a preservative, see Annex V, No 3.
(11) Solely for products which might be used for children under 3 years of age and which remain in prolonged contact with the skin.
(12) For use as a preservative, see Annex V, No 9.
(13) For use as a preservative, see AnnexV, No 23.
(14) For use as a preservative, see Annex V, No 8.

Official Journal of the European Union(4) These substances may be used singly or in combination provided that the sum of the ratios of the levels of each of them in the cosmetic product expressed with reference to the maximum level authorised for each of them does not exceed 2.

L 342/175

L 342/176

ANNEX IV
LIST OF COLORANTS ALLOWED IN COSMETIC PRODUCTS
PreambleEN

Without prejudice to other provisions in this Regulation, a colorant shall include its salts and lakes and when a colorant is expressed as a specific salt, its other salts and lakes shall also be included.

Substance identificationa

Chemical Name

Colour index
N umb er/Na me ofCommon Ingredients
Glossary

CAS number

EC number

Colour

b

c

d

e

f

Product type, Body parts

Maximum concentration inready for use
preparation

Other

Wording of conditions of use
and warnings

g

h

i

j

Sodium tris(1,2-naphthoquinone
1-oximato-O,O’)ferrate(1-)

10006

Green

Rinse-off products

2

Trisodium tris[5,6-dihydro-5(hydroxyimino)-6-oxonaphthalene-2sulphonato(2-)-N5,O6]ferrate(3-)

10020

Green

Not to be used in products
applied on mucous membranes

3

Disodium 5,7-dinitro-8oxidonaphthalene-2-sulphonate and its
insoluble barium, strontium and zirconium lakes, salts and pigments

10316

Yellow

Not to be used in eye products

42-[(4-Methyl-2-nitrophenyl)azo]-3-oxo-N- 11680
phenylbutyramide

Yellow

Not to be used in products
applied on mucous membranes

5

2-[(4-Chloro-2-nitrophenyl)azo]-N-(2chlorophenyl)-3-oxobutyramide

11710

Yellow

Not to be used in products
applied on mucous membranes

6

2-[(4-Methoxy-2-nitrophenyl)azo]-3-oxoN-(o-tolyl)butyramide

11725

OrangeRinse-off products7

4-(Phenylazo)resorcinol

11920

Orange84-[(4-Ethoxyphenyl)azo]naphthol

12010

Red

Not to be used in products
applied on mucous membranes

22.12.2009

1

Official Journal of the European Union

Referencen u mb er

Con dit ion sReferencen u mb era

Con dit ion s

Chemical Name

Colour index
N umb er/Na me ofCommon Ingredients
Glossary

CAS number

EC number

Colour

b

c

d

e

f

Product type, Body parts

Maximum concentration inready for use
preparation

Other

Wording of conditions of use
and warnings

g

h

i

j

12085

Red

10

1-[(4-Methyl-2-nitrophenyl)azo]-2naphthol

12120

Red

Rinse-off products

11

3-Hydroxy-N-(o-tolyl)-4-[(2,4,5trichlorophenyl)azo]naphthalene-2carboxamide

12370

Red

Rinse-off products

12

N-(4-Chloro-2-methylphenyl)-4-[(4chloro-2-methylphenyl)azo]-3hydroxynaphthalene-2-carboxamide

12420

Red

Rinse-off products

13

4-[(2,5-Dichlorophenyl)azo]-N-(2,512480
dimethoxyphenyl)-3-hydroxynaphthalene2-carboxamide

Brown

Rinse-off products

14

N-(5-Chloro-2,4-dimethoxyphenyl)-4-[[5- 12490[(diethylamino)sulphonyl]-2methoxyphenyl]azo]-3hydroxynaphthalene-2-carboxamide

Red

15

2,4-Dihydro-5-methyl-2-phenyl-4(phenylazo)-3H-pyrazol-3-one

12700

Yellow

16

Disodium 2-amino-5-[(413015
sulphonatophenyl)azo]benzenesulphonate

Yellow

17

Sodium 4-(2,4dihydroxyphenylazo)benzenesulphonate

14270

Orange18

Disodium 3-[(2,4-dimethyl-5sulphonatophenyl)azo]-4hydroxynaphthalene-1-sulphonate

14700

Red

19

Disodium 4-hydroxy-3-[(4sulphonatonaphthyl)azo]naphtha­
lenesulphonate

14720

Red

Rinse-off products

Purity criteria as set
out in Commission
Directive 95/45/EC(E 122)

L 342/177

222-657-4

3%

Official Journal of the European Union

1-[(2-Chloro-4-nitrophenyl)azo]-2naphthol and its insoluble barium, stron­
tium and zirconium lakes, salts andpigments

EN922.12.2009

Substance identification

Referencen u mb era

Con dit ion s

Chemical Name

Colour index
N umb er/Na me ofCommon Ingredients
Glossary

CAS number

EC number

Colour

b

c

d

e

f

Red

21

Sodium 4-[(2-hydroxy-1naphthyl)azo]benzenesulphonate and its
insoluble barium, strontium and zirco­nium lakes, salts and pigments

15510

Orange22

Calcium disodium bis[2-chloro-5-[(2hydroxy-1-naphthyl)azo]-4sulphonatobenzoate]

15525

Red

23

Barium bis[4-[(2-hydroxy-1naphthyl)azo]-2-methylbenzenesulphonate]

15580

Red

24

Sodium 4-[(2-Hydroxy-1naphthyl)azo]naphthalenesulphonate

15620

Red

25

Sodium 2-[(2hydroxynaphthyl)azo]naphthale­
nesulphonate and its insoluble barium,
strontium and zirconium lakes, salts andpigments

15630

Red

26

Calcium bis[3-hydroxy-4-(phenylazo)-2naphthoate]

15800

Red

27

Disodium 3-hydroxy-4-[(4-methyl-215850
sulphonatophenyl)azo]-2-naphthoate andits insoluble barium, strontium and zirco­nium lakes, salts and pigments

28

Disodium 4-[(5-chloro-4-methyl-2sulphonatophenyl)azo]-3-hydroxy-2naphthoate and its insoluble barium,
strontium and zirconium lakes, salts andpigments

15865

226-109-5

Red

Red

h

i

j

Not to be used in eye prod­ucts

Rinse-off products

3%

Not to be used in products
applied on mucous mem­branesPurity criteria as set
out in Commission
Directive 95/45/EC(E 180)22.12.2009

14815

g

Official Journal of the European Union

Disodium 6-[(2,4-dimethyl-6sulphonatophenyl)azo]-5hydroxynaphthalene-1-sulphonate

Other

Wording of conditions of use
and warnings

EN

20

Product type, Body parts

Maximum concentration inready for use
preparation

L 342/178

Substance identification

Referencen u mb era

Con dit ion s

Chemical Name

Colour index
N umb er/Na me ofCommon Ingredients
Glossary

CAS number

EC number

Colour

b

c

d

e

f

Product type, Body parts

Maximum concentration inready for use
preparation

Other

Wording of conditions of use
and warnings

g

h

i

j

Calcium 3-hydroxy-4-[(1-sulphonato-2naphthyl)azo]-2-naphthoate

15880

Red

30

Disodium 6-hydroxy-5-[(3sulphonatophenyl)azo]naphthalene-2sulphonate

15980

Orange31

Disodium 6-hydroxy-5-[(4sulphonatophenyl)azo]naphthalene-2sulphonate and its insoluble barium,
strontium and zirconium lakes, salts andpigments

15985

220-491-7

Yellow

Purity criteria as set
out in Commission
Directive 95/45/EC(E 110)32

Disodium 6-hydroxy-5-[(2-methoxy-4sulphonato-m-tolyl)azo]naphthalene-2sulphonate

16035

247-368-0

Red

Purity criteria as set
out in Commission
Directive 95/45/EC(E 129)33

Trisodium 3-hydroxy-4-[(4’16185
sulphonatonaphthyl)azo]naphthalene-2,7disulphonate

213-022-2

Red

Purity criteria as set
out in Commission
Directive 95/45/EC(E 123)34

Disodium 7-hydroxy-8(phenylazo)naphthalene-1,3-disulphonate

16230

35

Trisodium 1-(1-naphthylazo)-2hydroxynaphthalene-4’,6,8-trisulphonate
and its insoluble barium, strontium andzirconium lakes, salts and pigments

16255

36

Tetrasodium 7-hydroxy-8-[(4-sulphonato- 16290
1-naphthyl)azo]naphthalene-1,3,6trisulphonate

Red

37

Disodium 5-amino-4-hydroxy-3(phenylazo)naphthalene-2,7-disulphonate
and its insoluble barium, strontium andzirconium lakes, salts and pigments

Red

220-036-2

Red

Not to be used in products
applied on mucous mem­branes

Official Journal of the European Union

Purity criteria as set
out in Commission
Directive 95/45/EC(E 124)

L 342/179

17200

OrangeEN29

22.12.2009

Substance identification

Referencen u mb era

Con dit ion s

Chemical Name

Colour index
N umb er/Na me ofCommon Ingredients
Glossary

CAS number

EC number

Colour

b

c

d

e

f

18050

39

2,7-Naphthalenedisulfonic acid, 3-((4cyclohexyl-2-methylphenyl)azo)-4hydroxy-5-(((4methylphenyl)sulfonyl)amino)-, disodium
salt

18130

40

223-098-9

g

h

i

j

Red

Not to be used in products
applied on mucous mem­branesRed

Rinse-off products

Hydrogen bis[2-[(4,5-dihydro-3-methyl-5- 18690
oxo-1-phenyl-1H-pyrazol-4yl)azo]benzoato(2-)]chromate(1-)

Yellow

Rinse-off products

41

Disodium hydrogen bis[5-chloro-3-[(4,5dihydro-3-methyl-5-oxo-1-phenyl-1Hpyrazol-4-yl)azo]-2hydroxybenzenesulphonato(3)]chromate(3-)

18736

Red

Rinse-off products

42

Sodium 4-(3-hydroxy-5-methyl-4(phenylazo)pyrazol-2yl)benzenesulphonate

18820

Yellow

Rinse-off products

43

Disodium 2,5-dichloro-4-(5-hydroxy-3methyl-4-((sulphophenyl)azo)pyrazol-1yl)benzenesulphonate

18965

Yellow

44

Trisodium 5-hydroxy-1-(4-sulphophenyl)- 19140
4-((4-sulphophenyl)azo)pyrazole-3carboxylate and its insoluble barium,
strontium and zirconium lakes, salts andpigments

45

N,N’-(3,3’-Dimethyl[1,1’-biphenyl]-4,4’diyl)bis[2-[(2,4-dichlorophenyl)azo]-3oxobutyramide]

20040

Yellow

Rinse-off products

46

Sodium 4-amino-5-hydroxy-3-((4nitrophenyl)azo)-6(phenylazo)naphthalene-2,7-disulphonate

20470

Black

Rinse-off products

217-699-5

Yellow

Purity criteria as set
out in Commission
Directive 95/45/EC(E 128)

Official Journal of the European Union

Disodium 5-acetylamino-4-hydroxy-3(phenylazo)naphthalene-2,7-disulphonate

Other

Wording of conditions of use
and warnings

EN

38

Product type, Body parts

Maximum concentration inready for use
preparation

L 342/180

Substance identification

Purity criteria as set
out in Commission
Directive 95/45/EC(E 102)22.12.2009

Maximum 3,3’dimethylbenzidine
concentration in thecolouring agent:
5 ppm

Referencen u mb era

Con dit ion s

Chemical Name

Colour index
N umb er/Na me ofCommon Ingredients
Glossary

CAS number

EC number

Colour

b

c

d

e

f

Product type, Body parts

Maximum concentration inready for use
preparation

Other

Wording of conditions of use
and warnings

g

h

i

j

21100

Yellow

Rinse-off products

Maximum 3,3’dimethylbenzidine
concentration in thecolouring agent:
5 ppm

48

2,2’-[(3,3’-Dichloro[1,1’-biphenyl]-4,4’diyl)bis(azo)]bis[N-(4-chloro-2,5dimethoxyphenyl)-3-oxobutyramide]

21108

Yellow

Rinse-off products

Maximum 3,3’dimethylbenzidine
concentration in thecolouring agent:
5 ppm

49

2,2’-[Cyclohexylidenebis[(2-methyl-4,1phenylene)azo]]bis[4-cyclohexylphenol]

21230

Yellow

Not to be used in products
applied on mucous mem­branes50

Disodium 4,6-dihydroxy-3-[[4-[1-[4-[[1hydroxy-7-[(phenylsulphonyl)oxy]-3sulphonato-2naphthyl]azo]phenyl]cyclohexyl]
phenyl]azo]naphthalene-2-sulphonate

24790

Red

Rinse-off products

51

1-(4-(Phenylazo)phenylazo)-2-naphthol

26100

Red

Not to be used in products
applied on mucous mem­branesPurity criteria:aniline ≤ 0,2 %2-naphtol ≤ 0,2 %Official Journal of the European Union

2,2’-[(3,3’-Dichloro[1,1’-biphenyl]-4,4’diyl)bis(azo)]bis[N-(2,4-dimethylphenyl)3-oxobutyramide]EN

47

22.12.2009

Substance identification

4-aminoazobenzene≤ 0,1 %
1-(phenylazo)-2naphtol ≤ 3 %1-[2-(phenylazo)
phenylazo]-2napthalenol ≤ 2 %Tetrasodium 6-amino-4-hydroxy-3-[[7sulphonato-4-[(4-sulphonatophenyl)azo]1-naphthyl]azo]naphthalene-2,7disulphonate

27755

53

Tetrasodium 1-acetamido-2-hydroxy-3-(4- 28440((4-sulphonatophenylazo)-7-sulphonato1-naphthylazo))naphthalene-4,6disulphonate

Black219-746-5

Black

Purity criteria as set
out in Commission
Directive 95/45/EC(E 151)

L 342/181

52

Referencen u mb era

Con dit ion s

Chemical Name

Colour index
N umb er/Na me ofCommon Ingredients
Glossary

CAS number

EC number

Colour

b

c

d

e

f

55

beta Carotene

40800

56

8’-apo-.beta.-Caroten-8’-al

40820

57

Ethyl 8’-apo-.beta.-caroten-8’-oate

40825

58

Canthaxanthin

40850

59

Ammonium, (4-(alpha-(p(diethylamino)phenyl)-2,4disulfobenzylidene)-2,5-cyclohexadien-1ylidene)diethyl-, hydroxide, monosodium
salt

42045

60

Ethanaminium, N-(4-((4(diethylamino)phenyl)(5-hydroxy-2,4disulfophenyl)methylene)-2,5cyclohexadien-1-ylidene)-N-ethyl-,hydroxide, inner salt, calcium salt (2:1)
and its insoluble barium, strontium andzirconium lakes, salts and pigments

42051

61

Benzene-methanaminium, N-ethyl-N-(4((4-(ethyl((3-sulfophenyl)methyl)amino)
phenyl)(4-hydroxy-2sulfophenyl)methylene)-2,5cyclohexadien-1-ylidene)-3-sulfo-,hydroxide, inner salt, disodium salt

42053

Orange230-636-6hijRinse-off products

OrangePurity criteria as set
out in Commission
Directive 95/45/EC(E160a)OrangePurity criteria as set
out in Commission
Directive 95/45/EC(E 160e)

214-173-7

OrangePurity criteria as set
out in Commission
Directive 95/45/EC(E 160f)

208-187-2

OrangePurity criteria as set
out in Commission
Directive 95/45/EC(E 161g)

Blue

222-573-8

Blue

Not to be used in products
applied on mucous mem­branesPurity criteria as set
out in Commission
Directive 95/45/EC(E 131)

Green

22.12.2009

40215

g

Official Journal of the European Union

Benzenesulfonic acid, 2,2’-(1,2ethenediyl)bis[5-nitro-, disodium salt,
reaction products with 4-[(4aminophenyl)azo] benzenesulfonic acid,sodium salts

Other

Wording of conditions of use
and warnings

EN

54

Product type, Body parts

Maximum concentration inready for use
preparation

L 342/182

Substance identification

Referencen u mb era

Con dit ion s

Chemical Name

Colour index
N umb er/Na me ofCommon Ingredients
Glossary

CAS number

EC number

Colour

b

c

d

e

f

Other

Wording of conditions of use
and warnings

g

h

i

j

62

Hydrogen (benzyl)[4-[[442080[benzylethylamino]phenyl](2,4disulphonatophenyl)methylene]cyclohexa2,5-dien-1-ylidene](ethyl)ammonium,
sodium salt

63

Benzene-methanaminium, N-ethyl-N-(442090((4-(ethyl((3-sulfophenyl)methyl)amino)
phenyl)(2-sulfophenyl)methylene)-2,5cyclohexadien-1-ylidene)-3-sulfo-, hydrox­
ide, inner salt, disodium salt

64

Hydrogen [4-[(2-chlorophenyl)[4-[ethyl(3-sulphonatobenzyl)amino]phenyl]
methylene]cyclohexa-2,5-dien-1ylidene](ethyl)(3sulphonatobenzyl)ammonium, sodium
salt

42100

Green

Rinse-off products

65

Hydrogen [4-[(2-chlorophenyl)[4-[ethyl(3- 42170
sulphonatobenzyl)amino]-otolyl]methylene]-3-methylcyclohexa-2,5dien-1-ylidene](ethyl)(3sulphonatobenzyl)ammonium, sodium
salt

Green

Rinse-off products

66(4-(4-Aminophenyl)(4-iminocyclohexa2,5-dienylidene)methyl)-2-methylanilinehydrochloride

42510

Violet

Not to be used in products
applied on mucous mem­branes67

4-[(4-Amino-m-tolyl)(4-imino-3methylcyclohexa-2,5-dien-1ylidene)methyl]-o-toluidine
monohydrochloride

42520

VioletRinse-off products

68

Hydrogen [4-[[4-(diethylamino)phenyl][4- 42735[ethyl[(3-sulphonatobenzyl)amino]-otolyl]methylene]-3-methylcyclohexa-2,5dien-1-ylidene](ethyl)(3sulphonatobenzyl)ammonium, sodium
salt

Blue

Not to be used in products
applied on mucous mem­branes223-339-8

Rinse-off products

EN

Blue

Product type, Body parts

Maximum concentration inready for use
preparation

22.12.2009

Substance identification

Blue

Purity criteria as set
out in Commission
Directive 95/45/EC(E 133)

Official Journal of the European Union

5ppm

L 342/183

Referencen u mb era

Con dit ion s

Chemical Name

Colour index
N umb er/Na me ofCommon Ingredients
Glossary

CAS number

EC number

Colour

b

c

d

e

f

g

h

i

j

69

[4-[[4-Anilino-1-naphthyl][4(dimethylamino)phenyl]methylene]
cyclohexa-2,5-dien-1ylidene]dimethylammonium chloride

70

Hydrogen [4-[4-(dimethylamino)-.alpha.- 44090(2-hydroxy-3,6-disulphonato-1naphthyl)benzylidene]cyclohexa-2,5-dien1-ylidene]dimethylammonium,monosodium salt

71

Hydrogen 3,6-bis(diethylamino)-9-(2,4disulphonatophenyl)xanthylium, sodium
salt

45100

Red

Rinse-off products

72

Hydrogen 9-(2-carboxylatophenyl)-3-(2methylanilino)-6-(2-methyl-4sulphoanilino)xanthylium, monosodium
salt

45190

VioletRinse-off products

73

Hydrogen 9-(2,4-disulphonatophenyl)3,6-bis(ethylamino)-2,7dimethylxanthylium, monosodium salt

45220

Red

Rinse-off products

74

Disodium 2-(3-oxo-6-oxidoxanthen-9yl)benzoate

45350

Yellow75

4’,5’-Dibromo-3’,6’dihydroxyspiro[isobenzofuran-1(3H),9’[9H]xanthene]-3-one and its insolublebarium, strontium and zirconium lakes,
salts and pigments

45370

OrangeNot more than 1 %2-(6-hydroxy-3-oxo3H-xanthen-9-y1)
benzoic acid and 2 %2-(bromo-6-hydroxy3-oxo-3H-xanthen-9yl) benzoic acid76

Disodium 2-(2,4,5,7-tetrabromo-6-oxido- 45380
3-oxoxanthen-9-yl)benzoate and its
insoluble barium, strontium and zirco­nium lakes, salts and pigmentsRed

Not more than 1 %2-(6-hydroxy-3-oxo3H-xanthen-9-y1)
benzoic acid and 2 %2-(bromo-6-hydroxy3-oxo-3H-xanthen-9yl) benzoic acid77

3’,6’-Dihydroxy-4’,5’dinitrospiro[isobenzofuran-1(3H),9’[9H]xanthene]-3-one

Orange221-409-2

Not to be used in products
applied on mucous mem­branesGreen

Purity criteria as set
out in Commission
Directive 95/45/EC(E 142)

6%

Only in free acidform, when used inlip products

22.12.2009

1 %, whenused in lip
products

Official Journal of the European Union

45396

Blue

Other

Wording of conditions of use
and warnings

EN

44045

Product type, Body parts

Maximum concentration inready for use
preparation

L 342/184

Substance identification

Referencen u mb era

Con dit ion s

Chemical Name

Colour index
N umb er/Na me ofCommon Ingredients
Glossary

CAS number

EC number

Colour

b

c

d

e

f

Product type, Body parts

Maximum concentration inready for use
preparation

Other

Wording of conditions of use
and warnings

g

h

i

j

Red

79

3,4,5,6-Tetrachloro-2-(1,4,5,8tetrabromo-6-hydroxy-3-oxoxanthen-9yl)benzoic acid and its insoluble barium,
strontium and zirconium lakes, salts andpigments

45410

Red

Not more than 1 %2-(6-hydroxy-3oxo-3Η xanthen-9-yl)
benzoic acid and 2 %2-(bromo-6-hydroxy3-oxo-3H-xanthen-9yl) benzoic acid80

Disodium 2-(2,4,5,7-tetraiodo-6-oxido-3oxoxanthen-9-yl)benzoate and its
insoluble barium, strontium and zirco­nium lakes, salts and pigments

45430

Red

Purity criteria as set
out in Commission
Directive 95/45/EC(E 127)81

1,3-Isobenzofurandione, reaction prod­
ucts with methylquinoline and quinoline

47000

82

1H-Indene-1,3(2H)-dione, 2-(2quinolinyl)-, sulfonated, sodium salts

47005

83

Hydrogen 9-[(3-methoxyphenyl)amino]7-phenyl-5-(phenylamino)-4,10disulphonatobenzo[a]phenazinium,
sodium salt

50325

VioletRinse-off products

84

Sulfonated nigrosine color

50420

Black

Not to be used in products
applied on mucous mem­branes85

8,18-Dichloro-5,15-diethyl-5,15dihydrodiindolo[3,2-b:3’,2’m]triphenodioxazine

51319

VioletRinse-off products

86

1,2-Dihydroxyanthraquinone

58000

Red

87

Trisodium 8-hydroxypyrene-1,3,6trisulphonate

59040

Green

240-474-8

Yellow

305-897-5

Not to be used in eye prod­ucts

Not more than 1 %2-(6-hydroxy-3oxo-3Η xanthen-9-yl)
benzoic acid and 2 %2-(bromo-6-hydroxy3-oxo-3H-xanthen-9yl) benzoic acidNot to be used in products
applied on mucous mem­branesYellow

Purity criteria as set
out in Commission
Directive 95/45/EC(E 104)

Not to be used in products
applied on mucous mem­branes

L 342/185

45405

Official Journal of the European Union

Dipotassium 3,6-dichloro-2-(2,4,5,7tetrabromo-6-oxido-3-oxoxanthen-9yl)benzoate

EN78

22.12.2009

Substance identification

Referencen u mb era

Con dit ion s

Chemical Name

Colour index
N umb er/Na me ofCommon Ingredients
Glossary

CAS number

EC number

Colour

b

c

d

e

f

Product type, Body parts

Maximum concentration inready for use
preparation

Other

Wording of conditions of use
and warnings

g

h

i

j

1-Anilino-4-hydroxyanthraquinone

60724

Violet89

1-Hydroxy-4-(p-toluidino)anthraquinone

60725

Violet90

Sodium 4-[(9,10-dihydro-4-hydroxy-9,10- 60730
dioxo-1-anthryl)amino]toluene-3sulphonate

Violet91

1,4-bis(p-Tolylamino)anthraquinone

61565

Green

92

Disodium 2,2’-(9,10-dioxoanthracene-1,4- 61570
diyldiimino)bis(5-methylsulphonate)

Green

93

Sodium 3,3’-(9,10-dioxoanthracene-1,4diyldiimino)bis(2,4,6trimethylbenzenesulphonate)

61585

Blue

Rinse-off products

94

Sodium 1-amino-4-(cyclohexylamino)9,10-dihydro-9,10-dioxoanthracene-2sulphonate

62045

Blue

Rinse-off products

95

6,15-Dihydroanthrazine-5,9,14,18tetrone

69800

Blue

96

7,16-dichloro-6,15-dihydroanthrazine5,9,14,18-tetrone

69825

Blue

97

Bisbenzimidazo[2,1-b:2’,1’i]benzo[lmn][3,8]phenanthroline-8,17dione

71105

Orange98

2-(1,3-Dihydro-3-oxo-2H-indazol-2ylidene)-1,2-dihydro-3H-indol-3-one

73000

Blue

99

Disodium 5,5’-(2-(1,3-dihydro-3-oxo-2Hindazol-2-ylidene)-1,2-dihydro-3H-indol3-one)disulphonate

73015

100

6-Chloro-2-(6-chloro-4-methyl-3oxobenzo[b]thien-2(3H)-ylidene)-4methylbenzo[b]thiophene-3(2H)-one

73360

Blue

Not to be used in products
applied on mucous mem­branesPurity criteria as set
out in Commission
Directive 95/45/EC(E 132)22.12.2009Red

Not to be used in products
applied on mucous mem­branes

Official Journal of the European Union

212-728-8

Rinse-off products

EN

88

L 342/186

Substance identification

Referencen u mb era

Con di tion s

Chemical Name

Colour index
N umb er/Na me ofCommon Ingredients
Glossary

CAS number

EC number

Colour

b

c

d

e

f

Product type, Body parts

Maximum concentration inready for use
preparation

Other

Wording of conditions of use
and warnings

g

h

i

j

5-Chloro-2-(5-chloro-7-methyl-3oxobenzo[b]thien-2(3H)-ylidene)-7methylbenzo[b]thiophene-3(2H)-one

73385

Violet102

5,12-Dihydroquino[2,3-b]acridine-7,14dione

73900

VioletRinse-off products

103

5,12-Dihydro-2,9-dimethylquino[2,3b]acridine-7,14-dione

73915

Red

Rinse-off products

104

29H,31H-Phthalocyanine

74100

Blue

Rinse-off products

105

29H,31H-Phthalocyaninato(2-)N29,N30,N31,N32 copper

74160

Blue

106

Disodium [29H,31Hphthalocyaninedisulphonato (4-)N29,N30,N31,N32] cuprate (2-)

74180

Blue

Rinse-off products

107

Polychloro copper phthalocyanine

74260

Green

Not to be used in eye prod­
ucts

108

8,8’-diapo-.psi.,.psi.-Carotenedioic acid

75100

Yellow

109

Annatto75120

215-735-4/
289-561-2/
230-248-7

OrangePurity criteria as set
out in Commission
Directive 95/45/EC(E 160b)110

Lycopene

75125—

Yellow

Purity criteria as set
out in Commission
Directive 95/45/EC(E 160d)111

CI Food Orange 575130

214-171-6

OrangePurity criteria as set
out in Commission
Directive 95/45/EC(E 160a)112(3R)-beta-4-Caroten-3-ol

75135

Yellow

113

2-Amino-1,7-dihydro-6H-purin-6-one

75170

White

EN

101

22.12.2009

Substance identification

Official Journal of the European Union
L 342/187

Referencen u mb era

Con dit ion s

Chemical Name

Colour index
N umb er/Na me ofCommon Ingredients
Glossary

CAS number

EC number

Colour

b

c

d

e

f

Product type, Body parts

Maximum concentration inready for use
preparation

Other

Wording of conditions of use
and warnings

g

h

i

j

207-280-5

Yellow

Purity criteria as set
out in Commission
Directive 95/45/EC(E 100)115

Carmines

75470

215-680-6/
215-023-3/
215-724-4

Red

Purity criteria as set
out in Commission
Directive 95/45/EC(E 120)116

Trisodium (2S-trans)-[18-carboxy-20(carboxymethyl)-13-ethyl-2,3-dihydro3,7,12,17-tetramethyl-8-vinyl-21H,23Hporphine-2-propionato(5-)N21,N22,N23,N24]cuprate(3-)(Chlorophylls)

75810

215-800-7/
207-536-6/
208-272-4/
287-483-3/
239-830-5/
246-020-5

Green

Purity criteria as set
out in Commission
Directive 95/45/EC(E 140, E 141)

117

Aluminium

77000

231-072-3

White

Purity criteria as set
out in Commission
Directive 95/45/EC(E 173)

118

Aluminium hydroxide sulphate

77002

White

119

Natural hydrated aluminium silicate,
Al2O3.2SiO2.2H2O, containing calcium,magnesium or iron carbonates, ferrichydroxide, quartz-sand, mica, etc. as
impurities

77004

White

120

Lazurite

77007

Blue

121

Aluminum silicate coloured with ferric
oxide

77015

Red

122

Barium sulfate

77120

White

123

Bismuth chloride oxide

77163

White

22.12.2009

75300

Official Journal of the European Union

Curcumins

EN114

L 342/188

Substance identification

Referencen u mb era

Con dit ion s

Chemical Name

Colour index
N umb er/Na me ofCommon Ingredients
Glossary

CAS number

EC number

Colour

b

c

d

e

f

White

Other

Wording of conditions of use
and warnings

g

h

i

j

124

Calcium carbonate

77220

Purity criteria as set
out in Commission
Directive 95/45/EC(E 170)125

Calcium sulfate

77231

126

Carbon black

77266

127

Charcoal, bone. A fine black powder
obtained by burning animal bones in aclosed container. It consists primarily of
calcium phosphate and carbon

77267

Black

128

Coke black

77268:1

Black

129

Chromium (III) oxide

77288

Green

free from chromate
ion

130

Chromium (III) hydroxide

77289

Green

free from chromate
ion

131

Cobalt Aluminum Oxide

77346

Green

132

Copper

77400

Brown

133

Gold

77480

134

Iron oxide

77489

135

Iron Oxide Red

77491

EN

207-439-9/
215-279-6

Product type, Body parts

Maximum concentration inready for use
preparation

22.12.2009

Substance identification

White
215-609-9

Brown

Purity criteria as set
out in Commission
Directive 95/45/EC(E 153)

Official Journal of the European Union

231-165-9

Black

Purity criteria as set
out in Commission
Directive 95/45/EC(E 175)

OrangeRed

Purity criteria as set
out in Commission
Directive 95/45/EC(E 172)

L 342/189

215-168-2

Referencen u mb era

Con dit ion s

Product type, Body parts

Maximum concentration inready for use
preparation

Other

Wording of conditions of use
and warnings

g

h

i

j

EC number

Colour

b

c

d

e

f

51274-00-1

257-098-5

Yellow

Purity criteria as set
out in Commission
Directive 95/45/EC(E 172)235-442-5

Black

Purity criteria as set
out in Commission
Directive 95/45/EC(E 172)free from cyanide ions

136

Iron Oxide Yellow

77492

137

Iron Oxide Black

77499

138

Ferric Ammonium Ferrocyanide

77510

Blue

139

Magnesium carbonate

77713

White

140

Ammonium manganese(3+) diphosphate

77742

Violet141

Trimanganese bis (orthophosphate)

77745

Red

142

Silver77820

231-131-3

White

Purity criteria as set
out in Commission
Directive 95/45/EC(E 174)

143

Titanium dioxide (1)77891

236-675-5

White

Purity criteria as set
out in Commission
Directive 95/45/EC(E 171)

144

Zinc oxide

77947

145

Riboflavin

Lactoflavin201-507-1/
204-988-6

Yellow

Purity criteria as set
out in Commission
Directive 95/45/EC(E 101)

146

CaramelCaramel232-435-9

Brown

Purity criteria as set
out in Commission
Directive 95/45/EC(E 150a-d)

Official Journal of the European Union

CAS number

EN

Chemical Name

Colour index
N umb er/Na me ofCommon Ingredients
Glossary

L 342/190

Substance identification

White

22.12.2009

Con di tion s

CAS number

EC number

Colour

b

c

d

e

f

147

Paprika extract, Capsanthin, capsorubin

Capsanthin, cap­sorubin148

Beetroot red

Beetroot Red

149

Anthocyanins

AnthocyaninsaProduct type, Body parts

Maximum concentration inready for use
preparation

Other

Wording of conditions of use
and warnings

g

h

i

j

OrangePurity criteria as set
out in Commission
Directive 95/45/EC(E 160c)

7659-95-2

231-628-5

Red

Purity criteria as set
out in Commission
Directive 95/45/EC(E 162)528-58-5

208-438-6

Red(Cyanidin,

134-01-0

205-125-6

Peonidin528-53-0

211-403-8

Purity criteria as set
out in Commission
Directive 95/45/EC(E 163)

Malvidin643-84-5

208-437-0

Delphinidin

134-04-3—

Petunidin

205-127-7

Pelargonidin)
150

Aluminium, zinc, magnesium and calcium Aluminum stearate 7047-84-9
stearates
Zinc stearate557-05-1

230-325-5

Magnesium stearate 557-04-0

209-150-3

Calcium stearate

216-472-8

216-472-8

White

209-151-9

151

Phenol, 4,4’-(3H-2,1-benzoxathiol-3ylidene)bis[2-bromo-3-methyl-6-(1methylethyl)-, S,S-dioxide

Bromothymol blue 76-59-5

200-971-2

Blue

Rinse-off products

152

Phenol, 4,4’-(3H-2,1-benzoxathiol-3ylidene)bis[2,6-dibromo-3-methyl-,S,Sdioxide

Bromocresol green 76-60-8

200-972-8

Green

Rinse-off products

153

Sodium 4-[(4,5-dihydro-3-methyl-5-oxo1-phenyl-1H-pyrazol-4-yl)azo]-3hydroxynaphthalene-1-sulphonate

Acid red 195—

Red

Not to be used in products
applied on mucous mem­branes12220-24-5

Official Journal of the European Union

207-364-1/
207-425-2

EN

Chemical Name

Colour index
N umb er/Na me ofCommon Ingredients
Glossary

Referencen u mb er

22.12.2009

Substance identification(1) For use as a UV-Filter, see Annex VI, No. 27.

L 342/191

L 342/192

ANNEX V
LIST OF PRESERVATIVES ALLOWED IN COSMETIC PRODUCTS
PreambleEN

1. For the purposes of this list:—‘Salts’ is taken to mean: salts of the cations sodium, potassium, calcium, magnesium, ammonium and ethanolamines; salts of the anions chloride, bromide, sulphate, acetate.

—‘Esters’ is taken to mean: esters of methyl, ethyl, propyl, isopropyl, butyl, isobutyl, phenyl.

2. All finished products containing formaldehyde or substances in this Annex and which release formaldehyde must be labelled with the warning ‘contains formaldehyde’ where the concentration of formaldehyde in
the finished product exceeds 0,05 %.

Referencen u mb era1

Chemical name/INN

Name of C ommon
Ingredients Glossary

CAS number

b

c

d

Benzoic acid and its sodium salt Benzoic acid
Sodium Benzoate

1aCon dit ion s

E C n u mb er

Product type, Body
pa rts

Max imumconcentration inready for use
preparation

Other

Wording ofconditions of use
and warnings

e

f

g

h

i

65-85-0200-618-2

532-32-1

208-534-8

217-468-9,
218-235-4,
209-481-3,
209-045-2,
224-387-2,
202-259-7,
202-284-3,
219-020-8,
205-252-7,
204-401-3,
213-361-6,
202-293-2

Oral products

1,7 % (acid)

Leave-on products

0,5 % (acid)

0,5 % (acid)

22.12.2009

Salts of benzoic acid other than Ammonium benzoate, calcium 1863-63-4, 2090-05-3, 582that listed under reference num- benzoate, potassium benzoate, 25-2, 553-70-8, 4337-66-0,
ber 1 and esters of benzoic acid magnesium benzoate, MEA93-58-3, 93-89-0, 2315-68-6,
benzoate, methyl benzoate,
136-60-7, 120-50-3, 939-48-0,
ethyl benzoate, propyl benzoate, 93-99-2butyl benzoate, isobutyl benzoate, isopropyl benzoate, phenyl benzoate

Rinse-off products, 2,5 % (acid)except oral products

Official Journal of the European Union

Substance identification

Referencen u mb era

Con dit ion s

Chemical name/INN

Name of C ommon
Ingredients Glossary

CAS n u mb er

b

c

d

Max imumconcentration inready for use
preparation

Other

Wording ofconditions of use
and warnings

e

f

g

h

i

Not to be usedin products forchildren under3 years of age,
except for
shampoos

Not to be used
for children
under 3 years ofage (2)

Propionic acid and its salts

Propionic acid, ammonium pro­ 79-09-4, 17496-08-1, 4075201-176-3,
pionate, calcium propionate,
81-4, 557-27-7, 327-62-8, 137- 241-503-7,
magnesium propionate, potas­
40-6
223-795-8,
sium propionate, sodium propi­
209-166-0,
onate
206-323-5,
205-290-4

2 % (acid)

3

Salicylic acid (1) and its salts

Salicylic acid, calcium salicylate, 69-72-7, 824-35-1, 18917magnesium salicylate, MEA89-0, 59866-70-5, 54-21-7,
salicylate, sodium salicylate,578-36-9, 2174-16-5
potassium salicylate, TEAsalicylate

200-712-3,
212-525-4,
242-669-3,
261-963-2,
200-198-0,
209-421-6,
218-531-3

0,5 % (acid)4

Hexa-2,4-dienoic acid and its
salts

Sorbic acid, calcium sorbate,sodium sorbate, potassium sor­bate

110-44-1, 7492-55-9, 775781-5, 24634-61-5

203-768-7,
231-321-6,
231-819-3,
246-376-1

0,6 % (acid)5

Formal-dehyde, paraformalde­
hyde (3)Formaldehyde

50-00-0, 30525-89-4

200-001-8

Oral products

0,1 % (freeformaldehyde)

Other products

0,2 % (freeformaldehyde)

Paraformaldehyde

6

Moved or deleted

7Biphenyl-2-ol, and its salts

o-Phenylphenol, sodium
o-phenylphenate, potassiumo-phenylphenate, MEAo-phenylphenate

90-43-7, 132-27-4, 1370765-8, 84145-04-0

201-993-5,
205-055-6,
237-243-9,
282-227-7

8

Pyrithione zinc (4)Zinc pyrithione

13463-41-7

236-671-3

Not to be usedin aerosol dis­pensers (sprays)

Official Journal of the European Union

2EN

E C n u mb er

Product type, Body
pa rts22.12.2009

Substance identification

0,2 % (as phe­
nol)

1,0 %

Other products

0,5 %Only in rinseoff products
Not to be usedin oral products

L 342/193

Hair productsReferencen u mb era

Con dit ion s

E C n u mb er

Product type, Body
pa rts

Max imumconcentration inready for use
preparation

Other

Wording ofconditions of use
and warnings

e

f

g

h

i

b

c

d

Sodium sulfite, ammonium
bisulfite, ammonium sulfite,
potassium sulfite, potassiumhydrogen sulfite, sodium
bisulfite, sodium metabisulfite,
potassium metabisulfite

7757-83-7, 10192-30-0,
10196-04-0, 10117-38-1,
7773-03-7, 7631-90-5, 768157-4, 16731-55-8

231-821-4,
233-469-7,
233-484-9,
233-321-1,
231-870-1,
231-548-0,
231-673-0,
240-795-3

0,2 % (as freeSO2)

200-317-6

0,5 %

9

Inorganic sulphites andhydrogen- sulphites (5)10Moved or deleted

11

Chlorobutanol

Chlorobutanol

57-15-8

12

4-Hydroxybenzoic acid and its
salts and esters

4-Hydroxybenzoic acid, meth­ylparaben, butylparaben, potas­
sium ethylparaben, potassium
paraben, propylparaben, isobu­
tylparaben, sodium methylpara­ben, sodium ethylparaben,
sodium propylparaben, sodium
butylparaben, sodium isobu­
tylparaben, ethylparaben,
sodium paraben, isopropylpara­ben, potassium methylparaben,
potassium butylparaben, potas­
sium propylparaben, sodium
propylparaben, calcium para­ben, phenylparaben

99-96-7, 99-76-3, 94-26-8,
202-804-9,36457-19–9,16782-08-4,
202-785-7,
94-13-3, 4247-02-3, 5026202-318-7,
62-0, 35285-68-8, 35285-69-9, 253-048-1,
36457-20-2, 84930-15-4, 120- 240-830-2,
47-8, 114-63-6, 4191-73-5,
202-307-7,
2611-07-2, 38566-94-8,
224-208-8,
84930-17-4, 35285-69-9,
225-714-1,
69959-44-0, 17696-62-7
252-487-6,
252-488-1,
253-049-7,
284-595-4,
204-399-4,
204-051-1,
224-069-3,
247-464-2,
254-009-1,
284-597-5,
252-488-1,
274-235-4,
241-698-9

0,4 % (as acid)for single ester,Not to be used Contains Chlo­in aerosol dis­robutanol
pensers (sprays)

0,8 % (as acid)for mixtures ofesters3-Acetyl-6-methylpyran-2,4(3H)-dione and its salts

Dehydroacetic acid, sodium
dehydroacetate

520-45-6, 4418-26-2, 1680748-0

208-293-9,
224-580-1

0,6 % (as acid)14

Formic acid and its sodium salt

Formic acid, sodium formate

64-18-6, 141-53-7

200-579-1,
205-488-0

0,5 % (as acid)Not to be usedin aerosol dis­pensers (sprays)

22.12.2009

13

Official Journal of the European Union

CAS n u mb er

ENChemical name/INN

Name of C ommon
Ingredients Glossary

L 342/194

Substance identification

Referencen u mb era

Con dit ion s

Chemical name/INN

Name of C ommon
Ingredients Glossary

CAS n u mb er

b

c

d

E C n u mb er

Product type, Body
pa rts

Max imumconcentration inready for use
preparation

Other

Wording ofconditions of use
and warnings

e

f

g

h

i

3,3’-Dibromo-4,4’hexamethylenedioxydibenzamidine and its salts(including isethionate)

Dibromohexamidine Isethionate 93856-83-8

299-116-4

16

Thiomersal

Thimerosal

200-210-4

54-64-8

0,1 %Eye products

0,007 % (of Hg)

EN

15

Contains Thi­
omersalPhenylmercuric salts (including
borate)Phenyl Mercuric Acetate, Phenyl 62-38-4, 94-43-9
Mercuric Benzoate

200-532-5,
202-331-8

Eye products

0,007 % (of Hg)
If mixed withother mercurial
compounds
authorised bythis Regulation,
the maximum
concentrationof Hg remains
fixed at 0,007 %Undec-10-enoic acid and its
salts

Undecylenic acid, potassium
undecylenate, sodium unde­cylenate, calcium undecylenate,
TEA-undecylenate, MEAundecylenate112-38-9, 6159-41-7, 339833-2, 1322-14-1, 84471-25-0,56532-40-2

203-965-8,
222-264-8,
215-331-8,
282-908-9,
260-247-7

0,2 % (as acid)19

5- Pyrimidinamine, 1,3-bis(2-ethylhexyl) hexahydro-5methyl-

Hexetidine

141-94-6

205-513-5

0,1 %L 342/195

18

Contains Phe­nylmercuric
compounds

Official Journal of the European Union

If mixed withother mercurial
compounds
authorised bythis Regulation,
the maximum
concentrationof Hg remains
fixed at 0,007 %17

22.12.2009

Substance identification

Referencen u mb era

Con dit ion s

Chemical name/INN

Name of C ommon
Ingredients Glossary

CAS n u mb er

b

c

d

E C n u mb er

Product type, Body
pa rts

Max imumconcentration inready for use
preparation

Other

Wording ofconditions of use
and warnings

e

f

g

h

i

5-Bromo-5-nitro-1,3-dioxane

30007-47-7

250-001-7

21

Bronopol2-Bromo-2-nitropropane-1,3diol52-51-7

22

2,4-Dichlorobenzyl alcohol

Dichlorobenzyl Alcohol23

1-(4-Chlorophenyl)-3-(3,4dichlorophenyl) urea (6)Triclocarban

Rinse-off products

0,1 %Avoid forma­tion of nitro­samines200-143-0

0,1 %Avoid forma­tion of nitro­samines

1777-82-8

217-210-5

0,15 %

101-20-2

202-924-1

0,2 %Purity criteria:
3,3’,4,4’Tetrachloroa­
zobenzene< 1 ppm
3,3’,4,4’Tetrachloroa­
zoxybenzene< 1 ppm

24

Chlorocresol

p-Chloro-m-Cresol59-50-7

200-431-6

Not to be used in
0,2 %products applied
on mucuous mem­branes25

5-Chloro-2- (2,4- dichlorophe­noxy) phenol

Triclosan

3380-34-5

222-182-2

0,3 %

26

Chloro-xylenol

Chloroxylenol

88-04-0

201-793-8

0,5 %

27

N,N″-methylenebis[N′-[3(hydroxymethyl)-2,5dioxoimidazolidin-4-yl]urea]

Imidazolidinyl urea

39236-46-9

254-372-6

0,6 %

28

Poly(methylene),.alpha.,.omega.- Polyaminopropyl biguanidebis[[[(aminoiminomethyl)ami­no]iminomethyl] amino]-,dihydrochloride

70170-61-5, 28757-47-3,
133029-32-0

29

2-Phenoxyethanol

Phenoxyethanol

122-99-6

204-589-7

1,0 %

30

Methenamine

Methenamine

100-97-0

202-905-8

0,15 %

Official Journal of the European Union

5-Bromo-5-nitro-1,3-dioxane

EN20

L 342/196

Substance identification

0,3 %22.12.2009

Referencen u mb era

Con dit ion s

Chemical name/INN

Name of C ommon
Ingredients Glossary

CAS n u mb er

b

c

d

E C n u mb er

Product type, Body
pa rts

Max imumconcentration inready for use
preparation

Other

Wording ofconditions of use
and warnings

e

f

g

h

i

Quaternium-15

4080-31-3

223-805-0

0,2 %

32

1-(4-Chlorophenoxy)-1(imidazol-1-yl)-3,3dimethylbutan-2-one

Climbazole

38083-17-9

253-775-4

0,5 %

33

1,3-Bis (hydroxymethyl)-5,5DMDM Hydantoin
dimethylimidazolidine-2,4-dione

6440-58-0

229-222-8

0,6 %

34

Benzyl alcohol (7)Benzyl alcohol

100-51-6

202-859-9

1,0 %

35

1-Hydroxy-4-methyl-6-(2,4,4trimethylpentyl) 2-pyridon andits monoethanolamine salt

1-Hydroxy-4-methyl-6-(2,4,4trimethylpentyl) 2-pyridon,
Piroctone Olamine

50650-76-5, 68890-66-4

272-574-2

Rinse-off products

1,0 %Other products

0,5 %Moved or deleted

37

2,2’-methylenebis(6-bromo-4chlorophenol)

Bromochlorophene15435-29-7

239-446-8

0,1 %

38

4-Isopropyl-m-cresolo-Cymen-5-ol

3228-02-2

221-761-7

0,1 %

39

Mixture of 5-Chloro-2-methyl- Methylchloroisothiazolinone
isothiazol-3(2H)-one and 2and Methylisothiazolinone
methylisothiazol-3(2H)-one withmagnesium chloride and magne­
sium nitrate

26172-55-4, 2682-20-4,
55965-84-9

247-500-7,
220-239-6

0,0015 % (of amixture in theratio 3:1 of
5-chloro-2methylisothia­
zol 3(2H)-one
and 2-methyl­
isothiazol-3(2H)-one40

2-Benzyl-4-chlorophenol

Chlorophene

120-32-1

204-385-8

0,2 %

41

2-Chloroacetamide

Chloroacetamide

79-07-2

201-174-2

0,3 %Contains chloro­
acetamide

L 342/197

36

Official Journal of the European Union

Methenamine
3-chloroallylochlorideEN

31

22.12.2009

Substance identification

Referencen u mb era

Con dit ion s

E C n u mb er

Product type, Body
pa rts

Max imumconcentration inready for use
preparation

Other

Wording ofconditions of use
and warnings

e

f

g

h

i

0,1 %

Not to be usedin aerosols(sprays)Contains glut­aral (9)0,3 %Not to be usedin oral products
and in products
applied on
mucous mem­branesChemical name/INN

Name of C ommon
Ingredients Glossary

CAS n u mb er

b

c

d

42

N,N″-bis(4-chlorophenyl)-3,12diimino-2,4,11,13tetraazatetradecanediamidine
and its digluconate, diacetate
and dihydrochloride

Chlorhexidine, Chlorhexidine
Diacetate, Chlorhexidine Diglu­
conate, Chlorhexidine Dihydro­
chloride55-56-1, 56-95-1, 18472-51-0, 200-238-7,
3697-42-5
200-302-4,
242-354-0,
223-026-6

43

1-Phenoxypropan-2-ol (8)Phenoxyisopropanol

770-35-4

44

Alkyl (C 12-22) trimethyl ammo­ Behentrimonium chloride, cetri­ 17301-53-0, 57-09-0, 112nium bromide and chloride
monium bromide, cetrimonium 02-7, 1119-94-4, 112-00-5,
chloride, laurtrimonium bro­
1120-02-1, 112-03-8
mide, laurtrimonium chloride,steartrimonium bromide, steart­rimonium chloride

241-327-0,
200-311-3,
203-928-6,
214-290-3,
203-927-0,
214-294-5,
203-929-1

0,1 %

45

4,4-Dimethyl-1,3-oxazolidine

Dimethyl Oxazolidine

51200-87-4

257-048-2

0,1 %

46

N-(Hydroxymethyl)-N(dihydroxymethyl-1,3-dioxo2,5-imidazolidinyl-4)-N’(hydroxymethyl) urea

Diazolidinyl Urea

78491-02-8

278-928-2

0,5 %

47

Benzenecarboximidamide, 4,4’- Hexamidine, Hexamidine(1,6-hexanediylbis (oxy))bis- and diisethionate, Hexamidine para­
its salts (including isethionateben
and p-hydroxybenzoate)

3811-75-4, 659-40-5, 9384183-9

211-533-5,
299-055-3

0,1 %

48

Glutaraldehyde (Pentane-1,5dial)

Glutaral

111-30-8

203-856-5

49

5-Ethyl-3,7-dioxa-1-azabicyclo[3.3.0] octane

7-Ethylbicyclooxazolidine

7747-35-5

231-810-4

Only for rinse-off
products

EN

212-222-7

0,3 % (as chlo­rhexidine)

L 342/198

Substance identification

1,0 %Official Journal of the European Union

pH > 622.12.2009

Referencen u mb era

Con dit ion s

Chemical name/INN

Name of C ommon
Ingredients Glossary

CAS n u mb er

b

c

d

Chlorphenesin

51

Sodium hydroxymethylamino
acetate52

53

104-29-0

Other

Wording ofconditions of use
and warnings

e

f

g

h

i

203-192-6

0,3 %Sodium Hydroxymethylglycinate 70161-44-3

274-357-8

0,5 %Silver chloride deposited ontitanium dioxide

Silver chloride

7783-90-6

232-033-3

0,004 % (asAgCl)

Benzenemethanaminium, N,Ndimethyl-N-[2-[2-[4-(1,1,3,3,tetramethylbutyl)phenoxy]ethoxy] ethyl]-, chloride

Benzethonium Chloride

121-54-0

204-479-9

54

Benzalkonium chloride, bro­mide and saccharinate (10)Benzalkonium chloride, benza­
lkonium bromide, benzalko­nium saccharinate

8001-54-5, 63449-41-2,
91080-29-4, 68989-01-5,
68424-85-1, 68391-01-5,
61789-71-7, 85409-22-9

264-151-6,
293-522-5,
273-545-7,
270-325-2,
269-919-4,
263-080-8,
287-089-1

55

Methanol, (phenylmethoxy-)

Benzylhemiformal

14548-60-8

238-588-8(a) Rinse-off prod­
ucts

20 % AgCl(w/w) on TiO2.
Not to be usedin products forchildren under3 years of age,in oral products
and in eye andlip products

Official Journal of the European Union3-(p-Chlorophenoxy)-propane1,2 diol

Max imumconcentration inready for use
preparation

EN

50

E C n u mb er

Product type, Body
pa rts22.12.2009

Substance identification

0,1 %(b) Leave-on prod­
ucts other thanoral products

0,1 % (as benza­
lkonium chlo­
ride)

0,15 %

L 342/199

Rinse-off products

Avoid contact
with eyesReferencen u mb eraChemical name/INN

Name of C ommon
Ingredients Glossary

CAS n u mb er

b

c

d

3-Iodo-2propynylbutylcarbamate

Iodopropynyl butylcarbamate

55406-53-6

E C n u mb er

Product type, Body
pa rts

Max imumconcentration inready for use
preparation

Other

Wording ofconditions of use
and warnings

e

f

g

h

i

Not to be usedin oral and lip
products(a) Not to be
used for chil­dren under 3
years ofage (11)259-627-5(a) Rinse-off prod­ucts(b) Leave-on prod­
ucts(a) 0,02 %(b) 0,01 %,(c) 0,0075 %(c) Deodorants/antiperspirants(b) Not to be
used in body
lotion andbodycream (13)(b) and (c) Not
to be used in
products forchildren under3 years of age
57

2-Methyl-2H-isothiazol-3-one

Methylisothiazolinone

2682-20-4

220-239-6

0,01 %

22.12.2009(1) For use other than as a preservative, see Annex III, No. 98.
(2) Solely for products which might be used for children under 3 years of age and which remain in prolonged contact with the skin.
(3) For use other than as a preservative, see Annex III, No. 13.
(4) For use other than as a preservative, see Annex III. No. 101.
(5) For use other than as a preservative, see Annex III, No. 99.
(6) For use other than as a preservative, see Annex III, No. 100.
(7) For use other than as a preservative, see Annex III, No. 45, 68.
(8) For use other than as a preservative, see Annex III, No. 54.
(9) Only if the concentration exceeds 0,05 %.
(10) For use other than as a preservative, see Annex III, No. 65.
(11) Solely for products, other than bath products/shower gels and shampoo, which might be used for children under 3 years of age.
(12) Solely for products which might be used for children under 3 years of age.
(13) Concerns any products aimed to be applied on a large part of the body.

Official Journal of the European Union(a) Not to be
used in prod­
ucts for chil­ (b) and (c) Not
dren under 3 to be used foryears of age, children under 3
except inyears of age (12)bathproducts/
shower gelsand sham­
poo

EN

56

Con dit ion s

L 342/200

Substance identification

22.12.2009

ANNEX VI
LIST OF UV FILTERS ALLOWED IN COSMETIC PRODUCTS

Substance identification

Con dit ion s

Chemical name/INN/XAN

Name of Common Ingredients Glossary

CAS number

EC number

Product type,body parts

a

b

c

d

e

f

O therWording of conditions of use
and warnings

g

h

i

4-Aminobenzoic acidPABA

150-13-0

205-753-0

5%2

N,N,N-Trimethyl-4­(2-oxoborn-3-ylidenemethyl)anilinium methyl sulfatelCamphor Benzalkonium Methosulfate

52793-97-2

258-19 -8

6%3

Benzoic acid, 2-hydroxy-, 3,3,5-trimethylcyclohexyl
ester/Homosalate

Homosalate

118-56-9

204-260-8

10 %4

2-Hydroxy-4-methoxybenzophenone/Oxybenzone

Benzophenone-3

131-57-7

205-031-5

10 %5

Moved or deleted

62-Phenylbenzimidazole-5-sulfonic acid and its potassium, sodium and triethanolamine salts/Ensulizole

Phenylbenzimidazole Sulfonic Acid

27503-81-7

248-502-0

8 %(as acid)73,3’-(1,4-Phenylenedimethylene) bis(7, 7-dimethyl-2Terephthalylidene Dicamphor Suloxobicyclo-[2.2.1]hept-1-yl-methanesu fonic acid) and its fonic Acidsalts/Ecamsule92761-26-7,
90457-82-2

410-960-6

10 %(as acid)8

1-(4-tert-Butylphenyl)-3-(4-methoxyphenyl)propane-1,3- Butyl Methoxydibenzoylmethane
dione/Avobenzone

70356-09-1

274-581-6

5%9alpha-(2-Oxoborn-3-ylidene)-toluene-4-sulphonic acidand its salts

Benzylidene Camphor Sulfonic Acid

56039-58-8

10

2­Cyano-3,3-diphenyl acrylic acid, 2-ethylhexyl
ester/Octocrilene

Octocrylene

6197-30-4

11

Polymer of N-{(2 and 4)-[(2-oxoborn-3-ylidene)methyl]benzyl} acrylamide

Polyacrylamidomethyl Benzylidene
Camphor113783-61-2

122-Ethylhexyl 4-methoxycinnamate/Octinoxate

Ethylhexyl Methoxycinnamate

5466-77-3

13

Ethoxylated ethyl-4-aminobenzoate

PEG-25 PABA

116242-27-4

14

Isopentyl-4-methoxycinnamate/Amiloxate

Isoamyl p-Methoxycinnamate

71617-10-2

Contains
Benzophenone-3 (1)Official Journal of the European Union

1

EN

Referencen u mb er

Maximum concentration inready for use
preparation

6 % (as acid)228-250-8

10 % (as acid)6%0226-775-7

10 %

275-702-5

10 %L 342/201

10 %Con dit ion sReferencen u mb er

Chemical name/INN/XAN

Name of Common Ingredients Glossary

CAS number

a

b

c

d

88122-99-0

Maximum concentration inready for use
preparation

O therWording of conditions of use
and warnings

e

f

g

h

i

2,4,6-Trianilino-(p-carbo-2’-ethylhexyl-1’-oxy)-1,3,5triazine

402-070-1

5%

16

Phenol,2-(2H-benzotriazol-2-yl)-4-methyl-6-(2-methyl-3- Drometrizole Trisiloxane(1,3,3,3-tetramethyl-1-(trimethylsilyl)oxy)disiloxanyl)propyl)

155633-54-8

15 %

17

Benzoic acid, 4,4-((6-((4-(((1,1dimethylethyl)amino)carbonyl)phenyl)amino)-1,3,5triazine-2,4-diyl)diimino)bis-, bis (2-ethylhexyl)
ester/Iscotrizinol (USAN)

Diethylhexyl Butamido Triazone

154702-15-5

10 %

18

3-(4-Methylbenzylidene)-d1 camphor/Enzacamene

4-Methylbenzylidene Camphor

38102-62-4/
36861-47-9- / 253-242-6

4%

19

3-Benzylidene camphor

3-Benzylidene Camphor

15087-24-8

239-139-92%

20

2-Ethylhexyl salicylate/Octisalate

Ethylhexyl Salicylate

118-60-5

204-263-4

5%21

2-Ethylhexyl 4-(dimethylamino)benzoate/Padimate O(USAN:BAN)

Ethylhexyl Dimethyl PABA

21245-02-3

244-289-3

8%

22

2-Hydroxy-4-methoxybenzophenone-5-sulfonic acid and Benzophenone-4, Benzophenone-5
its sodium salt/Sulisobenzone

4065-45-6/
6628-37-1

223-772-2 / -

5 % (as acid)23

2,2’-Methylene-bis(6-(2H-benzotriazol-2-yl)-4-(1,1,3,3tetramethyl-butyl)phenol) / Bisoctrizole

Methylene Bis-Benzotriazolyl Tet­
ramethylbutylphenol

103597-45-1

403-800-1

10 %

24

Sodium salt of 2,2’-bis(1,4-phenylene)-1Hbenzimidazole-4,6-disulfonic acid) / Bisdisulizole diso­
dium (USAN)

Disodium Phenyl Dibenzimidazole
Tetrasulfonate

180898-37-7

429-750-0

10 % (as acid)25

2,2’-(6-(4-Methoxyphenyl)-1,3,5-triazine-2,4-diyl)bis(5((2-ethylhexyl)oxy)phenol) / Bemotrizinol

Bis-Ethylhexyloxyphenol Methox­
yphenyl Triazine

187393-00-6

26

Dimethicodiethylbenzalmalonate

Polysilicone-15

207574-74-1

426-000-4

10 %

27

Titanium dioxide (2)Titanium Dioxide

13463-67-7/
1317-70-0/
1317-80-2

236-675-5/
205-280-1/
215-282-2

25 %

28

Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-,hexylester

Diethylamino Hydroxybenzoyl Hexyl 302776-68-7
Benzoate

443-860-6

10 % in sun­screen prod­
ucts

Official Journal of the European Union

15

EN

Ethylhexyl Triazone

EC number

Product type,body parts

L 342/202

Substance identification

10 %(1) Not required if concentration is 0,5 % or less and when it is used only for product protection purposes.
(2) For use other than as a colorant, see Annex IV, No. 143.

22.12.2009

22.12.2009

Official Journal of the European UnionEN

ANNEX VIISYMBOLS USED ON PACKAGING/CONTAINER
1. Reference to enclosed or attached information

2. Period-after-opening

3. Date of minimum durability

L 342/203

L 342/204

Official Journal of the European Union

EN

22.12.2009

ANNEX VIII
LIST OF VALIDATED ALTERNATIVE METHODS TO ANIMAL TESTING
This Annex lists the alternative methods validated by the European Centre on Validation of Alternative Methods (ECVAM)of the Joint Research Centre available to meet the requirements of this Regulation and which are not listed in Commission
Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of
the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals(REACH). As animal testing may not be replaced completely by an alternative method, it should be mentioned in Annex VIII
whether the alternative method fully or partially replaces animal testing.
Reference number

Validated alternative methods

Nature of replacement full or partial

A

B

C

22.12.2009

EN

Official Journal of the European Union

ANNEX IXPART A
Repealed Directive with its successive amendments(referred to in Article 33)
Council Directive 76/768/EEC of 27 July 1976

(OJ L 262, 27.9.1976, p. 169)

Council Directive 79/661/EEC of 24 July 1979

(OJ L 192, 31.7.1979, p. 35)

Commission Directive 82/147/EEC of 11 February 1982

(OJ L 63, 6.3.1982, p. 26)

Council Directive 82/368/EEC of 17 May 1982

(OJ L 167, 15.6.1982, p. 1)

Commission Directive 83/191/EEC of 30 March 1983

(OJ L 109, 26.4.1983, p. 25)

Commission Directive 83/341/EEC of 29 June 1983

(OJ L 188, 13.7.1983, p. 15)

Commission Directive 83/496/EEC of 22 September 1983

(OJ L 275, 8.10.1983, p. 20)

Council Directive 83/574/EEC of 26 October 1983

(OJ L 332, 28.11.1983, p. 38)

Commission Directive 84/415/EEC of 18 July 1984

(OJ L 228, 25.8.1984, p. 31)

Commission Directive 85/391/EEC of 16 July 1985

(OJ L 224, 22.8.1985, p. 40)

Commission Directive 86/179/EEC of 28 February 1986

(OJ L 138, 24.5.1986, p. 40)

Commission Directive 86/199/EEC of 26 March 1986

(OJ L 149, 3.6.1986, p. 38)

Commission Directive 87/137/EEC of 2 February 1987

(OJ L 56, 26.2.1987, p. 20)

Commission Directive 88/233/EEC of 2 March 1988

(OJ L 105, 26.4.1988, p. 11)

Council Directive 88/667/EEC of 21 December 1988

(OJ L 382, 31.12.1988, p. 46)

Commission Directive 89/174/EEC of 21 February 1989

(OJ L 64, 8.3.1989, p. 10)

Council Directive 89/679/EEC of 21 December 1989

(OJ L 398, 30.12.1989, p. 25)

Commission Directive 90/121/EEC of 20 February 1990

(OJ L 71, 17.3.1990, p. 40)

Commission Directive 91/184/EEC of 12 March 1991

(OJ L 91, 12.4.1991, p. 59)

Commission Directive 92/8/EEC of 18 February 1992

(OJ L 70, 17.3.1992, p. 23)

Commission Directive 92/86/EEC of 21 October 1992

(OJ L 325, 11.11.1992, p. 18)

Council Directive 93/35/EEC of 14 June 1993

(OJ L 151, 23.6.1993, p. 32)

Commission Directive 93/47/EEC of 22 June 1993

(OJ L 203, 13.8.1993, p. 24)

Commission Directive 94/32/EC of 29 June 1994

(OJ L 181, 15.7.1994, p. 31)

Commission Directive 95/17/EC of 19 June 1995

(OJ L 140, 23.6.1995, p. 26)

Commission Directive 95/34/EC of 10 July 1995

(OJ L 167, 18.7.1995, p. 19)

Commission Directive 96/41/EC of 25 June 1996

(OJ L 198, 8.8.1996, p. 36)

Commission Directive 97/1/EC of 10 January 1997

(OJ L 16, 18.1.1997, p. 85)

Commission Directive 97/18/EC of 17 April 1997

(OJ L 114, 1.5.1997, p. 43)

Commission Directive 97/45/EC of 14 July 1997

(OJ L 196, 24.7.1997, p. 77)

Commission Directive 98/16/EC of 5 March 1998

(OJ L 77, 14.3.1998, p. 44)

Commission Directive 98/62/EC of 3 September 1998

(OJ L 253, 15.9.1998, p. 20)

Commission Directive 2000/6/EC of 29 February 2000

(OJ L 56, 1.3.2000, p. 42)

Commission Directive 2000/11/EC of 10 March 2000

(OJ L 65, 14.3.2000, p. 22)

Commission Directive 2000/41/EC of 19 June 2000

(OJ L 145, 20.6.2000, p. 25)

Commission Directive 2002/34/EC of 15 April 2002

(OJ L 102, 18.4.2002, p. 19)

Commission Directive 2003/1/EC of 6 January 2003

(OJ L 5, 10.1.2003, p. 14)

L 342/205

L 342/206

EN

Official Journal of the European Union

22.12.2009

Commission Directive 2003/16/EC of 19 February 2003

(OJ L 46, 20.2.2003, p. 24)

Directive 2003/15/EC of the European Parliament and of the Councilof 27 February 2003

(OJ L 66, 11.3.2003, p. 26)

Commission Directive 2003/80/EC of 5 September 2003

(OJ L 224, 6.9.2003, p. 27)

Commission Directive 2003/83/EC of 24 September 2003

(OJ L 238, 25.9.2003, p. 23)

Commission Directive 2004/87/EC of 7 September 2004

(OJ L 287, 8.9.2004, p. 4)

Commission Directive 2004/88/EC of 7 September 2004

(OJ L 287, 8.9.2004, p. 5)

Commission Directive 2004/94/EC of 15 September 2004

(OJ L 294, 17.9.2004, p. 28)

Commission Directive 2004/93/EC of 21 September 2004

(OJ L 300, 25.9.2004, p. 13)

Commission Directive 2005/9/EC of 28 January 2005

(OJ L 27, 29.1.2005, p. 46)

Commission Directive 2005/42/EC of 20 June 2005

(OJ L 158, 21.6.2005, p. 17)

Commission Directive 2005/52/EC of 9 September 2005

(OJ L 234, 10.9.2005, p. 9)

Commission Directive 2005/80/EC of 21 November 2005

(OJ L 303, 22.11.2005, p. 32)

Commission Directive 2006/65/EC of 19 July 2006

(OJ L 198, 20.7.2006, p. 11)

Commission Directive 2006/78/EC of 29 September 2006

(OJ L 271, 30.9.2006, p. 56)

Commission Directive 2007/1/EC of 29 January 2007

(OJ L 25, 1.2.2007, p. 9)

Commission Directive 2007/17/EC of 22 March 2007

(OJ L 82, 23.3.2007, p. 27)

Commission Directive 2007/22/EC of 17 April 2007

(OJ L 101, 18.4.2007, p. 11)

Commission Directive 2007/53/EC of 29 August 2007

(OJ L 226, 30.8.2007, p. 19)

Commission Directive 2007/54/EC of 29 August 2007

(OJ L 226, 30.8.2007, p. 21)

Commission Directive 2007/67/EC of 22 November 2007

(OJ L 305, 23.11.2007, p. 22)

Commission Directive 2008/14/EC of 15 February 2008

OJ L 42, 16.2.2008, p. 43

Commission Directive 2008/42/EC of 3 April 2008

OJ L 93, 4.4.2008, p. 13

Commission Directive 2008/88/EC of 23 September 2008

OJ L 256, 24.9.2008, p. 12

Commission Directive 2008/123/EC of 18 December 2008

OJ L 340, 19.12.2008, p. 71

Commission Directive 2009/6/EC of 4 February 2009

OJ L 36, 5.2.2009, p. 15

Commission Directive 2009/36/EC of 16 April 2009

OJ L 98, 17.4.2009, p. 31

PART B
List of time-limits for transposition into national law and application(referred to in Article 33)

Directive

Time-limit for transpositionCouncil Directive 76/768/EEC of 27 July 1976

30.1.1978

Council Directive 79/661/EEC of 24 July 1979

30.7.1979

Commission Directive 82/147/EEC of 11 February 1982

31.12.1982

Council Directive 82/368/EEC of 17 May 1982

31.12.1983

Commission Directive 83/191/EEC of 30 March 1983

31.12.1984

Commission Directive 83/341/EEC of 29 June 1983

31.12.1984

Commission Directive 83/496/EEC of 22 September 1983

31.12.1984

Council Directive 83/574/EEC of 26 October 1983

31.12.1984

Commission Directive 84/415/EEC of 18 July 1984

31.12.1985

Commission Directive 85/391/EEC of 16 July 1985

31.12.1986

22.12.2009

EN

Official Journal of the European Union
Directive

L 342/207
Time-limit for transposition

Commission Directive 86/179/EEC of 28 February 1986

31.12.1986

Commission Directive 86/199/EEC of 26 March 1986

31.12.1986

Commission Directive 87/137/EEC of 2 February 1987

31.12.1987

Commission Directive 88/233/EEC of 2 March 1988

30.9.1988

Council Directive 88/667/EEC of 21 December 1988

31.12.1993

Commission Directive 89/174/EEC of 21 February 1989

31.12.1989

Council Directive 89/679/EEC of 21 December 1989

3.1.1990

Commission Directive 90/121/EEC of 20 February 1990

31.12.1990

Commission Directive 91/184/EEC of 12 March 1991

31.12.1991

Commission Directive 92/8/EEC of 18 February 1992

31.12.1992

Commission Directive 92/86/EEC of 21 October 1992

30.6.1993

Council Directive 93/35/EEC of 14 June 1993

14.6.1995

Commission Directive 93/47/EEC of 22 June 1993

30.6.1994

Commission Directive 94/32/EC of 29 June 1994

30.6.1995

Commission Directive 95/17/EC of 19 June 1995

30.11.1995

Commission Directive 95/34/EC of 10 July 1995

30.6.1996

Commission Directive 96/41/EC of 25 June 1996

30.6.1997

Commission Directive 97/1/EC of 10 January 1997

30.6.1997

Commission Directive 97/18/EC of 17 April 1997

31.12.1997

Commission Directive 97/45/EC of 14 July 1997

30.6.1998

Commission Directive 98/16/EC of 5 March 1998

1.4.1998

Commission Directive 98/62/EC of 3 September 1998

30.6.1999

Commission Directive 2000/6/EC of 29 February 2000

1.7.2000

Commission Directive 2000/11/EC of 10 March 2000

1.6.2000

Commission Directive 2000/41/EC of 19 June 2000

29.6.2000

Commission Directive 2002/34/EC of 15 April 2002

15.4.2003

Commission Directive 2003/1/EC of 6 January 2003

15.4.2003

Commission Directive 2003/16/EC of 19 February 2003

28.2.2003

Directive 2003/15/EC of the European Parliament and of the Council of 27 Febru­
ary 2003

10.9.2004

Commission Directive 2003/80/EC of 5 September 2003

11.9.2004

Commission Directive 2003/83/EC of 24 September 2003

23.9.2004

Commission Directive 2004/87/EC of 7 September 2004

1.10.2004

Commission Directive 2004/88/EC of 7 September 2004

1.10.2004

Commission Directive 2004/94/EC of 15 September 2004

21.9.2004

Commission Directive 2004/93/EC of 21 September 2004

30.9.2004

Commission Directive 2005/9/EC of 28 January 2005

16.2.2006

Commission Directive 2005/42/EC of 20 June 2005

31.12.2005

Commission Directive 2005/52/EC of 9 September 2005

1.1.2006

Commission Directive 2005/80/EC of 21 November 2005

22.5.2006

Commission Directive 2006/65/EC of 19 July 2006

1.9.2006

Commission Directive 2006/78/EC of 29 September 2006

30.3.2007

L 342/208

EN

Official Journal of the European Union
Directive

22.12.2009
Time-limit for transposition

Commission Directive 2007/1/EC of 29 January 2007

21.8.2007

Commission Directive 2007/17/EC of 22 March 2007

23.9.2007

Commission Directive 2007/22/EC of 17 April 2007

18.1.2008

Commission Directive 2007/53/EC of 29 August 2007

19.4.2008

Commission Directive 2007/54/EC of 29 August 2007

18.3.2008

Commission Directive 2007/67/EC of 22 November 2007

31.12.2007

Commission Directive 2008/14/EC of 15 February 2008

16.8.2008

Commission Directive 2008/42/EC of 3 April 2008

4.10.2008

Commission Directive 2008/88/EC of 23 September 2008

14.2.2009

Commission Directive 2008/123/EC of 18 December 2008

8.7.2009

Commission Directive 2009/6/EC of 4 February 2009

5.8.2009

Commission Directive 2009/36/EC of 16 April 200915.11.2009

22.12.2009

EN

Official Journal of the European Union

L 342/209

ANNEX XCORRELATION TABLE
Directive 76/768/EEC

This Regulation

Article 1

Article 2(1)(a)Article 2

Article 3

Article 3—

Article 4(1)Article 14(1)Article 4(2)Article 17

Article 4a

Article 18

Article 4b

Article 15(1)Article 5—

Article 5a

Article 33

Article 6(1),(2)Article 19(1),(2),(3),(4)Article 6(3)Article 20

Article 7(1)Article 9

Article 7(2)Article 19(5), (6)Article 7(3)Article 13

Article 7a (1) (h)Article 21

Article 7a(1),(2),(3)Article 10, 11, Annex I

Article 7a(4)Article 13

Article 7a(5)Article 29, 34

Article 8(1)Article 12

Article 8(2)Article 31

Article 8a—

Article 9

Article 35

Article 10

Article 32

Article 11—

Article 12

Article 27

Article 13

Article 28

Article 14—

Article 15—

Annex I

Preamble, No. 7

Annex II

Annex II

Annex III

Annex III

Annex IV

Annex IV

Annex V—

Annex VI

Annex V

Annex VII

Annex VI

Annex VIII

Annex VII

Annex VIIIa

Annex VII

Annex IX

Annex VIII—

Annex IX—

Annex X