EUROPEAN UNIONTHE EUROPEAN PARLIAMENT

THE COUNCIL
Brussels, 10 November 2009
(OR. en)

2008/0035 (COD)

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MI 152
ENT 91CONSOM 77
SAN 74
ECO 49ENV 302
CHIMIE 34
CODEC 535
LEGISLATIVE ACTS AND OTHER INSTRUMENTS
Subject:
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE
COUNCIL on cosmetic products (recast)

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REGULATION (EC) No …/2009
OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
ofon cosmetic products(recast)(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and in particular Article 95
thereof,
Having regard to the proposal from the Commission,
Having regard to the opinion of the European Economic and Social Committee1,
Acting in accordance with the procedure laid down in Article 251 of the Treaty2,

1
2

OJ C 27, 3.2.2009, p. 34.
Opinion of the European Parliament of 24 March 2009 (not yet published in the Official
Journal) and Council Decision of ….

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Whereas:(1)

Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of theMember States relating to cosmetic products1 has been significantly amended on several
occasions. Since further amendments are to be made, in this particular case it should berecast 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 room for diverging transposition by Member States. Moreover, aRegulation ensures that legal requirements are implemented at the same time throughout
the Community.

(3)This Regulation aims at simplifying procedures and streamlining terminology, thereby
reducing administrative burden and ambiguities. Moreover, it strengthens certain elementsof the regulatory framework for cosmetics, such as in-market control, with a view toensuring a high level of protection of human health.

1

OJ L 262, 27.9.1976, p. 169.

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(4)

This Regulation comprehensively harmonises the rules in the Community in order toachieve an internal market for cosmetic products while ensuring a high level of protectionof human health.

(5)

The environmental concerns that substances used in cosmetic products may raise areconsidered through the application of Regulation (EC) No 1907/2006 of theEuropean Parliament and of the Council of 18 December 2006 concerning the Registration,
Evaluation, Authorisation and Restriction of Chemicals (REACH) and establishing a
European Chemicals Agency1, which enables the assessment of environmental safety in across-sectoral manner.

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

1

OJ L 396, 30.12.2006, p. 1.

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(7)

The assessment of whether a product is a cosmetic product has to be made on the basis of acase-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, bathand shower preparations (salts, foams, oils, gels), depilatories, deodorants and antiperspirants, hair colorants, products for waving, straightening and fixing hair, hair-setting
products, hair-cleansing products (lotions, powders, shampoos), hair-conditioning 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 this Regulation.

(9)

Cosmetic products should be safe under normal or reasonably foreseeable conditions ofuse. In particular, a risk-benefit reasoning should not justify a risk to human health.

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(10)

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 accordance with Council
Directive 87/357/EEC of 25 June 1987 on the approximation of the laws of theMember States concerning products which, appearing to be other than they are, endanger
the health or safety of consumers1.

(11)

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

(12)

Ensuring traceability of a cosmetic product throughout the whole supply chain helps tomake market surveillance simpler and more efficient. An efficient traceability systemfacilitates market surveillance authorities' task of tracing economic operators.

(13)

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

(14)

All legal or natural persons in the wholesale trade as well as retailers selling directly to theconsumer are covered by reference to the distributor. The obligations of the distributor
should therefore be adapted to the respective role and part of the activity of each ofthese operators.

1

OJ L 192, 11.7.1987, p. 49.

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(15)

The European cosmetics sector is one of the industrial activities affected by counterfeiting,which may increase risks to human health. Member States should pay particular attention
to the implementation of horizontal Community 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 rights1 and Directive 2004/48/EC of theEuropean parliament and of the Council of 29 April 2004 on the enforcement ofintellectual property rights2. In-market controls represent a powerful means of identifying
products that do not comply with the requirements of this Regulation.

(16)

To ensure their safety, cosmetic products placed on the market should be produced
according to good manufacturing practice.

(17)

For the purpose of effective market surveillance, a product information file should be madereadily accessible, at one single address within the Community, to the competent authorityof the Member State where the file is located.

(18)

In order to be comparable and of high quality, the results of 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.

1
2

OJ L 196, 2.8.2003, p. 7.
OJ L 157, 30.4.2004, p. 45.

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(19)

It should be made clear which information is to be made available to the competentauthorities. 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 information should include a cosmetic product safety report
documenting that a safety assessment has been conducted.

(20)

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

(21)

The term "mixture" as defined in this Regulation should have the same meaning as theterm "preparation" previously used in Community legislation.

(22)

For reasons of effective market surveillance, the competent authorities should be notifiedof 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, the notified information forcompetent authorities, poison control centres and assimilated entities should be submitted
centrally for the Community by way of an electronic interface.

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(25)

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

(26)

The general principle of the responsibility of the manufacturer or importer for the safety ofthe 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 andUV-filters should be listed in the Annexes IV, V and VI respectively in order to be allowed
for these uses.

(27)

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

(28)

To address safety concerns raised, Annex IV, which is currently restricted to skincolorants, should also include hair colorants once the risk assessment of these substancesby the Scientific Committee for Consumer Safety (SCCS) set up by Commission
Decision 2008/721/EC of 5 September 2008 setting up an advisory structure of ScientificCommittees and experts in the field of consumer safety, public health and the environment1
has been finalised. To this end, the Commission should have the possibility to include haircolorants in the scope of that Annex by the comitology procedure.

1

OJ L 241, 10.9.2008, p. 21.

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(29)

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

(30)

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 ofscientific progress.

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(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 the Council of 16 December 2008 on
classification, labelling and packaging of substances and mixtures1, their use in cosmetic
products should be prohibited. However, as a hazardous property of a substance does notnecessarily always entail a risk, there should be a possibility to allow the use of substancesclassified as CMR 2 substances where, in view of exposure and concentration, they havebeen found safe for use in cosmetic products by the SCCS and are regulated by theCommission in the Annexes to this Regulation. With regard to substances which areclassified as CMR 1A or 1B substances, there should be a possibility, in the exceptionalcase that these substances comply with food safety requirements, inter alia as a result of
their naturally occurring in food, and that no suitable alternative substances exist, to use
such substances in cosmetic products 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 becontinuously reviewed by the SCCS.

1OJ L 353, 31.12.2008, p. 1.

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(33)

A safety assessment of substances, particularly those classified as CMR 1A or 1B
substances, should consider the overall exposure to such substances stemming from all
sources. At the same time, for those involved in producing safety assessments, it isessential that there be a harmonised approach to the development and use of such overall
exposure estimates. In consequence, the Commission, in close cooperation with the SCCS,
the European Chemicals Agency (ECHA), the European Food Safety Authority (EFSA)
and other relevant stakeholders, should, as a matter of urgency, carry out a review anddevelop guidance regarding the production and use of overall exposure estimates forthese 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 ofvulnerable 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 the safety 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 healthshould be based on the precautionary principle.

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(37)

In order to ensure product safety, prohibited substances should be acceptable at trace levels
only if they are technologically inevitable with correct manufacturing processes andprovided that the product is safe.

(38)

The Protocol on protection and welfare of animals annexed to the Treaty provides that theCommunity and the Member States are to pay full regard to the welfare requirements ofanimals in the implementation of Community policies, in particular with regard to theinternal market.

(39)

Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws,
regulations and administrative provisions of the Member States regarding the protection ofanimals used for experimental and other scientific purposes1 established common rules forthe use of animals for experimental purposes within the Community and laid down theconditions under which such experiments must be carried out in the territory of theMember States. In particular, Article 7 of that Directive requires that animal experiments
be replaced by alternative methods, where such methods exist and are
scientifically satisfactory.

1

OJ L 358, 18.12.1986, p. 1.

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(40)

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

(41)

The safety of finished cosmetic products can already be ensured on the basis of knowledgeof the safety of the ingredients that they contain. Provisions prohibiting animal testing offinished cosmetic products should therefore be laid down. The application, in particular bysmall and medium-sized enterprises, of both test methods and assessment procedures forrelevant available data, including the use of read-across and weight-of-evidence
approaches, which do not involve the use of animals for assessing the safety of finishedcosmetic products could be facilitated by Commission guidelines.

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(42)

It will gradually become possible to ensure the safety of ingredients used in cosmetic
products by using non-animal alternative 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 and Development (OECD). Afterconsulting the SCCS as regards the applicability of the validated alternative methods to thefield of cosmetic products, the Commission should immediately publish the validated orapproved methods recognised as being applicable to such ingredients. In order to achieve
the highest possible degree of animal protection, a deadline should be set for the
introduction of a definitive prohibition.

(43)

The Commission established timetables of deadlines up to 11 March 2009 for prohibiting
the marketing of cosmetic products, the final formulation, ingredients or combinations ofingredients which have been tested on animals, and for prohibiting each test currently
carried out using animals. In view, however, of tests concerning repeated-dose toxicity,
reproductive toxicity and toxicokinetics, it is appropriate for the final deadline forprohibiting the marketing of cosmetic products for which those tests are used tobe 11 March 2013. On the basis of annual reports, the Commission should be authorised toadapt the timetables within the abovementioned maximum time limit.

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(44)

Better coordination of resources at Community level will contribute to increasing thescientific knowledge indispensable for the development of alternative methods. It isessential, for this purpose, that the Community continue and increase its efforts and takethe measures necessary for the 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. In order 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 obtain recognition of the results of safety
tests carried out in the Community using alternative methods so as to ensure that the exportof cosmetic products for which such methods have been used is not hindered and toprevent or avoid third countries requiring the repetition of such tests using animals.

(46)

Transparency is needed regarding the ingredients used in cosmetic products. Suchtransparency should be achieved by indication of the ingredients used in a cosmetic
product on its packaging. Where for practical reasons it is impossible to indicate theingredients on the packaging, such information should be enclosed so that the consumer
has access to this information.

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(47)

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

(48)

In order to inform consumers, cosmetic products should bear 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 and remain safe, it is important to know the date of minimum durability, i.e.
the date by which it is best to use the product. Where the minimum durability is morethan 30 months, the consumer should be informed of the period of time after opening thatthe cosmetic product may be used without any harm to the consumer. However, thisrequirement 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.

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(49)

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 are adequately informed, the presenceof these substances should be mentioned in the list of ingredients and consumers' attention
should be drawn to the presence of these ingredients. This information should improve thediagnosis of contact allergies among consumers and should enable them to avoid the use ofcosmetic products which they do not tolerate. For substances which are likely to cause
allergy to a significant part of the population, other restrictive measures such as a ban or a
restriction of concentration should be considered.

(50)

In the safety assessment of a cosmetic product it should be possible to take into accountresults of risk assessments that have been carried out in other relevant areas. The use ofsuch data should be duly substantiated and justified.

(51)

The consumer should be protected from misleading claims concerning efficacy and othercharacteristics of cosmetic products. In particular Directive 2005/29/EC of theEuropean Parliament and of the Council of 11 May 2005 concerning unfair business-toconsumer commercial practices in the internal market1 is applicable. Furthermore, theCommission, in cooperation with Member States, should define common criteria in
relation to specific claims for cosmetic products.

1

OJ L 149, 11.6.2005, p. 22.

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(52)

It should be possible to claim on a cosmetic product that no animal testing was carried out
in relation to its development. The Commission, in consultation with the Member States,
has developed guidelines to ensure that common criteria are applied in the use of claims
and that an aligned understanding of the claims is reached, and in particular that suchclaims do not mislead the consumer. In developing such guidelines, the Commission has
also taken into account the views of the many small and medium-sized enterprises whichmake up the majority of the "non-animal testing" producers, relevant non-governmentalorganisations, and the need for consumers to be able to make practical distinctions between
products on the basis of animal testing criteria.

(53)

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

(54)

Effective market surveillance is necessary in order to ensure that the provisions of thisRegulation are respected. To this end, serious undesirable effects should be notified andcompetent authorities should have a possibility to request from the responsible person a listof cosmetic products containing substances which have raised serious doubts in termsof safety.

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(55)

This Regulation is without prejudice to the possibility for Member States to regulate, incompliance with Community law, the notification by health professionals or consumers ofserious undesirable effects to the competent authorities of Member States.

(56)

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

(57)

In case of non-compliance with this Regulation, a clear and efficient procedure for thewithdrawal and recall of products 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 thisRegulation, might endanger human health, a safeguard procedure should be introduced.

(59)

The Commission should provide indications for the uniform interpretation and applicationof the concept of serious risks in order to facilitate the consistent implementation ofthis Regulation.

(60)

In order to comply with principles of good administrative practices, any decision by acompetent authority in the framework of market surveillance should be duly substantiated.

(61)

In order to ensure effective in-market control, a high degree of administrative cooperation
amongst the competent authorities is necessary. This concerns in particular mutual
assistance in the verification of product information files located in another Member State.

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(62)

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

(63)

The measures necessary for the implementation of this Regulation should be adopted inaccordance with Council Decision 1999/468/EC of 28 June 1999 laying down theprocedures for the exercise of implementing powers conferred on the Commission1.

(64)

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

(65)

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

(66)

Member States should lay down provisions on penalties applicable to infringements of theprovisions of this Regulation and ensure that they are implemented. Those penalties shouldbe effective, proportionate and dissuasive.

1

OJ L 184, 17.7.1999, p. 23.

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(67)

Economic operators as well as Member States and the Commission need sufficient time toadapt to the changes introduced by this Regulation. Therefore it is appropriate to provide
for a sufficient transitional period for that adaptation. However, in order to ensure a smoothtransition, economic operators should be allowed to place on the market cosmetic products
which comply with this Regulation before the expiry of that transitional period.

(68)

In order to enhance the safety of cosmetic products and strengthen the market surveillance,cosmetic products placed on the market after the date of application of this Regulation
should comply with its obligations regarding safety assessment, the product information
file and notification, even if similar obligations have already been fulfilled underDirective 76/768/EEC.

(69)

Directive 76/768/EEC should be repealed. However, in order to ensure appropriate medical
treatment in the event of difficulties and to ensure market surveillance, the information
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 of time.

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(70)

This Regulation should 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 inPart B of Annex IX.

(71)Since the objective of this Regulation, namely the achievement of the internal market and ahigh level of protection of human health through the compliance of cosmetic products withthe requirements laid down in this Regulation, cannot be sufficiently achieved by theMember States and can therefore, by reason of the scale of the action, be better achieved atCommunity level, the Community may adopt measures, in accordance with the principle ofsubsidiarity, as set out in Article 5 of the Treaty. In accordance with the principle ofproportionality, as set out in that Article, this Regulation does not go beyond what isnecessary in order to achieve that objective,

HAVE ADOPTED THIS REGULATION:

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Chapter I
Scope, definitions

Article 1
Scope and objective
This Regulation establishes rules to be complied with by any cosmetic product made available on
the market, in order to ensure the functioning of the internal market and a high level of protection ofhuman health.

Article 2
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 human body (epidermis, hair system, nails, lips andexternal genital organs) or with the teeth and the mucous membranes of the oralcavity with a view exclusively or mainly to cleaning them, perfuming them,changing their appearance, protecting them, keeping them in good condition or
correcting body odours;

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(b)

"substance" means a chemical element and its compounds in the natural state or
obtained by any manufacturing process, including any additive necessary to preserve
its stability and any impurity deriving from the process used but excluding any
solvent which may be separated without affecting the stability of the substance orchanging its composition;(c)"mixture" means a mixture or solution composed of two or more substances;(d)"manufacturer" means any natural or legal person who manufactures 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, who makes a cosmetic product available on theCommunity market;(f)"end user" means either a consumer or professional using the cosmetic product;

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(g)

"making available on the market" means any supply of a cosmetic product for
distribution, consumption or use on the Community market in the course of acommercial activity, whether in return for payment or free of charge;(h)"placing on the market" means the first making available of a cosmetic product on
the Community market;(i)"importer" means any natural or legal person established within the Community, whoplaces a cosmetic product from a 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 the Council of 22 June 1998 laying down a procedure for theprovision of information in the field of technical standards and regulations and ofrules on information society services1 on the basis of a request made by theCommission in accordance with Article 6 of that Directive;(k)"nanomaterial" means an insoluble or biopersistant and intentionally manufactured
material with one or more external dimensions, or an internal structure, on the scalefrom 1 to 100 nm;

1

OJ L 204, 21.7.1998, p. 37.

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(l)

"preservatives" means substances which are exclusively or mainly intended to inhibit
the development of micro-organisms in the cosmetic product;(m) "colorants" means substances which are exclusively or mainly intended to colour thecosmetic product, the body as a whole or certain parts thereof, by absorption orreflection of visible light; in addition, precursors of oxidative hair colorants shall bedeemed colorants;(n)"UV-filters" means substances which are exclusively or mainly intended to protect
the skin against certain UV radiation by absorbing, reflecting or scattering
UV radiation;(o)"undesirable effect" means an adverse reaction for human health attributable to thenormal 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 immediate vital risk or death;(q)"withdrawal" means any measure aimed at preventing the making available on themarket of a cosmetic product in the supply chain;

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(r)

"recall" means any measure aimed at achieving the return of a cosmetic product thathas already been made available to the end user;(s)"frame formulation" means a formulation which lists the category or function ofingredients and their maximum concentration in the cosmetic product or gives
relevant quantitative and qualitative information whenever a cosmetic product is notcovered or only partially covered by such a formulation. The Commission shallprovide indications for the establishment of the frame formulation and adapt them
regularly to technical and scientific progress.

2.

For the purposes of point (a) of paragraph 1, a substance or mixture intended to beingested, inhaled, injected or implanted into the human body shall not be considered to bea cosmetic product.

3.

In view of the various definitions of nanomaterials published by different bodies and theconstant technical and scientific developments in the field of nanotechnologies, theCommission shall adjust and adapt point (k) of paragraph 1 to technical and scientificprogress 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).

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Chapter II
Safety, responsibility, free movement

Article 3
SafetyA cosmetic product made available on the market shall be safe for human health when used undernormal or reasonably foreseeable conditions of use, taking account, in particular, of the following:(a)presentation including conformity with Directive 87/357/EEC;(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 compliancewith 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 theCommunity as "responsible person" shall be placed on the market.

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2.

For each cosmetic product placed on the market, the responsible person shall ensurecompliance with the relevant obligations set out in this Regulation.

3.

For a cosmetic product manufactured within the Community, and not subsequently
exported and imported back into the Community, the manufacturer established within theCommunity shall be the responsible person.
The manufacturer may designate, by written mandate, a person established within theCommunity as the responsible person who shall accept in writing.

4.

Where, for a cosmetic product manufactured within the Community, and not subsequently
exported and imported back into the Community, the manufacturer is established outside
the Community, he shall designate, by written mandate, a person established within theCommunity 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 places on the market.
The importer may, by written mandate, designate a person established within theCommunity as the responsible person who shall accept in writing.

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6.

The distributor shall be the responsible person where he places a cosmetic product on themarket under his name or trademark or modifies a product already placed on the market insuch a way that compliance with the applicable requirements may be affected.
The translation of information relating to a cosmetic product already placed on the market
shall not be considered as a modification of that product of such a nature that compliancewith the applicable requirements of this Regulation may be affected.

Article 5
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 believe that a cosmetic product which
they have placed on the market is not in conformity with this Regulation shall immediately
take the corrective measures necessary to bring that product into conformity, withdraw it orrecall it, as appropriate.

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Furthermore, where the cosmetic product presents a risk to human health, responsible
persons shall immediately inform the competent national authorities of the Member Statesin which they made the product available and of the Member State in which the productinformation file is readily accessible, giving details, in particular, of the non-complianceand of the corrective measures taken.
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 madeavailable on the market. In particular, responsible persons shall, further to a reasoned
request from a competent national authority, provide it with all the information anddocumentation necessary to demonstrate the conformity of specific aspects of the product,
in a language 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,

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–

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 thisRegulation, they shall not make the product available on the market until it has beenbrought into conformity with the applicable requirements,–a cosmetic product which they have made available on the market is not in
conformity with this Regulation, they shall make sure that the corrective measuresnecessary to bring that product into conformity, withdraw it or recall it, as
appropriate, are taken.

Furthermore, where the cosmetic product presents a risk to human health, distributors shallimmediately inform the responsible person and the competent national authorities of theMember States in which they made the product available, giving details, in particular, ofthe non-compliance and of the corrective measures taken.
4.

Distributors shall ensure that, while a product is under their responsibility, storage ortransport conditions do not jeopardise its compliance with the requirements set out inthis Regulation.

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5.

Distributors shall cooperate with competent authorities, at the request of the latter, on any
action to eliminate the risks posed by products which they have made available on themarket. In particular, distributors shall, further to a reasoned request from a competent
national authority, provide it with all the information and documentation necessary todemonstrate the conformity of the product with the requirements listed under paragraph 2,
in a language which can be easily understood by that authority.

Article 7
Identification within the supply chain
At the request of a competent authority:–

responsible persons shall identify the distributors to whom they supply thecosmetic product,–

the distributor shall identify the distributor or the responsible person from whom, and the
distributors to whom, the cosmetic product was supplied.

This obligation shall apply for a period of three years following the date on which the batch of thecosmetic product was made available to the distributor.

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Article 8
Good manufacturing practice1.

The manufacture of cosmetic products shall comply with good manufacturing practice witha view to ensuring the objectives of Article 1.

2.

Compliance with good manufacturing practice shall be presumed where the manufacture isin 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.

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Chapter III
Safety assessment,
product information file, notification

Article 10
Safety assessment
1.

In order to demonstrate that a cosmetic product complies with Article 3, the responsible
person shall, prior to placing a cosmetic product on the market, ensure that the cosmetic
product has undergone a safety assessment on the basis of the relevant information and thata cosmetic product safety report is set up in accordance with Annex I.
The responsible person shall ensure that:(a)the intended use of the cosmetic product and the anticipated systemic exposure toindividual ingredients in a final formulation are taken into account in the safetyassessment;(b)

an appropriate weight-of-evidence approach is used in the safety assessment forreviewing data from all existing sources;(c)the cosmetic product safety report is kept up to date in view of additional relevant
information generated subsequent to placing the product on the market.

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The first subparagraph shall also apply to cosmetic products that have been notified underDirective 76/768/EEC.
The Commission, in close cooperation with all stakeholders, shall adopt appropriate
guidelines to enable undertakings, in particular small and medium-sized enterprises, tocomply with the requirements laid down in Annex I. Those guidelines shall be adopted inaccordance with the regulatory procedure referred to in Article 32(2).
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 awardedon completion of a university course of theoretical and practical study in pharmacy,
toxicology, medicine or a similar discipline, or a course recognised as equivalent by aMember 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
product shall comply with Community legislation on the principles of good laboratory
practice, as applicable at the time of performance of the study, or with other international
standards recognised as being equivalent by the Commission or the ECHA.

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Article 11
Product information file1.

When a cosmetic product is placed on the market, the responsible 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 product was placed on
the market.

2.

The product information file shall contain the following information and data which shallbe updated as necessary:(a)a description of the cosmetic product which enables the product information file to
be clearly attributed to the cosmetic product;(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 withgood manufacturing practice referred to in Article 8;(d)where justified by the nature or the effect of the cosmetic product, proof of the effectclaimed for the cosmetic product;(e)data on any animal testing performed by the manufacturer, his agents or suppliers,
relating to the development or safety assessment of the cosmetic product or its
ingredients, including any animal testing performed to meet the legislative or
regulatory requirements of third countries.

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3.

The responsible person shall make the product information file readily accessible inelectronic or other format at his address indicated on the label to the competent authority of
the Member State in which the file is kept.
The information contained in the product information file shall be available in a language
which can be easily understood by the competent authorities of the Member State.

4.

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

Article 12
Sampling and analysis
1.

Sampling and analysis of cosmetic products shall be performed in a reliable andreproducible 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, the references of which have been published in the Official Journal of theEuropean Union.

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Article 13
Notification
1.

Prior to placing the cosmetic product on the market the responsible person shall submit, byelectronic means, the following 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 the product information file ismade readily accessible;(c)the country of origin in the case of import;(d)the Member State in which the cosmetic product is to be placed on the market;(e)the contact details of a physical person to contact in the case of necessity;(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 Preamble to Annexes II to VI to this Regulation;

(ii)
(g)

the reasonably foreseeable exposure conditions;the name and the Chemicals Abstracts Service (CAS) or EC number of substancesclassified as carcinogenic, mutagenic or toxic for reproduction (CMR), of category
1A or 1B, under Part 3 of Annex VI to Regulation (EC) No 1272/2008;

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(h)

the frame formulation allowing for prompt and appropriate medical treatment in theevent of difficulties.

The first subparagraph shall also apply to cosmetic products notified underDirective 76/768/EEC.
2.

When the cosmetic product is placed on the market, the responsible person shall notify to
the Commission the original labelling, and, where reasonably legible, a photograph of thecorresponding packaging.

3.

As from ...*, a distributor who makes available in a Member State a cosmetic productalready placed on the market in another Member State and translates, on his own initiative,
any element of the labelling of that product in order to comply with national law, shallsubmit, 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 made available;(c)his name and address;(d)the name and address of the responsible person where the product information file ismade readily accessible..

*

OJ: 42 months after the date of entry into force of this Regulation.

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4.

Where a cosmetic product has been placed on the market before ...* but is no longer placedon the market as from that date, and a distributor introduces that product in a Member Stateafter that date, that distributor shall communicate the following to the responsible person:(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 made available;(c)his name and address.

On the basis of that communication, the responsible person shall submit to theCommission, by electronic means, the information referred to in paragraph 1 ofthis 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 in which thecosmetic product is made available.
5.

The Commission shall, without delay, make the information referred to in points (a) to (g)of paragraph 1, and in paragraphs 2 and 3 available electronically to allcompetent authorities.
That information may be used by competent authorities only for the purposes of market
surveillance, market analysis, evaluation and consumer information in the context ofArticles 25, 26 and 27.

*

OJ: 42 months after the date of entry into force of this Regulation.

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6.

The Commission shall, without delay, make the information referred to in paragraphs 1, 2
and 3 available electronically to poison centres or similar bodies, where such centres orbodies have been established by Member States.
That information may be used by those bodies only for the purposes of medical treatment.

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.

8.

The Commission may, taking into account technical and scientific progress and specificneeds related to market surveillance, amend paragraphs 1 to 7 by adding requirements.
Those measures, 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).

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Chapter IV
Restrictions for certain substances

Article 14
Restrictions for substances listed in the Annexes
1.

Without prejudice to Article 3, cosmetic products shall not contain any of the following:(a)prohibited substances–(b)prohibited substances listed in Annex II;

restricted substances–

restricted substances which are not used in accordance with the restrictions laid
down in Annex III;(c)colorants(i)colorants other than those listed in Annex IV and colorants which are listed
there but not used in accordance with the conditions laid down in that Annex,
except for hair 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 not intended to be used as colorants, and which are notused in accordance with the conditions laid down in that Annex;

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(d)

preservatives(i)preservatives other than those listed in Annex V and preservatives which arelisted there but not used in accordance with the conditions laid down inthat 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 usedin accordance with the conditions laid down in that Annex;(e)

UV-filters(i)

UV-filters other than those listed in Annex VI and UV-filters which are listed
there but not used in accordance with the conditions laid down in that Annex;(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 inaccordance with the conditions laid down in that Annex.

2.

Subject to a decision of the Commission to extend the scope of Annex IV to hair colouring
products, such products shall not contain colorants intended to colour the hair, other thanthose listed 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.

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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 theregulatory 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 Regulation (EC) No 1272/2008 shall be prohibited. However,a substance classified in category 2 may be used in cosmetic products where the substancehas been evaluated by the SCCS and found safe for use in cosmetic products. To theseends the Commission shall adopt the necessary measures in accordance with the regulatory
procedure with scrutiny referred to in Article 32(3) of this Regulation.

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.

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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 ofAnnex VI to Regulation (EC) No 1272/2008, all of the following conditions are fulfilled:(a)they comply with the food safety requirements as defined in Regulation (EC)No 178/2002 of the European Parliament and of the Council of 28 January 2002
laying down the general principles and requirements of food law, establishing theEuropean Food Safety Authority and laying down procedures in matters offood safety1;(b)there are no suitable alternative substances available, as documented in an analysisof alternatives;(c)the application is made for a particular use of the product category 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 to these products and taking into consideration theoverall exposure from other sources, taking particular account of vulnerable
population groups.

1

OJ L 31, 1.2.2002, p. 1.

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Specific labelling in order to avoid misuse of the cosmetic product shall be provided inaccordance with Article 3 of this Regulation, taking into account possible risks linked tothe presence of hazardous substances and the routes of exposure.
In order to implement this paragraph, the Commission shall amend the Annexes to thisRegulation in accordance with the regulatory procedure with scrutiny referred to in
Article 32(3) of this 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 the urgency procedurereferred to in Article 32(4) of this Regulation.
The Commission shall mandate the SCCS to re-evaluate those substances as soon as safetyconcerns arise, and at the latest five years after their inclusion in Annexes III to VI to thisRegulation, and at least every subsequent five years.
3.

By ...*, the Commission shall ensure that appropriate guidance is developed with the aim ofenabling a harmonised approach to the development and use of overall exposure estimatesin assessing the safe use of CMR substances. This guidance shall be developed inconsultation with the SCCS, the ECHA, the EFSA and other relevant stakeholders,drawing, as appropriate, on relevant best practice.

*

OJ: Two years after the date of entry into force of this Regulation.

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4.

When Community or internationally agreed criteria for identifying substances withendocrine-disrupting properties are available, or at the latest on ...*, the Commission shallreview this Regulation with regard to substances with endocrine-disrupting properties.

Article 16
Nanomaterials
1.

For every cosmetic product that contains nanomaterials, a high level of protection ofhuman health shall be ensured.

2.

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

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 have already beenplaced on the market by the same responsible person before ...** .
In the latter case, cosmetic products containing nanomaterials placed on the market shall be
notified to the Commission by the responsible person between ...** and ...*** by electronicmeans, in addition to the notification in Article 13.

*
**
***

OJ: Five years after the date of entry into force of this Regulation.
OJ: 36 months after the date of entry into force of this Regulation.
OJ: 42 months after the date of entry into force of this Regulation.

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The first and the second subparagraphs shall not apply to cosmetic 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 chemical name (IUPAC) and otherdescriptors as specified in point 2 of the Preamble to Annexes II to VI;(b)the specification of the nanomaterial including size of particles, physical andchemical properties;(c)an estimate of the quantity of nanomaterial contained in cosmetic products intended
to be placed on the market per year;(d)the toxicological profile of the nanomaterial;(e)the safety data of the nanomaterial relating to the category of cosmetic product, as
used in such products;(f)

the reasonably foreseeable exposure conditions.

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 the information to be notified under point (d).

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4.

In the event that the Commission has concerns regarding the safety of a nanomaterial, theCommission shall, without delay, request the SCCS to give its opinion on the safety ofsuch nanomaterial for use in the relevant categories of cosmetic products and on thereasonably 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 Commission shall request the
responsible person to provide such data within an explicitly stated reasonable time, whichshall not be extended. The SCCS shall deliver its final opinion within six months ofsubmission of additional data. The opinion of the SCCS shall be made publicly available.

5.

The Commission may, at any time, invoke the procedure in paragraph 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 humanhealth, including when there is insufficient data, the Commission may amend Annexes II
and III.

7.

The Commission may, taking into account technical and scientific progress, amend
paragraph 3 by adding requirements.

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8.

The measures, referred to in paragraphs 6 and 7, designed to amend non-essential elementsof this Regulation, shall be adopted in accordance with the regulatory procedure withscrutiny 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 the Commission:(a)

By ...*, the Commission shall make available a catalogue of all nanomaterials used incosmetic products placed on the market, including those used as colorants, UV-filtersand preservatives in a separate section, indicating the categories of cosmetic products
and the reasonably foreseeable exposure conditions. This catalogue shall be regularly
updated thereafter and be made publicly available.

*

OJ: 48 months after the date of entry into force of this Regulation.

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(b)

The Commission shall submit to the European Parliament and the Council an annual
status report, which will give information on developments in the use of
nanomaterials in cosmetic products within the Community, including those used ascolorants, UV-filters and preservatives in a separate section. The first report shall bepresented by ...* . The report update shall summarise, in particular, the newnanomaterials in new categories of cosmetic products, the number of notifications,the progress made in developing nano-specific assessment methods and safetyassessment guides, and information on international cooperation programmes.

11.

The Commission shall regularly review the provisions of this Regulation concerning
nanomaterials in the light of scientific progress and shall, where necessary, propose
suitable amendments to those provisions.
The first review shall be undertaken by …** .

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 from packaging,which is technically unavoidable in good manufacturing practice, shall be permitted provided thatsuch presence is in conformity with Article 3.

***

OJ: 54 months after date of entry into force of this Regulation.
OJ: 5 years + 42 months after date of entry into force of this Regulation.

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Chapter V
Animal testing

Article 18
Animal testing1.

Without prejudice to the general obligations deriving from Article 3, the following shallbe prohibited:(a)the placing on the market of cosmetic products where the final formulation, in order
to meet the requirements of this Regulation, has been the subject of animal testing
using a method other than an alternative method after such alternative method has
been validated and adopted at Community level with due regard to the developmentof validation within the OECD;(b)

the placing on the market of cosmetic products containing ingredients or
combinations of ingredients which, in order to meet the requirements of thisRegulation, have been the subject of animal testing using a method other than analternative method after such alternative method has been validated and adopted atCommunity level with due regard to the development of validation within
the OECD;

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(c)

the performance within the Community of animal testing of finished cosmetic
products in order to meet the requirements of this Regulation;(d)the performance within the Community of animal testing of ingredients or
combinations of ingredients in order to meet the requirements of this Regulation,
after the date on which such tests are required to be replaced by one or more
validated 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 the OECD, has established timetables for the implementation of the provisions
under points (a), (b) and (d) of paragraph 1, including deadlines for the phasing-out of thevarious 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 implementation was limited
to 11 March 2009 in relation to points (a), (b) and (d) of paragraph 1.

1

OJ L 142, 31.5.2008, p. 1.

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In relation to the tests concerning repeated-dose toxicity, reproductive toxicity andtoxicokinetics, for which there are no alternatives yet under consideration, the period for
implementation of paragraph 1(a) and (b) shall be limited to 11 March 2013.
The Commission shall study possible technical difficulties in complying with the ban inrelation to tests, in particular those concerning repeated-dose toxicity, reproductive toxicity
and toxicokinetics, for which there are no alternatives yet under consideration. Information
about the provisional and final results of these 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 firstsubparagraph, could be adapted up to 11 March 2009 in relation to the first subparagraphand may be adapted up to 11 March 2013 in relation to the second subparagraph and after
consultation of the entities referred to in the first subparagraph.

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The Commission shall study progress and compliance with the deadlines as well as
possible technical difficulties in complying with the ban. Information about the provisionaland final results of the Commission studies forms part of the yearly reports presented
pursuant to Article 35. If these studies conclude, at the latest two years prior to the end of
the maximum period referred to in the second subparagraph, that for technical reasons one
or more 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 theCouncil and shall put forward a legislative proposal in accordance with Article 251 of
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 aderogation from paragraph 1. The request shall contain an evaluation of the situation andindicate the measures necessary. On this basis, the Commission may, after consulting
the SCCS and by means of a reasoned decision, authorise the derogation. Thatauthorisation shall lay down the conditions associated with this derogation in terms ofspecific objectives, duration and reporting of the results.

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A derogation shall be granted only where:(a)the ingredient is in wide use and cannot be replaced by another ingredient capable ofperforming a similar function;(b)

the specific human health problem is substantiated and the need to conduct animal
tests is justified and is supported by a detailed research protocol proposed as thebasis for the evaluation.

The decision on the authorisation, the conditions associated with it and the final result
achieved shall be part of the annual report presented by the Commission in accordancewith Article 35.
The measures referred to in the sixth 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).
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, andfrom which the finished cosmetic product is copied or finally developed.

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Chapter VI
Consumer information

Article 19
Labelling1.

Without prejudice to other provisions in this Article, cosmetic products shall be madeavailable 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. Suchinformation may be abbreviated in so far as the abbreviation makes it possible toidentify that person and his address. If several addresses are indicated, the one where
the responsible person makes readily available the product information file shall behighlighted. The country of origin shall be specified for imported cosmetic products;(b)

the nominal content at the time of packaging, given by weight or by volume, except
in the case of packaging containing less than five grams or five millilitres, freesamples and single-application packs; for pre-packages normally sold as 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 informationneed not be given if the number of items is easy to see from the outside or if the
product is normally only sold individually;

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(c)

the date until which the cosmetic product, stored under appropriate conditions, willcontinue 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 packaging shall be preceded by
the symbol shown in point 3 of Annex VII or the words: "best used before theend of".
The date of minimum durability shall be clearly expressed and shall consist of either
the month and year or the day, month and year, in that order. If necessary, thisinformation 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 durability of more than 30 months. For such products,
there shall be an indication of the period of time after opening for which the productis safe and can be used without any harm to the consumer. 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);

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(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 identifying the cosmetic
product. Where this is impossible for practical 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 from its presentation;(g)a list of ingredients. This information may be indicated on the packaging alone. The
list shall be preceded by the term "ingredients".
For the purpose of this Article, an ingredient means any substance or mixture
intentionally used in the cosmetic product during 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 ofwhich is required under the column "Other" in Annex III, shall be indicated in the listof ingredients in addition to the terms parfum or aroma.

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The list of ingredients shall be established in descending order of weight of theingredients at the time they are added to the cosmetic product. Ingredients inconcentrations of less than 1 % may be listed in any order after those inconcentrations of more than 1 %.
All ingredients present in the form of nanomaterials shall be clearly indicated in thelist of ingredients. The names of such ingredients 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 ingredients. For decorative cosmetic products marketed inseveral colour shades, all colorants other than colorants intended to colour the hairused in the range may be listed, provided that the 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 the information mentioned in points (d)and (g) of paragraph 1 as provided,the following applies:–

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–

unless impracticable, this information shall be referred to by abbreviated informationor the symbol given in point 1 of Annex VII, which must appear on the container orpackaging for the information referred in point (d) of paragraph 1 and on packaging
for the information referred in point (g) of paragraph 1.

3.

In the case of soap, bath balls and other small products where it is impossible for practicalreasons for the information referred 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 the cosmetic product is exposed for sale.

4.

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

5.

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

6.

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

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Article 20
Product claims
1.

In the labelling, making available on the market and advertising of cosmetic products, text,
names, trade marks, pictures and figurative or other signs shall not be used to imply thatthese products 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 useof a claim.
After consulting the SCCS or other relevant authorities, the Commission shall adopt a listof common criteria for claims which may be used in respect of cosmetic products, inaccordance with the regulatory procedure with scrutiny referred to in Article 32(3) of thisRegulation, taking into account the provisions of Directive 2005/29/EC.
By ...*, the Commission shall submit to the European Parliament and the Council a report
regarding the use of claims on the basis of the common criteria adopted under the second
subparagraph. If the report concludes that claims used in respect of cosmetic products are
not in conformity with the common criteria, the Commission shall take appropriate
measures to ensure compliance in cooperation with the Member States.

*

OJ: 3 years + 42 months after date of entry into force of this Regulation.

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3.

The responsible person may refer, on the product packaging or in any document, notice,label, ring or collar accompanying 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 notcarried out or commissioned any animal tests on the finished cosmetic product, or its
prototype, or any of the ingredients contained in it, or used any ingredients that have beentested on animals by others for the purpose of developing new cosmetic products.

Article 21
Access to information for the public
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 thecosmetic product and, in the case of perfume and aromatic compositions, 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.
The quantitative information regarding composition of the cosmetic product required to be madepublicly accessible shall be limited to hazardous substances in accordance with Article 3 ofRegulation (EC) No 1272/2008.

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Chapter VII
Market surveillance

Article 22
In-market control
Member States shall monitor compliance with this Regulation via in-market controls of thecosmetic 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 productinformation file and, where appropriate, physical and laboratory checks on the basis ofadequate samples.
Member States shall also monitor compliance with the principles of good manufacturing practices.
Member States shall entrust to market surveillance authorities the necessary powers, resources andknowledge in order for those authorities to properly perform their tasks.
Member States shall periodically review and assess the functioning 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 tothe public, by way of electronic communication and, where appropriate, by other means.

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Article 23
Communication of serious undesirable effects
1.

In the event of serious undesirable effects, the responsible person and distributors shallwithout 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;

2.

(b)

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

Where the responsible person reports serious undesirable effects to the competent authorityof the Member State where the effect occurred, that competent authority shall immediatelytransmit the information referred to in paragraph 1 to the competent authorities of the otherMember States.

3.

Where distributors report serious undesirable effects to the competent authority of theMember State where the effect occurred, that competent authority shall immediatelytransmit the information referred to in paragraph 1 to the competent authorities of the otherMember States and to the responsible person.

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4.

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

5.

Competent authorities may use the information referred to in this Article for the purposesof in-market surveillance, market analysis, evaluation and consumer information in thecontext of Articles 25, 26 and 27.

Article 24
Information on substances
In the event of serious doubt regarding the safety of any substance contained in cosmetic products,
the competent authority of a Member State in which a product containing such a substance is madeavailable on the market may by reasoned request require the responsible person to submit a list of
all cosmetic products for which he is responsible and which contain this substance. The list shallindicate 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 analysis, evaluation and consumer information in the context ofArticles 25, 26 and 27.

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

the safety assessment referred to in Article 10;(c)the requirements for the product information file referred to in Article 11;(d)the provisions on sampling and analysis referred to in Article 12;(e)the notification requirements referred to in Articles 13 and 16;(f)

the restrictions for substances referred to in Articles 14, 15 and 17;(g)

the animal testing requirements referred to in Article 18;

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2.

(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;(k)

the communication of serious undesirable effects referred to in Article 23;(l)the information requirements on substances referred to in Article 24.

Where applicable, a competent authority shall inform the competent authority of theMember 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 measures referred 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 competent authority considers thatthe non-compliance is not limited to the territory of the Member State in which thecosmetic product is made available on the market, it shall inform the Commission and thecompetent authorities of the other Member States of the measures which it has required the
responsible person to take.

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5.

The competent authority shall take all appropriate measures to prohibit or restrict themaking available on the market of the cosmetic product or to withdraw the product fromthe market or to recall it in the following cases:(a)where an immediate action is necessary in the event of serious risk to human health;or(b)where the responsible person does not take all appropriate measures within the time
limit referred to in paragraph 1.

In the event of serious risks to human health, that competent authority shall inform theCommission and the competent authorities of the other Member States, without delay, ofthe measures taken.
6.

In the absence of a serious risk to human health, in the event that the responsible person
does not take all appropriate measures, the competent authority shall without delay informthe competent authority of the Member State in which the responsible person is establishedof the measures taken.

7.

For the purposes of paragraphs 4 and 5 of this Article, the information exchange systemprovided for in Article 12(1) of Directive 2001/95/EC of the European Parliament and of
the Council of 3 December 2001 on general product safety1 shall be used.

1

OJ L 11, 15.1.2002, p. 4.

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Article 12(2), (3) and (4) of Directive 2001/95/EC and Article 23 of Regulation (EC)No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out therequirements for accreditation and market surveillance relating to the marketing ofproducts1 shall also apply.

Article 26
Non-compliance by distributors
Competent authorities shall require distributors to take all appropriate measures, including
corrective actions bringing the cosmetic 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 non-compliance with obligations laid down in Article 6.

Article 27
Safeguard clause1.

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

1

OJ L 218, 13.8.2008, p. 30.

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2.

The competent authority shall immediately communicate to the Commission and thecompetent authorities of the other Member States the measures taken and any
supporting data.
For the purposes of the first subparagraph, the information exchange system provided forin Article 12(1) of Directive 2001/95/EC shall be used.
Article 12(2), (3) and (4) of Directive 2001/95/EC shall apply.

3.

The Commission shall determine, as soon as possible, whether the provisional measuresreferred 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 competent authority concerned shall repeal the provisional measuresin question.

Article 28
Good administrative practices
1.

Any decision taken pursuant to Articles 25 and 27 shall state 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 thelaw of the Member State concerned and of the time limits to which remedies are subject.

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2.

Except in the case where immediate action is necessary for reasons of serious risk tohuman 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
Administrative cooperation

Article 29
Cooperation between competent authorities
1.

The competent authorities of the Member States shall cooperate with each other and with
the Commission to ensure the proper application and due enforcement of this Regulationand shall transmit to each other all information necessary with a view to applying thisRegulation uniformly.

2.

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

3.

Cooperation may be part of initiatives developed at international level.

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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 file satisfies the requirements referred
to in Article 11(2) and whether the information set out therein provides evidence of the safety of thecosmetic 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 competentauthority 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, arising from the use of substances incosmetic products, which needs to be addressed on a Community-wide basis, theCommission may, after consulting the SCCS, amend Annexes II to VI accordingly.

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Those measures, 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).
On imperative grounds of urgency, the Commission may use the urgency procedurereferred 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 to technical and scientific progress.
Those measures, 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).

3.

Where it appears necessary, in order to ensure the safety of cosmetic products placed on
the market, the Commission may, after consulting the SCCS, amend Annex I.
Those measures, 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 32
Committee procedure
1.

The Commission shall be assisted by the Standing Committee on Cosmetic Products.

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2.

Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shallapply, 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 ofDecision 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 ofDecision 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, theCommission shall take account of internationally recognised nomenclatures including theInternational Nomenclature of Cosmetic Ingredients (INCI). That glossary shall not constitute a listof the substances authorised for use in cosmetic products.
The common ingredient name shall be applied for the purpose of labelling cosmetic products placedon the market at the latest twelve months after publication of the glossary in the Official Journal of
the European Union.

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Article 34
Competent authorities, poison control centres or assimilated entities
1.

Member States shall designate their national competent authorities.

2.

Member States shall communicate the details of authorities referred to in paragraph 1 andof the poison centres and similar bodies referred to in Article 13(6) to the Commission.
They shall communicate an update of these details as necessary.

3.

The Commission shall compile and update a list of the authorities and bodies referred to inparagraph 2 and make it available 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 contain precise data on the number and type of experiments relating tocosmetic products carried out on animals. The Member States shall be obliged to collectthat 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;

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2)

progress made by the Commission in its efforts to obtain acceptance by the OECD ofalternative methods validated at Community level and recognition by third countries of theresults of the safety tests carried out in the Community using alternative methods, inparticular within the framework of cooperation agreements between the Community andthese countries;3)

the manner in which the specific needs of small and medium-sized enterprises have beentaken into account.

Article 36
Formal objection against harmonised standards
1.

When a Member State or the Commission considers that a harmonised standard does notentirely satisfy the requirements set out in the relevant provisions of this Regulation, theCommission or the Member State concerned shall bring the matter before the Committee
set up by Article 5 of Directive 98/34/EC, giving its arguments. The Committee shalldeliver its opinion without delay.

2.

In the light of the Committee's opinion, the Commission shall decide to publish, not topublish, 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 theEuropean Union.

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3.

The Commission shall inform the Member States and the European standardisation bodyconcerned. It shall, if necessary, request the revision of the harmonised
standards concerned.

Article 37
Penalties
Member States shall lay down the provisions on penalties applicable for infringement of theprovisions of this Regulation and shall take all measures necessary to ensure that they are
implemented. The penalties provided for must be effective, proportionate and dissuasive. The
Member States shall notify those provisions to the Commission by ...* and shall notify it without
delay of any subsequent amendment affecting them.

Article 38
RepealDirective 76/768/EEC is repealed with effect from ...** , with the exception of Article 4b which isrepealed with effect from 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 thetime-limits for transposition into national law of the Directives set out in Part B of Annex IX.

***

42 months after the date of entry into force of this Regulation.
OJ: 42 months after the date of entry into force of this Regulation.

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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 shallcontinue to keep readily accessible the information collected pursuant to Article 7a of that Directive
until ...*.

Article 39
Transitional provisions
By way of derogation from Directive 76/768/EEC, cosmetic products which comply with thisRegulation may be placed on the market before ...** .
As from ...***, by way of derogation from Directive 76/768/EEC, notification carried out inaccordance with Article 13 of this Regulation shall be considered to comply with Article 7(3) and
Article 7a(4) of that Directive.

*
**
***

OJ: Seven years + 42 months after the date of entry into force of this Regulation.
OJ: 42 months after the date of entry into force of this Regulation.
OJ: 24 months after the date of entry into force of this Regulation.

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Article 40
Entry into force and date of application
1.

This Regulation shall enter into force on the [twentieth day after its publication in the
Official Journal of the European Union].
It shall apply from ...* , with the exception of:2.

–

Article 15(1) and (2) which shall apply from 1 December 2010, as well as
Articles 14, 31 and 32 to the extent that they are necessary to apply Article 15(1)and (2); and–Article 16(3) second subparagraph , which shall apply from ...**.

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

For the European Parliament

For the Council

The President

The President***

42 months after the date of entry into force of this Regulation.
36 months after the date of entry into force of this Regulation.

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ANNEX I
Cosmetic product safety report
The 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 ofthe supplier.

2.

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

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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 andpersons 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 justifiedin particular in the light of warnings and other explanations in the product labelling.

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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.

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

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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 thecosmetic product for all relevant toxicological endpoints. A particular focus on local
toxicity evaluation (skin and eye irritation), skin sensitisation, 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 thesystemic 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.

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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 otherrelevant 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 inaccordance 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 thedescriptions set out under Part A. Where relevant, margins of safety shall be assessedand discussed.

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There shall be inter alia a specific assessment for cosmetic products intended for use on
children under the age of three and for cosmetic products intended exclusively for use inexternal 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.

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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, the hair or the mucous membranes;(b)"Leave-on product" means a cosmetic product which is intended to stay in prolonged
contact with the skin, the hair or the mucous membranes;(c)"Hair product" means a cosmetic product which is intended to be applied on the hairof head or face, except eye lashes;(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 skinof 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 of the oral cavity;

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(i)

"Product applied on mucous membranes" means a cosmetic product which isintended to be applied on the mucous membranes(j)–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 thevicinity of the eyes;(k)"Professional use" means the application and use of cosmetic products by persons in
the exercise of their professional 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;

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–

The XAN which is the name approved by specific country (X), e.g. USAN whichcorrespond 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.

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ANNEX II
LIST OF SUBSTANCES PROHIBITED IN COSMETIC PRODUCTS
Substance identification

Reference
numberChemical name/INNa

CAS numberb

EC numbercd1

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

35783-57-4

2(2-Acetoxyethyl)trimethylammonium

51-84-3

200-128-9hydroxide (Acetylcholine) and its salts
3

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-

51-24-1

200-086-1

diiodophenyl]acetic acid (Tiratricol (INN))
and its salts
6

Methotrexate (INN)

59-05-2

200-413-8

7

Aminocaproic acid (INN) and its salts

60-32-2

200-469-3

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8

Cinchophen (INN), its salts, derivatives and132-60-5

205-067-1

salts of these derivatives
9

Thyropropic acid (INN) and its salts

51-26-3

10

Trichloroacetic acid76-03-9

200-927-2

11

Aconitum napellus L. (leaves, roots and84603-50-9

283-252-6

302-27-2

206-121-7

galenical preparations)
12

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

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 their90106-13-1

290-234-1

salts
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

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20

Nalorphine (INN), its salts and ethers

62-67-9200-546-1

21

Sympathicomimetic amines acting on the300-62-9

206-096-2

62-53-3

200-539-3

central nervous system: any substancecontained in the first list of medicaments
which are subject to medical prescription andare referred to in resolution AP (69) 2 of theCouncil of Europe
22

Aniline, its salts and its halogenated andsulphonated derivatives

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

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29

2-Amino-1,2-bis(4-methoxyphenyl)ethanol

530-34-7

and its salts
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 and26915-12-8

248-105-2

1300-73-8

215-091-4

482-44-0

207-581-1

291-072-4

halogenated and sulphonated derivatives
33

Xylidines, their isomers, salts andhalogenated and sulphonated derivatives

34

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

35

Ammi majus L. and its galenical preparations

90320-46-0

36

2,3-Dichloro-2-methylbutane

507-45-937

Substances with androgenic effect38

Anthracene oil

39

Antibiotics

40

Antimony and its compounds

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120-12-7

204-371-1

7440-36-0

231-146-5

AK/kr
DG C

4

EN

41

Apocynum cannabinum L. and its

84603-51-0

283-253-1

58-00-4

200-360-0

preparations
42

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

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 the conditions laid down inAnnex 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

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50

1-Dimethylaminomethyl-1-methylpropyl644-26-8

211-411-1

benzoate (amylocaine) and its salts
51

2,2,6-Trimethyl-4-piperidyl benzoate

500-34-5(eucaine) and its salts
52

Isocarboxazid (INN)

59-63-2

200-438-4

53

Bendroflumethiazide (INN) and its

73-48-3

200-800-1

derivatives
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

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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

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

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206-117-5

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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

5909-04-6

hydrochloride (chrysoidine citratehydrochloride)
82

Chlorzoxazone (INN)

95-25-0

202-403-983

2-Chloro-6-methylpyrimidin-4-

535-89-7

208-622-6

yldimethylamine (crimidine-ISO)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

126-85-2

and its salts
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

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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-

3691-35-8

223-003-0

1,3-dione (chlorophacinone-ISO)
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 and84775-56-4

283-885-8

85116-75-2

285-527-6

211-557-6

galenical preparations
99

Conium maculatum L. (fruit, powder,
galenical preparations)100

Glycyclamide (INN)

664-95-9

101

Cobalt benzenesulphonate

23384-69-2

102

Colchicine, its salts and derivatives

64-86-8PE-CONS 3623/09
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200-598-5

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103

Colchicoside and its derivatives

477-29-2

207-513-0

104

Colchicum autumnale L. and its galenical

84696-03-7

283-623-2

508-75-8

208-086-3

preparations
105

Convallatoxin

106

Anamirta cocculus L. (fruit)

107

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

108

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

52964-42-8

109

Curare and curarine

8063-06-7 /

232-511-1 /22260-42-0

244-880-6

200-821-6

110

Synthetic curarizants

111

Hydrogen cyanide and its salts

74-90-8112

Feclemine (INN); 2-(alpha-3590-16-7

Cyclohexylbenzyl)-N,N,N',N'-tetraethyl-1,3propanediamine
113

Cyclomenol (INN) and its salts

5591-47-9

114

Sodium hexacyclonate (INN)

7009-49-6

115

Hexapropymate (INN)

358-52-1

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227-002-6

206-618-9

AK/kr
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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-

511-75-1

208-133-8

N,N'-Pentamethylenebis(trimethylammonium) 541-20-8

208-771-7

methylhydantoin
120

salts, e. g. pentamethonium bromide (INN)
121

N,N'-

306-53-6

206-186-1[(Methylimino)diethylene]bis(ethyldimethyla
mmonium) salts, e. g. azamethonium bromide
(INN)
122

Cyclarbamate (INN)5779-54-4

227-302-7

123

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

124

N,N'-Hexamethylenebis(trimethylammonium)

55-97-0200-249-7

107-06-2

203-458-1

75-35-4

200-864-0

salts, e. g. hexamethonium bromide (INN)
125

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

126

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

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127

Lysergide (INN) (LSD) and its salts

50-37-3200-033-2

128

2-Diethylaminoethyl 3-hydroxy-4-

3572-52-9

222-686-2

201-632-1

phenylbenzoate and its salts
129

Cinchocaine (INN) and its salts

85-79-0130

3-Diethylaminopropyl cinnamate

538-66-9

131

O,O'-Diethyl-O-4-nitrophenyl

56-38-2

200-271-7

115-79-7

204-107-5

phosphorothioate (Parathion - ISO)
132

[Oxalylbis(iminoethylene)]bis[(ochlorobenzyl)diethylammonium] salts, e. g.
ambenonium chloride (INN)

133

Methyprylon (INN) and its salts

125-64-4

204-745-4

134

Digitaline and all heterosides of Digitalis752-61-4

212-036-6

purpurea L.
135

7-[2-Hydroxy-3-(2-hydroxyethyl-N-

2530-97-4

methylamino)propyl]theophylline (xanthinol)
136

Dioxethedrin (INN) and its salts

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207-849-8

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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

963-07-5

213-512-6

benzoate (amydricaine, alypine) and its salts
144

Methapyrilene (INN) and its salts

91-80-5

202-099-8

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

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151

Dinitrophenol isomers

51-28-5 /200-087-7 /

329-71-5 /

206-348-1 /

573-56-8 /

209-357-9 /

25550-58-7

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-

71-81-8

200-766-8

206-123-8

diisopropylmethyl-ammonium salts, e. g.
isopropamide iodide (INN)
157

Benactyzine (INN)

302-40-9

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 (Doxenitoin3254-93-1

221-851-6

57-66-9200-344-3(INN))
161

Probenecid (INN)

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162

Disulfiram (INN); thiram (INN)

97-77-8 /202-607-8 /

137-26-8

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

67-48-1

200-655-4

amino group, with the exception of that given
in Annex VI
168

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

169

Caramiphen (INN) and its salts

77-22-5

201-013-6

170

Diethyl 4-nitrophenyl phosphate (Paraoxon -311-45-5

206-221-0

ISO)
171

Metethoheptazine (INN) and its salts

509-84-2

172

Oxpheneridine (INN) and its salts

546-32-7

173

Ethoheptazine (INN) and its salts

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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 /203-083-3 /622-62-8

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

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

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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

7664-39-3

231-634-8

541-64-0

208-789-5

complexes and hydrofluorides with the
exception of those given in Annex III
192

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

193

Galantamine (INN)

357-70-0

194

Progestogens

195

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

58-89-9200-401-2

72-20-8

200-775-7

67-72-1

200-666-4

ISO)
196

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

197

Hexachloroethane

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198

(1R,4S,5R,8S)-1,2,3,4,10,10-Hexachloro-

465-73-6

207-366-2

118-08-1 /

204-233-0 /6592-85-4

229-533-9

54-85-3

200-214-6

206-114-9

1,4,4a,5,8,8a-hexahydro-1,4:5,8dimethanonaphthalene (isodrin-ISO)
199

200

Hydrastine, hydrastinine and their salts

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

201

Hydrazine, its derivatives and their salts

302-01-2

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-

548-00-5

208-940-5yl)acetate and salts of the acid205

Methocarbamol (INN)

532-03-6

208-524-3

206

Propatylnitrate (INN)

2921-92-8

220-866-5

207

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

208

Fenadiazole (INN)

PE-CONS 3623/09
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1008-65-7

AK/kr
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EN

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

84603-65-6

283-265-7

and galenical preparations)
212

Pemoline (INN) and its salts

2152-34-3

218-438-8

213

Iodine7553-56-2

231-442-4

214

Decamethylenebis(trimethylammonium) salts, 541-22-0

208-772-2

e. g. decamethonium bromide (INN)
215

Ipecacuanha (Cephaelis ipecacuanha Brot.

8012-96-2

232-385-8

and related species) (roots, powder andgalenical preparations)216(2-Isopropylpent4-enoyl)urea (apronalide)528-92-7

208-443-3

217

α-Santonin [(3S,5aR,9bS)-3,3a,4,5,5a,9b-

481-06-1

207-560-7

84696-23-1

283-642-6

90-69-7

202-012-3

hexahydro-3,5a,9-trimethylnaphto [1,2-b]furan-2,8-dione]
218

Lobelia inflata L. and its galenicalpreparations

219

Lobeline (INN) and its salts

220

Barbiturates

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EN

221

Mercury and its compounds, except those7439-97-6

231-106-7

54-04-6

200-190-7

special cases included in Annex V
222

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

223

Metaldehyde

9002-91-9

224

2-(4-Allyl-2-methoxyphenoxy)-N,N-

305-13-5

diethylacetamide and its salts
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

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234

3,4-Dihydro-2-methoxy-2-methyl-4-phenyl-518-20-7

208-248-3

2H,5H-pyrano [3,2-c]-[1] benzopyran-5-one(cyclocoumarol)
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 /

205-138-7 /91-59-8

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

114-80-7

204-054-8

bromide (INN)

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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

14797-65-0

sodium nitrite
249

Nitrobenzene

98-95-3

202-716-0

250

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 /

238-373-9 / -13755-38-9
256

Nitrostilbenes, their homologues and theirderivatives

257

Noradrenaline and its salts

51-41-2

200-096-6

258

Noscapine (INN) and its salts

128-62-1

204-899-2

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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 /

220-673-6 /

4396-01-4

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

83-12-5

201-454-4

90-49-3

201-998-2(INN))
272

Ethylphenacemide (pheneturide (INN))

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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

24558-01-8

threoform (levofacetoperane (INN)) and its
salts
285

Pipradrol (INN) and its salts

467-60-7

207-394-5

286

Azacyclonol (INN) and its salts

115-46-8

204-092-5

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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

89997-54-6

289-689-9

54-36-4

200-206-2

90046-04-1

289-971-1

51-34-3200-090-3

water")
292

Metyrapone (INN)293

Radioactive substances, as defined by
Directive 96/29/Euratom1 laying down basic
safety standards for the protection of thehealth of workers and the general publicagainst the dangers arising from ionisingradiation

294

Juniperus sabina L. (leaves, essential oil andgalenical preparations)295

Hyoscine, its salts and derivatives

296Gold salts

1

OJ L 159, 29.6.1996, p. 1

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EN

297

Selenium and its compounds with the7782-49-2

231-957-4

84929-77-1

284-555-6

90-39-1

201-988-8

84696-08-2

283-627-4

11005-63-3

234-239-9

57-24-9200-319-7

exception of selenium disulphide under theconditions set out under reference No 49 inAnnex III
298

Solanum nigrum L. and its galenicalpreparations

299

Sparteine (INN) and its salts

300

Glucocorticoids (Corticosteroids)

301

Datura stramonium L. and its galenicalpreparations

302

Strophantines, their aglucones and theirrespective derivatives

303

Strophantus species and their galenicalpreparations

304

Strychnine and its salts

305

Strychnos species and their galenicalpreparations

306

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

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EN

307

Sulphonamides (sulphanilamide and its
derivatives obtained by substitution of one ormore 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

84696-42-4

283-649-4

galenical preparations
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

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EN

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

62-56-6

200-543-5

59-47-2

200-427-4

exception of the one listed in Annex III
322

Mephenesin (INN) and its esters

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

75-80-9

200-903-1

alcohol)
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

84650-62-4

283-520-2

preparations

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EN

331

Veratrine, its salts and galenical preparations

8051-02-3

613-062-00-4

332

Schoenocaulon officinale Lind (seeds and84604-18-2

283-296-6

galenical preparations)
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

50-14-6 /200-014-9 /(vitamins D2 and D3)

67-97-0200-673-2

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

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EN

345.

Pyrethrum album L. and its galenicalpreparations346

2-[4-Methoxybenzyl-N-(2-59-33-6

200-422-7

202-100-1

pyridyl)amino]ethyldimethylamine maleate(Mepyramine maleate; pyrilamine maleate)347

Tripelennamine (INN)

91-81-6

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-

68-12-2

200-679-5

122-57-6

204-555-1

Dimethylformamide)356

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

acetone)PE-CONS 3623/09
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EN

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-

3902-71-4 /223-459-0 /methoxypsoralen, 5-methoxypsoralen) except

298-81-7 /206-066-9 /for normal content in natural essences used.

484-20-8

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

94-59-7

202-345-4

natural essences used and provided theconcentration does not exceed:
100 ppm in the finished product, 50 ppm inproducts for dental and oral hygiene, andprovided that Safrole is not present in
toothpastes intended specifically for children

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EN

361

5,5'-Di-isopropyl-2,2'-dimethylbiphenyl-4,4'-552-22-7

209-007-5

88-29-9

201-817-7diyl dihypoiodite (thymol iodide)362

3'-Ethyl-5',6',7',8'-tetrahydro-5',5',8',8'tetramethyl-2'-acetonaphthone or 7-acetyl-6ethyl-1,1,4,4-tetramethyl-1,2,3,4tetrahydronaphtalen (AETT; Versalide)363

o-Phenylenediamine and its salts

95-54-5

202-430-6

364

4-Methyl-m-phenylenediamine (Toluene-2,4-95-80-7

202-453-1

Aristolochic acid and its salts; Aristolochia

475-80-9 /202-499-6 /spp. and their preparations

313-67-7 /

206-238-3 / -diamine) and its salts
365

15918-62-4
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 acetate828-00-2

212-579-9

3811-73-2

223-296-5(Dimethoxane)
369

1

Pyrithione sodium (INNM)1

Modified INNM-name.

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EN

370

N-(Trichloromethylthio)-4-cyclohexene-1,2-

133-06-2

205-087-0

70-30-4

200-733-8

38304-91-5

253-874-2

87-10-5

201-723-6

dicarboximide (Captan - ISO)371

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

372

6-(Piperidinyl)-2,4-pyrimidinediamine 3oxide (Minoxidil (INN)) and its salts373

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

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 (2,4-615-05-4

210-406-1

5307-02-8

226-161-9

diaminoanisole - CI 76050) and its salts
377

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

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

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EN

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

14779-78-3

238-849-6

Colouring agent CI 42555:2
381

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

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

80-75-1

201-306-9

1694-09-3

216-901-9

209-608-2

esters386

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

387

Colouring agent CI 13065

587-98-4

388

Colouring agent CI 42535 (Basic Violet 1)

8004-87-3

389

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

PE-CONS 3623/09
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AK/kr
DG C

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EN

390

Anti-androgens of steroidal structure391

Zirconium and its compounds, with the

7440-67-7

231-176-9

exception of the substances listed underreference number 50 in Annex III, and thezirconium lakes, pigments or salts of thecolouring agents when listed in Annex IV
392

Moved or deleted

393

Acetonitrile

75-05-8

200-835-2

394

Tetrahydrozoline (Tetryzoline (INN)) and its

84-22-0

201-522-3

Hydroxy-8-quinoline and its sulphate, except

148-24-3 /205-711-1 /for the uses provided for in No 51 in

134-31-6

205-137-1

43143-11-9

256-115-3

3468-63-1

222-429-4

salts
395

Annex III
396

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

397

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

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EN

398

Colouring agent CI 45170 and CI 45170:1

81-88-9 /201-383-9 /(Basic Violet 10)

509-34-2

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 /

225-935-3 /2092-56-0

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

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EN

410

411

Nitrosamines e.g. Dimethylnitrosoamine;

62-75-9 /

200-549-8 /Nitrosodipropylamine; 2,2'-621-64-7 /

210-698-0 /Nitrosoimino)bisethanol

1116-54-7

214-237-4

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-

823-40-5

212-513-9

83-66-9

201-493-7

77-09-8

201-004-7

3-Imidazol-4-ylacrylic acid (Urocanic acid)104-98-3 /203-258-4 /and its ethyl ester

27538-35-8

248-515-1

diamine)414

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

415

Moved or deleted

416

Cells, tissues or products of human origin

417

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

418

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EN

419

Category 1 material and Category 2 material
as defined in Articles 4 and 5 respectively ofRegulation (EC) No 1774/2002 of theEuropean Parliament and of the Council1, andingredients derived therefrom

420

Crude and refined coal tars

8007-45-2

232-361-7

421

1,1,3,3,5-Pentamethyl-4,6-dinitroindane116-66-5

204-149-4

145-39-1

205-651-6(Moskene)422

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

423

Alanroot oil (Inula helenium L.), when used

97676-35-2

as a fragrance ingredient
424

Benzyl cyanide, when used as a fragrance

140-29-4

205-410-5

4756-19-8

225-289-2

141-05-9

205-451-9

ingredient425

Cyclamen alcohol, when used as a fragrance
ingredient

426

Diethyl maleate, when used as a fragrance
ingredient1

OJ L 273, 10.10.2002, p. 1.

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EN

427

3,4-Dihydrocoumarin, when used as a

119-84-6

204-354-9

6248-20-0

228-369-5

40607-48-5

254-999-5

17874-34-9

241-827-9

fragrance ingredient428

2,4-Dihydroxy-3-methylbenzaldehyde, whenused as a fragrance ingredient429

3,7-Dimethyl-2-octen-1-ol (6,7Dihydrogeraniol), when used as a fragrance
ingredient430

4,6-Dimethyl-8-tert-butylcoumarin, whenused as a fragrance ingredient431

Dimethyl citraconate, when used as a617-54-9

fragrance ingredient432

7,11-Dimethyl-4,6,10-dodecatrien-3-one

26651-96-7

247-878-3

141-10-6

205-457-1

122-39-4

204-539-4(Pseudomethylionone), when used as afragrance ingredient433

6,10-Dimethyl-3,5,9-undecatrien-2-one(Pseudoionone) , when used as a fragrance
ingredient434

Diphenylamine, when used as a fragrance
ingredient

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EN

435

Ethyl acrylate, when used as a fragrance

140-88-5

205-438-8

ingredient436

Fig leaf absolute (Ficus carica L.), when used

68916-52-9

as a fragrance ingredient437

trans-2-Heptenal, when used as a fragrance

18829-55-5

242-608-0

67746-30-9

266-989-8

18318-83-7

242-204-4

13393-93-6

236-476-3

34131-99-2

251-841-7

531-59-9

208-513-3

ingredient438

trans-2-Hexenal diethyl acetal, when used asa fragrance ingredient439

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

440

Hydroabietyl alcohol, when used as afragrance ingredient441

6-Isopropyl-2-decahydronaphthalenol, whenused as a fragrance ingredient442

7-Methoxycoumarin, when used as afragrance ingredient

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EN

443

4-(4-Methoxyphenyl)-3-butene-2-one

943-88-4

213-404-9

104-27-8

203-190-5

623-43-8

210-793-7

2445-83-2

219-499-3

13706-86-0

237-241-8

25677-40-1

247-178-8

1117-41-5

214-245-8(Anisylidene acetone), when used as afragrance ingredient444

1-(4-Methoxyphenyl)-1-penten-3-one (alphaMethylanisylideneacetone), when used as afragrance ingredient

445

Methyl trans-2-butenoate, when used as afragrance ingredient446

7-Methylcoumarin, when used as a fragrance
ingredient447

5-Methyl-2,3-hexanedione (Acetyl
isovaleryl), when used as a fragrance
ingredient448

2-Pentylidenecyclohexanone, when used as afragrance ingredient449

3,6,10-Trimethyl-3,5,9-undecatrien-2-one(Pseudo-Isomethyl ionone), when used as afragrance ingredient

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

41

EN

450

Verbena oil (Lippia citriodora Kunth.), when8024-12-2

used as a fragrance ingredient451

Moved or deleted452

6-(2-Chloroethyl)-6-(2-methoxyethoxy)-37894-46-5

253-704-7

2,5,7,10-tetraoxa-6-silaundecane
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

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

42

EN

463

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

106-99-0

203-450-8464

Isobutane, if it contains ≥ 0,1 % w/w

75-28-5

200-857-2

Butadiene
465

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

203-448-7

466

Gases (petroleum), C3-4, if they contain

68131-75-9

268-629-5

68307-98-2

269-617-2

68307-99-3

269-618-8

68308-00-9

269-619-3> 0,1 % w/w Butadiene467

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

468

Tail gas (petroleum), catalytic polymn.
naphtha fractionation stabiliser, if it contains> 0,1 % w/w Butadiene469

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

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

43

EN

470

Tail gas (petroleum), cracked distillate

68308-01-0

269-620-9

68308-03-2

269-623-5

68308-04-3

269-624-0

68308-05-4

269-625-6

68308-06-5

269-626-1

68308-07-6

269-627-7hydrotreater stripper, if it contains > 0,1 %w/w Butadiene471

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

472

Tail gas (petroleum), gas recovery plant, if it
contains > 0,1 % w/w Butadiene473

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

474

Tail gas (petroleum), hydrodesulfurised
distillate and hydrodesulfurised naphtha
fractionator, acid-free, if it contains > 0,1 %w/w Butadiene475

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

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

44

EN

476

Tail gas (petroleum), isomerised naphtha

68308-08-7

269-628-2

68308-09-8

269-629-8

68308-10-1

269-630-3

68308-11-2

269-631-9

fractionation stabiliser, if it contains > 0,1 %w/w Butadiene477

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

478

Tail gas (petroleum), straight-run distillatehydrodesulfurised, hydrogen sulfide-free, if it
contains > 0,1 % w/w Butadiene479

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

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

45

EN

480

Tail gas (petroleum), vacuum gas oil

68308-12-3

269-632-4

68409-99-4

270-071-2

68475-57-0

270-651-5

68475-58-1

270-652-0

68475-59-2

270-653-668475-60-5

270-654-1

68476-26-6

270-667-2

Fuel gases, crude oil distillates, if they contain 68476-29-9

270-670-9hydrodesulfurised, hydrogen sulfide-free, if it
contains > 0,1 % w/w Butadiene481

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

482

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

483

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

484

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

485

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

486

Fuel-gases, if they contain > 0,1 % w/w
Butadiene487> 0,1 % w/w Butadiene

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

46

EN

488

Hydrocarbons, C3-4, if they contain > 0,1 %68476-40-4

270-681-968476-42-6

270-682-4

68476-49-3

270-689-2

68476-85-7

270-704-2

68476-86-8

270-705-8

68477-33-8

270-724-1

68477-35-0

270-726-2

68477-65-6

270-746-1

w/w Butadiene489

Hydrocarbons, C4-5, if they contain > 0,1 %w/w Butadiene490

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

491

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

492

Petroleum gases, liquefied, sweetened, if they
contain > 0,1 % w/w Butadiene493

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

494

Distillates (petroleum), C3-6, piperylene-rich,
if they contain > 0,1 % w/w Butadiene495

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

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

47

EN

496

Gases (petroleum), benzene unit

68477-66-7

270-747-7

68477-67-8

270-748-2

68477-68-9

270-749-8

68477-69-0

270-750-368477-70-3

270-751-968477-71-4

270-752-4hydrodesulfurised off, if they contain > 0,1 %w/w Butadiene497

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

498

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

499

Gases (petroleum), butane splitter overheads,
if they contain > 0,1 % w/w Butadiene500

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

501

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

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

48

EN

502

Gases (petroleum), catalytic-cracked naphtha

68477-72-5

270-754-5

68477-73-6

270-755-0

68477-74-7

270-756-6

68477-75-8

270-757-1

68477-76-9

270-758-7

Gases (petroleum), catalytic reformed naphtha 68477-77-0

270-759-2

debutaniser bottoms, C3-5-rich, if they contain> 0,1 % w/w Butadiene503

Gases (petroleum), catalytic cracked naphtha
depropaniser overhead, C3-rich acid-free, ifthey contain > 0,1 % w/w Butadiene504

Gases (petroleum), catalytic cracker, if they
contain > 0,1 % w/w Butadiene505

Gases (petroleum), catalytic cracker, C1-5rich, if they contain > 0,1 % w/w Butadiene506

Gases (petroleum), catalytic polymd. naphthastabiliser overhead, C2-4-rich, if they contain> 0,1 % w/w Butadiene507

stripper overheads, if they contain > 0,1 %w/w Butadiene508

Gases (petroleum), catalytic reformer, C1-4-

68477-79-2

270-760-8

rich, if they contain > 0,1 % w/w Butadiene

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

49

EN

509

Gases (petroleum), C6-8 catalytic reformer

68477-80-5

270-761-3

68477-81-6

270-762-968477-82-7

270-763-4

68477-83-8

270-765-568477-84-9

270-766-0

68477-85-0

270-767-6

68477-86-1

270-768-1

recycle, if they contain > 0,1 % w/w
Butadiene
510

Gases (petroleum), C6-8 catalytic reformer, if
they contain > 0,1 % w/w Butadiene511

Gases (petroleum), C6-8 catalytic reformer
recycle, hydrogen-rich, if they contain> 0,1 % w/w Butadiene512

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

513

Gases (petroleum), C2-return stream, if they
contain > 0,1 % w/w Butadiene514

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

515

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

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

50

EN

516

Gases (petroleum), deisobutaniser tower

68477-87-2

270-769-7

68477-90-7

270-772-3

68477-91-8

270-773-968477-92-9

270-774-4

68477-93-0

270-776-5

68477-94-1

270-777-0

68477-95-2

270-778-6

overheads, if they contain > 0,1 % w/w
Butadiene
517

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

518

Gases (petroleum), depropaniser overheads, if
they contain > 0,1 % w/w Butadiene519

Gases (petroleum), dry sour, gas-concn. -unitoff, if they contain > 0,1 % w/w Butadiene520

Gases (petroleum), gas concn. reabsorber
distn., if they contain > 0,1 % w/w Butadiene521

Gases (petroleum), gas recovery plant
depropaniser overheads, if they contain> 0,1 % w/w Butadiene522

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

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

51

EN

523

Gases (petroleum), hydrogen absorber off, if

68477-96-3

270-779-1

68477-97-4

270-780-7

68477-98-5

270-781-2

68477-99-6

270-782-8

68478-00-2

270-783-3

68478-01-3

270-784-968478-02-4

270-785-4

they contain > 0,1 % w/w Butadiene524

Gases (petroleum), hydrogen-rich, if they
contain > 0,1 % w/w Butadiene525

Gases (petroleum), hydrotreater blend oil
recycle, hydrogen-nitrogen-rich, if they
contain > 0,1 % w/w Butadiene526

Gases (petroleum), isomerised naphtha
fractionator, C4-rich, hydrogen sulfide-free, ifthey contain > 0,1 % w/w Butadiene527

Gases (petroleum), recycle, hydrogen-rich, ifthey contain > 0,1 % w/w Butadiene528

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

529

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

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

52

EN

530

Gases (petroleum), reforming hydrotreater,

68478-03-5

270-787-5

68478-04-6

270-788-0

68478-05-7

270-789-6

68478-21-7

270-802-5

68478-22-8

270-803-0hydrogen-methane-rich, if they contain> 0,1 % w/w Butadiene531

Gases (petroleum), reforming hydrotreater
make-up, hydrogen-rich, if they contain> 0,1 % w/w Butadiene532

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

533

Tail gas (petroleum), catalytic cracked
clarified oil and thermal cracked vacuum
residue fractionation reflux drum, if it
contains > 0,1 % w/w Butadiene534

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

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

53

EN

535

Tail gas (petroleum), catalytic cracker,

68478-24-0

270-804-6

68478-25-1

270-805-1

68478-26-2

270-806-7

68478-27-3

270-807-2

68478-28-4

270-808-8

68478-29-5

270-809-3

catalytic reformer and hydrodesulfurised
combined fractionater, if it contains > 0,1 %w/w Butadiene
536

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

537

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

538

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

539

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

540

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

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

54

EN

541

Tail gas (petroleum), hydrodesulfurised

68478-30-8

270-810-968478-32-0

270-813-5

68478-33-1

270-814-0

68478-34-2

270-815-6

68512-91-4

270-990-9

68513-14-4

270-999-8

straight-run naphtha separator, if it contains> 0,1 % w/w Butadiene
542

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

543

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

544

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

545

Hydrocarbons, C3-4-rich, petroleum distillate,
if they contain > 0,1 % w/w Butadiene546

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

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

55

EN

547

Gases (petroleum), full-range straight-run

68513-15-5

271-000-8

68513-16-6

271-001-3

68513-17-7

271-002-9

68513-18-8

271-003-4

68513-19-9

271-005-5

68513-66-6

271-010-2

naphtha dehexaniser off, if they contain> 0,1 % w/w Butadiene548

Gases (petroleum), hydrocracking
depropaniser off, hydrocarbon-rich, if they
contain > 0,1 % w/w Butadiene549

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

550

Gases (petroleum), reformer effluent highpressure flash drum off, if they contain> 0,1 % w/w Butadiene551

Gases (petroleum), reformer effluent lowpressure flash drum off, if they contain> 0,1 % w/w Butadiene552

Residues (petroleum), alkylation splitter, C4rich, if they contain > 0,1 % w/w Butadiene

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

56

EN

553

Hydrocarbons, C1-4, if they contain > 0,1 %68514-31-8

271-032-2

68514-36-3

271-038-5

68527-15-1

271-258-1

68527-16-2

271-259-7

68527-19-5

271-261-8

68602-82-4

271-623-5

68602-83-5

271-624-0

w/w Butadiene554

Hydrocarbons, C1-4, sweetened, if they
contain > 0,1 % w/w Butadiene555

Gases (petroleum), oil refinery gas distn. off,
if they contain > 0,1 % w/w Butadiene556

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

557

Hydrocarbons, C1-4, debutaniser fraction, if
they contain > 0,1 % w/w Butadiene558

Gases (petroleum), benzene unit hydrotreater
depentaniser overheads, if they contain> 0,1 % w/w Butadiene559

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

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

57

EN

560

Gases (petroleum), secondary absorber off,

68602-84-6

271-625-6

68606-25-7

271-734-9

68606-26-8

271-735-4

68606-27-9

271-737-5

68606-34-8

271-742-2

68607-11-4

271-750-6

68783-06-2

272-182-1

fluidised catalytic cracker overheads
fractionator, if they contain > 0,1 % w/w
Butadiene
561

Hydrocarbons, C2-4, if they contain > 0,1 %w/w Butadiene562

Hydrocarbons, C3, if they contain > 0,1 %w/w Butadiene563

Gases (petroleum), alkylation feed, if they
contain > 0,1 % w/w Butadiene564

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

565

Petroleum products, refinery gases, if they
contain > 0,1 % w/w Butadiene566

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

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

58

EN

567

Gases (petroleum), refinery blend, if they

68783-07-3

272-183-7

68783-64-2

272-203-4

68783-65-3

272-205-5

68814-67-5

272-338-9

68814-90-4

272-343-6

Gases (petroleum), hydrotreated sour kerosine 68911-58-0

272-775-5

contain > 0,1 % w/w Butadiene568

Gases (petroleum), catalytic cracking, if they
contain > 0,1 % w/w Butadiene569

Gases (petroleum), C2-4, sweetened, if they
contain > 0,1 % w/w Butadiene570

Gases (petroleum), refinery, if they contain> 0,1 % w/w Butadiene571

Gases (petroleum), platformer products
separator off, if they contain > 0,1 % w/w
Butadiene572

depentaniser stabiliser off, if they contain> 0,1 % w/w Butadiene573

Gases (petroleum), hydrotreated sour kerosine 68911-59-1

272-776-0

flash drum, if they contain > 0,1 % w/w
Butadiene

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

59

EN

574

Gases (petroleum), crude oil fractionation off,

68918-99-0

272-871-7

68919-00-6

272-872-2

68919-01-7

272-873-8

68919-02-8

272-874-3

68919-03-9

272-875-968919-04-0

272-876-4

if they contain > 0,1 % w/w Butadiene575

Gases (petroleum), dehexaniser off, if they
contain > 0,1 % w/w Butadiene576

Gases (petroleum), distillate unifiner
desulfurisation stripper off, if they contain> 0,1 % w/w Butadiene577

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

578

Gases (petroleum), fluidised catalytic cracker
scrubbing secondary absorber off, if they
contain > 0,1 % w/w Butadiene579

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

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

60

EN

580

Gases (petroleum), light straight run gasoline

68919-05-1

272-878-5

68919-06-2

272-879-0

68919-07-3

272-880-6

68919-08-4

272-881-1

68919-09-5

272-882-7

68919-10-8

272-883-2

fractionation stabiliser off, if they contain> 0,1 % w/w Butadiene581

Gases (petroleum), naphtha unifiner
desulfurisation stripper off, if they contain> 0,1 % w/w Butadiene582

Gases (petroleum), platformer stabiliser off,
light ends fractionation, if they contain> 0,1 % w/w Butadiene583

Gases (petroleum), preflash tower off, crude
distn., if they contain > 0,1 % w/w Butadiene584

Gases (petroleum), straight-run naphtha
catalytic reforming off, if they contain> 0,1 % w/w Butadiene585

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

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

61

EN

586

Gases (petroleum), tar stripper off, if they

68919-11-9

272-884-8

68919-12-0

272-885-3

68919-20-0

272-893-7

68952-76-1

273-169-3

68952-77-2

273-170-968952-79-4

273-173-5

68952-80-7

273-174-0

contain > 0,1 % w/w Butadiene587

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

588

Gases (petroleum), fluidised catalytic cracker
splitter overheads, if they contain > 0,1 %w/w Butadiene589

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

590

Tail gas (petroleum), catalytic cracked
distillate and naphtha stabiliser, if it contains> 0,1 % w/w Butadiene591

Tail gas (petroleum), catalytichydrodesulfurised naphtha separator, if it
contains > 0,1 % w/w Butadiene592

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

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

62

EN

593

Tail gas (petroleum), thermal-cracked

68952-81-8

273-175-6

68952-82-9

273-176-1

68955-28-2

273-265-5

68955-33-9

273-269-7

68955-34-0

273-270-2

distillate, gas oil and naphtha absorber, if it
contains > 0,1 % w/w Butadiene594

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

595

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

596

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

597

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

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

63

EN

598

Gases (petroleum), crude distn. and catalytic

68989-88-8

273-563-5

87741-01-3

289-339-5

90622-55-2

292-456-4

92045-15-3

295-397-2

92045-16-4

295-398-8

92045-17-5

295-399-3

92045-18-6

295-400-7

cracking, if they contain > 0,1 % w/w
Butadiene
599

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

600

Alkanes, C1-4, C3-rich, if they contain > 0,1 %w/w Butadiene601

Gases (petroleum), gas oil diethanolamine
scrubber off, if they contain > 0,1 % w/w
Butadiene

602

Gases (petroleum), gas oilhydrodesulfurisation effluent, if they contain> 0,1 % w/w Butadiene603

Gases (petroleum), gas oilhydrodesulfurisation purge, if they contain> 0,1 % w/w Butadiene604

Gases (petroleum), hydrogenator effluent
flash drum off, if they contain > 0,1 % w/w
Butadiene

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

64

EN

605

Gases (petroleum), naphtha steam cracking

92045-19-7

295-401-2

92045-20-0

295-402-8

92045-22-2

295-404-992045-23-3

295-405-4

92045-80-2

295-463-0

95465-89-7

306-004-1

97722-19-5

307-769-4

high-pressure residual, if they contain > 0,1 %w/w Butadiene606

Gases (petroleum), residue visbreaking off, if
they contain > 0,1 % w/w Butadiene607

Gases (petroleum), steam-cracker C3-rich, ifthey contain > 0,1 % w/w Butadiene608

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

609

Petroleum gases, liquefied, sweetened, C4
fraction, if they contain > 0,1 % w/w
Butadiene

610

Hydrocarbons, C4, 1,3-butadiene- andisobutene-free, if they contain > 0,1 % w/w
Butadiene

611

Raffinates (petroleum), steam-cracked C4
fraction cuprous ammonium acetate extn., C35 and C3-5 unsatd., butadiene-free, if they

contain > 0,1 % w/w Butadiene

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

65

EN

612

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

613

Pitch, coal tar-petroleum, if it contains

68187-57-5

269-109-0

68188-48-7

269-159-3

90640-85-0

292-606-9

90669-57-1

292-651-4

90669-58-2

292-653-5

90669-59-3

292-654-0> 0,005 % w/w benzo[a]pyrene
614

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

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

618

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

619

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

620

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

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

66

EN

621

Extract residues (coal), brown, if they contain91697-23-3

294-285-092045-71-1

295-454-1

92045-72-2

295-455-7

92062-34-5

295-549-8

94114-13-3

302-650-3

94114-46-2

302-681-2

94114-47-3

302-682-8> 0,005 % w/w benzo[a]pyrene
622

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

623

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

624

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

625

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

626

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

627

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

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

67

EN

628

Coal liquids, liq. solvent extn., if they contain

94114-48-4

302-683-3

97926-76-6

308-296-6

97926-77-7

308-297-1

97926-78-8

308-298-7

101316-45-4

309-851-5

101794-74-5

309-956-6> 0,005 % w/w benzo[a]pyrene
629

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

630

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

631

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

632

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

633

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

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

68

EN

634

Aromatic hydrocarbons, C20-28, polycyclic,

101794-75-6

309-957-1

101794-76-7

309-958-7

121575-60-8

310-162-7

mixed coal-tar pitch-polyethylene pyrolysisderived, if they contain > 0,005 % w/w
benzo[a]pyrene
635

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

636

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

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

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

69

EN

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

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

106-89-8

203-439-8(Epichlorohydrin)

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

70

EN

658

R-1-Chloro-2,3-epoxypropane

51594-55-9

424-280-2

659

1,2-Epoxy-3-phenoxypropane

122-60-1

204-557-2(Phenylglycidyl ether)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-(4-133855-98-8

406-850-2

fluorophenyl)-[1H-1,2,4-triazol-1yl)methyl]oxirane; Epoxiconazole
664

Chloromethyl methyl ether

107-30-2

203-480-1

665

2-Methoxyethanol and its acetate (2-109-86-4 /203-713-7 /Methoxyethyl acetate)110-49-6

203-772-9

2-Ethoxyethanol and its acetate (2-110-80-5 /203-804-1 /Ethoxyethyl acetate)111-15-9

203-839-2

Oxybis[chloromethane], bis (Chloromethyl)542-88-1

208-832-8

1589-47-5

216-455-5

666

667

ether
668

2-Methoxypropanol

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

71

EN

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

111-96-6

203-924-4

117-81-7

204-211-0(Dimethoxydiglycol)677

bis(2-Ethylhexyl) phthalate (Diethylhexyl
phthalate)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)-4-80387-97-9

279-452-8hydroxyphenyl]-methyl]thio]acetate

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

72

EN

681

Acrylamide, unless regulated elsewhere in

79-06-1

201-173-7

this Regulation
682

Acrylonitrile

107-13-1

203-466-5

683

2-Nitropropane

79-46-9201-209-1

684

Dinoseb, its salts and esters with the

88-85-7

201-861-7

exception of those specified elsewhere in this
list
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 /204-450-0 /25321-14-6

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

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

73

EN

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

2475-45-8

219-603-7

70-25-7

200-730-1

101-77-9

202-974-4

Blue 1)
701

Moved or deleted

702

1-Methyl-3-nitro-1-nitrosoguanidine

703

Moved or deleted

704

Moved or deleted

705

4,4′-Methylenedianiline

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

74

EN

706

4,4′-(4-Iminocyclohexa-2,5-

569-61-9

209-321-2

dienylidenemethylene) dianilinehydrochloride
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)

119-90-4

204-355-4

and its salts
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

531-86-2

208-520-1

sulphate715

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

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

75

EN

718

3,3′-Dichlorobenzidine dihydrogen

64969-34-2

265-293-1

74332-73-3

277-822-3

bis(sulphate)719

3,3′-Dichlorobenzidine sulphate

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′-64969-36-4

265-294-7

74753-18-7

277-985-0diyl]diammonium bis(hydrogen sulphate)724

4,4′-Bi-o-toluidine sulphate725

o-Tolidine based dyes

726

Biphenyl-4-ylamine (4-Aminobiphenyl) and

611-030-00-4
92-67-1

202-177-1

its salts
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

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

76

EN

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-

2451-62-9

219-514-3

62-55-5

200-541-4

2,4,6(1H,3H,5H)-trione (TGIC)
742

Thioacetamide

743

Moved or deleted

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

77

EN

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-(4-403-250-2

Fluorophenyl)methylsilyl]methyl]-4H-1,2,4triazole and 1-[[bis-(4fluorophenyl)methylsilyl]methyl]-1H-1,2,4triazole

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

78

EN

755

(+/–)-Tetrahydrofurfuryl –(R)-2-[4-(6-119738-06-6

607-373-00-4

85136-74-9-400-340-3

108225-03-2

402-060-7

chloroquinoxalin-2yloxy)phenyloxy]propionate756

6-Hydroxy-1-(3-Isopropoxypropyl)-4-methyl2-oxo-5-[4-(phenylazo)phenylazo]-1,2dihydro-3-pyridinecarbonitrile757(6-(4-Hydroxy-3-(2-methoxyphenylazo)-2sulfonato-7-naphthylamino)-1,3,5-triazine2,4-diyl)bis[(amino-1methylethyl)ammonium] formate

758

Trisodium [4′-(8-acetylamino-3,6-

413-590-3

disulfonato-2-naphthylazo)-4″-(6benzoylamino-3-Sulfonato-2-naphthylazo)biphenyl-1,3′,3″,1″′-tetraolatoO,O′,O″,O″′]copper(II)759

A mixture of: N-[3-Hydroxy-2-(2-412-790-8

methylacryloylaminomethoxy)propoxymethyl]-2-methylacrylamide and N-[2,3-bis-(2Methylacryloylaminomethoxy)propoxymethyl]-2-methylacrylamide and methacrylamide
and 2-methyl-N-(2methylacryloylaminomethoxymethyl)acrylamide and N-(2,3dihydroxypropoxymethyl)-2methylacrylamide

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

79

EN

760

1,3,5-tris-[(2S and 2R)-2,3-Epoxypropyl]-59653-74-6

616-091-00-0

1,3,5-triazine-2,4,6-(1H,3H,5H)-trione(Teroxirone)
761

Erionite

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,

64741-76-0

265-077-7

64741-88-4

265-090-864741-89-5

265-091-3

64741-95-3

265-096-0

if they contain > 3 % w/w DMSO extract
765

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

766

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

767

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

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

80

EN

768

Distillates (petroleum), solvent-refined heavy

64741-96-4

265-097-6

64741-97-5

265-098-1

64742-01-4

265-101-6

64742-36-5

265-137-2

64742-37-6

265-138-8

64742-41-2

265-143-5

64742-44-5

265-146-1

naphthenic, if they contain > 3 % w/w DMSO
extract
769

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

770

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

771

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

772

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

773

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

774

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

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

81

EN

775

Distillates (petroleum), clay-treated light64742-45-6

265-147-7

64742-52-5

265-155-0

64742-53-6

265-156-6

64742-54-7

265-157-1

64742-55-8

265-158-7

64742-56-9

265-159-2

64742-57-0

265-160-8

naphthenic, if they contain > 3 % w/w DMSO
extract
776

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

777

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

778

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

779

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

780

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

781

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

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

82

EN

782

Residual oils (petroleum), solvent-dewaxed, if 64742-62-7

265-166-0

they contain > 3 % w/w DMSO extract
783

Distillates (petroleum), solvent-dewaxed

64742-63-8

265-167-6

64742-64-9

265-168-1

64742-65-0

265-169-7

64742-67-2

265-171-8

64742-68-3

265-172-3

64742-69-4

265-173-9

heavy naphthenic, if they contain > 3 % w/w
DMSO extract
784

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

785

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

786

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

787

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

788

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

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

83

EN

789

Paraffin oils (petroleum), catalytic dewaxed

64742-70-7

265-174-4

64742-71-8

265-176-5

64742-75-2

265-179-1

64742-76-3

265-180-7

68783-00-6

272-175-3

68783-04-0

272-180-0

heavy, if they contain > 3 % w/w DMSO
extract
790

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

791

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

792

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

793

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

794

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

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

84

EN

795

Extracts (petroleum), heavy paraffinic

68814-89-1

272-342-0

72623-85-9

276-736-3

72623- 86-0

276-737-9

72623- 87-1

276-738-4

74869-22-0

278-012-2

90640-91-8

292-613-7

distillates, solvent-deasphalted, if they contain> 3 % w/w DMSO extract
796

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

797

Lubricating oils (petroleum), C15-30,hydrotreated neutral oil-based, if they contain> 3 % w/w DMSO extract798

Lubricating oils (petroleum), C20-50,hydrotreated neutral oil-based, if they contain> 3 % w/w DMSO extract799

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

800

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

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

85

EN

801

Distillates (petroleum), complex dewaxed

90640-92-9

292-614-2

90640-94-1

292-616-3

90640-95-2

292-617-9

90640-96-3

292-618-4

90640-97-4

292-620-5

light paraffinic, if they contain > 3 % w/w
DMSO extract
802

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

803

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

804

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

805

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

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

86

EN

806

Extracts (petroleum), heavy naphthenic

90641-07-9

292-631-5

90641-08-0

292-632-0

90641-09-1

292-633-6

90669-74-2

292-656-1

91770-57-9

294-843-3

distillate solvent, hydrotreated, if they contain> 3 % w/w DMSO extract
807

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

808

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

809

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

810

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

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

87

EN

811

Distillates (petroleum), dewaxed heavy

91995-39-0

295-300-3

91995-40-3

295-301-9

91995-45-8

295-306-6

91995-54-9

295-316-0

91995- 73-2

295-335-4

paraffinic, hydrotreated, if they contain > 3 %w/w DMSO extract
812

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

813

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

814

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

815

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

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

88

EN

816

Extracts (petroleum), light naphthenic

91995-75-4

295-338-0

91995-76-5

295-339-6

91995-77-6

295-340-1

91995-79-8

295-342-2

92045-12-0

295-394-6

distillate solvent, hydrodesulfurised, if they
contain > 3 % w/w DMSO extract
817

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

818

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

819

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

820

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

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

89

EN

821

Lubricating oils (petroleum), C17-35, solvent-

92045-42-6

295-423-2

92045-43-7

295-424-8

92061-86-4

295-499-7

92129-09-4

295-810-6

92704-08-0

296-437-1

extd., dewaxed, hydrotreated, if they contain> 3 % w/w DMSO extract822

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

823

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

824

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

825

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

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

90

EN

826

Lubricating oils (petroleum), base oils,

93572-43-1

297-474-6

93763-10-1

297-827-4

93763-11-2

297-829-593763-38-3

297-857-8

93924-31-3

300-225-7

93924-32-4

300-226-2

paraffinic, if they contain > 3 % w/w DMSO
extract
827

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

828

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

829

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

830

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

831

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

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

91

EN

832

Hydrocarbons, C20-50, residual oil

93924-61-9

300-257-1

94733-08-1

305-588-5

94733-09-2

305-589-0

94733-15-0

305-594-8

94733-16-1

305-595-3hydrogenation vacuum distillate, if they
contain > 3 % w/w DMSO extract
833

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

834

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

835

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

836

Lubricating oils (petroleum), C18-40, solventdewaxed hydrogenated raffinate-based, if they
contain > 3 % w/w DMSO extract

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

92

EN

837

Hydrocarbons, C13-30, arom. -rich, solvent-

95371-04-3

305-971-7

95371-05-4

305-972-2

95371-07-6

305-974-3

95371-08-7

305-975-997488-73-8

307-010-7

extd. naphthenic distillate, if they contain> 3 % w/w DMSO extract
838

Hydrocarbons, C16-32, arom. rich, solventextd. naphthenic distillate, if they contain> 3 % w/w DMSO extract

839

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

840

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

841

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

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

93

EN

842

Distillates (petroleum), solvent-refined

97488-74-9

307-011-2

97488-95-4

307-034-897675-87-1

307-661-7

97722-06-0

307-755-8

97722-09-3

307-758-4hydrogenated heavy, if they contain > 3 %w/w DMSO extract843

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

844

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

845

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

846

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

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

94

EN

847

Hydrocarbons, C14-29, solvent-extd. light97722-10-6

307-760-5

97862-76-5

308-126-0

97862-77-6

308-127-6

97862-81-2

308-131-8

97862-82-3

308-132-3

97862-83-4

308-133-9

naphthenic, if they contain > 3 % w/w DMSO
extract
848

Foots oil (petroleum), carbon-treated, if it
contains > 3 % w/w DMSO extract849

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

850

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

851

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

852

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

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

95

EN

853

Hydrocarbons, C27-45, dearomatised, if they97926-68-6

308-287-7

97926-70-0

308-289-8

97926-71-1

308-290-3

100684-02-4

309-672-2

100684- 03-5

309-673-8

100684-04-6

309-674-3

contain > 3 % w/w DMSO extract
854

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

855

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

856

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

857

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

858

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

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

96

EN

859

Extracts (petroleum), light vacuum gas oil

100684-05-7

309-675-9100684-37-5

309-710-8100684-38-6

309-711-3

101316-69-2

309-874-0

101316-70-5

309-875-6

solvent, clay-treated, if they contain > 3 %w/w DMSO extract
860

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

861

Residual oils (petroleum), clay-treatedsolvent-dewaxed, if they contain > 3 % w/w
DMSO extract862

Lubricating oils (petroleum), C>25, solventextd., deasphalted, dewaxed, hydrogenated, if
they contain > 3 % w/w DMSO extract863

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

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

97

EN

864

Lubricating oils (petroleum), C20-35, solvent-

101316-71-6

309-876-1

101316-72-7

309-877-7

64741-86-2

265-088-7

64741-90-8

265-092-964741-91-9

265-093-4

extd., dewaxed, hydrogenated, if they contain> 3 % w/w DMSO extract
865

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

866

Distillates (petroleum), sweetened middle,
except if the full refining history is known
and it can be shown that the substance fromwhich it is produced is not a carcinogen867

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

868

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

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

98

EN

869

Gas oils (petroleum), acid-treated, except if

64742-12-7

265-112-6

64742-13-8

265-113-1

64742-14-9

265-114-7

64742-29-6

265-129-9

the full refining history is known and it can beshown that the substance from which it isproduced is not a carcinogen
870

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

871

Distillates (petroleum), acid-treated light,
except if the full refining history is known
and it can be shown that the substance fromwhich it is produced is not a carcinogen872

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

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

99

EN

873

Distillates (petroleum), chemically neutralised 64742-30-9

265-130-4

middle, except if the full refining history is
known and it can be shown that the substancefrom which it is produced is not a carcinogen
874

Distillates (petroleum), clay-treated middle,

64742-38-7

265-139-3

64742-46-7

265-148-2

64742-79-6

265-182-8

except if the full refining history is known
and it can be shown that the substance fromwhich it is produced is not a carcinogen
875

Distillates (petroleum), hydrotreated middle,
except if the full refining history is known
and it can be shown that the substance fromwhich it is produced is not a carcinogen876

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

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

100

EN

877

Distillates (petroleum), hydrodesulfurised

64742-80-9

265-183-3

68477-29-2

270-719-4

68477-30-5

270-721-5

68477-31-6

270-722-0

middle, except if the full refining history is
known and it can be shown that the substancefrom which it is produced is not a carcinogen
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 isproduced is not a carcinogen

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 fromwhich it is produced is not a carcinogen

880

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

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

101

EN

881

Alkanes, C12-26, branched and linear, except if

90622-53-0

292-454-3

90640-93-0

292-615-8

91995-34-5

295-294-2

93924-33-5

300-227-8

the full refining history is known and it can beshown that the substance from which it isproduced is not a carcinogen
882

Distillates (petroleum), highly refined middle,
except if the full refining history is known
and it can be shown that the substance fromwhich it is produced is not a carcinogen883

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
carcinogen884

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

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

102

EN

885

Naphtha (petroleum), solvent-refined

97488-96-5

307-035-3

97675- 85-9

307-659-6

97675-86-0

307-660-1

97722-08-2

307-757-9hydrodesulfurised heavy, except if the fullrefining history is known and it can be shownthat the substance from which it is produced
is not a carcinogen
886

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

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

888

Hydrocarbons, C11-17, solvent-extd. lightnaphthenic, except if the full refining history
is known and it can be shown that thesubstance from which it is produced is not a
carcinogen

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

103

EN

889

Gas oils, hydrotreated, except if the full97862-78-7

308-128-1

100683-97-4

309-667-5

100683-98-5

309-668-0

100683-99-6

309-669-6

refining history is known and it can be shownthat the substance from which it is produced
is not a carcinogen
890

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

891

Distillates (petroleum), intermediate
paraffinic, carbon-treated, except if the fullrefining history is known and it can be shownthat the substance from which it is produced
is not a carcinogen

892

Distillates (petroleum), intermediate
paraffinic, clay-treated, except if the fullrefining history is known and it can be shownthat the substance from which it is produced
is not a carcinogen

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

104

EN

893

Lubricating greases, except if the full refining

74869-21-9

278-011-7

64742-61-6

265-165-5

90669-77-5

292-659-8

90669-78-6

292-660-3

history is known and it can be shown that thesubstance from which it is produced is not a
carcinogen894

Slack wax (petroleum), except if the fullrefining history is known and it can be shownthat the substance from which it is produced
is not a carcinogen895

Slack wax (petroleum), acid-treated, except if
the full refining history is known and it can beshown that the substance from which it isproduced is not a carcinogen

896

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

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

105

EN

897

Slack wax (petroleum), hydrotreated, except

92062-09-4

295-523-6

92062-10-7

295-524-1

92062-11-8

295-525-7

97863-04-2

308-155-9

if the full refining history is known and it canbe shown that the substance from which it isproduced is not a carcinogen
898

Slack wax (petroleum), low-melting, except if
the full refining history is known and it can beshown that the substance from which it isproduced is not a carcinogen899

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

900

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

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

106

EN

901

Slack wax (petroleum), low-melting, clay-

97863-05-3

308-156-4

97863-06-4

308-158-5

100684-49-9

309-723-9

8009-03-8

232-373-2

treated, except if the full refining history is
known and it can be shown that the substancefrom which it is produced is not a carcinogen
902

Slack wax (petroleum), low-melting, silicic
acid-treated, except if the full refining history
is known and it can be shown that thesubstance from which it is produced is not a
carcinogen903

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

904

Petrolatum, except if the full refining history
is known and it can be shown that thesubstance from which it is produced is not a
carcinogen

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

107

EN

905

Petrolatum (petroleum), oxidised, except if

64743-01-7

265-206-7

85029-74-9

285-098-5

92045-77-7

295-459-9

97862-97-0

308-149-6

the full refining history is known and it can beshown that the substance from which it isproduced is not a carcinogen
906

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

907

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

908

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

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

108

EN

909

Petrolatum (petroleum), silicic acid-treated,

97862-98-1

308-150-1

Petrolatum (petroleum), clay-treated, except if 100684-33-1

309-706-6

except if the full refining history is known
and it can be shown that the substance fromwhich it is produced is not a carcinogen910

the full refining history is known and it can beshown that the substance from which it isproduced is not a carcinogen
911

Distillates (petroleum), light catalytic cracked

64741-59-9

265-060-4

912

Distillates (petroleum), intermediate catalytic

64741-60-2

265-062-5

cracked
913

Distillates (petroleum), light thermal cracked

64741-82-8

265-084-5

914

Distillates (petroleum), hydrodesulfurised

68333-25-5

269-781-568475-80-9

270-662-5

light catalytic cracked
915

Distillates (petroleum), light steam-cracked
naphtha

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

109

EN

916

Distillates (petroleum), cracked steam-

68477-38-3

270-727-8

cracked petroleum distillates
917

Gas oils (petroleum), steam-cracked

68527-18-4

271-260-2

918

Distillates (petroleum), hydrodesulfurised

85116-53-6

285-505-6

92045-29-9

295-411-7

92062-00-5

295-514-7

92062-04-9

295-517-3

92201-60-0

295-991-1

93763-85-0

297-905-8

97926-59-5

308-278-8

101316-59-0

309-865-1

thermal cracked middle
919

Gas oils (petroleum), thermal-cracked,
hydrodesulfurised

920

Residues (petroleum), hydrogenated steamcracked naphtha

921

Residues (petroleum), steam-cracked naphtha
distn.

922

Distillates (petroleum), light catalytic
cracked, thermally degraded

923

Residues (petroleum), steam-cracked heatsoaked naphtha924

Gas oils (petroleum), light vacuum, thermalcracked hydrodesulfurised

925

Distillates (petroleum), hydrodesulfurised
middle coker

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

110

EN

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

64741-61-3

265-063-0

cracked930

Clarified oils (petroleum), catalytic cracked

64741-62-4

265-064-6

931

Residues (petroleum), catalytic reformer

64741-67-9

265-069-3

fractionator
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

64742-78-5

265-181-2

atmospheric tower

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

111

EN

937

Gas oils (petroleum), hydrodesulfurised heavy 64742-86-5

265-189-6

vacuum938

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

68333-26-6

269-782-0

68333-27-7

269-783-6

68333-28-8

269-784-1

68476-32-4

270-674-0

catalytic cracked
941

Distillates (petroleum), hydrodesulfurisedintermediate catalytic cracked

942

Distillates (petroleum), hydrodesulfurised
heavy catalytic cracked

943

Fuel oil, residues-straight-run gas oils, highsulfur

944

Fuel oil, residual

68476-33-5

270-675-6

945

Residues (petroleum), catalytic reformer

68478-13-7

270-792-2

Residues (petroleum), heavy coker gas oil and 68478-17-1

270-796-4

fractionator residue distn.
946

vacuum gas oil

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

112

EN

947

Residues (petroleum), heavy coker and light

68512-61-8

270-983-0

vacuum948

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-

68607-30-7

271-763-7

sulfur952

Gas oils (petroleum), heavy atmospheric

68783-08-4

272-184-2

953

Residues (petroleum), coker scrubber,

68783-13-1

272-187-968955-27-1

273-263-4

68955-36-2

273-272-3

condensed-ring-arom. -contg
954

Distillates (petroleum), petroleum residues
vacuum955

Residues (petroleum), steam-cracked,
resinous

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

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

113

EN

959

Gas oils (petroleum), hydrodesulfurised coker

85117-03-9

285-555-9

90669-75-3

292-657-7

heavy vacuum
960

Residues (petroleum), steam-cracked,
distillates

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

92201-59-7

295-990-6

cracked, thermally degraded
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

101316-57-8

309-863-0

full-range middle
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

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

114

EN

971

Distillates (petroleum), heavy naphthenic

64741-53-3

265-054-1

972

Distillates (petroleum), acid-treated heavy

64742-18-3

265-117-3

64742-19-4

265-118-964742-20-7

265-119-4

64742-21-8

265-121-5

Distillates (petroleum), chemically neutralised 64742-27-4

265-127-8

naphthenic
973

Distillates (petroleum), acid-treated lightnaphthenic

974

Distillates (petroleum), acid-treated heavyparaffinic

975

Distillates (petroleum), acid-treated lightparaffinic976

heavy paraffinic
977

Distillates (petroleum), chemically neutralised 64742-28-5

265-128-3

light paraffinic
978Distillates (petroleum), chemically neutralised 64742-34-3

265-135-1

heavy naphthenic
979

Distillates (petroleum), chemically neutralised 64742-35-4

265-136-7

light naphthenic
980

Extracts (petroleum), light naphthenic

64742-03-6

265-102-1

distillate solvent

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

115

EN

981

Extracts (petroleum), heavy paraffinic

64742-04-7

265-103-7

64742-05-8

265-104-2

64742-11-6

265-111-0

91995-78-7

295-341-7

distillate solvent
982

Extracts (petroleum), light paraffinic distillate
solvent

983

Extracts (petroleum), heavy naphthenic
distillate solvent

984

Extracts (petroleum), light vacuum gas oil
solvent

985

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

307-753-7

986

Disodium 3,3′-[[1,1′-biphenyl]-4,4′-573-58-0

209-358-4

1937-37-7

217-710-3

2602-46-2

220-012-1

diylbis(azo)]bis(4-aminonaphthalene-1sulphonate)
987

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

988

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

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

116

EN

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-[(2-16071-86-6

240-221-1hydroxy-5sulphophenyl)azo]phenyl]azo][1,1′-biphenyl]4-yl]azo]salicylato(4-)]cuprate(2-)
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

111-77-3

203-906-6

glycol monomethyl ether; DEGME)

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

117

EN

1001

(+/–)-2-(2,4-Dichlorophenyl)-3-(1H-1,2,4-112281-77-3

407-760-6114565-66-1

406-057-1

115662-06-1

405-100-1

triazol-1-yl)propyl-1,1,2,2tetrafluoroethylether (Tetraconazole - ISO)1002

4-[4-(1,3-Dihydroxyprop-2-yl)phenylamino]1,8-dihydroxy-5-nitroanthraquinone

1003

5,6,12,13-Tetrachloroanthra(2,1,9-def:6,5,10d'e'f')diisoquinoline-1,3,8,10(2H,9H)-tetrone1004

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-

125051-32-3

412-000-1

130728-76-6

410-060-3(pyrrol-1-yl)-phenyl)titanium
1010

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

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

118

EN

1011

Divanadium pentaoxide

1314-62-1

215-239-8

1012

Pentachlorophenol and its alkali salts

87-86-5 /201-778-6 /

131-52-2 /205-025-2 /7778-73-6

231-911-3

1013

Phosphamidon

13171-21-6

236-116-5

1014

N-(Trichloromethylthio)phthalimide (Folpet -133-07-3

205-088-6

ISO)
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

140-41-0

006-043-00-1

trichloroacetate; monuron-TCA
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

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

119

EN

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-

166242-53-1

422-720-8

1689-83-4 /216-881-1 /

3861-47-0

223-375-4

Bromoxynil (ISO) (3,5-Dibromo-4-

1689-84-5 /

216-882-7 /hydroxybenzonitrile) and Bromoxynil

56634-95-8

260-300-4

1689-99-2

216-885-3

17630-75-0

412-200-9hydroxymethylphosphonium chloride, urea
and distilled hydrogenated C16-18 tallow
alkylamine
1030

1031

Ioxynil and Ioxynil octanoate (ISO)heptanoate (ISO)1032

2,6-Dibromo-4-cyanophenyl octanoate

1033

Moved or deleted

1034

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

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

120

EN

1035

Benomyl

17804-35-2

241-775-7

1036

Chlorothalonil

1897-45-6

217-588-1

1037

N′-(4-Chloro-o-tolyl)-N,N-

19750-95-9

243-269-1

dimethylformamidine monohydrochloride
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

26447-14-3

247-711-4

ether
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

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

121

EN

1048

Dodecachloropentacyclo[5.2.1.02,6.03,905,8]dec

2385-85-5

219-196-6

ane (Mirex)
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

1052

Chinomethionate

2439-01-2

219-455-3

1053(R)-α-Phenylethylammonium (-)-(1R,2S)-

25383-07-7

418-570-8

2593-15-9

219-991-8(1,2-epoxypropyl)phosphonate monohydrate
1054

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

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

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

122

EN

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

34123-59-6

251-835-4

36734-19-7

253-178-9

41107-56-6

415-360-8

4170-30-3

224-030-0(Isoproturon - ISO)
1062

Iprodione1063

Moved or deleted1064

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

1065

Crotonaldehyde

1066

Hexahydrocyclopenta(c)pyrrole-1-(1H)-

418-350-1

ammonium N-ethoxycarbonyl-N-(ptolylsulfonyl)azanide
1067

4,4′-Carbonimidoylbis[N,N-dimethylaniline]

492-80-8

207-762-5 .

and its salts
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

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

123

EN

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-

60568-05-0

262-302-0

furamide (Furmecyclox - ISO)
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

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

124

EN

1085

(3-Chlorophenyl)-(4-methoxy-3-

66938-41-8

423-290-4

Fuels, diesel, except if the full refining history 68334-30-5

269-822-7

nitrophenyl)methanone1086

is known and it can be shown that thesubstance from which it is produced is not a
carcinogen
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

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

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

125

EN

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

78-59-1

201-126-0(Isophorone)
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-

81880-96-8

406-090-1

methylmethanesulfonamide hydrochloride
1107

CI Solvent Yellow 14

842-07-9

212-668-2

1108

Chlozolinate

84332-86-5

282-714-4

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

126

EN

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-

88671-89-0

410-400-0(1H-1,2,4-triazol-1-ylmethyl)hexanenitrile)
1115

Fentin acetate

900-95-8

212-984-01116

Biphenyl-2-ylamine

90-41-5

201-990-91117

Trans-4-cyclohexyl-L-proline monohydro-

90657-55-9

419-160-1

91-08-7

202-039-0

584-84-9

209-544-5

26471-62-5

247-722-4

chloride1118

2-Methyl-m-phenylene diisocyanate (Toluene
2,6-diisocyanate)1119

4-Methyl-m-phenylene diisocyanate (Toluene
2,4-diisocyanate)1120

m-Tolylidene diisocyanate (Toluene
diisocyanate)

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

127

EN

1121

Fuels, jet aircraft, coal solvent extn.,

94114-58-6

302-694-3

94114-59-7

302-695-961789-60-4

263-072-4hydrocracked hydrogenated1122

Fuels, diesel, coal solvent extn., hydrocracked
hydrogenated1123

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

1124

2-Butanone oxime

96-29-7

202-496-6

1125

Hydrocarbons, C16-20, solvent-dewaxed

97675-88-2

307-662-2

98-87-3

202-709-2

hydrocracked paraffinic distn. Residue
1126

α,α-Dichlorotoluene

1127

Mineral wool, with the exception of thosespecified elsewhere in this Annex; [Manmade vitreous (silicate)fibres with randomorientation with alkaline oxide and alkali
earth oxide (Na2O + K2O + CaO + MgO +BaO) content greater than 18 % by weight]

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

128

EN

1128

Reaction product of acetophenone,406-230-1

formaldehyde, cyclohexylamine, methanol
and acetic acid1129

Moved or deleted

1130

Moved or deleted

1131

Trisodium bis(7-acetamido-2-(4-nitro-2-

400-810-8oxidophenylazo)-3-sulfonato-1naphtholato)chromate(1-)
1132

A mixture of: 4-allyl-2,6-bis(2,3-417-470-1

epoxypropyl)phenol, 4-allyl-6-(3-(6-(3-(6-(3(4-allyl-2,6-bis(2,3-epoxypropyl)-phenoxy)2hydroxypropyl)-4-allyl-2-(2,3epoxypropyl)phenoxy)-2-hydroxypropyl)-4allyl-2-(2,3-epoxypropyl)-phenoxy-2hydroxypropyl-2-(2,3-epoxypropyl)phenol, 4allyl-6-(3-(4-allyl-2,6-bis(2,3epoxypropyl)phenoxy)-2- hydroxypropyl)-2(2,3-epoxypropyl)phenoxy)phenol and 4allyl-6-(3-(6-(3-(4-allyl-2,6-bis(2,3epoxypropyl)-phenoxy)-2-hydroxypropyl)-4allyl-2-(2,3-epoxypropyl)phenoxy)2hydroxypropyl)-2-(2,3-epoxypropyl)phenol

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

129

EN

1133

Costus root oil (Saussurea lappa Clarke),8023-88-9

when used as a fragrance ingredient1134

7-Ethoxy-4-methylcoumarin, when used as a87-05-8

201-721-5

700-82-3

211-851-4

8007-00-9

232-352-8

fragrance ingredient
1135

Hexahydrocoumarin, when used as afragrance ingredient

1136

Peru balsam (INCI name: Myroxylon
pereirae), when used as a fragrance ingredient

1137

Isobutyl nitrite542-56-2

208-819-7

1138

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

78-79-5

201-143-3

butadiene)
1139

1-Bromopropane; n-Propyl bromide

106-94-5

203-445-0

1140

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

126-99-8

204-818-0

96-18-4

202-486-1

diene)
1141

1,2,3-Trichloropropane

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

130

EN

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

25376-45-8

246-910-3of [4-methyl-m-phenylenediamine]1 and [2methyl-m-phenylenediamine]2
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

112-49-2

203-977-3

glycol dimethyl ether (TEGDME)
1148

Tetrahydrothiopyran-3-carboxaldehyde

61571-06-0

407-330-8

1149

4,4′-bis(Dimethylamino)benzophenone

90-94-8

202-027-5(Michler's ketone)
1150

Oxiranemethanol, 4-methylbenzene-sulfonate, 70987-78-9

417-210-7

(S)-

1
2

for the individual ingredient see reference number 364 in Annex II.
for the individual ingredient see reference number 413 in Annex II.

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

131

EN

1151

1,2-Benzenedicarboxylic acid, dipentylester,

84777-06-0 [1]284-032-2

branched and linear [1]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

1152

Benzyl butyl phthalate (BBP)

85-68-7

201-622-7

1153

1,2-Benzenedicarboxylic acid, di-C7-11,

68515-42-4

271-084-6

branched and linear alkyl esters
1154

A mixture of: disodium 4-(3-ethoxycarbonyl-402-660-9

4-(5-(3-ethoxycarbonyl-5-hydroxy-1-(4sulfonatophenyl) pyrazol-4-yl)penta-2,4dienylidene)-4,5-dihydro-5-oxopyrazol-1yl)benzenesulfonate and trisodium 4-(3ethoxycarbonyl-4-(5-(3-ethoxycarbonyl-5oxido-1-(4-sulfonatophenyl)pyrazol-4yl)penta-2,4-dienylidene)-4,5-dihydro-5oxopyrazol-1-yl)benzenesulfonate

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

132

EN

1155

(Methylenebis(4,1-phenylenazo(1-(3-401-500-5(dimethylamino)propyl)-1,2-dihydro-6hydroxy-4-methyl-2-oxopyridine-5,3-diyl)))1,1′-dipyridinium dichloride dihydrochloride1156

2-[2-Hydroxy-3-(2-chlorophenyl)carbamoyl-

420-580-2

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

101-80-4

202-977-0

101-61-1

202-959-2

120-71-8

204-419-1

205-282-0

its salts
1161

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

1162

6-Methoxy-m-toluidine; (p-Cresidine)

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

133

EN

1163

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

143860-04-2

421-150-7

oxazolidine
1164

A mixture of: 1,3,5-tris(3-421-550-1aminomethylphenyl)-1,3,5-(1H,3H,5H)triazine-2,4,6-trione and a mixture ofoligomers of 3,5-bis(3-aminomethylphenyl)1-poly[3,5-bis(3-aminomethylphenyl)-2,4,6trioxo-1,3,5-(1H,3H,5H)-triazin-1-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

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

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

134

EN

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

218-661-0

1181

Fenpropimorph (ISO)67564-91-4

266-719-9

1182

Moved or deleted

1183

Methyl isocyanate

624-83-9

210-866-3

1184

N,N-Dimethylanilinium

118612-00-3

422-050-6

tetrakis(pentafluorophenyl)borate
1185

O,O′-(Ethenylmethylsilylene) di[(4-421-870-1

methylpentan-2-one) oxime]

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

135

EN

1186

A 2:1 mixture of: 4-(7-hydroxy-2,4,4-

140698-96-0

414-770-4

trimethyl-2-chromanyl)resorcinol-4-yl-tris(6diazo-5,6-dihydro-5-oxonaphthalen-1sulfonate) and 4-(7-hydroxy-2,4,4-trimethyl2-chromanyl)resorcinolbis(6-diazo-5,6dihydro-5-oxonaphthalen-1-sulfonate)
1187

A mixture of: reaction product of 4,4′-417-980-4

methylenebis[2-(4-hydroxybenzyl)-3,6dimethylphenol] and 6-diazo-5,6-dihydro-5oxo-naphthalenesulfonate (1:2) and reaction
product of 4,4′-methylenebis[2-(4hydroxybenzyl)-3,6-dimethylphenol] and 6diazo-5,6-dihydro-5-oxonaphthalenesulfonate
(1:3)
1188

1189

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

Malachite green oxalate [2]18015-76-4 [2]241-922-5

1-(4-Chlorophenyl)-4,4-dimethyl-3-(1,2,4-107534-96-3

403-640-2

triazol-1-ylmethyl)pentan-3-ol

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

136

EN

1190

5-(3-Butyryl-2,4,6-trimethylphenyl)-2-[1-138164-12-2

414-790-3

96314-26-0

416-020-1

163879-69-4

418-230-9(ethoxyimino)propyl]-3-hydroxycyclohex-2en-1-one
1191

trans-4-Phenyl-L-proline

1192

Moved or deleted

1193

A mixture of: 5-[(4-[(7-amino-1-hydroxy-3sulfo-2-naphthyl)azo]-2,5diethoxyphenyl)azo]-2-[(3phosphonophenyl)azo]benzoic acid and 5-[(4[(7-amino-1-hydroxy-3-sulfo-2naphthyl)azo]-2,5-diethoxyphenyl)azo]-3-[(3phosphonophenyl)azo]benzoic acid1194

2-{4-(2-Ammoniopropylamino)-6-[4-424-260-3hydroxy-3-(5-methyl-2-methoxy-4sulfamoylphenylazo)-2-sulfonatonaphth-7ylamino]-1,3,5-triazin-2-ylamino}-2aminopropyl 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

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

137

EN

1196

1-(1-Naphthylmethyl)quinolinium chloride

65322-65-8

406-220-7

1197(R)-5-Bromo-3-(1-methyl-2-

143322-57-0

422-390-5

pyrrolidinylmethyl)-1H-indole
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-

15545-48-9

239-592-2

dimethylurea)
1201

N-[2-(3-Acetyl-5-nitrothiophen-2-ylazo)-5-416-860-9

diethylaminophenyl]acetamide
1202

1,3-bis(Vinylsulfonylacetamido)propane

93629-90-4

428-350-3

1203

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

92061-93-3

295-506-3

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

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

138

EN

1206

Creosote oil, acenaphthene fraction, wash oil,

90640-84-9

292-605-3

61789-28-4

263-047-8

8001-58-9

232-287-5

70321-79-8

274-565-9122384-77-4

310-189-4

70321-80-1

274-566-4

94166-62-8

303-358-9

if it contains > 0,005 % w/w benzo[a]pyrene
1207

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

1208

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

1209

Creosote oil, high-boiling distillate, wash oil,
if it contains > 0,005 % w/w benzo[a]pyrene

1210

Extract residues (coal), creosote oil acid,wash oil extract residue, if it contains> 0,005 % w/w benzo[a]pyrene

1211

Creosote oil, low-boiling distillate, wash oil,
if it contains > 0,005 % w/w benzo[a]pyrene

1212

6-Methoxy-2,3-Pyridinediamine and its HCl
salt, when used as a substance in hair dye
products

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

139

EN

1213

2,3-Naphthalenediol, when used as a

92-44-4

202-156-7

substance in hair dye products
1214

2,4-Diaminodiphenylamine, when used as a136-17-4

substance in hair dye products
1215

2,6-Bis(2-Hydroxyethoxy)-3,5-117907-42-3

Pyridinediamine and its HCl salt, when used
as a substance in hair dye products
1216

2-Methoxymethyl-p-Aminophenol and its

135043-65-1 /HCl salt, when used as a substance in hair dye

29785-47-5

products
1217

4,5-Diamino-1-Methylpyrazole and its HCl

20055-01-0 /salt, when used as a substance in hair dye

21616-59-1

products
1218

4,5-Diamino-1-((4-Chlorophenyl)Methyl)-

163183-00-4

1H-Pyrazole Sulfate, when used as a
substance in hair dye products
1219

4-Chloro-2-Aminophenol, when used as a95-85-2

202-458-9

substance in hair dye products

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

140

EN

1220

4-Hydroxyindole, when used as a substance in 2380-94-1

219-177-2

hair dye products
1221

4-Methoxytoluene-2,5-Diamine and its HCl

56496-88-9

salt, when used as a substance in hair dye
products
1222

5-Amino-4-Fluoro-2-Methylphenol Sulfate,

163183-01-5

when used as a substance in hair dye
products
1223

1224

N,N-Diethyl-m-Aminophenol, when used as a

91-68-9 /202-090-9 /substance in hair dye products

68239-84-9

269-478-8

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

104903-49-3

as a substance in hair dye products
1226

N-(2-Methoxyethyl)-p-phenylenediamine and72584-59-9 /its HCl salt, when used as a substance in hair

66566-48-1

276-723-2

dye products

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

141

EN

1227

2,4-Diamino-5-methylphenetol and its HCl

113715-25-6

salt, when used as a substance in hair dye
products
1228

1,7-Naphthalenediol, when used as a575-38-2

209-383-0

619-05-6

210-577-2

substance in hair dye products
1229

3,4-Diaminobenzoic acid, when used as a
substance in hair dye products

1230

2-Aminomethyl-p-aminophenol and its HCl

79352-72-0

salt, when used as a substance in hair dye
products
1231

Solvent Red 1 (CI 12150), when used as a1229-55-6

214-968-9

1320-07-6

215-296-9

5413-75-2

226-502-1

substance in hair dye products
1232

Acid Orange 24 (CI 20170), when used as a
substance in hair dye products

1233

Acid Red 73 (CI 27290), when used as a
substance in hair dye products

1234

PEG-3,2′,2′-di-p-Phenylenediamine

PE-CONS 3623/09
ANNEX II

144644-13-3

AK/kr
DG C

142

EN

1235

6-Nitro-o-Toluidine

570-24-1

209-329-6

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 /- / 306-778-0

97404-14-3
1240

Tetrahydro-6-nitroquinoxaline and its salts

158006-54-3 /
41959-35-7 /
73855-45-5

1241

Disperse Red 15, except as impurity in

116-85-8

204-163-0

Disperse Violet 1
1242

4-Amino-3-fluorophenol

399-95-1

402-230-0

1243

N,N′-dihexadecyl-N,N′-bis(2-149591-38-8

422-560-9hydroxyethyl)propanediamide
Bishydroxyethyl Biscetyl Malonamide

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

143

EN

1244

1-Methyl-2,4,5-trihydroxybenzene and its

1124-09-0

214-390-7

4664-16-8

225-108-7

10288-36-5

233-639-0

533-31-3

208-561-5

14268-66-7

238-161-6

822-89-9

212-506-0

salts, when used as a substance in hair dye
products
1245

2,6-Dihydroxy-4-methylpyridine and its salts,
when used as a substance in hair dye products

1246

5-Hydroxy-1,4-benzodioxane and its salts,
when used as a substance in hair dye products

1247

3,4-Methylenedioxyphenol and its salts, whenused as a substance in hair dye products

1248

3,4-Methylenedioxyaniline and its salts, whenused as a substance in hair dye products

1249

Hydroxypyridinone and its salts, when used
as a substance in hair dye products

1250

3-Nitro-4-aminophenoxyethanol and its salts,

50982-74-6

when used as a substance in hair dye products
1251

2-methoxy-4-nitrophenol (4-Nitroguaiacol)

3251-56-7

221-839-0

and its salts, when used as a substance in hairdye products

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

144

EN

1252

CI Acid Black 131 and its salts, when used as

12219-01-1

a substance in hair dye products
1253

1,3,5-Trihydroxybenzene (Phloroglucinol)

108-73-6

203-611-2

613-03-6

210-327-2

and its salts, when used as a substance in hairdye products
1254

1,2,4-Benzenetriacetate and its salts, whenused as a substance in hair dye products

1255

Ethanol, 2,2'-iminobis-, reaction products

68478-64-8 /with epichlorohydrin and 2-nitro-1,4-

158571-58-5

benzenediamine (HC Blue No. 5) and its salts,
when used as a substance in hair dye products
1256

N-Methyl-1,4-diaminoanthraquinone, reaction 158571-57-4
products with epichlorohydrin andmonoethanolamine (HC Blue No. 4) and its
salts, when used as a substance in hair dye
products

1257

4-Aminobenzenesulfonic acid (Sulfanilic

121-57-3 /204-482-5 /acid) and its salts, when used as a substance515-74-2

208-208-5

in hair dye products

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

145

EN

1258

3,3'-(Sulfonylbis(2-nitro-4,1-

6373-79-1

228-922-0

3(or5)-((4-(Benzylmethylamino)phenyl)azo)-

89959-98-8 /

289-660-0

1,2-(or1,4)-dimethyl-1H-1,2,4-triazolium and12221-69-1

phenylene)imino)bis(6-(phenylamino))
benzenesulfonic acid and its salts, when used
as a substance in hair dye products1259

its salts, when used as a substance in hair dye
products
1260

2,2'-((3-Chloro-4-((2,6-dichloro-4-

23355-64-8

245-604-7

12270-13-2

235-546-0

13515-40-7

236-852-7

nitrophenyl)azo)phenyl)imino)bisethanol(Disperse Brown 1) and its salts, when used
as a substance in hair dye products
1261

Benzothiazolium, 2-[[4-[ethyl(2hydroxyethyl)amino]phenyl]azo]-6-methoxy3-methyl-, and its salts, when used as a
substance in hair dye products1262

2-[(4-Chloro-2-nitrophenyl)azo]-N-(2methoxyphenyl)-3-oxobutanamide (Pigment
Yellow 73) and its salts, when used as a
substance in hair dye products

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

146

EN

1263

2,2'-[(3,3'-Dichloro[1,1'-biphenyl]-4,4'-

6358-85-6

228-787-8

2870-32-8

220-698-2

4197-25-5

224-087-1

3(or5)-[[4-[(7-amino-1-hydroxy-3-

3442-21-5 /

222-351-0 /sulphonato-2-naphthyl)azo]-1-

34977-63-4

252-305-5

2610-11-9

220-028-9diyl)bis(azo)]bis[3-oxo-N-phenylbutanamide](Pigment Yellow 12) and its salts, when used
as a substance in hair dye products
1264

2,2'-(1,2-Ethenediyl)bis[5-((4ethoxyphenyl)azo]benzenesulfonic acid) andits salts, when used as a substance in hair dye
products

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

1266

naphthyl]azo]salicylic acid and its salts, whenused as a substance in hair dye products
1267

2-Naphthalenesulfonic acid, 7(benzoylamino)-4-hydroxy-3-[[4-[(4sulfophenyl)azo]phenyl]azo]-, and its salts,
when used as a substance in hair dye products

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

147

EN

1268

(μ-((7,7'-Iminobis(4-hydroxy-3-((2-hydroxy-37279-54-2

253-441-8

3441-14-3

222-348-4

2-Naphthalenesulfonic acid, 7,7'-2610-10-8 /

220-027-3(carbonyldiimino)bis(4-hydroxy-3-[[2-sulfo-

25188-41-45-(Nmethylsulphamoyl)phenyl)azo)naphthalene-2sulphonato))(6-)))dicuprate(2-) and its salts,
when used as a substance in hair dye products1269

3-[(4-(Acetylamino)phenyl)azo]-4-hydroxy7-[[[[5-hydroxy-6-(phenylazo)-7-sulfo-2naphthalenyl]amino]carbonyl]amino]-2naphthalenesulfonic acid and its salts, whenused as a substance in hair dye products1270

4-[(4-sulfophenyl)azo]phenyl]azo]-, and its
salts, when used as a substance in hair dye
products
1271

Ethanaminium, N-(4-[bis[4-2390-59-2

219-231-5(diethylamino)phenyl]methylene]-2,5cyclohexadien-1-ylidene)-N-ethyl-, and its
salts, when used as a substance in hair dye
products

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

148

EN

1272

3H-Indolium, 2-[[(4-54060-92-3

258-946-7

4208-80-4

224-132-5

methoxyphenyl)methylhydrazono]methyl]1,3,3-trimethyl-, and its salts, when used as a
substance in hair dye products
1273

3H-Indolium, 2-(2-((2,4dimethoxyphenyl)amino)ethenyl)-1,3,3trimethyl-, and its salts, when used as a
substance in hair dye products

1274

Nigrosine spirit soluble (Solvent Black 5),11099-03-9

when used as a substance in hair dye products
1275

Phenoxazin-5-ium, 3,7-bis(diethylamino)-,47367-75-9 /and its salts, when used as a substance in hair

33203-82-6

251-403-5

dye products
1276

Benzo[a]phenoxazin-7-ium, 9-7057-57-0 /

230-338-6 /(dimethylamino)-, and its salts, when used as

966-62-1

213-524-1

2478-20-8

219-607-9

a substance in hair dye products
1277

6-Amino-2-(2,4-dimethylphenyl)-1Hbenz[de]isoquinoline-1,3(2H)-dione (Solvent
Yellow 44) and its salts, when used as a
substance in hair dye products

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

149

EN

1278

1-Amino-4-[[4-67905-56-0 /267-677-4 /[(dimethylamino)methyl]phenyl]amino]anthra 12217-43-5

235-398-7

quinone and its salts, when used as a
substance in hair dye products
1279

Laccaic Acid (CI Natural Red 25 ) and its

60687-93-6

salts, when used as a substance in hair dye
products
1280

Benzenesulfonic acid, 5-[(2,4-6373-74-6 /228-921-5 /dinitrophenyl)amino]-2-(phenylamino)-, and

15347-52-1

239-377-3

4-[(4-Nitrophenyl)azo]aniline (Disperse

730-40-5 /211-984-8

Orange 3) and its salts, when used as a

70170-61-5

its salts, when used as a substance in hair dye
products
1281

substance in hair dye products
1282

4-Nitro-m-phenylenediamine and its salts,

5131-58-8

225-876-3

1220-94-6

214-944-8

2973-21-9

221-014-5

when used as a substance in hair dye products
1283

1-Amino-4-(methylamino)-9,10anthracenedione (Disperse Violet 4) and its
salts, when used as a substance in hair dye
products

1284

N-Methyl-3-nitro-p-phenylenediamine and its
salts, when used as a substance in hair dye
products

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

150

EN

1285

N1-(2-Hydroxyethyl)-4-nitro-o-56932-44-6

260-450-0

56932-45-7

260-451-6

phenylenediamine (HC Yellow No. 5) and its
salts, when used as a substance in hair dye
products1286

N1-(Tris(hydroxymethyl))methyl-4-nitro-1,2phenylenediamine (HC Yellow No. 3) and its
salts, when used as a substance in hair dye
products

1287

2-Nitro-N-hydroxyethyl-p-anisidine and its

57524-53-5

salts, when used as a substance in hair dye
products
1288

N,N'-Dimethyl-N-Hydroxyethyl-3-nitro-p-10228-03-2

233-549-1

93633-79-5

403-440-5

4-Ethylamino-3-nitrobenzoic acid (N-Ethyl-3- 2788-74-1

412-090-2

phenylenediamine and its salts, when used asa substance in hair dye products1289

3-(N-Methyl-N-(4-methylamino-3nitrophenyl)amino)propane-1,2-diol and its
salts, when used as a substance in hair dye
products

1290

Nitro PABA) and its salts, when used as a
substance in hair dye products

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

151

EN

1291

(8-[(4-Amino-2-nitrophenyl)azo]-7-hydroxy-71134-97-9

275-216-3

2-naphthyl)trimethylammonium and its salts,
except Basic Red 118 (CAS 71134-97-9) as
impurity in Basic Brown 17, when used as a
substance in hair dye products1292

5-((4-(Dimethylamino)phenyl)azo)-1,4-

12221-52-2

dimethyl-1H-1,2,4-triazolium and its salts,
when used as a substance in hair dye products
1293

m-Phenylenediamine, 4-(phenylazo)-, and its

495-54-5

207-803-7

4438-16-8

224-654-3

6441-93-6

229-231-7

salts, when used as a substance in hair dye
products
1294

1,3-Benzenediamine, 4-methyl-6(phenylazo)- and its salts, when used as a
substance in hair dye products

1295

2,7-Naphthalenedisulfonic acid, 5(acetylamino)-4-hydroxy-3-((2methylphenyl)azo)-, and its salts, when used
as a substance in hair dye products

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

152

EN

1296

4,4'-[(4-Methyl-1,3-phenylene)bis(azo)]bis[6-4482-25-1

224-764-1

83803-99-0

280-920-983803-98-9

280-919-3

633-03-4

211-190-1

9,10-Anthracenedione, 1-[(2-2475-46-9 /219-604-2 /hydroxyethyl)amino]-4-(methylamino)-, and

86722-66-9

289-276-3

methyl-1,3-benzenediamine] (Basic Brown 4)
and its salts, when used as a substance in hairdye products
1297

Benzenaminium, 3-[[4[[diamino(phenylazo)phenyl]azo]-2methylphenyl]azo]-N,N,N-trimethyl-, and its
salts, when used as a substance in hair dye
products

1298

Benzenaminium, 3-[[4[[diamino(phenylazo)phenyl]azo]-1naphthalenyl]azo]-N,N,N-trimethyl-, and its
salts, when used as a substance in hair dye
products

1299

Ethanaminium, N-[4-[(4(diethylamino)phenyl)phenylmethylene]-2,5cyclohexadien-1-ylidene]-N-ethyl- and its
salts, when used as a substance in hair dye
products

1300

its derivatives and salts, when used as a
substance in hair dye products

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

153

EN

1301

1,4-Diamino-2-methoxy-9,10-2872-48-2

220-703-8

3179-90-6

221-666-0

22366-99-0

244-938-0

66612-11-1

266-424-5

56330-88-2

260-116-4

anthracenedione (Disperse Red 11) and its
salts, when used as a substance in hair dye
products
1302

1,4-Dihydroxy-5,8-bis[(2hydroxyethyl)amino]anthraquinone (Disperse
Blue 7) and its salts, when used as a substancein hair dye products1303

1-[(3-Aminopropyl)amino]-4(methylamino)anthraquinone and its salts,
when used as a substance in hair dye products

1304

N-[6-[(2-Chloro-4-hydroxyphenyl)imino]-4methoxy-3-oxo-1,4-cyclohexadien-1yl]acetamide (HC Yellow No. 8) and its salts,
when used as a substance in hair dye products1305[6-[[3-Chloro-4(methylamino)phenyl]imino]-4-methyl-3oxocyclohexa-1,4-dien-1-yl]urea (HC Red
No. 9) and its salts, when used as a substancein hair dye products

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

154

EN

1306

Phenothiazin-5-ium, 3,7-bis(dimethylamino)-,61-73-4

200-515-2

and its salts, when used as a substance in hairdye products
1307

4,6-Bis(2-Hydroxyethoxy)-m-

94082-85-6

Phenylenediamine and its salts, when used asa substance in hair dye products
1308

5-Amino-2,6-Dimethoxy-3-Hydroxypyridine

104333-03-1

and its salts, when used as a substance in hairdye products
1309

4,4'-Diaminodiphenylamine and its salts,

537-65-5

208-673-4

4-Diethylamino-o-toluidine and its salts,

148-71-0 /205-722-1 /when used as a substance in hair dye products

24828-38-4 /

246-484-9 /2051-79-8

218-130-3

N,N-Diethyl-p-phenylenediamine and its

93-05-0 /202-214-1 /salts, when used as a substance in hair dye

6065-27-6 /

227-995-6 /products

6283-63-2

228-500-6

N,N-Dimethyl-p-phenylenediamine and its

99-98-9 /202-807-5 /salts, when used as a substance in hair dye

6219-73-4

228-292-7

when used as a substance in hair dye products
1310

1311

1312

products

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

155

EN

1313

Toluene-3,4-Diamine and its salts, when used

496-72-0

207-826-2

as a substance in hair dye products
1314

2,4-Diamino-5-methylphenoxyethanol and its

141614-05-3 /salts, when used as a substance in hair dye

113715-27-8

products
1315

6-Amino-o-cresol and its salts, when used as a 17672-22-9
substance in hair dye products

1316

Hydroxyethylaminomethyl-p-aminophenol

110952-46-0 /and its salts, when used as a substance in hair

135043-63-9

dye products
1317

2-Amino-3-nitrophenol and its salts, when603-85-0

210-060-1

50610-28-1

256-652-3

2-Nitro-p-phenylenediamine and its salts,

5307-14-2 /226-164-5 /when used as a substance in hair dye products

18266-52-9

242-144-9

used as a substance in hair dye products
1318

2-Chloro-5-nitro-N-hydroxyethyl-pphenylenediamine and its salts, when used asa substance in hair dye products

1319

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

156

EN

1320

Hydroxyethyl-2,6-dinitro-p-anisidine and its

122252-11-3

salts, when used as a substance in hair dye
products
1321

6-Nitro-2,5-pyridinediamine and its salts,

69825-83-8

when used as a substance in hair dye products
1322

Phenazinium, 3,7-diamino-2,8-dimethyl-5-

477-73-6

207-518-8

3-Hydroxy-4-[(2-hydroxynaphthyl)azo]-7-

16279-54-2 /

240-379-1 /nitronaphthalene-1-sulphonic acid and its

5610-64-0

227-029-3

phenyl-, and its salts, when used as a
substance in hair dye products
1323

salts, when used as a substance in hair dye
products1324

3-[(2-nitro-4-

104333-00-8(trifluoromethyl)phenyl)amino]propane-1,2diol (HC Yellow No. 6) and its salts, whenused as a substance in hair dye products1325

2-[(4-chloro-2-nitrophenyl)amino]ethanol

59320-13-7(HC Yellow No. 12) and its salts, when used
as a substance in hair dye products

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

157

EN

1326

3-[[4-[(2-Hydroxyethyl)Methylamino]-2-

173994-75-7 /Nitrophenyl]Amino]-1,2-Propanediol and its

102767-27-1

salts, when used as a substance in hair dye
products1327

3-[[4-[Ethyl(2-Hydroxyethyl)Amino]-2-

114087-41-1 /Nitrophenyl]Amino]-1,2-Propanediol and its

114087-42-2

salts, when used as a substance in hair dye
products
1328

Ethanaminium, N-[4-[[4-2390-60-5

219-232-0(diethylamino)phenyl][4-(ethylamino)-1naphthalenyl]methylene]-2,5-cyclohexadien1-ylidene]-N-ethyl-, and its salts, when used
as a substance in hair dye products

PE-CONS 3623/09
ANNEX II

AK/kr
DG C

158

EN

ANNEX III
LIST OF SUBSTANCES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS LAID DOWN
Reference
numbera
1a

Substance identification
Chemical name/INN

Name of Common
Ingredients Glossary

CAS number

EC number

Product type,body parts

Maximum
concentration inready for use
preparation

Other

Wording ofconditions of use andwarnings

b

c

d

e

f

g

h

i

10043-35-3 /11113-50-1

233-139-2 /234-343-4(a) 5 % (as boricacid)(a) Not to be usedin products forchildren under 3
years of age(a) Not to be used forchildren under 3
years of age

Boric acid, borates andtetraborates with the
exception of substanceNo 1184 in Annex II

Boric acidRestrictions(a) Talc

Not to be used on
peeling or irritatedskin if theconcentration offree soluble borates
exceeds 1,5 % ( asboric acid)

PE-CONS 3623/09
ANNEX III

AK/kr
DG C

Not to be used on
peeling or irritated
skin

1

EN

(b) Oralproducts

1b

Tetraborates, see also
1a)PE-CONS 3623/09
ANNEX III(b) 0,1 % (asboric acid)(c) Otherproducts(excluding bathproducts andhair waving
products)(c) 3 % (as boricacid)(a) Bathproducts(a) 18 % (as boricacid)(b) Hairproducts(b) 8 % (as boricacid)(b) Not to be usedin products forchildren under 3
years of age(b) Not to be
swallowed(c) Not to be usedin products forchildren under 3
years of age(c) Not to be used forchildren under 3
years of age

Not to be used on
peeling or irritatedskin if theconcentration offree soluble borates
exceeds 1,5 % ( asboric acid)(a) Not to be usedin products forchildren under 3
years of age

Not to be used on
peeling or irritatedskin(a) Not to be used forchildren under 3
years of age(b) Rinse well

AK/kr
DG C

Not to be used forchildren under 3
years of age

2

EN

2a

Thioglycolic acid andits salts

Thioglycolic acid68-11-1

200-677-4(a) Hairproducts

8%

General use

Conditions of use:

ready for use pH 7(a) (b) (c)to 9,5
11 %Avoid contact witheyes

Professional use
ready for use pH 7
to 9,5(b) Depilatories

5%

ready for use pH 7
to 12,7(c) Hair rinseoff products

2%

ready for use pH 7
to 9,5In the event ofcontact with eyes,
rinse immediately
with plenty of waterand seek medical
advice(a) (c)Wear suitable gloves

The
abovementioned
percentages arecalculated as
thioglycolic acidWarnings:(a) (b) (c)Contains
thioglycolate
Follow the
instructions
Keep out of reach ofchildren(a) For professionaluse only

PE-CONS 3623/09
ANNEX III

AK/kr
DG C

3

EN

2b

Thioglycolic acid
estersHair waving or
straightening
products(a) 8 %

General use

Conditions of use:

ready for use pH 6(a) (b)

to 9,5May cause
sensitization in theevent of skin contact
Avoid contact witheyes
In the event ofcontact with eyes,
rinse immediately
with plenty of waterand seek medical
adviceWear suitable gloves
Warnings:
Contains
thioglycolate
Follow the
instructions
Keep out of reach ofchildren

PE-CONS 3623/09
ANNEX III

AK/kr
DG C

4

EN

Professional use

Theabovementioned
percentages arecalculated as
thioglycolic acidready for use pH 6
to 9,5

5%

Professional use

3

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

6 % (as NH3)

5

Tosylchloramide
sodium (INN)

Chloramine-T

127-65-1

204-854-7

0,2 %

6

Chlorates of alkali
metalsSodium chlorate

7775-09-9

231-887-4

7

Dichloromethane

PE-CONS 3623/09
ANNEX III

Potassium chlorate

3811-04-9

223-289-7

Dichloromethane75-09-2

200-838-9

Hair products(b) 11 %(a) Toothpaste(a) 5 %(b) Otherproducts(b) 3 %

use only

For professional use
only
Above 2%: Contains
ammonia

35 % (whenmixed with 1,1,1trichloro-ethane,
total
concentrationmust not exceed
35 %)0,2 % as maximum
impurity content

AK/kr
DG C

(b) For professional

5

EN

8

p-Phenylenediamine,
its N-substituted
derivatives and its
salts; N-substituted
derivatives of oPhenylenediamine1,
with the exception of
those derivatives listed
elsewhere in thisAnnex and underreference numbers
1309, 1311, and 1312
in Annex II

p-Phenylenediamine

106-50-3

203-404-7

Oxidisingcolouring agentsfor hair dyeing

6 % (as free base)(a) General use
Not to be used oneyebrows(a) Can cause anallergic reaction
Contains
phenylenediamines
Do not use to dyeeyelashes or
eyebrows(b) Professional use(b) For professionaluse onlyContains
phenylenediamines
Can cause an allergic
reaction
Wear suitable gloves

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 productexpressed with reference to the maximum level authorised for each of them does not exceed 1.

PE-CONS 3623/09
ANNEX III

AK/kr
DG C

6

EN

9

Methylphenylenediamines, their N-substituted
derivatives1 and theirsalts with the exceptionof substances underreference numbers 364,
413, 1144, 1310 and
1313 in Annex II

Toluene-2,5diamine

95-70-5

202-442-1

Oxidisingcolouring agentsfor hair dyeing

10 % (as freebase)(a) General use
Not to be used oneyebrows(a) Can cause anallergic reaction
Contains phenylenediamines
Do not use to dyeeyelashes or
eyebrows(b) Professional use(b) For professionaluse onlyContains phenylenediamines
Can cause an allergic
reaction
Wear suitable gloves

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 productexpressed with reference to the maximum level authorised for each of them does not exceed 1.

PE-CONS 3623/09
ANNEX III

AK/kr
DG C

7

EN

Diaminophenols1

10

Oxidisingcolouring agentsfor hair dyeing

10 % (as freebase)(a) General use
Not to be used oneyebrows(b) Professional use(a) Can cause anallergic reaction
Do not use to dyeeyelashes or
eyebrows(b) For professionaluse only
Can cause an allergic
reaction
Wear suitable gloves

11

Dichlorophen

1

Dichlorophen

97-23-4

202-567-1

0,5 %Contains
Dichlorophen

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 productexpressed with reference to the maximum level authorised for each of them does not exceed 1.

PE-CONS 3623/09
ANNEX III

AK/kr
DG C

8

EN

12

Hydrogen peroxide,and other compounds
or mixtures that releasehydrogen peroxide,
including carbamide
peroxide and zinc
peroxide

Formaldehyde1

13

1
2

Hydrogen peroxide

Formaldehyde

7722-84-1

50-00-0

231-765-0

200-001-8(a) Hairproducts

12 % H2O2 (40volumes), present
or released(b) Skinproducts

4 % H2O2, present
or released(c) Nailhardeningproducts

2 % of H2O2,
present or
released(d) Oralproducts

0,1 % of H2O2,
present or
released

Nail hardening
products

5 % (asformaldehyde)(a) Wear suitable
gloves(a) (b) (c): Containshydrogen peroxide
Avoid contact witheyes
Rinse eyes
immediately if
product comes into
contact with them

For purposes otherthan inhibiting thedevelopment of
micro-organisms in
the product. This
purpose has to beapparent from thepresentation of the
product

Protect cuticles withgrease or oil
Contains
formaldehyde2

For use as a preservative, see Annex V, No. 5.
Only if the concentration exceeds 0,05 %.

PE-CONS 3623/09
ANNEX III

AK/kr
DG C

9

EN

Hydroquinone1

14

Hydroquinone

123-31-9

204-617-8(a) Oxidisingcolouring agent
for hair dyeing

0,3 %General use
Not to be used oneyebrows

Do not use to dyeeyelashes or
eyebrows
Rinse eyes
immediately if the
product comes into
contact with themContains
Hydroquinone

Professional use

For professional use
only
Contains
hydroquinone
Rinse eyes
immediately if
product comes into
contact with them

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 productexpressed with reference to the maximum level authorised for each of them does not exceed 2.

PE-CONS 3623/09
ANNEX III

AK/kr
DG C

10

EN

(b) Artificial
nail systems

0,02 % (after
mixing for use)

Professional use(b) For professionaluse only
Avoid skin contact
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 %1(a) Contains alkali
Avoid contact witheyes
Can cause blindness
Keep out of reach ofchildren(b) Hairstraightener

2%2

General use

Contains alkali
Avoid contact witheyes
Can cause blindness
Keep out of reach ofchildren

1
2

The quantity of sodium, potassium or lithium hydroxide is expressed as weight of sodium hydroxide. In cases of mixtures, the sum should notexceed the limits given in column g.
The quantity of sodium, potassium or lithium hydroxide is expressed as weight of sodium hydroxide. In cases of mixtures, the sum should notexceed the limits given in column g.

PE-CONS 3623/09
ANNEX III

AK/kr
DG C

11

EN

4,5 % 1

Professional use

For professional use
only
Avoid contact witheyes
Can cause blindness(c) pH adjuster
for depilatories(c) pH < 12,7(c) Keep out of reachof children
Avoid contact witheyes(d) Other uses
as pH adjuster

1(d) pH < 11

The quantity of sodium, potassium or lithium hydroxide is expressed as weight of sodium hydroxide. In cases of mixtures, the sum should notexceed the limits given in column g.

PE-CONS 3623/09
ANNEX III

AK/kr
DG C

12

EN

15b

Lithium hydroxide

Lithium hydroxide

1310-65-2

215-183-4(a) Hairstraighteners

2 %1

General use(a) Contains alkali
Avoid contact witheyes
Can cause blindness
Keep out of reach ofchildren

4,5 %2

Professional use

Avoid contact witheyes
Can cause blindness(b) pH adjuster
for depilatories

pH < 12,7(b) Contains alkali
Keep out of reach ofchildren
Avoid contact witheyes(c) Other uses as
pH adjuster (forrinse-offproducts only)1
2

pH < 11

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.
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.

PE-CONS 3623/09
ANNEX III

AK/kr
DG C

13

EN

15c

Calcium hydroxide

Calcium hydroxide

1305-62-0

215-137-3(a) Hairstraighteners
containing two
components:
calciumhydroxide and a
guanidine salt(a) 7 % (ascalciumhydroxide)(a) Contains alkali
Avoid contact witheyes
Keep out of reach ofchildrenCan cause blindness(b) pH adjuster
for depilatories(b) pH < 12,7(b) Contains alkali
Keep out of reach ofchildren
Avoid contact witheyes(c) Other uses
(e.g. pHadjuster,processing aid)
16

1-Naphthol and its salts

PE-CONS 3623/09
ANNEX III

1-Naphtol

90-15-3

201-969-4

Oxidisingcolouring agentsfor hair dyeing(c) pH < 112,0 %In combination withhydrogen peroxide
the maximum use
concentration upon
application is 1,0 %

AK/kr
DG C

Can cause an allergic
reaction

14

EN

17

Sodium nitrite

Sodium nitrite

7632-00-0

231-555-9

Rust inhibitor

0,2 %

18

Nitromethane

Nitromethane

75-52-5

200-876-6

Rust inhibitor

0,3 %

19

Moved or deleted

20

Moved or deleted

21

Cinchonan-9-ol, 6'methoxy-, (8.alpha.,9R)- and its salts

205-003-2(a) Hair rinseoff products(a) 0,5 % (asquinine base)(b) Hair leaveon products(b) 0,2 % (asquinine base)PE-CONS 3623/09
ANNEX III

Quinine130-95-0

Not to be used withsecondary and/or
tertiary amines orother substances
forming
nitrosamines

AK/kr
DG C

15

EN

Resorcinol1

22

Resorcinol

108-46-3

203-585-2(a) Oxidisingcolouring agent
for hair dyeing

5%

General use

Contains resorcinol

Not to be used oneyebrows

Rinse hair well after
application
Do not use to dyeeyelashes or
eyebrows
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 them(b) Hair lotions
and shampoos

1

0,5 %

Contains resorcinol

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 productexpressed with reference to the maximum level authorised for each of them does not exceed 2.

PE-CONS 3623/09
ANNEX III

AK/kr
DG C

16

EN

23

(a) Alkali sulphides(a) Depilatories(a) 2 % (assulphur)(b) Alkaline earth
sulphides(b) Depilatories(b) 6 % (assulphur)

24

Water-soluble zinc salts
with the exception ofzinc 4-hydroxybenzenesulphonate(entry 25) and zinc
pyrithione (entry 101
and Annex V, entry 8)

Zinc acetate, zincchloride, zinc
gluconate, zincglutamate

25

Zinc 4-hydroxybenzene
sulphonate

Zinc phenolsulfonate

PE-CONS 3623/09
ANNEX IIIpH ≤ 12,7(a) (b) Keep out ofreach of children
Avoid contact witheyes

1 % (as zinc)

127-82-2

204-867-8

Deodorants,
antiperspirants
and astringent
lotions

6 % (as %anhydrous
substance)

Avoid contact with
eyes

AK/kr
DG C

17

EN

26

Ammoniummonofluorophosphate

Ammoniummonofluorophosphate20859-38-5/ 66115-193

Oral products

0,15 % (as F).
When mixed withother fluorinecompounds
permitted under
this Annex, total
F concentrationmust not exceed
0,15 %

Contains ammonium
monofluorophosphate
For any toothpaste
containing 0,1 to 0,15
% fluoride unless it isalready labelled ascontra-indicated forchildren (e.g. "foradult use only") the
following labelling is
obligatory:"Children of 6 years
and younger: Use a
pea sized amount forsupervised brushing
to minimize
swallowing. In caseof intake of fluoride
from other sources
consult a dentist or
doctor"PE-CONS 3623/09
ANNEX III

AK/kr
DG C

18

EN

27

Disodiumfluorophosphate

Sodiummonofluorophosphate

10163-15-2/ 7631-972

233-433-0 /231-552-2

Oral products

0,15 % (as F).
When mixed withother fluorinecompounds
permitted under
this Annex, total
F concentrationmust not exceed
0,15 %

Contains sodium
monofluorophosphate
For any toothpaste
containing 0,1 to 0,15
% fluoride unless it isalready labelled ascontra-indicated forchildren (e.g. "foradult use only") the
following labelling is
obligatory:"Children of 6 years
and younger: Use a
pea sized amount forsupervised brushing
to minimize
swallowing. In caseof intake of fluoride
from other sources
consult a dentist or
doctor"PE-CONS 3623/09
ANNEX III

AK/kr
DG C

19

EN

28

Dipotassium
fluorophosphate

Potassium
monofluorophosphate14104-28-0

237-957-0

Oral products

0,15 % (as F).
When mixed withother fluorinecompounds
permitted 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 forchildren (e.g. "foradult use only") the
following labelling is
obligatory:"Children of 6 years
and younger: Use a
pea sized amount forsupervised brushing
to minimize
swallowing. In caseof intake of fluoride
from other sources
consult a dentist or
doctor"PE-CONS 3623/09
ANNEX III

AK/kr
DG C

20

EN

29

Calcium
fluorophosphate

Calciummonofluorophosphate7789-74-4

232-187-1

Oral products

0,15 % (as F).
When mixed withother fluorinecompounds
permitted under
this Annex, total
F concentrationmust not exceed
0,15 %

Contains calcium
monofluorophosphate
For any toothpaste
containing 0,1 to 0,15
% fluoride unless it isalready labelled ascontra-indicated forchildren (e.g. "foradult use only") the
following labelling is
obligatory:"Children of 6 years
and younger: Use a
pea sized amount forsupervised brushing
to minimize
swallowing. In caseof intake of fluoride
from other sources
consult a dentist or
doctor"PE-CONS 3623/09
ANNEX III

AK/kr
DG C

21

EN

30

Calcium fluoride

Calcium fluoride

7789-75-5

232-188-7

Oral products

0,15 % (as F).
When mixed withother fluorinecompounds
permitted under
this Annex, total
F concentrationmust not exceed
0,15 %

Contains calcium
fluoride
For any toothpaste
containing 0,1 to 0,15
% fluoride unless it isalready labelled ascontra-indicated forchildren (e.g. "foradult use only") the
following labelling is
obligatory:"Children of 6 years
and younger: Use a
pea sized amount forsupervised brushing
to minimize
swallowing. In caseof intake of fluoride
from other sources
consult a dentist or
doctor"PE-CONS 3623/09
ANNEX III

AK/kr
DG C

22

EN

31

Sodium fluoride

Sodium fluoride

7681-49-4

231-667-8

Oral products

0,15 % (as F).
When mixed withother fluorinecompounds
permitted under
this Annex, total
F concentrationmust not exceed
0,15 %

Contains sodium
fluoride
For any toothpaste
containing 0,1 to 0,15
% fluoride unless it isalready labelled ascontra-indicated forchildren (e.g. "foradult use only") the
following labelling is
obligatory:"Children of 6 years
and younger: Use a
pea sized amount forsupervised brushing
to minimize
swallowing. In caseof intake of fluoride
from other sources
consult a dentist or
doctor"PE-CONS 3623/09
ANNEX III

AK/kr
DG C

23

EN

32

Potassium fluoride

Potassium fluoride

7789-23-3

232-151-5

Oral products

0,15 % (as F).
When mixed withother fluorinecompounds
permitted under
this Annex, total
F concentrationmust not exceed
0,15 %

Contains potassium
fluoride
For any toothpaste
containing 0,1 to 0,15
% fluoride unless it isalready labelled ascontra-indicated forchildren (e.g. "foradult use only") the
following labelling is
obligatory:"Children of 6 years
and younger: Use a
pea sized amount forsupervised brushing
to minimize
swallowing. In caseof intake of fluoride
from other sources
consult a dentist or
doctor"PE-CONS 3623/09
ANNEX III

AK/kr
DG C

24

EN

33

Ammonium fluoride

Ammonium fluoride

12125-01-8

235-185-9

Oral products

0,15 % (as F).
When mixed withother fluorinecompounds
permitted under
this Annex, total
F concentrationmust not exceed
0,15 %

Contains ammonium
fluoride
For any toothpaste
containing 0,1 to 0,15
% fluoride unless it isalready labelled ascontra-indicated forchildren (e.g. "foradult use only") the
following labelling is
obligatory:"Children of 6 years
and younger: Use a
pea sized amount forsupervised brushing
to minimize
swallowing. In caseof intake of fluoride
from other sources
consult a dentist or
doctor"PE-CONS 3623/09
ANNEX III

AK/kr
DG C

25

EN

34

Aluminium fluoride

Aluminium fluoride

7784-18-1

232-051-1

Oral products

0,15 % (as F).
When mixed withother fluorinecompounds
permitted under
this Annex, total
F concentrationmust not exceed
0,15 %

Contains aluminiumfluoride
For any toothpaste
containing 0,1 to 0,15
% fluoride unless it isalready labelled ascontra-indicated forchildren (e.g. "foradult use only") the
following labelling is
obligatory:"Children of 6 years
and younger: Use a
pea sized amount forsupervised brushing
to minimize
swallowing. In caseof intake of fluoride
from other sources
consult a dentist or
doctor"PE-CONS 3623/09
ANNEX III

AK/kr
DG C

26

EN

35

Tin difluoride

Stannous fluoride

7783-47-3

231-999-3

Oral products

0,15 % (as F).
When mixed withother fluorinecompounds
permitted under
this Annex, total
F concentrationmust not exceed
0,15 %

Contains stannous
fluoride
For any toothpaste
containing 0,1 to 0,15
% fluoride unless it isalready labelled ascontra-indicated forchildren (e.g. "foradult use only") the
following labelling is
obligatory:"Children of 6 years
and younger: Use a
pea sized amount forsupervised brushing
to minimize
swallowing. In caseof intake of fluoride
from other sources
consult a dentist or
doctor"PE-CONS 3623/09
ANNEX III

AK/kr
DG C

27

EN

36

Hexadecyl ammonium
fluoride

Cetylaminehydrofluoride

3151-59-5

221-588-7

Oral products

0,15 % (as F).
When mixed withother fluorinecompounds
permitted under
this Annex, total
F concentrationmust not exceed
0,15 %

Contains Cetylaminehydrofluoride
For any toothpaste
containing 0,1 to 0,15
% fluoride unless it isalready labelled ascontra-indicated forchildren (e.g. "foradult use only") the
following labelling is
obligatory:"Children of 6 years
and younger: Use a
pea sized amount forsupervised brushing
to minimize
swallowing. In caseof intake of fluoride
from other sources
consult a dentist or
doctor"PE-CONS 3623/09
ANNEX III

AK/kr
DG C

28

EN

37

3-(N-Hexadecyl-N-2hydroxyethylammonio)
propylbis (2hydroxyethyl)ammonium difluoride--

Oral products

0,15 % (as F).
When mixed withother fluorinecompounds
permitted under
this Annex, total
F concentrationmust not exceed
0,15 %

Contains 3-(NHexadecyl-N-2hydroxyethylammonio) propylbis (2hydroxyethyl)ammonium difluoride
For any toothpaste
containing 0,1 to 0,15
% fluoride unless it isalready labelled ascontra-indicated forchildren (e.g. "foradult use only") the
following labelling is
obligatory:"Children of 6 years
and younger: Use a
pea sized amount forsupervised brushing
to minimize
swallowing. In caseof intake of fluoride
from other sources
consult a dentist or
doctor"PE-CONS 3623/09
ANNEX III

AK/kr
DG C

29

EN

38

N,N',N'Tris(polyoxyethylene)Nhexadecylpropylenedia
mine dihydrofluoride--

Oral products

0,15 % (as F).
When mixed withother fluorinecompounds
permitted under
this Annex, total
F concentrationmust not exceed
0,15 %

Contains N,N',N'Tris(polyoxyethylene)-Nhexadecylpropylenedi
amine
dihydrofluoride
For any toothpaste
containing 0,1 to 0,15
% fluoride unless it isalready labelled ascontra-indicated forchildren (e.g. "foradult use only") the
following labelling is
obligatory:"Children of 6 years
and younger: Use a
pea sized amount forsupervised brushing
to minimize
swallowing. In caseof intake of fluoride
from other sources
consult a dentist or
doctor"PE-CONS 3623/09
ANNEX III

AK/kr
DG C

30

EN

39

9-Octadecenamine,hydrofluoride

Octadecenylammonium fluoride

2782-81-2-

Oral products

0,15 % (as F).
When mixed withother fluorinecompounds
permitted 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 forchildren (e.g. "foradult use only") the
following labelling is
obligatory:"Children of 6 years
and younger: Use a
pea sized amount forsupervised brushing
to minimize
swallowing. In caseof intake of fluoride
from other sources
consult a dentist or
doctor"PE-CONS 3623/09
ANNEX III

AK/kr
DG C

31

EN

40

Disodiumhexafluorosilicate

Sodium fluorosilicate

16893-85-9

240-934-8

Oral products

0,15 % (as F).
When mixed withother fluorinecompounds
permitted under
this Annex, total
F concentrationmust not exceed
0,15 %

Contains sodium
fluorosilicate
For any toothpaste
containing 0,1 to 0,15
% fluoride unless it isalready labelled ascontra-indicated forchildren (e.g. "foradult use only") the
following labelling is
obligatory:"Children of 6 years
and younger: Use a
pea sized amount forsupervised brushing
to minimize
swallowing. In caseof intake of fluoride
from other sources
consult a dentist or
doctor"PE-CONS 3623/09
ANNEX III

AK/kr
DG C

32

EN

41

Dipotassium
hexafluorosilicate

Potassium
fluorosilicate

16871-90-2

240-896-2

Oral products

0,15 % (as F).
When mixed withother fluorinecompounds
permitted under
this Annex, total
F concentrationmust not exceed
0,15 %

Contains potassium
fluorosilicate
For any toothpaste
containing 0,1 to 0,15
% fluoride unless it isalready labelled ascontra-indicated forchildren (e.g. "foradult use only") the
following labelling is
obligatory:"Children of 6 years
and younger: Use a
pea sized amount forsupervised brushing
to minimize
swallowing. In caseof intake of fluoride
from other sources
consult a dentist or
doctor"PE-CONS 3623/09
ANNEX III

AK/kr
DG C

33

EN

42

Ammoniumhexafluorosilicate

Ammoniumfluorosilicate

16919-19-0

240-968-3

Oral products

0,15 % (as F).
When mixed withother fluorinecompounds
permitted under
this Annex, total
F concentrationmust not exceed
0,15 %

Contains ammonium
fluorosilicate
For any toothpaste
containing 0,1 to 0,15
% fluoride unless it isalready labelled ascontra-indicated forchildren (e.g. "foradult use only") the
following labelling is
obligatory:"Children of 6 years
and younger: Use a
pea sized amount forsupervised brushing
to minimize
swallowing. In caseof intake of fluoride
from other sources
consult a dentist or
doctor"PE-CONS 3623/09
ANNEX III

AK/kr
DG C

34

EN

43

Magnesium
hexafluorosilicate

Magnesium
fluorosilicate

16949-65-8

241-022-2

Oral products

0,15 % (as F).
When mixed withother fluorinecompounds
permitted under
this Annex, total
F concentrationmust not exceed
0,15 %

Contains magnesium
fluorosilicate
For any toothpaste
containing 0,1 to 0,15
% fluoride unless it isalready labelled ascontra-indicated forchildren (e.g. "foradult use only") the
following labelling is
obligatory:"Children of 6 years
and younger: Use a
pea sized amount forsupervised brushing
to minimize
swallowing. In caseof intake of fluoride
from other sources
consult a dentist or
doctor"PE-CONS 3623/09
ANNEX III

AK/kr
DG C

35

EN

44

1,3-Bis(hydroxymethyl)imidaz
olidine-2-thione

Dimethylol ethylene
thiourea

15534-95-9

239-579-1(a) Hairproducts(a) 2 %(a) Not to be used inaerosol dispensers(sprays)(b) Nailproducts(b) 2 %(b) pH < 445

Benzyl alcohol1

Benzyl alcohol

100-51-6

202-859-9

Solvents,
perfumes andflavourings

46

6-Methylcoumarin

6-Methylcoumarin

92-48-8

202-158-8

Oral products

1

Contains Dimethylol
ethylene thiourea

For purposes otherthan inhibiting thedevelopment of
micro-organisms in
the product. This
purpose has to beapparent from thepresentation of the
product
0,003 %For use as a preservative, see Annex V, No. 34.

PE-CONS 3623/09
ANNEX III

AK/kr
DG C

36

EN

47

3-Pyridinemethanol,hydrofluoride

Nicomethanolhydrofluoride

62756-44-9-

Oral products

0,15 % (as F).
When mixed withother fluorinecompounds
permitted 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 forchildren (e.g. "foradult use only") the
following labelling is
obligatory:"Children of 6 years
and younger: Use a
pea sized amount forsupervised brushing
to minimize
swallowing. In caseof intake of fluoride
from other sources
consult a dentist or
doctor"PE-CONS 3623/09
ANNEX III

AK/kr
DG C

37

EN

48

49

Silver nitrate

Selenium sulfide

Silver nitrate

Selenium disulphide

7761-88-8

7488-56-4

231-853-9

231-303-8

Only forcolouringeyelashes andeyebrows

4%

Antidandruff
shampoos1%

Contains silver nitrate
Rinse eyes
immediately if
product comes into
contact with themContains selenium
disulphide
Avoid contact witheyes or damaged skin50

Aluminium zirconium
chloride hydroxide
complexes

Anti-perspirants

AlxZr(OH)yClz and thealuminium zirconium
chloride hydroxide
glycine complexes

20 % (asanhydrous
aluminium
zirconium
chloridehydroxide)

1. The ratio of thenumber ofaluminium atoms tothat of zirconium
atoms must be
between 2 and 10

5,4 % (aszirconium)

2. The ratio of thenumber of (Al + Zr)
atoms to that ofchlorine atoms must
be between 0,9 and
2,1

Do not apply toirritated or damaged
skin

3. Not to be used inaerosol dispensers(sprays)

PE-CONS 3623/09
ANNEX III

AK/kr
DG C

38

EN

51

Quinolin-8-ol and bis(8-hydroxy-quinolium)
sulphate

Oxyquinoline andoxyquinoline sulfate148-24-3 /
134-31-6

205-711-1 /
205-137-1

Stabilizer forhydrogenperoxide inrinse-off hairproducts

0,3 % (as base)Stabilizer forhydrogenperoxide inleave-on hairproducts

0,03 % (as base)52

Methanol

Methyl alcohol

67-56-1

200-659-6

Denaturant forethanol andisopropyl
alcohol

5 % (as a %ethanol andisopropyl alcohol)

53(1-Hydroxyethylidenediphosphonic acid) andits salts

Etidronic acid2809-21-4

220-552-8(a) Hairproduct1,5 % (asetidronic acid)(b) Soap

0,2 % (asetidronic acid)Use only inrinse-offproducts

2%

1-Phenoxypropan-2-ol1

54

Phenoxyisopropanol

770-35-4

212-222-7

Not to be usedin oral products

1

For purposes otherthan inhibiting thedevelopment of
micro-organisms in
the product. This
purpose has to beapparent from thepresentation of the
product

For use as a preservative, see Annex V, No 43.

PE-CONS 3623/09
ANNEX III

AK/kr
DG C

39

EN

55

Moved or deleted

56

Magnesium fluoride

Magnesium fluoride

7783-40-6

231-995-1

Oral products

0,15 % (as F).
When mixed withother fluorinecompounds
permitted under
this Annex, total
F concentrationmust not exceed
0,15 %

Contains magnesium
fluoride
For any toothpaste
containing 0,1 to 0,15
% fluoride unless it isalready labelled ascontra-indicated forchildren (e.g. "foradult use only") the
following labelling is
obligatory:"Children of 6 years
and younger: Use a
pea sized amount forsupervised brushing
to minimize
swallowing. In caseof intake of fluoride
from other sources
consult a dentist or
doctor"PE-CONS 3623/09
ANNEX III

AK/kr
DG C

40

EN

57

58

Strontium chloride
hexahydrate

Strontium acetatehemihydrate

PE-CONS 3623/09
ANNEX III

Strontium chloride

Strontium acetate

10476-85-4

543-94-2

233-971-6

208-854-8(a) Oralproducts

3,5 % (asstrontium). Whenmixed with otherpermitted
strontiumcompounds thetotal strontium
content must notexceed 3,5 %(b) Shampoo
and face
products

2,1 % (asstrontium). Whenmixed with otherpermitted
strontiumcompounds thetotal strontium
content must notexceed 2,1 %Oral products

3,5 % (asstrontium). Whenmixed with otherpermitted
strontiumcompounds thetotal strontium
content must notexceed 3,5 %

AK/kr
DG C

Contains strontium
chloride
Frequent use by
children is notadvisable

Contains strontium
acetateFrequent use by
children is notadvisable

41

EN

59

Talc: Hydrated
magnesium silicate

Talc

14807-96-6

238-877-9(a) Powdery
products
intended to be
used forchildren under 3
years of age(a) Keep powder
away from children's
nose and mouth(b) Otherproducts
60

Fatty acid
dialkylamides anddialkanolamides

Maximum
secondary aminecontent: 0,5 %- Not to be usedwith nitrosating
systems- Maximum
secondary aminecontent: 5 %(applies to raw
materials)- Maximum
nitrosaminecontent: 50 μg/kg- Keep in nitritefree containers

PE-CONS 3623/09
ANNEX III

AK/kr
DG C

42

EN

61

Monoalkylamines,
monoalkanolamines
and their salts

Maximum
secondary aminecontent: 0,5 %- Not to be usedwith nitrosating
systems- Minimum
purity: 99 %- Maximum
secondary aminecontent: 0,5 %(applies to raw
materials)- Maximum
nitrosaminecontent: 50 μg/kg- Keep in nitritefree containers

PE-CONS 3623/09
ANNEX III

AK/kr
DG C

43

EN

62

Trialkylamines,
trialkanolamines andtheir salts(a) Leave-on
products(a) 2,5 %(a) (b)- Not to be usedwith nitrosating
systems(b) Rinse-off
products- Minimum purity:
99 %- Maximum
secondary aminecontent: 0,5 %(applies to raw
materials)- Maximum
nitrosaminecontent: 50 μg/kg- Keep in nitritefree containers
63

Strontium hydroxide

Strontium hydroxide

18480-07-4

242-367-1

pH adjuster for
depilatories

3,5 % (asstrontium)

pH ≤ 12,7

Keep out of reach ofchildren
Avoid contact witheyes

PE-CONS 3623/09
ANNEX III

AK/kr
DG C

44

EN

64

Strontium peroxide

Strontium peroxide

1314-18-7

215-224-6

Rinse-off hairproducts

4,5 % (asstrontium)

All products mustmeet the hydrogen
peroxide release
requirements
Professional use

Avoid contact witheyes
Rinse eyes
immediately if
product comes into
contact with them
For professional use
only
Wear suitable gloves

65

Benzalkonium
chloride, bromide andsaccharinate 1

1

Benzalkonium
bromide91080-29-4

293-522-5

Rinse-off hair(head) products

3 % (asbenzalkonium
chloride)

In the final products
the concentrationsof benzalkonium
chloride, bromide
and saccharinate
with an alkyl chainof C14, or less must
not exceed 0,1 %(as benzalkonium
chloride)

Avoid contact witheyes

For use as a preservative, see Annex V, No. 54.

PE-CONS 3623/09
ANNEX III

AK/kr
DG C

45

EN

For purposes otherthan inhibiting thedevelopment of
micro-organisms in
the product. This
purpose has to beapparent from thepresentation of the
product

66

Benzalkonium
chloride63449-41-2/ 68391-015 / 6842485-1 /85409-22-9

264-151-6 /
269-919-4 /
270-325-2 /287-089-1

Benzalkonium
saccharinate

68989-01-5

273-545-7

Polyacrylamides

PE-CONS 3623/09
ANNEX III(a) Body- leaveon products(a) Maximum
residual acrylamide
content 0,1 mg/kg(b) Otherproducts(b) Maximum
residual acrylamide
content 0,5 mg/kg

AK/kr
DG C

46

EN

67

2-Benzylideneheptanal

Amyl cinnamal

122-40-7

204-541-5

The presence of thesubstance must be
indicated in the listof ingredientsreferred to in
Article 19(1)(g)when its
concentration
exceeds:– 0,001 % inleave-onproducts– 0,01 % in rinseoff products

68

Benzyl alcohol

Benzyl alcohol

100-51-6

202-859-9

The presence of thesubstance must be
indicated in the listof ingredientsreferred to in
Article 19(1)(g)when its
concentration
exceeds:– 0,001 % inleave-onproducts– 0,01 % in rinseoff products

PE-CONS 3623/09
ANNEX III

AK/kr
DG C

47

EN

69

Cinnamyl alcohol

Cinnamyl alcohol

104-54-1

203-212-3

The presence of thesubstance must be
indicated in the listof ingredientsreferred to in
Article 19(1)(g)when its
concentration
exceeds:– 0,001 % inleave-onproducts– 0,01 % in rinseoff products

70

3,7-Dimethyl-2,6octadienal

Citral5392-40-5

226-394-6

The presence of thesubstance must be
indicated in the listof ingredientsreferred to in
Article 19(1)(g)when its
concentration
exceeds:– 0,001 % inleave-onproducts– 0,01 % in rinseoff products

PE-CONS 3623/09
ANNEX III

AK/kr
DG C

48

EN

71

Phenol, 2-methoxy-4(2-propenyl)

Eugenol

97-53-0

202-589-1

The presence of thesubstance must be
indicated in the listof ingredientsreferred to in
Article 19(1)(g)when its
concentration
exceeds:– 0,001 % inleave-onproducts– 0,01 % in rinseoff products

72

7-Hydroxycitronellal

Hydroxycitronellal

107-75-5

203-518-7

The presence of thesubstance must be
indicated in the listof ingredientsreferred to in
Article 19(1)(g)when its
concentration
exceeds:– 0,001 % inleave-onproducts– 0,01 % in rinseoff products

PE-CONS 3623/09
ANNEX III

AK/kr
DG C

49

EN

73

Phenol, 2-methoxy-4(1-propenyl)-

Isoeugenol

97-54-1

202-590-7

The presence of thesubstance must be
indicated in the listof ingredientsreferred to in
Article 19(1)(g)when its
concentration
exceeds:– 0,001 % inleave-onproducts– 0,01 % in rinseoff products

74

2-Pentyl-3-phenylprop2-en-1-ol

Amylcinnamyl alcohol

101-85-9

202-982-8

The presence of thesubstance must be
indicated in the listof ingredientsreferred to in
Article 19(1)(g)when its
concentration
exceeds:– 0,001 % inleave-onproducts– 0,01 % in rinseoff products

PE-CONS 3623/09
ANNEX III

AK/kr
DG C

50

EN

75

Benzyl salicylate

Benzyl salicylate

118-58-1

204-262-9

The presence of thesubstance must be
indicated in the listof ingredientsreferred to in
Article 19(1)(g)when its
concentration
exceeds:– 0,001 % inleave-onproducts– 0,01 % in rinseoff products

762-Propenal, 3-phenyl-

Cinnamal

104-55-2

203-213-9

The presence of thesubstance must be
indicated in the listof ingredientsreferred to in
Article 19(1)(g)when its
concentration
exceeds:– 0,001 % inleave-onproducts– 0,01 % in rinseoff products

PE-CONS 3623/09
ANNEX III

AK/kr
DG C

51

EN

77

2H-1-Benzopyran-2one

Coumarin

91-64-5

202-086-7

The presence of thesubstance must be
indicated in the listof ingredientsreferred to in
Article 19(1)(g)when its
concentration
exceeds:– 0,001 % inleave-onproducts– 0,01 % in rinseoff products

78

2,6-Octadien-1-ol, 3,7dimethyl-, (2E)-

Geraniol

106-24-1

203-377-1

The presence of thesubstance must be
indicated in the listof ingredientsreferred to in
Article 19(1)(g)when its
concentration
exceeds:– 0,001 % inleave-onproducts– 0,01 % in rinseoff products

PE-CONS 3623/09
ANNEX III

AK/kr
DG C

52

EN

79

3 and 4-(4-Hydroxy-4methylpentyl)cyclohex-3-ene-1-carbaldehyde

Hydroxyisohexyl 3cyclohexene
carboxaldehyde

51414-25-6/ 31906-044

257-187-9 /
250-863-4

The presence of thesubstance must be
indicated in the listof ingredientsreferred to in
Article 19(1)(g)when its
concentration
exceeds:– 0,001 % inleave-onproducts– 0,01 % in rinseoff products

80

4-Methoxybenzyl
alcohol

Anise alcohol

105-13-5

203-273-6

The presence of thesubstance must be
indicated in the listof ingredientsreferred to in
Article 19(1)(g)when its
concentration
exceeds:– 0,001 % inleave-onproducts– 0,01 % in rinseoff products

PE-CONS 3623/09
ANNEX III

AK/kr
DG C

53

EN

81

2-Propenoic acid, 3phenyl-, phenylmethyl
ester

Benzyl cinnamate

103-41-3

203-109-3

The presence of thesubstance must be
indicated in the listof ingredientsreferred to in
Article 19(1)(g)when its
concentration
exceeds:– 0,001 % inleave-onproducts– 0,01 % in rinseoff products

82

2,6,10-Dodecatrien-1ol, 3,7,11-trimethyl-

Farnesol4602-84-0

225-004-1

The presence of thesubstance must be
indicated in the listof ingredientsreferred to in
Article 19(1)(g)when its
concentration
exceeds:– 0,001 % inleave-onproducts– 0,01 % in rinseoff products

PE-CONS 3623/09
ANNEX III

AK/kr
DG C

54

EN

83

2-(4-tertButylbenzyl)propional
dehydeButylphenyl
methylpropional

80-54-6

201-289-8

The presence of thesubstance must be
indicated in the listof ingredientsreferred to in
Article 19(1)(g)when its
concentration
exceeds:– 0,001 % inleave-onproducts– 0,01 % in rinseoff products

84

1,6-Octadien-3-ol, 3,7dimethyl-

Linalool

78-70-6

201-134-4

The presence of thesubstance must be
indicated in the listof ingredientsreferred to in
Article 19(1)(g)when its
concentration
exceeds:– 0,001 % inleave-onproducts– 0,01 % in rinseoff products

PE-CONS 3623/09
ANNEX III

AK/kr
DG C

55

EN

85

Benzyl benzoate

Benzyl benzoate

120-51-4

204-402-9

The presence of thesubstance must be
indicated in the listof ingredientsreferred to in
Article 19(1)(g)when its
concentration
exceeds:– 0,001 % inleave-onproducts– 0,01 % in rinseoff products

86

Citronellol / (±)-3,7dimethyloct-6-en-1-ol

Citronellol

106-22-9 /26489-01-0

203-375-0 /247-737-6

The presence of thesubstance must be
indicated in the listof ingredientsreferred to in
Article 19(1)(g)when its
concentration
exceeds:– 0,001 % inleave-onproducts– 0,01 % in rinseoff products

PE-CONS 3623/09
ANNEX III

AK/kr
DG C

56

EN

87

2-Benzylideneoctanal

Hexyl cinnamal

101-86-0

202-983-3

The presence of thesubstance must be
indicated in the listof ingredientsreferred to in
Article 19(1)(g)when its
concentration
exceeds:– 0,001 % inleave-onproducts– 0,01 % in rinseoff products

88(4R)-1-Methyl-4-(1methylethenyl)cyclohe
xene

Limonene

5989-27-5

227-813-5

The presence of thesubstance must be
indicated in the listof ingredientsreferred to in
Article 19(1)(g)when its
concentration
exceeds:– 0,001 % inleave-onproducts– 0,01 % in rinseoff products

PE-CONS 3623/09
ANNEX III

AK/kr
DG C

57

EN

89

Methyl heptin
carbonate

Methyl 2-octynoate

111-12-6

203-836-6

The presence of thesubstance must be
indicated in the listof ingredientsreferred to in
Article 19(1)(g)when its
concentration
exceeds:– 0,001 % inleave-onproducts– 0,01 % in rinseoff products

90

3-Methyl-4-(2,6,6trimethyl-2cyclohexen-1-yl)-3buten-2-one

alpha-Isomethyl
ionone127-51-5

204-846-3

The presence of thesubstance must be
indicated in the listof ingredientsreferred to in
Article 19(1)(g)when its
concentration
exceeds:– 0,001 % inleave-onproducts– 0,01 % in rinseoff products

PE-CONS 3623/09
ANNEX III

AK/kr
DG C

58

EN

91

Oak moss extract

Evernia prunastri
extract

90028-68-5

289-861-3

The presence of thesubstance must be
indicated in the listof ingredientsreferred to in
Article 19(1)(g)when its
concentration
exceeds:– 0,001 % inleave-onproducts– 0,01 % in rinseoff products

92

Treemoss extract

Evernia furfuracea
extract

90028-67-4

289-860-8

The presence of thesubstance must be
indicated in the listof ingredientsreferred to in
Article 19(1)(g)when its
concentration
exceeds:– 0,001 % inleave-onproducts– 0,01 % in rinseoff products

PE-CONS 3623/09
ANNEX III

AK/kr
DG C

59

EN

93

2,4Pyrimidinediamine, 3oxide

Diaminopyrimidine
oxide74638-76-9-

Hair products

1,5 %

94

Dibenzoyl peroxide

Benzoyl peroxide

94-36-0

202-327-6

Artificial nailsystems

0,7 % (after
mixing for use)

Professional use

For professional use
only
Avoid skin contact
Read directions foruse carefully95

Hydroquinone
methylether/Mequinolp-Hydroxyanisol

150-76-5

205-769-8

Artificial nailsystems

0,02 % (after
mixing for use)

Professional use

For professional use
only
Avoid skin contact
Read directions foruse carefully

96

5-tert-Butyl-2,4,6trinitro-m-xylene

Musk xylene

81-15-2

201-329-4

All cosmetic
products, withthe exception oforal products(a) 1,0 % in finefragrance(b) 0,4 % in eau
de toilette(c) 0,03 % inother products

PE-CONS 3623/09
ANNEX III

AK/kr
DG C

60

EN

97

4'-tert-Butyl-2',6'dimethyl-3',5'dinitroacetophenone

Musk ketone

81-14-1

201-328-9

All cosmetic
products, withthe exception oforal products(a) 1,4 % in finefragrance(b) 0,56 % in eau
de toilette(c) 0,042 % inother products

98

Benzoic acid, 2hydroxy-1

Salicylic acid

69-72-7

200-712-3(a) Rinse-off
hair products(a) 3,0 %(b) 2,0 %(b) Otherproducts

Not to be used in
preparations forchildren under 3
years of age, except
for shampoos

Not to be used forchildren under 3
years of age2

For purposes otherthan inhibiting thedevelopment of
micro-organisms in
the product. This
purpose has to beapparent from thepresentation of the
product

1
2

For use as a preservative, see Annex V, No 3.
Solely for products which might be used for children under 3 years of age and which remain in prolonged contact with the skin.

PE-CONS 3623/09
ANNEX III

AK/kr
DG C

61

EN

99

Inorganic sulfites andbisulfites11(a) Oxidative
hair dyeproducts(a) 0,67 % (as freeSO2)(b) Hairstraightening
products(b) 6,7 % (as freeSO2)(c) Self-tanning
products for theface(c) 0,45 % (as freeSO2)(d) Other selftanning products(d) 0,40 % (asfree SO2)

For purposes otherthan inhibiting thedevelopment of
micro-organisms in
the product. This
purpose has to beapparent from thepresentation of the
product

For use as a preservative, see Annex V, No 9.

PE-CONS 3623/09
ANNEX III

AK/kr
DG C

62

EN

100

1-(4-Chlorophenyl)-3(3,4dichlorophenyl)urea1

Triclocarban

101-20-2

202-924-1

Rinse-offproducts

1,5 %Purity criteria:
3,3',4,4'Tetrachloroazobenz
ene ≤ 1 ppm
3,3',4,4'Tetrachloroazoxybe
nzene ≤ 1 ppm
For purposes otherthan inhibiting thedevelopment of
micro-organisms in
the product. This
purpose has to beapparent from thepresentation of the
product

Pyrithione zinc2

101

1
2

Zinc pyrithione

13463-41-7

236-671-3

Leave-on hairproducts

0,1 %For purposes otherthan inhibiting thedevelopment of
micro-organisms in
the product. This
purpose has to beapparent from thepresentation of the
product

For use as a preservative, see AnnexV, No 23.
For use as a preservative, see Annex V, No 8.

PE-CONS 3623/09
ANNEX III

AK/kr
DG C

63

EN

102

1,2-Dimethoxy-4-(2propenyl)-benzene

PE-CONS 3623/09
ANNEX III

Methyl eugenol

93-15-2

202-223-0

Fine fragrance

0,01 %

Eau de toilette

0,004 %

Fragrance cream

0,002 %

Other leave-on
products and oral
products

0,0002 %Rinse-offproducts

0,001 %

AK/kr
DG C

64

EN

215

216

4-Amino-3-nitrophenol
and its salts

2,7-Naphthalenediol
and its salts

4-Amino-3nitrophenol

Naphthalene-2,7-diol

610-81-1

582-17-2

210-236-8

209-478-7(a) Oxidisingcolouring agentsfor hair dyeing(a) 3,0 %(b) Nonoxidisingcolouring agentsfor hair dyeing(b) 3,0 %Oxidisingcolouring agentsfor hair dyeing

1,0 %In combination withhydrogen peroxide
the maximum use
concentration upon
application is 1,5 %(a) (b) Can cause
allergic reaction

Not to be used after
31.12.2009
In combination withhydrogen peroxide
the maximum use
concentration 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

Oxidisingcolouring agentsfor hair dyeing

2,0 %In combination withhydrogen peroxide
the maximum use
concentration upon
application is 1,0 %Can cause allergic
reaction

Not to be used after
31.12.2009

PE-CONS 3623/09
ANNEX III

AK/kr
DG C

65

EN

218

2,6-Dihydroxy-3,4dimethylpyridine andits salts

2,6-Dihydroxy-3,4dimethylpyridine

84540-47-6

283-141-2

Oxidisingcolouring agentsfor hair dyeing

2,0 %In combination withhydrogen peroxide
the maximum use
concentration upon
application is 1,0 %Not to be used after
31.12.2009

219

220

1-Hydroxy-3-nitro-4(3hydroxypropylamino)b
enzene and its salts

1-[(2'Methoxyethyl)amino]2-nitro-4-[di-(2'hydroxyethyl)amino]benzene and its salts

PE-CONS 3623/09
ANNEX III

4Hydroxypropylamino3-nitrophenol

HC Blue No 1192952-81-3

23920-15-2

406-305-9

459-980-7(a) Oxidisingcolouring agentsfor hair dyeing(a) 5,2 %(b) Nonoxidisingcolouring agentsfor hair dyeing(b) 2,6 %(a) Oxidisingcolouring agentsfor hair dyeing(a) 3,0 %(b) Nonoxidisingcolouring agentsfor hair dyeing(b) 2,0 %In combination withhydrogen peroxide
the maximum use
concentration upon
application is 2,6 %Not to be used after
31.12.2009
In combination withhydrogen peroxide
the maximum use
concentration upon
application is 1,5 %(a) (b) Can cause
allergic reaction

Not to be used after
31.12.2009

AK/kr
DG C

(a) (b) Can cause
allergic reaction

66

EN

221

222

223

1-Methyl-3-nitro-4(.beta.hydroxyethyl)aminobe
nzene and its salts

1-Hydroxy-2-.beta.hydroxyethylamino4,6-dinitrobenzene andits salts

4-Methylaminophenol
and its salts

Hydroxyethyl-2-nitrop-toluidine

2Hydroxyethylpicramicacidp-Methylaminophenol

100418-335

99610-72-7

150-75-4

408-090-7

412-520-9

205-768-2(a) Oxidisingcolouring agentsfor hair dyeing(a) 2,0 %(b) Nonoxidisingcolouring agentsfor hair dyeing(b) 1,0 %(a) Oxidisingcolouring agentsfor hair dyeing(a) 3,0 %(b) Nonoxidisingcolouring agentsfor hair dyeing(b) 2,0 %Oxidisingcolouring agent
for hair dyeing

3,0 %In combination withhydrogen peroxide
the maximum use
concentration upon
application is 1,0 %(a) (b) Can cause
allergic reaction

Not to be used after
31.12.2009
In combination withhydrogen peroxide
the maximum use
concentration upon
application is 1,5 %(a) (b) Can cause
allergic reaction

Not to be used after
31.12.2009
In combination withhydrogen peroxide
the maximum use
concentration upon
application is 1,5 %Can cause allergic
reaction

Not to be used after
31.12.2009

PE-CONS 3623/09
ANNEX III

AK/kr
DG C

67

EN

224

1-(3Hydroxypropylamino)2-nitro-4-bis(2hydroxyethylamino)benzene and its salts

HC Violet No 2104226-199

410-910-3

Non-oxidisingcolouring agent
for hair dyeing

2,0 %Not to be used after
31.12.2009

225

1-(.beta.Hydroxyethyl)amino2-nitro-4-N-ethyl-N(.beta.hydroxyethyl)aminobe
nzene and its salts

HC Blue No 12104516-930

407-020-2(a) Oxidisingcolouring agentsfor hair dyeing(a) 1,5 %(b) Nonoxidisingcolouring agentsfor hair dyeing(b) 1,5 %In combination withhydrogen peroxide
the maximum use
concentration upon
application is0,75 %

Oxidisingcolouring agentsfor hair dyeing

2,0 %

226

4,4'-[1,3Propanediylbis(oxy)]bis-, benzene-1,3diamine and its salts

1,3-Bis-(2,4diaminophenoxy)prop
ane81892-72-0

279-845-4(a) (b) Can cause
allergic reaction

Not to be used after
31.12.2009
In combination withhydrogen peroxide
the maximum use
concentration upon
application is 1,0 %Can cause allergic
reaction

Not to be used after
31.12.2009

PE-CONS 3623/09
ANNEX III

AK/kr
DG C

68

EN

227

3-Amino-2,4dichlorophenol and its
salts

3-Amino-2,4dichlorophenol

61693-43-4

262-909-0

Oxidisingcolouring agentsfor hair dyeing

2,0 %In combination withhydrogen peroxide
the maximum use
concentration upon
application is 1,0 %Can cause allergic
reaction

Not to be used after
31.12.2009
228

3-Methyl-1-phenyl-5pyrazolone and its salts

Phenyl methyl
pyrazolone

89-25-8

201-891-0

Oxidisingcolouring agentsfor hair dyeing

0,5 %In combination withhydrogen peroxide
the maximum use
concentration upon
application is0,25 %
Not to be used after
31.12.2009229

5-[(2Hydroxyethyl)amino]o-cresol and its salts

2-Methyl-5hydroxyethylaminophe
nol55302-96-0

259-583-7

Oxidisingcolouring agentsfor hair dyeing

2,0 %In combination withhydrogen peroxide
the maximum use
concentration upon
application is 1,0 %Can cause allergic
reaction

Not to be used after
31.12.2009

PE-CONS 3623/09
ANNEX III

AK/kr
DG C

69

EN

230

3,4-Dihydro-2H-1,4benzoxazin-6-ol and its
salts

Hydroxybenzomorpholine

26021-57-8

247-415-5

Oxidisingcolouring agentsfor hair dyeing

2,0 %In combination withhydrogen peroxide
the maximum use
concentration upon
application is 1,0 %Can cause allergic
reaction

Not to be used after
31.12.2009231

1,5-bis(.beta.Hydroxyethyl)amino2-nitro-4chlorobenzene and its
salts

HC Yellow No 10109023-838

416-940-3

Non-oxidisingcolouring agentsfor hair dyeing

0,2 %Not to be used after
31.12.2009232

3,5-Diamino-2,6dimethoxypyridine andits salts

2,6-Dimethoxy-3,5pyridinediamine HCl

85679-78-3/ 56216-285- / 260-062-1

Oxidisingcolouring agentsfor hair dyeing

0,5 %In combination withhydrogen peroxide
the maximum use
concentration upon
application is0,25 %Can cause allergic
reaction

Not to be used after
31.12.2009

PE-CONS 3623/09
ANNEX III

AK/kr
DG C

70

EN

233

1-(2Aminoethyl)amino-4(2-hydroxyethyl)oxy2-nitrobenzene and its
salts

HC Orange No 285765-48-6

416-410-1

Non-oxidisingcolouring agentsfor hair dyeing

1,0 %Not to be used
after 31.12.2009234

Ethanol, 2-[(4-amino2-methyl-5nitrophenyl)amino]and its salts

HC Violet No 182576-75-8

417-600-7(a) Oxidisingcolouring agentsfor hair dyeing(a) 0,5 %(b) Nonoxidisingcolouring agentsfor hair dyeing(b) 0,5 %In combination withhydrogen peroxide
the maximum use
concentration upon
application is0,25 %
Not to be used after
31.12.2009

235

2-[3-(Methylamino)-4nitrophenoxy]ethanol
and its salts

3-Methylamino-4nitro-phenoxyethanol

59820-63-2

261-940-7

Non-oxidisingcolouring agentsfor hair dyeing

1,0 %Not to be used
after 31.12.2009236

2-[(2-Methoxy-4nitrophenyl)amino]etha
nol and its salts

2-Hydroxyethylamino-5-nitroanisole

66095-81-6

266-138-0

Non-oxidisingcolouring agentsfor hair dyeing

1,0 %Not to be used after
31.12.2009

PE-CONS 3623/09
ANNEX III

AK/kr
DG C

71

EN

237

2,2'-[(4-Amino-3nitrophenyl)imino]bisethanol hydrochloride
and other salts

HC Red No 13

94158-13-1

303-083-4(a) Oxidisingcolouring agentsfor hair dyeing(a) 2,5 %(b) Nonoxidisingcolouring agentsfor hair dyeing(b) 2,5 %In combination withhydrogen peroxide
the maximum use
concentration upon
application is
1,25 %
Not to be used after
31.12.2009

238

Naphthalene-1,5-dioland its salts

1,5-Naphthalenediol

83-56-7

201-487-4

Oxidisingcolouring agentsfor hair dyeing

1,0 %Not to be used after
31.12.2009

239

Hydroxypropyl bis(Nhydroxyethyl-pphenylenediamine) andits salts

Hydroxypropyl bis(Nhydroxyethyl-pphenyldiamine) HCl

128729-306

416-320-2

Oxidisingcolouring agentsfor hair dyeing

3,0 %In combination withhydrogen peroxide
the maximum use
concentration upon
application is 1,5 %Can cause allergic
reaction

Not to be used after
31.12.2009

PE-CONS 3623/09
ANNEX III

AK/kr
DG C

72

EN

240

o-Aminophenol and its
salts

o-Aminophenol

95-55-6

202-431-1

Oxidisingcolouring agentsfor hair dyeing

2,0 %In combination withhydrogen peroxide
the maximum use
concentration upon
application is 1,0 %Not to be used after
31.12.2009

241

5-Amino-o-cresol andits salts

4-Amino-2hydroxytoluene2835-95-2

220-618-6

Oxidisingcolouring agentsfor hair dyeing

3,0 %In combination withhydrogen peroxide
the maximum use
concentration upon
application is 1,5 %Not to be used after
31.12.2009

242

2,4Diaminophenoxyethan
ol and its salts

2,4Diaminophenoxyethan
ol HCl

66422-95-5

266-357-1

Oxidisingcolouring agentsfor hair dyeing

4,0 %In combination withhydrogen peroxide
the maximum use
concentration upon
application is 2,0 %Not to be used after
31.12.2009

PE-CONS 3623/09
ANNEX III

AK/kr
DG C

73

EN

243

1,3-Benzenediol, 2methyl-, and its salts -2-Methylresorcinol

608-25-3

210-155-8

Oxidisingcolouring agentsfor hair dyeing

2,0 %In combination withhydrogen peroxide
the maximum use
concentration upon
application is 1,0 %Not to be used after
31.12.2009244

4-Amino-m-cresol andits salts

4-Amino-m-cresol

2835-99-6

220-621-2

Oxidisingcolouring agentsfor hair dyeing

3,0 %In combination withhydrogen peroxide
the maximum use
concentration upon
application is 1,5 %Not to be used after
31.12.2009245

2-[(3-amino-4methoxyphenyl)amino]
ethanol and its salts

2-Amino-4hydroxyethylaminoani
sole

83763-47-7

280-733-2

Oxidisingcolouring agentsfor hair dyeing

3,0 %In combination withhydrogen peroxide
the maximum use
concentration upon
application is 1,5 %Not to be used after
31.12.2009

PE-CONS 3623/09
ANNEX III

AK/kr
DG C

74

EN

246

Hydroxyethyl-3,4methylenedioxyaniline
2-(1,3-benzodioxol-5ylamino)ethanolhydrochloride andother salts

Hydroxyethyl-3,4methylenedioxyaniline
HCI

81329-90-0

303-085-5

Oxidisingcolouring agentsfor hair dyeing

3,0 %In combination withhydrogen peroxide
the maximum use
concentration upon
application is 1,5 %Not to be used after
31.12.2009247

2,2'-[[4-[(2Hydroxyethyl)amino]3nitrophenyl]imino]bisethanol. and its salts

HC Blue No 233229-34-4

251-410-3

Non-oxidisingcolouring agentsfor hair dyeing

2,8 %Not to be used
after 31.12.2009

248

4-[(2Hydroxyethyl)amino]3-nitrophenol and its
salts

3-Nitro-phydroxyethylaminophe
nol65235-31-6

265-648-0(a) Oxidisingcolouring agentsfor hair dyeing(a) 6,0 %(b) Nonoxidisingcolouring agentsfor hair dyeing(b) 6,0 %In combination withhydrogen peroxide
the maximum use
concentration upon
application is 3,0 %PE-CONS 3623/09
ANNEX III

Not to be used after
31.12.2009

AK/kr
DG C

75

EN

249

250

251

1-(.beta.Ureidoethyl)amino-4nitrobenzene and its
salts

4-Nitrophenyl
aminoethylurea

1-amino-2-nitro-4(2',3'dihydroxypropyl)amin
o-5-chlorobenzene and1,4-bis-(2',3'dihydroxypropyl)amin
o-2-nitro-5chlorobenzene and its
salts

HC Red No 10
and HC Red No 11

Phenol, 2-chloro-6(ethylamino)-4-nitroand its salts

2-Chloro-6ethylamino-4nitrophenol

PE-CONS 3623/09
ANNEX III

27080-42-895576-89-9
and 9557692-4

131657-788

410-700-1-

411-440-1(a) Oxidisingcolouring agentsfor hair dyeing(a) 0,5 %(b) Nonoxidisingcolouring agentsfor hair dyeing(b) 0,5 %(a) Oxidisingcolouring agentsfor hair dyeing(a) 2,0 %(b) Nonoxidisingcolouring agentsfor hair dyeing(b) 1,0 %(a) Oxidisingcolouring agentsfor hair dyeing(a) 3,0 %(b) Nonoxidisingcolouring agentsfor hair dyeing(b) 3,0 %In combination withhydrogen peroxide
the maximum use
concentration upon
application is0,25 %
Not to be used after
31.12.2009
In combination withhydrogen peroxide
the maximum use
concentration upon
application is 1,0 %Not to be used after
31.12.2009

In combination withhydrogen peroxide
the maximum use
concentration upon
application is
1,5 %Not to be used after
31.12.2009

AK/kr
DG C

76

EN

252

253

254

2-Amino-6-chloro-4nitrophenol and its
salts

2-Amino-6-chloro-4nitrophenol[4-[[4-Anilino-1naphthyl][4(dimethylamino)phenyl]methylene]cyclohexa2,5-dien-1ylidene]dimethylammo
nium chloride (CI44045) and other salts

Basic Blue 26 (CI44045)

Disodium 5-amino-4hydroxy-3(phenylazo)naphthalen
e-2,7-disulphonate (CI17200) and other salts

Acid Red 33 (CI17200)

PE-CONS 3623/09
ANNEX III6358-09-4

2580-56-5

3567-66-6

228-762-1

219-943-6

222-656-9(a) Oxidisingcolouring agentsfor hair dyeing(a) 2,0 %(b) Nonoxidisingcolouring agentsfor hair dyeing(b) 2,0 %(a) Oxidisingcolouring agentsfor hair dyeing(a) 0,5 %(b) Nonoxidisingcolouring agentsfor hair dyeing(b) 0,5 %Non-oxidisingcolouring agentsfor hair dyeing

2,0 %In combination withhydrogen peroxide
the maximum use
concentration upon
application is 1,0 %Not to be used after
31.12.2009
In combination withhydrogen peroxide
the maximum use
concentration upon
application is0,25 %
Not to be used after
31.12.2009
Not to be used after
31.12.2009

AK/kr
DG C

77

EN

255

Disodium 3-[(2,4dimethyl-5sulphonatophenyl)azo]-4hydroxynaphthalene-1sulphonate (CI 14700)
and other salts

Ponceau SX (CI14700)

4548-53-2

224-909-9

Non-oxidisingcolouring agentsfor hair dyeing

2,0 %Not to be used after
31.12.2009

256(4-(4-Aminophenyl)(4iminocyclohexa-2,5dienylidene)methyl)-2methylanilinehydrochloride (CI42510) and other salts

Basic Violet 14 (CI42510)

632-99-5

211-189-6(a) Oxidisingcolouring agentsfor hair dyeing(a) 0,3 %(b) Nonoxidisingcolouring
agents forhair dyeing(b) 0,3 %In combination withhydrogen peroxide
the maximum use
concentration upon
application is0,15 %

PE-CONS 3623/09
ANNEX III

Not to be used after
31.12.2009

AK/kr
DG C

78

EN

ANNEX IV
LIST OF COLORANTS ALLOWED IN COSMETIC PRODUCTS
PREAMBLE
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 identification
Chemical Name

Colour index
Number/Name ofCommonIngredients
GlossaryCASnumberEC number

ColourProduct type, Body
parts

Maximum
concentration inready for use
preparation

Other

Wordingofconditionsof use andwarnings

b

c

d

e

f

g

h

i

j

Reference

numbera

Conditions

1

Sodium tris(1,2-naphthoquinone
1-oximato-O,O')ferrate
(1-)

10006

Green

Rinse-off products

2

Trisodium tris[5,6-dihydro-5(hydroxyimino)-6oxonaphthalene-2-sulphonato(2)-N5,O6]ferrate(3-)

10020

Green

Not to be used in
products applied on
mucous membranes

PE-CONS 3623/09
ANNEX IV

AK/kr
DG C

1

EN

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 ineye products

42-[(4-Methyl-2nitrophenyl)azo]-3-oxo-Nphenylbutyramide

11680

Yellow

Not to be used in
products applied on
mucous membranes

5

2-[(4-Chloro-2-nitrophenyl)azo]N-(2-chlorophenyl)-3oxobutyramide

11710

Yellow

Not to be used in
products applied on
mucous membranes

6

2-[(4-Methoxy-2nitrophenyl)azo]-3-oxo-N-(otolyl)butyramide

11725

OrangeRinse-off products7

4-(Phenylazo)resorcinol

11920

Orange84-[(4Ethoxyphenyl)azo]naphthol

12010

Red

PE-CONS 3623/09
ANNEX IV

Not to be used in
products applied on
mucous membranes

AK/kr
DG C

2

EN

9

1-[(2-Chloro-4-nitrophenyl)azo]2-naphthol and its insolublebarium, strontium and zirconium
lakes, salts and pigments

12085

Red

10

1-[(4-Methyl-2nitrophenyl)azo]-2-naphthol

12120

Red

Rinse-off products

11

3-Hydroxy-N-(o-tolyl)-4-[(2,4,5trichlorophenyl)azo]naphthalene-2-carboxamide

12370

Red

Rinse-off products

12

N-(4-Chloro-2-methylphenyl)-4[(4-chloro-2-methylphenyl)azo]3-hydroxynaphthalene-2carboxamide

12420

Red

Rinse-off products

13

4-[(2,5-Dichlorophenyl)azo]-N(2,5-dimethoxyphenyl)-3hydroxynaphthalene-2carboxamide

12480

Brown

Rinse-off products

14

N-(5-Chloro-2,4dimethoxyphenyl)-4-[[5[(diethylamino)sulphonyl]-2methoxyphenyl]azo]-3hydroxynaphthalene-2carboxamide

12490

Red

PE-CONS 3623/09
ANNEX IV

3%

AK/kr
DG C

3

EN

15

2,4-Dihydro-5-methyl-2-phenyl4-(phenylazo)-3H-pyrazol-3-one

12700

Yellow

16

Disodium 2-amino-5-[(4sulphonatophenyl)azo]benzenes
ulphonate

13015

Yellow

17

Sodium 4-(2,4dihydroxyphenylazo)benzenesul
phonate14270

Orange18

Disodium 3-[(2,4-dimethyl-5sulphonatophenyl)azo]-4hydroxynaphthalene-1sulphonate

14700

Red

19

Disodium 4-hydroxy-3-[(4sulphonatonaphthyl)azo]naphtha
lenesulphonate

14720

20

Disodium 6-[(2,4-dimethyl-6sulphonatophenyl)azo]-5hydroxynaphthalene-1sulphonate

14815

PE-CONS 3623/09
ANNEX IV

222-657-4

Rinse-off products

Red

Purity criteria as set
out in Commission
Directive 95/45/EC(E 122)

Red

AK/kr
DG C

4

EN

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-chloro5-[(2-hydroxy-1-naphthyl)azo]4-sulphonatobenzoate]

15525

Red

23

Barium bis[4-[(2-hydroxy-1naphthyl)azo]-2methylbenzenesul-phonate]

15580

Red

24

Sodium 4-[(2-Hydroxy-1naphthyl)azo]naphthalenesulpho
nate

15620

Red

25

Sodium 2-[(2hydroxynaphthyl)azo]naphthalen
esulphonate and its insolublebarium, strontium and zirconium
lakes, salts and pigments

15630

Red

26

Calcium bis[3-hydroxy-4(phenylazo)-2-naphthoate]

15800

Red

PE-CONS 3623/09
ANNEX IV

Not to be used ineye products

Rinse-off products

3%

Not to be used in
products applied on
mucous membranes

AK/kr
DG C

5

EN

27

Disodium 3-hydroxy-4-[(4methyl-2sulphonatophenyl)azo]-2naphthoate and its insolublebarium, strontium and zirconium
lakes, salts and pigments

15850

28

Disodium 4-[(5-chloro-4methyl-2sulphonatophenyl)azo]-3hydroxy-2-naphthoate and its
insoluble barium, strontium andzirconium lakes, salts andpigments

15865

Red

29

Calcium 3-hydroxy-4-[(1sulphonato-2-naphthyl)azo]-2naphthoate

15880

Red

30

Disodium 6-hydroxy-5-[(3sulphonatophenyl)azo]naphthalene-2-sulphonate

15980

Orange31

Disodium 6-hydroxy-5-[(4sulphonatophenyl)azo]naphthalene-2-sulphonate and its insolublebarium, strontium and zirconium
lakes, salts and pigments

15985

PE-CONS 3623/09
ANNEX IV

226-109-5

220-491-7

Red

Purity criteria as set
out in Commission
Directive 95/45/EC(E 180)

Yellow

Purity criteria as set
out in Commission
Directive 95/45/EC(E 110)

AK/kr
DG C

6

EN

32

Disodium 6-hydroxy-5-[(2methoxy-4-sulphonato-mtolyl)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'sulphonatonaphthyl)azo]naphtha
lene-2,7-disulphonate

16185

213-022-2

Red

Purity criteria as set
out in Commission
Directive 95/45/EC(E 123)34

Disodium 7-hydroxy-8(phenylazo)naphthalene-1,3disulphonate

16230

35

Trisodium 1-(1-naphthylazo)-2hydroxynaphthalene-4',6,8trisulphonate and its insolublebarium, strontium and zirconium
lakes, salts and pigments

16255

36

Tetrasodium 7-hydroxy-8-[(4sulphonato-1naphthyl)azo]naphthalene-1,3,6trisulphonate

16290

PE-CONS 3623/09
ANNEX IV

Orange220-036-2

Not to be used in
products applied on
mucous membranes

Red

Purity criteria as set
out in Commission
Directive 95/45/EC(E 124)

Red

AK/kr
DG C

7

EN

37

Disodium 5-amino-4-hydroxy-3(phenylazo)naphthalene-2,7disulphonate and its insolublebarium, strontium and zirconium
lakes, salts and pigments

17200

38

Disodium 5-acetylamino-4hydroxy-3(phenylazo)naphthalene-2,7disulphonate

18050

39

2,7-Naphthalenedisulfonic acid,3-((4-cyclohexyl-2methylphenyl)azo)-4-hydroxy-5(((4methylphenyl)sulfonyl)amino)-,disodium salt

40

Hydrogen bis[2-[(4,5-dihydro3-methyl-5-oxo-1-phenyl-1Hpyrazol-4-yl)azo]benzoato(2)]chromate(1-)

PE-CONS 3623/09
ANNEX IVRed

223-098-9

Red

Not to be used in
products applied on
mucous membranes

18130

Red

Rinse-off products

18690

Yellow

Rinse-off products

Purity criteria as set
out in Commission
Directive 95/45/EC(E 128)

AK/kr
DG C

8

EN

41

Disodium hydrogen bis[5chloro-3-[(4,5-dihydro-3methyl-5-oxo-1-phenyl-1Hpyrazol-4-yl)azo]-2hydroxybenzenesulphonato(3)]chromate(3-)

18736

Red

Rinse-off products

42

Sodium 4-(3-hydroxy-5-methyl4-(phenylazo)pyrazol-2yl)benzenesulphonate

18820

Yellow

Rinse-off products

43

Disodium 2,5-dichloro-4-(5hydroxy-3-methyl-4((sulphophenyl)azo)pyrazol-1yl)benzenesulphonate

18965

Yellow

44

Trisodium 5-hydroxy-1-(4sulphophenyl)-4-((4sulphophenyl)azo)pyrazole-3carboxylate and its insolublebarium, strontium and zirconium
lakes, salts and pigments

19140

45

N,N'-(3,3'-Dimethyl[1,1'biphenyl]-4,4'-diyl)bis[2-[(2,4dichlorophenyl)azo]-3oxobutyramide]

20040

PE-CONS 3623/09
ANNEX IV

217-699-5

Yellow

Yellow

Purity criteria as set
out in Commission
Directive 95/45/EC(E 102)

Rinse-off products

Maximum 3,3'dimethylbenzidine
concentration in thecolouring agent:
5 ppm

AK/kr
DG C

9

EN

46

Sodium 4-amino-5-hydroxy-3((4-nitrophenyl)azo)-6(phenylazo)naphthalene-2,7disulphonate

20470

Black

Rinse-off products

47

2,2'-[(3,3'-Dichloro[1,1'biphenyl]-4,4'diyl)bis(azo)]bis[N-(2,4dimethylphenyl)-3oxobutyramide]

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-chloro2,5-dimethoxyphenyl)-3oxobutyramide]

21108

Yellow

Rinse-off products

Maximum 3,3'dimethylbenzidine
concentration in thecolouring agent:
5 ppm

49

2,2'-[Cyclohexylidenebis[(2methyl-4,1phenylene)azo]]bis[4cyclohexylphenol]

21230

Yellow

Not to be used in
products applied on
mucous membranes

50

Disodium 4,6-dihydroxy-3-[[4[1-[4-[[1-hydroxy-7[(phenylsulphonyl)oxy]-3sulphonato-2naphthyl]azo]phenyl]cyclohexyl]phenyl]azo]naphthalene-2sulphonate

24790

Red

Rinse-off products

PE-CONS 3623/09
ANNEX IV

AK/kr
DG C

10

EN

51

1-(4-(Phenylazo)phenylazo)-2naphthol

26100

Red

Not to be used in
products applied on
mucous membranes

Purity criteria:aniline ≤ 0,2 %2-naphtol ≤ 0,2 %4-aminoazobenzene≤ 0,1 %
1-(phenylazo)-2naphtol ≤ 3 %1-[2(phenylazo)phenylazo]-2-napthalenol ≤ 2 %52

Tetrasodium 6-amino-4hydroxy-3-[[7-sulphonato-4-[(4sulphonatophenyl)azo]-1naphthyl]azo]naphthalene-2,7disulphonate

27755

53

Tetrasodium 1-acetamido-2hydroxy-3-(4-((4sulphonatophenylazo)-7sulphonato-1naphthylazo))naphthalene-4,6disulphonate

28440

PE-CONS 3623/09
ANNEX IVBlack

219-746-5

Black

Purity criteria as set
out in Commission
Directive 95/45/EC(E 151)

AK/kr
DG C

11

EN

54

Benzenesulfonic acid, 2,2'-(1,2ethenediyl)bis[5-nitro-, disodium
salt, reaction products with 4[(4-aminophenyl)azo]
benzenesulfonic acid, sodium
salts

40215

55

beta Carotene

40800

56

8'-apo-.beta.-Caroten-8'-al

40820

57

Ethyl 8'-apo-.beta.-caroten-8'oate

40825

PE-CONS 3623/09
ANNEX IV

Orange230-636-6

214-173-7

Rinse-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)OrangePurity criteria as set
out in Commission
Directive 95/45/EC(E 160f)

AK/kr
DG C

12

EN

58

Canthaxanthin

40850

59

Ammonium, (4-(alpha-(p(diethylamino)phenyl)-2,4disulfobenzylidene)-2,5cyclohexadien-1ylidene)diethyl-, hydroxide,monosodium salt

42045

60

Ethanaminium, N-(4-((4(diethylamino)phenyl)(5hydroxy-2,4disulfophenyl)methylene)-2,5cyclohexadien-1-ylidene)-Nethyl-, hydroxide, inner salt,
calcium salt (2:1) and its
insoluble barium, strontium andzirconium lakes, salts andpigments

42051

PE-CONS 3623/09
ANNEX IV

208-187-2

OrangeBlue222-573-8

Purity criteria as set
out in Commission
Directive 95/45/EC(E 161g)
Not to be used in
products applied on
mucous membranes

Blue

Purity criteria as set
out in Commission
Directive 95/45/EC(E 131)

AK/kr
DG C

13

EN

61

Benzene-methanaminium, Nethyl-N-(4-((4-(ethyl((3sulfophenyl)methyl)amino)
phenyl)(4-hydroxy-2sulfophenyl)methylene)-2,5cyclohexadien-1-ylidene)-3sulfo-, hydroxide, inner salt,
disodium salt

42053

Green

62

Hydrogen (benzyl)[4-[[4[benzylethylamino]phenyl](2,4disulphonatophenyl)methylene]c
yclohexa-2,5-dien-1ylidene](ethyl)ammonium,
sodium salt

42080

Blue

63

Benzene-methanaminium, Nethyl-N-(4-((4-(ethyl((3sulfophenyl)methyl)amino)
phenyl)(2sulfophenyl)methylene)-2,5cyclohexadien-1-ylidene)-3sulfo-, hydroxide, inner salt,
disodium salt

42090

PE-CONS 3623/09
ANNEX IV

223-339-8

Rinse-off products

Blue

Purity criteria as set
out in Commission
Directive 95/45/EC(E 133)

AK/kr
DG C

14

EN

64

Hydrogen [4-[(2chlorophenyl)[4-[ethyl(3sulphonatobenzyl)amino]phenyl]
methylene]cyclohexa-2,5-dien1-ylidene](ethyl)(3sulphonatobenzyl)ammonium,
sodium salt

42100

Green

Rinse-off products

65

Hydrogen [4-[(2chlorophenyl)[4-[ethyl(3sulphonatobenzyl)amino]-otolyl]methylene]-3methylcyclohexa-2,5-dien-1ylidene](ethyl)(3sulphonatobenzyl)ammonium,
sodium salt

42170

Green

Rinse-off products

66(4-(4-Aminophenyl)(4iminocyclohexa-2,5dienylidene)methyl)-2methylaniline hydrochloride

42510

Violet

Not to be used in
products applied on
mucous membranes

67

4-[(4-Amino-m-tolyl)(4-imino3-methylcyclohexa-2,5-dien-1ylidene)methyl]-o-toluidine
monohydrochloride

42520

VioletRinse-off products

PE-CONS 3623/09
ANNEX IV

5ppm

AK/kr
DG C

15

EN

68

Hydrogen [4-[[4(diethylamino)phenyl][4[ethyl[(3sulphonatobenzyl)amino]-otolyl]methylene]-3methylcyclohexa-2,5-dien-1ylidene](ethyl)(3sulphonatobenzyl)ammonium,
sodium salt

42735

Blue

Not to be used in
products applied on
mucous membranes

69[4-[[4-Anilino-1-naphthyl][4(dimethylamino)phenyl]methylene]cyclohexa-2,5-dien-1ylidene]dimethylammonium
chloride

44045

Blue

Not to be used in
products applied on
mucous membranes

70

Hydrogen [4-[4(dimethylamino)-.alpha.-(2hydroxy-3,6-disulphonato-1naphthyl)benzylidene]cyclohexa-2,5-dien-1ylidene]dimethylammonium,monosodium salt

44090

71

Hydrogen 3,6-bis(diethylamino)9-(2,4disulphonatophenyl)xanthylium,
sodium salt

45100

PE-CONS 3623/09
ANNEX IV

221-409-2

Green

Red

Purity criteria as set
out in Commission
Directive 95/45/EC(E 142)

Rinse-off products

AK/kr
DG C

16

EN

72

Hydrogen 9-(2carboxylatophenyl)-3-(2methylanilino)-6-(2-methyl-4sulphoanilino)xanthylium,monosodium salt

45190

VioletRinse-off products

73

Hydrogen 9-(2,4disulphonatophenyl)-3,6bis(ethylamino)-2,7dimethylxanthylium,monosodium salt

45220

Red

Rinse-off products

74

Disodium 2-(3-oxo-6oxidoxanthen-9-yl)benzoate

45350

Yellow75

4',5'-Dibromo-3',6'dihydroxyspiro[isobenzofuran1(3H),9'-[9H]xanthene]-3-one
and its insoluble barium,
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-tetrabromo6-oxido-3-oxoxanthen-9yl)benzoate and its insolublebarium, strontium and zirconium
lakes, salts and pigments

45380

Red

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 acid

PE-CONS 3623/09
ANNEX IV

6%

AK/kr
DG C

17

EN

77

3',6'-Dihydroxy-4',5'dinitrospiro[isobenzofuran1(3H),9'-[9H]xanthene]-3-one

45396

Orange78

Dipotassium 3,6-dichloro-2(2,4,5,7-tetrabromo-6-oxido-3oxoxanthen-9-yl)benzoate

45405

Red

79

3,4,5,6-Tetrachloro-2-(1,4,5,8tetrabromo-6-hydroxy-3oxoxanthen-9-yl)benzoic acidand its insoluble barium,
strontium and zirconium lakes,
salts and pigments

45410

Red

Not more than 1 % 2(6-hydroxy-3-oxo-3Η
xanthen-9-yl) benzoic
acid and 2 % 2(bromo-6-hydroxy-3oxo-3H-xanthen-9-yl)
benzoic acid80

Disodium 2-(2,4,5,7-tetraiodo-6oxido-3-oxoxanthen-9yl)benzoate and its insolublebarium, strontium and zirconium
lakes, salts and pigments

45430

Red

Purity criteria as set
out in Commission
Directive 95/45/EC(E 127)PE-CONS 3623/09
ANNEX IV

240-474-8

1%, when used inlip products
Not to be used ineye products

Not more than 1 % 2(6-hydroxy-3-oxo-3Η
xanthen-9-yl) benzoic
acid and 2 % 2(bromo-6-hydroxy-3oxo-3H-xanthen-9-yl)
benzoic acid

AK/kr
DG C

Only in free acidform, when used inlip products

18

EN

81

1,3-Isobenzofurandione, reaction
products with methylquinoline
and quinoline

47000

82

1H-Indene-1,3(2H)-dione,
2-(2-quinolinyl)-, sulfonated,
sodium salts

47005

83

Hydrogen 9-[(3methoxyphenyl)amino]-7phenyl-5-(phenylamino)-4,10disulphonatobenzo[a]phenaziniu
m, sodium salt

50325

VioletRinse-off products

84

Sulfonated nigrosine color

50420

Black

Not to be used in
products applied on
mucous membranes

85

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

PE-CONS 3623/09
ANNEX IV

Yellow

305-897-5

Not to be used in
products applied on
mucous membranes

Yellow

Purity criteria as set
out in Commission
Directive 95/45/EC(E 104)

AK/kr
DG C

19

EN

87

Trisodium 8-hydroxypyrene1,3,6-trisulphonate

59040

Green

Not to be used in
products applied on
mucous membranes

88

1-Anilino-4hydroxyanthraquinone

60724

VioletRinse-off products

89

1-Hydroxy-4-(ptoluidino)anthraquinone

60725

Violet90

Sodium 4-[(9,10-dihydro-4hydroxy-9,10-dioxo-1anthryl)amino]toluene-3sulphonate

60730

Violet91

1,4-bis(pTolylamino)anthraquinone

61565

Green

92

Disodium 2,2'-(9,10dioxoanthracene-1,4diyldiimino)bis(5methylsulphonate)

61570

Green

93

Sodium 3,3'-(9,10dioxoanthracene-1,4diyldiimino)bis(2,4,6trimethylbenzenesulphonate)

61585

Blue

PE-CONS 3623/09
ANNEX IV

Not to be used in
products applied on
mucous membranes

Rinse-off products

AK/kr
DG C

20

EN

94

Sodium 1-amino-4(cyclohexylamino)-9,10dihydro-9,10-dioxoanthracene-2sulphonate

62045

Blue

95

6,15-Dihydroanthrazine5,9,14,18-tetrone

69800

Blue

96

7,16-dichloro-6,15dihydroanthrazine-5,9,14,18tetrone

69825

Blue

97

Bisbenzimidazo[2,1-b:2',1'i]benzo[lmn][3,8]phenanthroline-8,17-dione

71105

Orange98

2-(1,3-Dihydro-3-oxo-2Hindazol-2-ylidene)-1,2-dihydro3H-indol-3-one

73000

Blue

99

Disodium 5,5'-(2-(1,3-dihydro-3oxo-2H-indazol-2-ylidene)-1,2dihydro-3H-indol-3one)disulphonate

73015

PE-CONS 3623/09
ANNEX IV

212-728-8

Rinse-off products

Not to be used in
products applied on
mucous membranes

Blue

Purity criteria as set
out in Commission
Directive 95/45/EC(E 132)

AK/kr
DG C

21

EN

100

6-Chloro-2-(6-chloro-4-methyl3-oxobenzo[b]thien-2(3H)ylidene)-4methylbenzo[b]thiophene3(2H)-one

73360

Red

101

5-Chloro-2-(5-chloro-7-methyl3-oxobenzo[b]thien-2(3H)ylidene)-7methylbenzo[b]thiophene3(2H)-one

73385

Violet102

5,12-Dihydroquino[2,3b]acridine-7,14-dione

73900

VioletRinse-off products

103

5,12-Dihydro-2,9dimethylquino[2,3-b]acridine7,14-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

PE-CONS 3623/09
ANNEX IV

Rinse-off products

AK/kr
DG C

22

EN

107

Polychloro copper
phthalocyanine

74260

Green

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

PE-CONS 3623/09
ANNEX IV

Not to be used ineye products

Yellow

AK/kr
DG C

23

EN

113

2-Amino-1,7-dihydro-6H-purin6-one

75170

114

Curcumins

75300

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)-[18carboxy-20-(carboxymethyl)-13ethyl-2,3-dihydro-3,7,12,17tetramethyl-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)PE-CONS 3623/09
ANNEX IV

White

AK/kr
DG C

24

EN

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 withferric oxide

77015

Red

122

Barium sulfate

77120

White

123

Bismuth chloride oxide

77163

White

124

Calcium carbonate

77220

125

Calcium sulfate

77231

PE-CONS 3623/09
ANNEX IV

207-439-9 /215-279-6

White

Purity criteria as set
out in Commission
Directive 95/45/EC(E 170)

White

AK/kr
DG C

25

EN

126

Carbon black

77266

127

Charcoal, bone. A fine black
powder obtained by burning
animal bones in a closed
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

PE-CONS 3623/09
ANNEX IV

215-609-9

231-165-9

Black

Purity criteria as set
out in Commission
Directive 95/45/EC(E 153)

Brown

Purity criteria as set
out in Commission
Directive 95/45/EC(E 175)

AK/kr
DG C

26

EN

134

Iron oxide

77489

135

Iron Oxide Red

77491

136

Iron Oxide Yellow

77492

137

Iron Oxide Black

77499

138

Ferric Ammonium Ferrocyanide

139

Orange215-168-2

Red

Purity criteria as set
out in Commission
Directive 95/45/EC(E 172)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)

77510

Blue

free from cyanide
ions

Magnesium carbonate

77713

White

140

Ammonium manganese(3+)
diphosphate

77742

Violet141

Trimanganese bis(orthophosphate)

77745

Red

PE-CONS 3623/09
ANNEX IV

51274-00-1

AK/kr
DG C

27

EN

142

Silver77820

231-131-3

White

Purity criteria as set
out in Commission
Directive 95/45/EC(E 174)

143

Titanium dioxide1

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)

1

White

For use as a UV-Filter, see Annex VI, No. 27.

PE-CONS 3623/09
ANNEX IV

AK/kr
DG C

28

EN

147

Paprika extract, Capsanthin,capsorubin

Capsanthin,capsorubin

148

Beetroot red

Beetroot Red

149

Anthocyanins

Anthocyanins

7659-95-2

207-364-1 /
207-425-2

OrangePurity criteria as set
out in Commission
Directive 95/45/EC(E 160c)

231-628-5

Red

Purity criteria as set
out in Commission
Directive 95/45/EC(E 162)Red

Purity criteria as set
out in Commission
Directive 95/45/EC(E 163)(Cyanidin,

528-58-5

208-438-6

Peonidin134-01-0

205-125-6

Malvidin528-53-0

211-403-8

Delphinidin

643-84-5

208-437-0

Petunidin
Pelargonidin)

PE-CONS 3623/09
ANNEX IV

134-04-3

205-127-7

AK/kr
DG C

29

EN

150

Aluminium, zinc, magnesiumand calcium stearates

Aluminum
stearate

White

Zinc stearate
Magnesium
stearate
Calciumstearate

7047-84-9

230-325-5

557-05-1

209-151-9

557-04-0

209-150-3

216-472-8

216-472-8

151

Phenol, 4,4'-(3H-2,1benzoxathiol-3-ylidene)bis[2bromo-3-methyl-6-(1methylethyl)-, S,S-dioxide

Bromothymolblue

76-59-5

200-971-2

Blue

Rinse-off products

152

Phenol, 4,4'-(3H-2,1benzoxathiol-3-ylidene)bis[2,6dibromo-3-methyl-,S,S-dioxide

Bromocresolgreen

76-60-8

200-972-8

Green

Rinse-off products

153

Sodium 4-[(4,5-dihydro-3methyl-5-oxo-1-phenyl-1Hpyrazol-4-yl)azo]-3hydroxynaphthalene-1sulphonate

Acid red 195

12220-24-5-

Red

Not to be used in
products applied on
mucous membranes

PE-CONS 3623/09
ANNEX IV

AK/kr
DG C

30

EN

ANNEX V
LIST OF PRESERVATIVES ALLOWED IN COSMETIC PRODUCTS
PREAMBLE
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.

–
2.

"Esters" is taken to mean: esters of methyl, ethyl, propyl, isopropyl, butyl, isobutyl, phenyl.

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 %.

PE-CONS 3623/09
ANNEX V

AK/kr
DG C

1

EN

Substance identification

Reference
numbera

1

Conditions

Chemical
name/INN

Name of Common
Ingredients Glossary

CAS number

EC number

Product type, Body
parts

Maximum
concentration inready for use
preparation

Other

b

c

d

e

f

g

h

Benzoic acid andits sodium salt

PE-CONS 3623/09
ANNEX V

Benzoic acid65-85-0200-618-2

Sodium Benzoate

532-32-1

208-534-8

Rinse-off products,
except oral products

2,5 % (acid)

Oral products

1,7 % (acid)

Leave-on products

0,5 % (acid)

AK/kr
DG C

Wording ofconditions ofuse andwarnings

i

2

EN

1a

Salts of benzoic
acid other than that
listed underreference number 1
and esters ofbenzoic acid

Ammonium
benzoate,calcium
benzoate, potassium
benzoate, magnesium
benzoate, MEA-benzoate,
methyl benzoate, ethyl
benzoate, propyl benzoate,butyl benzoate, isobutyl
benzoate, isopropyl
benzoate, phenyl benzoate

1863-63-4, 209005-3, 582-25-2,
553-70-8, 4337-660, 93-58-3, 93-890, 2315-68-6, 13660-7, 120-50-3,
939-48-0, 93-99-2

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

0,5 % (acid)2

Propionic acid andits salts

Propionic acid, ammonium
propionate, calcium
propionate, magnesium
propionate, potassium
propionate, sodium
propionate

79-09-4, 17496-081, 4075-81-4, 55727-7, 327-62-8,
137-40-6

201-176-3,
241-503-7,
223-795-8,
209-166-0,
206-323-5,
205-290-4

2 % (acid)

3

Salicylic acid1 andits salts

Salicylic acid, calcium
salicylate, magnesium
salicylate, MEA-salicylate,sodium salicylate,potassium salicylate, TEAsalicylate

69-72-7, 824-35-1,
18917-89-0,
59866-70-5, 54-217, 578-36-9, 217416-5

200-712-3,
212-525-4,
242-669-3,
261-963-2,
200-198-0,
209-421-6,
218-531-3

0,5 % (acid)1
2

Not to be used in
products forchildren under 3
years of age,
except for
shampoos

Not to be used
for children
under 3 yearsof age2

For use other than as a preservative, see Annex III, No. 98.
Solely for products which might be used for children under 3 years of age and which remain in prolonged contact with the skin.

PE-CONS 3623/09
ANNEX V

AK/kr
DG C

3

EN

4

Hexa-2,4-dienoic
acid and its salts

Sorbic acid, calcium
sorbate, sodium sorbate,
potassium sorbate

110-44-1, 7492-559, 7757-81-5,
24634-61-5

203-768-7,
231-321-6,
231-819-3,
246-376-1

5

Formal-dehyde,paraformaldehyde1

Formaldehyde

50-00-0, 30525-894

200-001-8

0,6 % (acid)

Oral products

0,1 % ( freeformaldehyde)

Other products

0,2 % ( freeformaldehyde)

Paraformaldehyde

6

Moved or deleted

7Biphenyl-2-ol,
and its salts

1o-Phenylphenol, sodium ophenylphenate, potassium ophenylphenate, MEA ophenylphenate

90-43-7, 132-27-4,
13707-65-8,
84145-04-0

201-993-5,
205-055-6,
237-243-9,
282-227-7

Not to be used inaerosol dispensers(sprays)

0,2 % (as phenol)

For use other than as a preservative, see Annex III, No. 13.

PE-CONS 3623/09
ANNEX V

AK/kr
DG C

4

EN

8

Pyrithione zinc1

Zinc pyrithione

13463-41-7

236-671-3

Hair products

Other products

9

Inorganicsulphites andhydrogensulphites2

10

Moved or deleted

11

Chlorobutanol

1
2

Sodium sulfite, ammonium
bisulfite, ammonium sulfite,
potassium sulfite, potassiumhydrogen sulfite, sodium
bisulfite, sodium
metabisulfite, potassium
metabisulfite

Chlorobutanol

1,0 %

0,5 %

7757-83-7, 1019230-0, 10196-04-0,
10117-38-1, 777303-7, 7631-90-5,
7681-57-4, 1673155-8

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)

57-15-8200-317-6

0,5 %Only in rinse-off
products
Not to be used inoral products

Not to be used inaerosol dispensers(sprays)Contains
Chlorobutanol

For use other than as a preservative, see Annex III. No. 101.
For use other than as a preservative, see Annex III, No. 99.

PE-CONS 3623/09
ANNEX V

AK/kr
DG C

5

EN

12

13

4-Hydroxybenzoic
acid and its salts
and esters

3-Acetyl-6methylpyran-2,4(3H)-dione and its
salts

PE-CONS 3623/09
ANNEX V

4-Hydroxybenzoic acid,methylparaben,butylparaben, potassium
ethylparaben, potassium
paraben, propylparaben,
isobutylparaben, sodium
methylparaben, sodium
ethylparaben, sodium
propylparaben, sodium
butylparaben, sodium
isobutylparaben,
ethylparaben, sodium
paraben, isopropylparaben,
potassium methylparaben,
potassium butylparaben,
potassium propylparaben,
sodium propylparaben,calcium paraben,
phenylparaben

99-96-7, 99-76-3,
94-26-8, 36457-199,16782-08-4, 9413-3, 4247-02-3,
5026-62-0, 3528568-8, 35285-69-9,36457-20-2,
84930-15-4, 12047-8, 114-63-6,
4191-73-5, 261107-2, 38566-94-8,
84930-17-4,
35285-69-9,
69959-44-0,
17696-62-7

202-804-9,
202-785-7,
202-318-7,
253-048-1,
240-830-2,
202-307-7,
224-208-8,
225-714-1,
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,

Dehydroacetic acid,sodium dehydroacetate

520-45-6, 4418-262, 16807-48-0

208-293-9,
224-580-1

0,6 % (as acid)

0,8 % (as acid)for mixtures ofestersAK/kr
DG C

Not to be used inaerosol dispensers(sprays)

6

EN

14

Formic acid and its
sodium salt

Formic acid, sodium
formate64-18-6, 141-53-7

200-579-1,
205-488-0

0,5 % ( as acid)15

3,3'-Dibromo-4,4'hexamethylenediox
ydi-benzamidine
and its salts(including
isethionate)

Dibromohexamidine
Isethionate

93856-83-8

299-116-4

0,1 %

16

Thiomersal

Thimerosal

54-64-8200-210-4

Eye products

0,007 % (of Hg)

Contains
Thiomersal

If mixed withother mercurial
compounds
authorised by thisRegulation, themaximum
concentration of
Hg remains fixed
at 0,007 %PE-CONS 3623/09
ANNEX V

AK/kr
DG C

7

EN

17

Phenylmercuric
salts (including
borate)Phenyl Mercuric Acetate,
Phenyl Mercuric Benzoate

18

Undec-10-enoic
acid and its salts

Undecylenic acid,potassium undecylenate,sodium undecylenate,calcium undecylenate,
TEA-undecylenate, MEAundecylenate112-38-9, 6159-417, 3398-33-2,
1322-14-1, 8447125-0, 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 (2ethylhexyl)
hexahydro-5methyl-

Hexetidine

141-94-6

205-513-5

0,1 %

20

5-Bromo-5-nitro1,3-dioxane

5-Bromo-5-nitro-1,3dioxane

30007-47-7

250-001-7

PE-CONS 3623/09
ANNEX V

62-38-4, 94-43-9

200-532-5,
202-331-8

Eye products

0,007 % (of Hg)

Contains
Phenylmercuri
c compounds

If mixed withother mercurial
compounds
authorised by thisRegulation, themaximum
concentration of
Hg remains fixed
at 0,007 %Rinse-off products

0,1 %

AK/kr
DG C

Avoid formationof nitrosamines

8

EN

21

Bronopol2-Bromo-2-nitropropane1,3-diol

52-51-7200-143-0

0,1 %

22

2,4-Dichlorobenzyl
alcohol

Dichlorobenzyl Alcohol

1777-82-8

217-210-5

0,15 %

23

1-(4Chlorophenyl)-3(3,4dichlorophenyl)
urea1Triclocarban

101-20-2

202-924-1

0,2 %Avoid formationof nitrosamines

Purity criteria:
3,3',4,4'Tetrachloroazobe
nzene <1 ppm
3,3',4,4'Tetrachloroazoxy
benzene <1 ppm

24

Chlorocresol

p-Chloro-m-Cresol59-50-7

200-431-6

25

5-Chloro-2- (2,4dichlorophenoxy)
phenol

Triclosan

3380-34-5

222-182-2

1

Not to be used in
products applied on
mucuous membranes

0,2 %

0,3 %

For use other than as a preservative, see Annex III, No. 100.

PE-CONS 3623/09
ANNEX V

AK/kr
DG C

9

EN

26

Chloro-xylenol

Chloroxylenol

88-04-0

201-793-8

0,5 %

27

N,N''methylenebis[N'[3(hydroxymethyl)2,5dioxoimidazolidin4-yl]urea]

Imidazolidinyl urea

39236-46-9

254-372-6

0,6 %

28

Poly(methylene),.alpha.,.omega.bis[[[(aminoimino
methyl)amino]imin
omethyl] amino]-,dihydrochloride

Polyaminopropyl
biguanide

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 %

31

Methenamine 3chloroallylochlorideQuaternium-15

4080-31-3

223-805-0

0,2 %

32

1-(4Chlorophenoxy)-1(imidazol-1-yl)3,3-dimethylbutan2-one

Climbazole

38083-17-9

253-775-4

0,5 %PE-CONS 3623/09
ANNEX V

0,3 %

AK/kr
DG C

10

EN

33

1,3-Bis(hydroxymethyl)5,5dimethylimidazolid
ine-2,4-dione

DMDM Hydantoin

6440-58-0

229-222-8

0,6 %

34

Benzyl alcohol1

Benzyl alcohol

100-51-6

202-859-9

1,0 %

35

1-Hydroxy-4methyl-6-(2,4,4trimethylpentyl) 2pyridon and its
monoethanolamine
salt

1-Hydroxy-4-methyl-6(2,4,4-trimethylpentyl) 2pyridon, Piroctone
Olamine50650-76-5,
68890-66-4

272-574-2

Rinse-off products

1,0 %Other products

0,5 %

36

Moved or deleted

37

2,2'methylenebis(6bromo-4chlorophenol)

Bromochlorophene15435-29-7

239-446-8

0,1 %

38

4-Isopropyl-mcresolo-Cymen-5-ol

3228-02-2

221-761-7

0,1 %

1

For use other than as a preservative, see Annex III, No. 45, 68.

PE-CONS 3623/09
ANNEX V

AK/kr
DG C

11

EN

39

Mixture of 5Chloro-2-methylisothiazol-3(2H)one and 2methylisothiazol3(2H)-one withmagnesiumchloride andmagnesium nitrate

Methylchloroisothiazolino
ne andMethylisothiazolinone

26172-55-4, 268220-4, 55965-84-9

247-500-7,
220-239-6

0,0015 % (of amixture in theratio 3:1 of 5chloro-2methylisothiazol
3(2H)-one and 2methylisothiazol3 (2H)-one

40

2-Benzyl-4chlorophenol

Chlorophene

120-32-1

204-385-8

0,2 %

41

2-Chloroacetamide

Chloroacetamide

79-07-2

201-174-2

0,3 %

42

N,N"-bis(4chlorophenyl)3,12-diimino2,4,11,13tetraazatetradecane
diamidine and its
digluconate,diacetate anddihydrochloride

Chlorhexidine,
Chlorhexidine Diacetate,
Chlorhexidine
Digluconate,
Chlorhexidine
Dihydrochloride

55-56-1, 56-95-1,
18472-51-0, 369742-5

200-238-7,
200-302-4,
242-354-0,
223-026-6

0,3 % (aschlorhexidine)

43

1-Phenoxypropan2-ol1

Phenoxyisopropanol

770-35-4

212-222-7

1

Only for rinse-off
products

Contains
chloroacetami
de

1,0 %

For use other than as a preservative, see Annex III, No. 54.

PE-CONS 3623/09
ANNEX V

AK/kr
DG C

12

EN

44

Alkyl (C 12-22)
trimethylammoniumbromide andchloride

Behentrimonium chloride,
cetrimonium bromide,
cetrimonium chloride,laurtrimonium bromide,
laurtrimonium chloride,steartrimonium bromide,
steartrimonium chloride

17301-53-0, 57-090, 112-02-7, 111994-4, 112-00-5,
1120-02-1, 112-038

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-1,3oxazolidine

Dimethyl Oxazolidine

51200-87-4

257-048-2

0,1 %

46

N(Hydroxymethyl)N(dihydroxymethyl1,3-dioxo-2,5imidazolidinyl-4)N'(hydroxymethyl)urea

Diazolidinyl Urea

78491-02-8

278-928-2

0,5 %

47

Benzenecarboximi
damide, 4,4'-(1,6hexanediylbis(oxy))bis-

Hexamidine, Hexamidine
diisethionate, Hexamidine
paraben3811-75-4, 659-405, 93841-83-9

211-533-5,
299-055-3

0,1 %Glutaral

111-30-8

203-856-5

0,1 %pH > 6and its salts(including
isethionate and phydroxybenzoate)
48

1

Glutaraldehyde(Pentane-1,5-dial)

Not to be used inaerosols (sprays)

Contains
glutaral1

Only if the concentration exceeds 0,05%.

PE-CONS 3623/09
ANNEX V

AK/kr
DG C

13

EN

49

5-Ethyl-3,7-dioxa1-azabicyclo[3.3.0] octane

7-Ethylbicyclooxazolidine

7747-35-5

231-810-4

0,3 %

50

3-(pChlorophenoxy)propane-1,2 diol

Chlorphenesin104-29-0

203-192-6

0,3 %

51

Sodiumhydroxymethylamino acetate

SodiumHydroxymethylglycinate

70161-44-3

274-357-8

0,5 %

52

Silver chloride
deposited ontitanium dioxide

Silver chloride

7783-90-6

232-033-3

0,004 % (asAgCl)

PE-CONS 3623/09
ANNEX V

AK/kr
DG C

Not to be used inoral products andin products
applied on
mucousmembranes

20 % AgCl (w/w)
on TiO2. Not to
be used in
products forchildren under 3
years of age, inoral products andin eye and lip
products

14

EN

53

Benzenemethanami
nium, N,Ndimethyl-N-[2-[2[4-(1,1,3,3,tetramethylbutyl)phenoxy]ethoxy]
ethyl]-, chloride

Benzethonium Chloride

54

Benzalkonium
chloride, bromide
and saccharinate1

Benzalkonium chloride,
benzalkonium bromide,
benzalkonium saccharinate

8001-54-5, 6344941-2, 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

1

121-54-0

204-479-9(a) Rinse-off
products

0,1 %(b) Leave-on
products other thanoral products
0,1% (asbenzalkonium
chloride)

Rinse-off products

Avoid contact
with eyes

0,15 %For use other than as a preservative, see Annex III, No. 65.

PE-CONS 3623/09
ANNEX V

AK/kr
DG C

15

EN

56

3-Iodo-2propynylbutylcarba
mate

Iodopropynyl
butylcarbamate

55406-53-6

259-627-5(a) Rinse-off
products(a) 0,02 %(b) 0,01 %,(b) Leave-on
products(c) 0,0075 %(c) Deo-dorants/antiperspirants

1
2

Not to be used inoral and lip
products(a) Not to be usedin products forchildren under 3
years of age,
except in bathproducts/shower
gels and shampoo(a) Not to be
used forchildren under3 years of age1(b) and (c) Not
to be used forchildren under3 years of age2

Solely for products, other than bath products/shower gels and shampoo, which might be used for children under 3 years of age.
Solely for products which might be used for children under 3 years of age.

PE-CONS 3623/09
ANNEX V

AK/kr
DG C

16

EN

(b) Not to be usedin body lotion andbody cream1(b) and (c)Not to be used in
products forchildren under 3
years of age
57

1

2-Methyl-2Hisothiazol-3-one

Methylisothiazolinone

2682-20-4

220-239-6

0,01 %

Concerns any products aimed to be applied on a large part of the body.

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ANNEX VI
LIST OF UV FILTERS ALLOWED IN COSMETIC PRODUCTS
Substance identification

Reference
numbera

Conditions

Chemical name/INN/XAN

Name of Common
Ingredients Glossary

CAS number

EC number

b

c

d

e

Product type,body parts

Maximum
concentration inready for use
preparation

Other

f

g

h

1

4-Aminobenzoic acidPABA

150-13-0

205-753-0

5%2

N,N,N-Trimethyl-4-(2oxoborn-3-ylidenemethyl)anilinium methyl sulfate

CamphorBenzalkonium
Methosulfate

52793-97-2

258-190-8

6%3

Benzoic acid, 2-hydroxy-,
3,3,5-trimethylcyclohexyl
ester / Homosalate

Homosalate

118-56-9

204-260-8

10 %4

2-Hydroxy-4methoxybenzophenone /Oxybenzone

Benzophenone-3

131-57-7

205-031-5

10 %1

Wording ofconditions ofuse andwarnings

i

Contains
Benzophenone-3 1

Not required if concentration is 0,5 % or less and when it is used only for product protection purposes.

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5

Moved or deleted

62-Phenylbenzimidazole-5sulfonic acid and its
potassium, sodium andtriethanolamine salts /Ensulizole

Phenylbenzimidazole
Sulfonic Acid

27503-81-7

248-502-0

8 %(as acid)

73,3'-(1,4Phenylenedimethylene)bis(7, 7-dimethyl-2oxobicyclo-[2.2.1]hept-1yl-methanesulfonic acid)and its salts / Ecamsule

Terephthalylidene
Dicamphor SulfonicAcid

92761-26-7,
90457-82-2

410-960-6

10 %(as acid)8

1-(4-tert-Butylphenyl)-3(4methoxyphenyl)propane1,3-dione / Avobenzone

Butyl
Methoxydibenzoylmethane70356-09-1

274-581-6

5%9alpha-(2-Oxoborn-3ylidene)-toluene-4sulphonic acid and its salts

Benzylidene Camphor
Sulfonic Acid

56039-58-8

10

2-Cyano-3,3-diphenyl
acrylic acid, 2-ethylhexyl
ester / Octocrilene

Octocrylene

6197-30-4

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6 % (as acid)228-250-8

10 % (as acid)

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11

Polymer of N-{(2 and 4)[(2-oxoborn-3ylidene)methyl]benzyl}
acrylamide

Polyacrylamidomethyl
Benzylidene Camphor

113783-61-2

122-Ethylhexyl 4methoxycinnamate /Octinoxate

Ethylhexyl
Methoxycinnamate

5466-77-3

13

Ethoxylated ethyl-4aminobenzoate

PEG-25 PABA

116242-27-4

14

Isopentyl-4methoxycinnamate /Amiloxate

Isoamyl pMethoxycinnamate

71617-10-2

275-702-5

10 %

15

2,4,6-Trianilino-(p-carbo2'-ethylhexyl-1'-oxy)1,3,5-triazine

Ethylhexyl Triazone

88122-99-0

402-070-1

5%

16

Phenol,2-(2Hbenzotriazol-2-yl)-4methyl-6-(2-methyl-3(1,3,3,3-tetramethyl-1(trimethylsilyl)oxy)disiloxanyl)propyl)

Drometrizole
Trisiloxane

155633-54-8

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226-775-7

10 %

10 %

15 %

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17

Benzoic acid, 4,4-((6-((4(((1,1dimethylethyl)amino)carb
onyl)phenyl)amino)-1,3,5triazine-2,4diyl)diimino)bis-, bis (2ethylhexyl) ester /Iscotrizinol (USAN)

Diethylhexyl Butamido
Triazone154702-15-518

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-4methoxybenzophenone-5sulfonic acid and its
sodium salt /Sulisobenzone

Benzophenone-4,
Benzophenone-5

4065-45-6 /6628-37-1

223-772-2 / -

5 % ( as acid)

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10 %

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23

2,2'-Methylene-bis(6-(2Hbenzotriazol-2-yl)-4(1,1,3,3-tetramethylbutyl)phenol) /Bisoctrizole

Methylene BisBenzotriazolyl
Tetramethylbutylphenol

103597-45-1

403-800-1

10 %

24

Sodium salt of 2,2'bis(1,4-phenylene)-1Hbenzimidazole-4,6disulfonic acid) /Bisdisulizole disodium(USAN)

Disodium Phenyl
Dibenzimidazole
Tetrasulfonate

180898-37-7

429-750-0

10 % ( as acid)25

2,2'-(6-(4Methoxyphenyl)-1,3,5triazine-2,4-diyl)bis(5-((2ethylhexyl)oxy)phenol) /Bemotrizinol

BisEthylhexyloxyphenol
Methoxyphenyl
Triazine

187393-00-6

26

Dimethicodiethylbenzalma
lonatePolysilicone-15

207574-74-1

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10 %

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27

Titanium dioxide1

Titanium Dioxide

13463-67-7/
1317-70-0/
1317-80-2

236-675-5/205280-1/ 215-282-2

25 %

28

Benzoic acid, 2-[4(diethylamino)-2hydroxybenzoyl]-,hexylester

Diethylamino
Hydroxybenzoyl Hexyl
Benzoate

302776-68-7

443-860-6

10 % in sunscreen
products

1

For use other than as a colorant, see Annex IV, No. 143.

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ANNEX VII
Symbols used on packaging/container
1.

Reference to enclosed or attached information

2.

Period-after-opening

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3.

Date of minimum durability

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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 ofthis 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 theEuropean Parliament and of the Council on the Registration, Evaluation, Authorisation andRestriction of Chemicals (REACH). As animal testing may not be replaced completely by analternative 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

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ANNEX IXPart A
Repealed Directive with its successive amendments(referred to in Article 33)
Council Directive 76/768/EEC(OJ L 262, 27.9.1976, p. 169)

of 27 July 1976
Council Directive 79/661/EEC of 24 July 1979

(OJ L 192, 31.7.1979, p. 35)

Commission Directive 82/147/EEC(OJ L 63, 6.3.1982, p. 26)

of 11 February 1982
Council Directive 82/368/EEC(OJ L 167, 15.6.1982, p. 1)of 17 May 1982
Commission Directive 83/191/EEC(OJ L 109, 26.4.1983, p. 25)

of 30 March 1983
Commission Directive 83/341/EEC(OJ L 188, 13.7.1983, p. 15)

of 29 June 1983
Commission Directive 83/496/EEC(OJ L 275, 8.10.1983, p. 20)

of 22 September 1983
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)

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Commission Directive 85/391/EEC of 16 July 1985

(OJ L 224, 22.8. 1985, p. 40)

Commission Directive 86/179/EEC(OJ L 138, 24.5.1986, p. 40)

of 28 February 1986
Commission Directive 86/199/EEC(OJ L 149, 3.6.1986, p. 38)

of 26 March 1986
Commission Directive 87/137/EEC(OJ L 56, 26.2.1987, p. 20)

of 2 February 1987
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(OJ L 64, 8.3.1989, p. 10)of 21 February 1989
Council Directive 89/679/EEC(OJ L 398, 30.12.1989, p. 25)

of 21 December 1989
Commission Directive 90/121/EEC(OJ L 71, 17.3.1990, p. 40)

of 20 February 1990
Commission Directive 91/184/EEC(OJ L 91, 12.4.1991, p. 59)

of 12 March 1991

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Commission Directive 92/8/EEC(OJ L 70, 17.3.1992, p. 23)

of 18 February 1992
Commission Directive 92/86/EEC(OJ L 325, 11.11.1992, p. 18)

of 21 October 1992
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)

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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(OJ L 253, 15.9.1998, p. 20)

of 3 September 1998
Commission Directive 2000/6/EC(OJ L 56, 1.3.2000, p. 42)

of 29 February 2000
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)

Commission Directive 2003/16/EC(OJ L 46, 20.2.2003, p. 24)

of 19 February 2003
Directive 2003/15/EC of the European Parliament(OJ L 66, 11.3.2003, p. 26)

and of the Council of 27 February 2003

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Commission Directive 2003/80/EC(OJ L 224, 6.9.2003, p. 27)

of 5 September 2003
Commission Directive 2003/83/EC(OJ L 238, 25.9.2003, p. 23)

of 24 September 2003
Commission Directive 2004/87/EC(OJ L 287, 8.9.2004, p. 4)

of 7 September 2004
Commission Directive 2004/88/EC(OJ L 287, 8.9.2004, p. 5)of 7 September 2004
Commission Directive 2004/94/EC(OJ L 294, 17.9.2004, p. 28)

of 15 September 2004
Commission Directive 2004/93/EC(OJ L 300, 25.9.2004, p. 13)

of 21 September 2004
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(OJ L 234, 10.9.2005, p. 9)

of 9 September 2005
Commission Directive 2005/80/EC(OJ L 303, 22.11.2005, p. 32)

of 21 November 2005

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Commission Directive 2006/65/EC of 19 July 2006

(OJ L 198, 20.7.2006, p. 11)

Commission Directive 2006/78/EC(OJ L 271, 30.9.2006, p. 56)

of 29 September 2006
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(OJ L 226, 30.8. 2007, p. 19)

of 29 August 2007
Commission Directive 2007/54/EC(OJ L 226, 30.8. 2007, p. 21)

of 29 August 2007
Commission Directive 2007/67/EC(OJ L 305, 23.11.2007, p. 22)

of 22 November 2007
Commission Directive 2008/14/EC

OJ L 42, 16.2.2008, p. 43

of 15 February 2008
Commission Directive 2008/42/EC of 3 April 2008

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OJ L 93, 4.4.2008, p. 13

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Commission Directive 2008/88/EC

OJ L 256, 24.9.2008, p. 12

of 23 September 2008
Commission Directive 2008/123/EC

OJ L 340, 19.12.2008, p. 71

of 18 December 2008
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

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OJ L L 98, 17.4.2009, p. 31

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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

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

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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

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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

10.9.2004

Council of 27 February 2003
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

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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

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

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ANNEX X
CORRELATION TABLE
Directive 76/768/EEC

This Regulation

Article 1

Article 2(1)(a)Article 2

Article 3

Article 3-

Article 4(1)Article 11(1)Article 4(2)Article 13

Article 4a

Article 14

Article 4b

Article 12(1)Article 5-

Article 5a

Article 28

Article 6(1),(2)Article 15(1),(2),(3),(4)Article 6(3)Article 16

Article 7(1)Article 6

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Article 7(3)Article 10

Article 7a (1) (h)Article 17

Article 7a(1),(2),(3)Article 7, 8, Annex I

Article 7a(4)Article 10

Article 7a(5)Article 24, 29

Article 8(1)Article 9

Article 8(2)Article 26

Article 8a-

Article 9

Article 30

Article 10

Article 27

Article 11-

Article 12

Article 22

Article 13

Article 23

Article 14-

Article 15-

Annex I

Preamble, No. 10

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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

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