Proposal for a Regulation of the European Parliament and of the Council on cosmetic products (recast) - Montesquieu Instituut

 

COUNCIL OFBrussels, 26 February 2009

THE EUROPEAN UNIONPUBLIC

6972/09

LIMITE

Interinstitutional File:

2008/0035 (COD)

MI 81 ENT 38 CONSOM 40 SAN 39 ECO 22 ENV 148 CHIMIE 21 CODEC 252

WORKING DOCUMENT from :

General Secretariat of the Council/Presidency

to : Working Party on Technical Harmonisation

No. prev. doc. : 17069/08 MI 540 ENT 314 CONSOM 219 SAN 331 ECO 184 ENV 978

CHIMIE 81 CODEC 1784

No. Cion prop. : 6725/1/08 REV 1 MI 71 ENT 40 CONSOM 25 SAN 37 ECO 27 ENV 109

CHIMIE 7 CODEC 240

Subject : Proposal for a Regulation of the European Parliament and of the Council on cosmetic products (recast)

Delegations will find attached a Compromise Proposal from the Presidency for a Regulation of the

ANNEX

2008/0025 (COD)

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

on cosmetic products

(recast)

(Text with EEA relevance)

OE 76/768/EEC (adapted)

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 Commission1,

Having regard to the opinion of the European Economic and Social Committee2,

[]

Acting in accordance with the procedure laid down in Article 251 of the Treaty3,

new

(1) Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the

Member States relating to cosmetic products4 has been significantly amended on several

occasions. Since further amendments are to be made, in this particular case it should be

recast as one single text in the interests of clarity.

(2) This Regulation The recast aims at simplifying procedures and streamlining terminology

thereby reducing administrative burden and ambiguities. Moreover, the recast it strengthens

certain elements of the regulatory framework for cosmetics, such as in-market control, with

a view to ensuring a high level of protection of human health.

(3) A recast as 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, a

Regulation ensures that legal requirements are implemented at the same time throughout the

Community.

OE 76/768/EEC Recital 1

(4) The provisions laid down by law, regulation or administrative action in force in the Member

States define the composition characteristics to which cosmetic products must conform and

prescribe rules for their labelling and for their packaging. These provisions differ from one

Member State to another.

OE 76/768/EEC Recital 3

(6) The main objective of these laws is the safeguarding of public health and, as a result, the

pursuit of the same objective must inspire Community legislation in this sector. However,

this objective must be attained by means which also take account of economic and

technological requirements.

OE 76/768/EEC Recital 4

(7) It is necessary to determine at Community level the regulations which must be observed as

regards the composition, labelling and packaging of cosmetic products.

OE 03/15/EC Recital 1 (adapted)

(8) Council Directive 76/768/EEC5 This Regulation has comprehensively harmonised

harmonises the national laws rules in the Community in order to achieve an

internal market for cosmetic products while ensuring a high level of relating to cosmetic

products and has as its main objective the protection of human public health. To this

end, it continues to be indispensable to carry out certain toxicological tests to evaluate the

safety of cosmetic products.

(8a) The environmental concerns that substances used in cosmetic products may raise are

considered through the application of Regulation ...[REACH], which enables the

assessment of environmental safety in a cross-sectoral manner.

OE 76/768/EEC Recital 5 (adapted)

(9) This Directive Regulation relates only to cosmetic products and not to medicinal

products, medical devices or biocidal products pharmaceutical specialities and medicinal

products. For this purpose it is necessary to define the scope of the Directive by delimiting

the field of cosmetics from that of pharmaceuticals. Theis 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. This Directive is not applicable to the products

that fall under the definition of cosmetic product but are exclusively intended to protect from

disease. Moreover, it is advisable to specify that certain products come under this definition,

whilst products containing substances or preparations intended to be ingested, inhaled,

injected or implanted in the human body do not come under the field of cosmetics.

OE 76/768/EEC Annex I (adapted)

new

(10) The assessment whether a product is a cosmetic product has to be taken on the basis of a

case by case assessment, taking into account all characteristics of the product. Typical

examples for cosmetic products may include creams, emulsions, lotions, gels and oils for

the skin (hands face feet etc.), face masks (with the exception of peeling products), tinted

bases (liquids, pastes, powders), make-up powders, after-bath powders, hygienic powders,

etc. toilet soaps, deodorant soaps, etc. perfumes, toilet waters and eau de Cologne, bath and

shower preparations (salts, foams, oils, gels, etc.), depilatories, deodorants and anti-

perspirants, hair care products, hair tints and bleaches 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, etc.), products for making up and removing make-up from the face

and the eyes, 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.

OE 76/768/EEC Recital 6 (new)

(11) The Commission should define the categories of cosmetic products which are relevant

(12a) 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 the Member States

concerning products which, appearing to be other than they are, endanger the health

or safety of consumers.

(13) In order to establish clear responsibilities, each cosmetic product should be linked to a

responsible person who is established within the Community. It is in particular

necessary to determine who is the responsible person for cosmetic products placed on the

Community market and which are sold directly to the consumer without recurring to an

importer.6

(13a) Ensuring traceability of a product throughout the whole supply chain helps to make

market surveillance simpler and more efficient. An efficient traceability system

facilitates market surveillance authorities' task of tracing economic operators.

(13aa) It is necessary to determine under which conditions a distributor is to be considered as

responsible person.

(13b) All legal or natural persons in the wholesale trade as well as retailers selling directly to

the consumer 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

(14) To ensure their safety, cosmetic products placed on the market should be produced

according to good manufacturing practice.

(15) For the purpose of efficient market surveillance, a product information file should be

made readily accessible at one single address within the Community to the competent

authority of the Member State where the file is located.

(16) 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.

OE 93/35/EEC Recital 4 (adapted)

new

(17) Whereas, with regard to the finished cosmetic product, Iit should be made clear which

information is to be made available to the monitoring competent authorities. of the

place of manufacture or of initial importation into the Community market; whereas Tthat

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.

(18) To ensure a uniform application and control of the restrictions for substances, sampling

and analysis should be carried out in a reproducible and standardised manner.

OE 93/35/EEC Recital 5 (adapted)

new

(19) Whereas, however, Ffor reasons of monitoring effective market surveillance , the

competent authorities should be notified apprised of certain information about the

cosmetic product placed on the market. the place of manufacture and of the information

needed for rapid and appropriate medical treatment in the event of difficultires.

(20) In order to allow for rapid and appropriate medical treatment in the event of difficulties,

the necessary information about the product formula should be submitted to poison control

centres and assimilated entities if such centres are established by Member States to that

effect.

(21) In order to keep administrative burdens to a minimum, both notifications should be

submitted centrally for the Community by way of an electronic interface.

(21a) 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.

OE 83/574/EEC Recital 2 (adapted)

(22) Whereas, on the basis of the latest scientific and technical research, a list of substances

authorized as ultra-violet filters can be established;

(24) To avoid ambiguities, it should be clarified that the list of allowed colorants contained in

Annex IV only includes substances which colour through absorption and reflection and not

substances which colour through photoluminescence, interference, or chemical reaction.

new

(25) To address safety concerns raised, Annex IV, which is currently restricted to skin colorants,

should also include hair colorants once the risk assessment of these substances by the

Scientific Committee for Consumer [] Safety (SCCS) has been finalised. To this end, the

Commission should have the possibility to include hair colorants in the scope of this Annex

by Comitology procedure.7

(25a) The use of nanomaterials in cosmetic products may increase with the further

development of technology. In order to ensure a high level of consumer protection, free

movement of goods 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 be reached, the definition of nanomaterials in this

Regulation should be adapted accordingly.

(25b) At present, there is inadequate information on the risks associated with nanomaterials

[regardless of their persistence and solubility]. In order to better assess their safety the

SCCS should provide guidance in cooperation with relevant bodies on test

OE 03/15/EC Recital 13 (adapted)

new

(26) Given the hazardous properties of special risks that substances classified as

carcinogenic, mutagenic or toxic for reproduction (CMR) , [] category 1A, 1B and 2,

pursuant to Regulation (EC) No ... of the European Parliament and of the Council of ...

on Classification, Labelling and Packaging of Substances and Mixtures [category 1, 2 and

3, pursuant to Council Directive 67/548/EEC of 27 June 1967 on the approximation of

laws, regulations and administrative provisions relating to the classification, packaging and

labelling of dangerous substances] Directive 67/548/EEC may entail for human health,

their use in cosmetic products should be prohibited. A substance classified in category 3 may

be used in cosmetics if the substance has been evaluated by the SCCNFP and found

acceptable for use in cosmetic products. However, as a hazardous property of a substance

does not necessarily always entail a risk, there should be a possibility to allow the use of

substances classified as CMR []2 substances if, in view of exposure and concentration, they

have been found safe for use in cosmetic products by the [SCCP] SCCS and are regulated by

the Commission in the Annexes to this Regulation. With regard to substances which

are classified as CMR 1A or 1B [2] substances, there should be a possibility, in the

exceptional case where these substances are legally used in food and no suitable alternative

substances exist, to use such substances in cosmetic products if such use has been found safe

by the [SCCP] SCCS. This possibility can apply within 15 months at the latest after

classification of substances as carcinogenic, mutagenic or toxic for reproduction of

category 1A or 1B under Regulation (EC) No ...[]. Such substances should be continuously

(26a) A safety assessment of substances, particularly those classified as CMR 1A or 1B

substances, should consider the global overall exposure to such substances stemming

from all sources. At the same time, for those involved in producing safety assessments,

it is essential that there be a harmonised approach to the development and use of such

global 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 and develop guidance regarding the production and use of

global overall exposure estimates for these substances.

(26b) The assessment of SCCS of the use of substances classified as CMR 1A and 1B in

cosmetic products should also take into account the exposure to these substances of

vulnerable populations groups, such as children under three years of age, elderly

people, pregnant and breast-feeding women and persons showing compromised

immune responses.

(26c) 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 made available by the responsible person.

(26d) Action by the Commission and Member States relating to the protection of human

health should be based on the precautionary principle.

OE 82/368/EEC Recital 11 (adapted)

(27) Whereas the presence of traces of substances which cosmetic products must not contain

according to Annex II to Directive 76/768/EEC In order to ensure product safety,

prohibited substances should only be acceptable at trace levels if they are is

technologically inevitable with correct manufacturing processes and provided that the

product is safe. ; whereas therefore certain provisions should be made in this connection;

OE 03/15/EC Recital 2 (adapted)

(28) The Protocol on protection and welfare of animals annexed by the Treaty of Amsterdam to

the Treaty establishing the European Community provides that the Community and the

Member States are to pay full regard to the welfare requirements of animals in the

implementation of Community policies, in particular with regard to the internal market.

OE 03/15/EC Recital 3 (adapted)

(29) Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws,

regulations and administrative provisions of the Member States regarding the protection of

animals used for experimental and other scientific purposes8 has established common rules

for the use of animals for experimental purposes within the Community and laid down the

conditions under which such experiments must be carried out in the territory of the Member

However, these provisions concern only alternative methods which do not use animals and

they do not take account of alternative methods developed in order to reduce the number of

animals used for experiments or to reduce their suffering. Therefore, in order to afford

optimal protection to animals used for testing cosmetic products pending implementation of

the prohibition of animal tests for cosmetic products and the marketing of animal-tested

cosmetic products in the Community, these provisions should be amended in order to

provide for the systematic use of alternative methods, which reduce the number of animals

used or reduce the suffering caused, in those cases where full replacement alternatives are

not yet available, as provided by Article 7(2) and (3) of Directive 86/609/EEC, when these

methods offer consumers a level of protection equivalent to that of the conventional

methods which they are intended to replace.

OE 03/15/EC Recital 5 (adapted)

(30) Currently, only alternative methods which are scientifically validated by the European

Centre for the Validation of Alternative Methods (ECVAM) or the Organisation for

Economic Cooperation and Development (OECD) and applicable to the whole chemical

sector are systematically adopted at Community level. However, Tthe safety of cosmetic

products and their ingredients may be ensured through the use of alternative methods which

are not necessarily applicable to all uses of chemical ingredients. Therefore, the use of such

methods by the whole cosmetic industry should be promoted and their adoption at

Community level ensured, when such methods offer an equivalent level of protection to

consumers.

OE 03/15/EC Recital 6 (adapted)

new

(31) The safety of finished cosmetic products can already be ensured on the basis of knowledge

of the safety of the ingredients that they contain. Provisions prohibiting animal testing of

finished cosmetic products can should therefore be provided. be incorporated

into Directive 76/768/EEC. The Commission should establish guidelines in order to

facilitate the The application, in particular by small and medium-sized enterprises, of

both test methods and assessment procedures for relevant 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 finished cosmetic products could be facilitated by

Commission guidelines .

OE 03/15/EC Recital 7 (adapted)

(32) 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) ECVAM and with due regard to the development of

validation within the Organisation for Economic Cooperation and Development

(OECD) OECD. After consulting the Scientific Committee on Cosmetic Products and

Non-Food Products intended for Consumers (SCCNFP) []SCCS as regards the

applicability of the validated alternative methods to the field of cosmetic products, the

Commission should immediately publish the validated or approved methods recognised as

OE 03/15/EC Recital 8 (adapted)

(33) The Commission should establish has established timetables of deadlines for the

prohibition of the marketing of cosmetic products, the final formulation, ingredients or

combinations of ingredients which have been tested on animals, and for the prohibition of

each test currently carried out using animals, up to 11 March 2009 a maximum of six

years from the date of entry into force of this Directive. In view, however, of the fact that

there are no alternatives yet under consideration for tests concerning repeated-dose toxicity,

reproductive toxicity and toxicokinetics, it is appropriate for the maximum deadline for the

prohibition of the marketing of cosmetic products for which those tests are used to be 11

March 2013 10 years from the date of entry into force of this Directive. On the basis of

annual reports, the Commission should be authorised to adapt the timetables within the

respective abovementioned maximum time limits.

OE 03/15/EC Recital 9 (adapted)

(34) Better coordination of resources at Community level will contribute to increasing the

scientific knowledge indispensable for the development of alternative methods. It is

essential, for this purpose, that the Community continue and increase its efforts and take the

measures necessary for the promotion of research and the development of new non-animal

alternative methods, in particular within its Sixth Framework Programmes for

research as set out in Decision No 1513/EC/2002 of the European Parliament and of the

Council10.

OE 03/15/EC Recital 10 (adapted)

(35) The recognition by third non-member countries of alternative methods developed in

the Community should be encouraged. In order to achieve this objective, the Commission

and the Member States should take all appropriate steps to facilitate acceptance of such

methods by the OECD. The Commission should also endeavour, within the framework of

European 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 export

of cosmetic products for which such methods have been used is not hindered and to prevent

or avoid third non-member countries requiring the repetition of such tests using

animals.

OE 93/35/EEC Recital 3 (adapted)

(36) Whereas greater Ttransparency is needed regarding the ingredients employed in cosmetics

products. if the latter are to be placed on the market without any prior procedure, if

the necessary information on the finished product is to be available solely at the place of

manufacture or of initial importation into the Community and if better information is to be

provided to the consumer; whereas Ssuch transparency should be achieved by indication of a

product's function and of the ingredients used in a cosmetic product on its packaging.;

whereas Wwhere for practical reasons it is impossible to indicate the ingredients and any

warnings regarding use on the container or the packaging, such particulars should be

enclosed so that the consumer may can have access to this all necessary

OE 93/35/EEC Recital 2 (adapted)

(37) Whereas it has become apparent that it is desirable that data on the ingredients employed in

cosmetic products be gathered so that all issues relating to their use and the resulting action

at Community level may be assessed with a view, in particular, to the establishment of a

common nomenclature of ingredients used in cosmetic products; whereas the gathering of

that data can be facilitated if the Commission compiles an inventory of the ingredients

concerned; A glossary of common ingredient names should be compiled by the

Commission to ensure uniform labelling and to facilitate identification of cosmetics

ingredients. whereas that inventory This glossary should not be intended to will

be indicative and is not intended to constitute a limitative list of substances used in cosmetic

products;

OE 03/15/EC Recital 14 (adapted)

(38) In order to inform improve the information provided to consumers, cosmetic

products should bear more precise and easily understandable indications concerning

their durability for use. Given that consumers should be informed of the date until which

the product continues to fulfil its initial function and remains safe, it is important to

know the date of minimum durability, i.e. the date by which it is best to use the

product. When the date of minimum durability is more than 30 months, the consumer

must be informed of the period of time after opening during which the product can be

used without any harm to the consumer. However this requirement does not apply

OE 03/15/EC Recital 15 (adapted)

new

(39) A number of substances have been identified by the []SCCS as likely to cause allergenic

reactions and it will be necessary to restrict their use and/or impose certain conditions

concerning them. Certain substances have been identified as an important cause of

contact-allergy reactions in fragrance-sensitive consumers. In order to ensure that such

consumers are adequately informed, it is therefore necessary to amend the provisions of

Directive 76/768/EEC to require that the presence of 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 will improve the diagnosis

of contact allergies among such consumers and should will enable them to avoid the

use of cosmetic 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

ban and restriction of concentration should be considered.

(39a) In the safety assessment of a cosmetic product it should be possible to take into account

results of risk assessments that have been carried out in other relevant areas. The use

of such data should be duly substantiated and justified.

(40) The consumer should be protected from misleading claims concerning efficacy and other

characteristics of cosmetic products. [] In particular European Parliament and

Council Directive 2005/29/EC concerning unfair business-to-consumer commercial

OE 03/15/EC Recital 11 (adapted)

(41) 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 should develop 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 such claims do not mislead the consumer. In developing such guidelines, the

Commission has must also taken take into account the views of the many

small and medium-sized enterprises which make up the majority of the "non-animal testing"

producers, relevant non-governmental organisations, and the need of consumers to be able to

make practical distinctions between products on the basis of animal testing criteria.

(42) In addition to the labelled information, consumers should be given the possibility to

request certain product-related information from the responsible person in order to make

informed product choices.

OE 76/768/EEC Recital 8

(43) In particular, the determination of the methods of analysis together with possible

modifications or additions which may have to be made to them on the basis of the results of

scientific and technical research, are implementing measures of a technical nature. It is

advisable to entrust their adoption to the Commission, subject to certain conditions specified

in this Directive, for the purpose of simplifying and accelerating the procedure.

new

(44) An effective market surveillance is necessary in order to ensure that the provisions of this

Regulation are respected. To this end, serious undesirable effects should be notified and

competent authorities should have a possibility to request from the responsible person a list

of cosmetic products containing substances which have raised serious doubts in terms of

safety.

(44a) This Regulation is without prejudice to the possibility for Member States to regulate,

within the respect of Community law, the notification by health professionals or

consumers of serious undesirable effects to the competent authorities of Member

States.

(44b) This Regulation is without prejudice to the possibility for Member States to regulate,

within the respect of Community law, establishment of economic operators in the area

of cosmetic products.

(45) In case of non-compliance with this Regulation, a clear and efficient procedure for the

withdrawal and recall of products may be necessary. This procedure should build, where

possible, upon existing Community rules for unsafe goods.

OE 76/768/EEC Recital 11 (adapted)

(46) In order to address products which, albeit It could happen that although conforming

with to the provisions of this Regulation Directive and its Annexes, cosmetic

products placed on the market might endanger human public health , a safeguard

procedure should be introduced. It is therefore advisable to provide for a procedure

intended to remove this danger.

(46a) The Commission should provide indications for the uniform interpretation and

application of the concept of serious risks in order to facilitate the consistent

implementation of this Regulation.

new

(47) In order to comply with principles of good administrative practices, any decision by a

competent authority in the framework of market surveillance should be duly substantiated.

(48) In order to ensure an efficient in-market control, a high degree of administrative cooperation

amongst the enforcing authorities is necessary. This concerns in particular the mutual

assistance in the verification of product informations files located in another Member State.

OE 76/768/EEC Recital 10

(49) It is necessary, on the basis of scientific and technical research, to draw up proposals for lists

of authorized substances which could include antioxidants, hair dyes, preservatives and

new

(51) The Commission should be assisted by the []SCCS, an independent risk assessment body.

(52) The measures necessary for the implementation of this Regulation should be adopted in

accordance with Council Decision 1999/468/EC of 28 June 1999 laying down procedures

for the exercise of implementing powers conferred on the Commission11.

(53) In particular power should be conferred on the Commission to adapt the Annexes to this

Regulation to technical progress. Since those measures are of general scope and are

designed to amend non-essential elements of this Regulation they must be adopted in

accordance with the regulatory procedure with scrutiny provided for in Article 5a of

Decision 1999/468/EC.

(54) Member States should lay down provisions on penalties applicable to infringements of the

provisions of this Regulation and ensure that they are implemented. Those penalties should

be effective, proportionate and dissuasive.

(55) Economic operators as well as Member States and the Commission need sufficient time to

adapt to the changes introduced by this Regulation. [Therefore, this Regulation should apply

36 months after its publication.] Therefore it is appropriate to provide for a sufficient

transitional period for that adaptation. However, in order to ensure a smooth

transition, economic operators should be allowed to place on the market cosmetic

products which comply with this Regulation before the expiry of that transitional

(55a) In order to strengthen the safety of cosmetic products and 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, product information

file and notification, even if similar obligations have already been performed under

Directive 76/768/EEC.

(56) Directive 76/768/EEC should be repealed. However, in order to guarantee an

appropriate medical treatment in case 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

during a certain period of time and the information kept by the responsible person

should be still available for the same period of time.

(57) 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 in Part B of

Annex IX.

(58) Since the objective of this Regulation, namely the achievement of the internal market

and a high level of protection of human health through the compliance of cosmetic

products, cannot be sufficiently achieved by the Member States and can therefore, by

reason of the scale of the action, be better achieved at Community level, the

Community may adopt measures, in accordance with the principle of subsidiarity, as

set out in Article 5 of the Treaty. In accordance with the principle of proportionality,

OE 76/768/EEC (adapted)

HAVE ADOPTED THIS DIRECTIVE REGULATION :

OE 93/35/EEC (adapted)

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 of human health.

Article 1 2

Definitions

• 1. 

  For the purposes of this Regulation, the following definitions shall apply:

(a) `cosmetic product' means A `cosmetic product' shall mean any substance or

OE 76/768/EEC (adapted)

• 2. 

  The products to be considered as cosmetic products within the meaning of this definition are

listed in Annex I.

OE 88/667/EEC

• 3. 

  Cosmetic products containing one of the substances listed in Annex V shall be excluded from the

scope of this Directive. Member States may take such measures as they deem necessary with regard

to those products.

new

(aa) `substance' means a chemical element and its compounds in the natural state or

obtained by any manufacturing process, including any additive necessary to

preserve its stability and any impurity deriving from the process used but

excluding any solvent which may be separated without affecting the stability of

the substance or changing its composition;

(ab) 'mixture' means a mixture or solution composed of two or more substances.

(b) `manufacturer' means any natural or legal person who designs or manufactures

a cosmetic product or who has such a product designed or manufactured12, and

(ba) `distributor' means any natural or legal person in the supply chain, other than

the manufacturer or the importer[], who makes a product available on the

Community market ;

-

(bb) `end user' means either consumers or professionals using the cosmetic product;

(c) `making available on the market' means any supply [by any means , including

electronic means,] of a product for distribution, consumption or use on the

Community market in the course of a commercial activity, whether in return for

payment or free of charge;

(d) `placing on the market' means the first making available of a product on the

Community market;13

(e) `importer' means any natural or legal person established within the Community, who

places a product from a third country on the Community market;

(f) `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 laying down a procedure for the provision of

information in the field of technical standards and regulations and of rules on

information society services14 on the basis of a request made by the Commission

in accordance with Article 6 of that Directive;

(g) `nanomaterial' means an insoluble or biopersistant and intentionally

manufactured material with one or more external dimensions, or an internal

structure, on the scale from 1 to 100 nm;15

(h) `preservatives' means substances which are exclusively or mainly intended to inhibit

the development of micro-organisms in the cosmetic product;

(i) `colorants' means substances which are exclusively or mainly intended to colour the

cosmetic product, the body as a whole or certain parts thereof, by absorption or

reflection of visible light; in addition, precursors of oxidative hair colorants shall be

deemed colorants;

(j) `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;

(k) `undesirable effect' means an adverse a harmful reaction for human health

attributable to the normal or reasonably foreseeable use of a cosmetic product;

(l) `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; 16

(m) `withdrawal' means any measure aimed at preventing the making available on the

market of a cosmetic product in the supply chain;

(n) `recall' means any measure aimed at achieving the return of a cosmetic product that

has already been made available to the end user.

(o) `frame formulation' means a formulation which lists the category or function of

ingredients and their maximum concentration in the cosmetic product or gives

relevant quantitative and qualitative information whenever a cosmetic product

is not covered or only partially covered by such a formula. The Commission

shall provide indications permitting the establishment of the frame formulation

and adapt them regularly to technical and scientific progress.

OE 76/768/EEC, recital 5 (adapted)

• 2. 

  For the purposes of point (a) of paragraph 1, a substance or mixture intended to be

ingested, inhaled, injected or implanted into the human body17 shall not be considered to be

a cosmetic product.

• 3. 

  In view of the various definitions of nanomaterials published by different bodies and

the constant technical and scientific developments in the field of nanotechnologies, the

Commission shall adjust and adapt point (g) of paragraph 1 to technical and scientific

OE 93/35/EEC (adapted)

Chapter II

Safety, responsibility, free movement

Article 23

Safety

A cosmetic product made available on the market put on the market within the Community

must shall be safe for not cause damage to human health when used [] under normal or

reasonably foreseeable conditions of use, taking account, in particular, of the following :

(a) the product's presentation including conformity with Directive 87/357;

(b) its labelling,;

(c) any instructions for its use and disposal;

(d) as well as any other indication or information provided by the manufacturer or his

authorized agent or by any other person responsible for placing the product on the

Community market. the responsible person defined in Article 4.

The provision of such warnings shall not, in any event, exempt any person persons defined in

Articles 2 and 4 from compliance with the other requirements laid down in this Directive

new

Article 4

Responsible person18

• 1. 

  For each cosmetic product placed on the market, a legal or natural person shall ensure

compliance with the relevant obligations set out in this Regulation (hereinafter `responsible

person'):

• 2. 

  For a cosmetic product manufactured within the Community, and not subsequently

exported and imported back into the Community, the manufacturer established within the

Community shall be the responsible person.

The manufacturer may designate, by written mandate, a person established within the

Community as the responsible person who shall accept in writing.

• 3. 

  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 the

Community as the responsible person who shall accept in writing.19

• 4. 

  For an imported cosmetic product, each importer shall be the responsible person for the

specific cosmetic product he places on the market.

• 5. 

  For a cosmetic product [] placed on the market directly to the end user from outside the

Community by any means and in the absence of an importer, the person placing the

cosmetic product on the market shall designate, by written mandate, a person established

within the Community as the responsible person who shall accept in writing.21 22

• 6. 

  The distributor shall be the responsible person when he places a product on the

market under his name or trademark or modifies a product already placed on the

market in such a way that compliance with the applicable requirements may be

affected.

Translation of information related to a cosmetic product already placed on the

market shall not be considered as a modification of this product of such a nature that

compliance with the applicable requirements of this Regulation may be affected.

Article 4 a

Obligations of the responsible person

• 1. 

  The responsible person shall ensure compliance with Articles 3 (safety), 5 (GMP), 7

(safety assessment), 8 (product information file), 9 (sampling and analysis), 10

(notification), 11 (restrictions for substances listed in Annexes), 12 (CMR), [12a

(nanomaterials),] 13 (traces), 14 (animal testing), 15 paragraphs (1),(2),(5) and (6)

(labelling), 16 (claims), 17 (information to the public), 19 (communication of SUE)

and 20 (information on substances)23.

• 2. 

  Responsible persons who consider or have reason to believe that a product which they

have placed on the market is not in conformity with this regulation shall immediately

take the necessary corrective measures to bring that product into conformity or

withdraw it from the market and recall it, if appropriate.

Furthermore, where the product presents a risk24, they shall immediately inform the

competent national authorities of the Member States where they made the product

available and of the Member State where the product information file is readily

accessible to this effect, giving details, in particular, of the non-compliance and 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 products which they have made

available on the market. In particular, responsible persons shall, further to a

reasoned request from a competent national authority, provide it with all the

information and documentation necessary to demonstrate the conformity of specific

aspects of the product, in a language which can be easily understood by that

authority.

Article 4 b

Obligations of the distributors

• 1. 

  In the context of their activities, when making a product available on the market,

distributors shall act with due care in relation to the applicable requirements.

• 2. 

  Before making a product available on the market distributors shall verify that:
• - 

  the labelling information provided by Article 15 (1)(a), (e) and (g) and Article 15

(3) and (4) is present;

• - 

  the language requirements provided by Article 15(5) are fulfilled;
• - 

  date of minimum durability specified, when applicable in Article 15(1) is not

expired.

• 3. 

  Where distributors consider or have reason to believe that:
• - 

  a product is not in conformity with the requirements provided by this

Regulation, they shall not make the product available on the market until it has

been brought into conformity with the applicable requirements;

• - 

  a product which they have made available on the market is not in conformity

with the Regulation, they shall make sure that the corrective measures

necessary to bring that product into conformity, to withdraw it or to recall it

are taken.

Furthermore, where the product presents a risk, distributors shall immediately

inform the responsible person and the competent national authorities of the Member

States where they made the product available to this effect, giving details, in

particular, of the non-compliance and of the corrective measures taken.

• 4. 

  Distributors shall ensure that, while a product is under their responsibility, storage or

transport conditions do not jeopardise its compliance with the requirements set out in

this Regulation.

• 5. 

  Distributors shall cooperate with competent authorities, at the request of the latter,

on any action to eliminate the risks posed by products which they have made

available on the market. In particular, distributors shall, further to a reasoned

request from a competent national authority, provide it with all the information and

documentation necessary to demonstrate the conformity of the product with the

requirements listed under paragraph 2, in a language which can be easily understood

by that authority.

Article 4 c

Identification within the supply chain

On request of the competent authorities:

• - 

  the responsible persons shall be able to identify the distributors to whom they supply

the cosmetic product [] ;

• - 

  the distributor shall be able to identify the distributor or the responsible person from

whom, and the distributors to whom, the cosmetic product was supplied.

This obligation shall be kept during a period of 3 years following the date when the batch of

the cosmetic product was made available to the distributor.

OE 76/768/EEC (adapted)

Article 3

Member States shall take all necessary measures to ensure that only cosmetic products which

conform to the provisions of this Directive and its Annexes may be put on the market.

OE 93/35/EEC (adapted)

Article 5

Good manufacturing practice

• 1. 

  Manufacturing of cosmetic products shall comply with good manufacturing practice25 with

a view to ensure the objectives of Article 1.

new

• 2. 

  Compliance with good manufacturing practice shall be presumed where manufacturing is

in accordance with the relevant harmonised standards, the references of which have been

published in the Official Journal of the European Union.26

OE 76/768/EEC (adapted)

Article 6

Free movement

Member States may not, for reasons related to the requirements laid down in this Directive and the

Annexes thereto Regulation , refuse, prohibit or restrict the marketing making available

on the market of any cosmetic products which comply with the requirements of this Directive

and the Annexes thereto Regulation .

OE 93/35/EEC (adapted)

new

Chapter III

Safety assessment, product information file, notification

Article 7a 7

Safety assessment

• 1. 

  In order to ascertain compliance of cosmetic product 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 that

a cosmetic product safety report in accordance with Annex I is set up.

The responsible person shall ensure that:

(a) the intended use of the cosmetic product and the anticipated systemic exposure to

individual ingredients in a final formulation is taken into account in the safety

assessment;

(b) an appropriate weight-of-evidence approach is used in the safety assessment for

reviewing [relevant] data from [several] all existing sources [, including data from in-

vitro, in-silico, existing GLP (Good Laboratory Practice) or non-GLP in-vivo and

• 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, certificate or other evidence of formal

qualifications awarded on completion of a university course of study of theoretical and

practical study in pharmacy, toxicology, medicine or a similar discipline, or a course

recognised as equivalent by a Member State, [extending over a period of at least three

years of theoretical and practical study in pharmacy, toxicology, medicine or a similar

discipline27.

• 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 the 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 European Chemicals

Agency.

28

Article 8

Product information file

• 1. 

  When a cosmetic product is placed on the market, the responsible person

manufacturer or his agent or the person to whose order a cosmetic product is manufactured

or the person responsible for placing an imported cosmetic product on the Community

market shall for control purposes keep a product information file for the cosmetic

product for which he is the responsible person. the following information readily

accessible to the competent authorities of the Member State concerned at the address

specified on the label in accordance with Article 6 (1) (a):The product information file

shall be kept during a period of ... [10 years] following the date when 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 shall

be [regularly] updated when necessary:

(a) a description of the cosmetic product which allows for a clear attribution of the product

information file to the cosmetic product;

(b) the cosmetic product safety report referred to in Article 7(1);

(c) a description of the method of manufacturing and a statement on compliance with good

manufacturing practice referred to in Article 5;

(c) the method of manufacture complying with the good manufacturing practice laid down

-

by Community law or, failing that, laid down by the law of the Member State concerned;

the person responsible for manufacture or first importation into the Community must

possess an appropriate level of professional qualification or experience in accordance with

the legislation and practice of the Member State which is the place of manufacture or first

importation;

OE 2003/15/EC Art. 1.6 (adapted)

(d) assessment of the safety for human health of the finished product. To that end the

manufacturer shall take into consideration the general toxicological profile of the

ingredients, their chemical structure and their level of exposure. It shall take particular

account of the specific exposure characteristics of the areas on which the product will be

applied or of the population for which it is intended. 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 in external intimate hygiene.

Should the same product be manufactured at several places within Community territory,

the manufacturer may choose a single place of manufacture where that information will be

available. In this connection, and when so requested for monitoring purposes, it shall be

obliged to indicate the place so chosen to the monitoring authority or authorities

concerned. In this case this information shall be easily accessible;

OE 93/35/EEC (adapted)

(e) the name and address of the qualified person or persons responsible for the assessment

referred to in (d). That person must hold a diploma as defined in Article 1 of Directive

89/48/EEC in the field of pharmacy, toxicology, dermatology, medicine or a similar

discipline;

(f) existing data on undesirable effects on human health resulting from use of the cosmetic

-

product;

(dg) where justified by the nature or the effect of the cosmetic product, proof of the

effect claimed for the cosmetic product, where justified by the nature of the effect or

product;

OE 2003/15/EC Art. 1.7 (new)

(eh) data on any animal testing performed by the manufacturer, his agents or suppliers,

relating to the development or safety evaluation assessment of the cosmetic

product or its ingredients, including any animal testing performed to meet the legislative or

regulatory requirements of third non-member countries.

Without prejudice to the protection, in particular, of commercial secrecy and of intellectual

property rights, Member States shall ensure that the information required under (a) and (f)

shall be made easily accessible to the public by any appropriate means, including

electronic means. The quantitative information required under (a) to be made publicly

accessible shall be limited to dangerous substances covered by Directive 67/548/EEC.

• 2. 

  The assessment of the safety for human health referred to in paragraph 1 (d) shall be

carried out in accordance with the principle of good laboratory practice laid down in

Council Directive 87/18/EEC of 18 December 1986 on the harmonization of laws,

regulations and administrative provisions relating to the application of the principles of

good laboratory practice and the verification of their application for tests on chemical

substances (29).

• 3. 

  The responsible person shall make the product information file readily accessible in

electronic or other format at his address indicated on the label to the competent authority

of the Member State where the file is kept.

The information referred to in paragraph 1 contained in the product information file

must shall be available in [ ] a language readily which can be easily understood by

the competent authorities of the Member State [as determined by the Member State

concerned].

• 4. 

  The requirements provided in paragraphs 1 to 3 shall also apply to cosmetic products

that have been notified under Directive 76/768/EEC.

• 4. 

  The manufacturer or his agent, or the person to whose order a cosmetic product is

manufactured, or the person responsible for placing imported cosmetic products on the

Community market, shall notify the competent authority of the Member State of the place

of manufacture or of the initial importation of the address of the place of manufacture or of

initial importation into the Community of the cosmetic products before the latter are placed

on the Community market.

• 5. 

  Member States shall designate the competent authorities referred to in paragraphs 1 and 4

and shall send details thereof to the Commission, which shall publish that information in

the Official Journal of the European Communities.

The Member States shall ensure that the abovementioned authorities continue to cooperate

in areas where such cooperation is necessary to the smooth application of this Directive.

OE 82/368/EEC (adapted)

Article 930

Sampling and analysis

• 1. 

  Sampling and analysis of cosmetic products shall be performed in a reliable and

reproducible manner. new

• 2. 

  In 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 the European Union.

OE 76/768/EEC (adapted)

Article 710

otification

OE 93/35/EEC

• 2. 

  They may, however, require that the particulars provided for in Article 6 (1) (b), (c), (d) and (f)

be expressed at least in their own national or official language or languages; they may also require

that the particulars provided for in Article 6 (1) (g) be expressed in a language easily understood by

the consumer. To that end, the Commission shall adopt a common ingredients nomenclature in

accordance with the Article 10 procedure.

• 3. 

  Furthermore, a Member State may, for purposes of prompt and appropriate medical treatment in

the event of difficulties, require that appropriate and adequate information on substances used in

cosmetic products be made available to the competent authority, which shall ensure that that

information is used only for the purposes of such treatment.

Each Member State shall designate a competent authority and send details thereof to the

Commission, which shall publish that information in the Official Journal of the European

Communitites.

new

• 1. 

  Prior to placing the cosmetic product on the market the responsible person shall

submit, through electronic means, prior to placing the cosmetic product on the market, 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 is made

readily accessible;

(ba) the country of origin in case of import;

(c) the Member State where the cosmetic product is placed on the market31;

(d) the contact details of a physical person to contact in the case of necessity;

(f) the name and the CAS or EC number of substances classified as carcinogenic,

mutagenic or toxic for reproduction, of category 1A or 1B, under part 3 of Annex VI to

Regulation (EC) No ... [];

(g) the frame formulation allowing for prompt and appropriate medical treatment in the event of

-

difficulties;

32

[2. The frame formulation referred in point (g) of paragraph 1 shall ...]

The first subparagraph shall also apply to cosmetic products notified under Directive

76/768/EEC.

[When the product is placed on the market, the responsible person shall notify the original

labelling, and, where reasonably practicable, a photograph of the corresponding packaging.]33

• 2. 

  As from the date referred to in Article 34(2), a distributor who makes available in a

Member State a cosmetic product already 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, shall submit, through 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 where it is made available, enabling its specific

identification;

(b) the Member State where the cosmetic product is made available;

(c) the name and address of the responsible person where the product information

file is made readily accessible;

(d) his name and address.

• 3. 

  Where a cosmetic product is not placed on the market as from the date referred to in

Article 34(2), the distributor who makes available introduces that product in a

Member State 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 where it is made available, enabling its specific

identification;

(b) the Member State where the cosmetic product is made available;

(c) his name and address.

On the basis of that communication, the responsible person shall submit, through

electronic means, to the Commission the information referred to paragraph 1 of this

Article, where notifications according to Article 7(3) and Article 7a (4) of Directive

76/768/EEC have not been carried out in the Member State where the cosmetic

product is made available.

• 4. 

  The Commission shall, without delay, make [] the information referred to in points (a) to

(f) of paragraph 1 and in paragraph 2 available electronically to all the competent

authorities.

That information may only be used by the competent authorities for the purposes of market

surveillance, market analysis, evaluation and consumer information [in the context of

Articles 21, 21a and 22]34.

• 5. 

  The Commission shall, without delay, make [] the information referred to in paragraphs 1

and 2 available electronically to poison centres or similar bodies, where established to

this end by Member States.

That information may only be used by those bodies for the purposes of medical treatment.

• 6. 

  Where any of the information set out in paragraphs 1, 2 and 3 changes, the responsible

person and the distributor shall provide an update without delay.

• 7. 

  The Commission may, taking into account technical and scientific progress and specific

needs related to market surveillance, amend paragraphs 1 to 6 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 27 (3).

OE 82/368/EEC (adapted)

new

Chapter IV

Restrictions for certain substances

Article 411

Restrictions for substances listed in the Annexes

• 1. 

  Without prejudice to Article 3, their general obligations deriving from Article 2,

Member States shall prohibit the marketing of cosmetic products shall not contain

containing any of the following :

(a) Prohibited Substances

• - 

  prohibited substances listed in Annex II;

(b) Restricted Substances

• - 

  restricted substances listed in the first part of Annex III, beyond the limits and outside

the conditions which are not used in accordance with the restrictions laid down

in Annex III ;

OE 88/667/EEC (new)

new

(c) Colorants

i)colorants other than those listed in Annex IV and colorants thereby listed but

which are not used in accordance with the conditions laid down in that Annex, except

for hair colouring products referred to in paragraph 2colorants colouring agents other

than those listed in Annex IV, Part 1, with the exception of cosmetic products containing

colouring agents intended solely to colour hair and colorants which are not used in

accordance with the conditions laid down in that Annex ;

(d) colouring agents listed in Annex IV, Part 1, used outside the conditions laid down, with

the exception of cosmetic products containing colouring agents intended solely to colour

hair;

• 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 a colorant, and which are not used in accordance

with the conditions laid down in that Annex.

OE 82/368/EEC (adapted)

(d) Preservatives

• i) 

  preservatives other than those listed in Annex VI, Part 1, V and preservatives

thereby listed but which are not used in accordance with the conditions laid down in that

Annex ;

new

• ii) 

  without prejudice to points (b) (c) i) and (e) i), substances listed in Annex V but which

are not intended to be used as preservatives, and which are not used in accordance with the

conditions laid down in that Annex.

OE 82/368/EEC (new)

(f) preservatives listed in Annex VI, Part 1, beyond the limits and outside the conditions laid

down, unless other concentrations are used for specific purposes apparent from the

presentation of the product;

OE 83/574/EEC (adapted)

(e) UV-filters

• i) 

  UV-filters other than those listed in Part 1 of Annex VII VI and UV-filters thereby

listed but which are not used in accordance with the conditions set out 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 in accordance with the

conditions laid down in that Annex.

(h) UV filters listed in Part 1 of Annex VII, beyond the limits and outside the conditions

laid down therein.

new

• 2. 

  Subject to a Commission Decision to extend the scope of Annex IV to hair colouring

products, these products shall not contain colorants intended to colour the hair, other than

those listed in Annex IV and colorants intended to colour the hair, which are not used in

accordance with the conditions laid down in that Annex.

OE 2003/15/EC Art. 1.2 (adapted)

new

Article 4b1235

Substances classified as carcinogenic, mutagenic or toxic for reproduction

(1) The use in cosmetic products of substances classified as carcinogenic, mutagenic or toxic

for reproduction, of category 1, 2 and [3, under Annex I to Directive 67/548/EEC] 2,

under part 3 of Annex VI of Regulation (EC) No ... of the European Parliament and

of the Council of ... on Classification, Labelling and Packaging of Substances and

Mixtures shall be prohibited. To that end the Commission shall adopt the necessary

measures in accordance with the procedure referred to in Article 10(2). However, a

A substance classified in category []2 may be used in cosmetic products cosmetics

if the substance has been evaluated by the []SCCS SCCNFP and found acceptable

safe for use in cosmetic products. To these ends the Commission shall adopt the

necessary measures in accordance with the procedure referred to in Article 27(3) 36 .

new

(2) The use in cosmetic products of substances classified as carcinogenic, mutagenic or toxic

for reproduction, of category [1 or 2, under Annex I to Directive 67/548/EEC] 1A, 1B

under part 3 of Annex VI of Regulation (EC) No ... of the European Parliament and

of the Council of ... on Classification, Labelling and Packaging of Substances and

Mixtures shall be prohibited.

However, such substances may be used in cosmetic products by way of exception if,

subsequent to [] their classification as carcinogenic, mutagenic or toxic for reproduction of

category[1 or 2 under Directive 67/548/EEC] 1A and 1B under part 3 of Regulation

(EC) No ... of the European Parliament and of the Council of ... on Classification,

Labelling and Packaging of Substances and Mixtures, all of the following conditions

are fulfilled in the following order:

[shifted]

either:

(a) (i) they are complying37 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 the European Food Safety Authority and laying down procedures in

matters of food safety38;

[or, in case the above sub-paragraph does not apply:

• - 

  they have a history of safe use as ingredients in cosmetic products without

safety concerns in regard to their carcinogenic, mutagenic or reproduction

toxic properties, and

• - 

  in establishing adequate safety margins, the threshold and specificity of the

CMR effect have been taken into account together with possible mixture

effects.]

(ii) there are no suitable alternative substances available, as documented in an

analysis of alternatives;

(iii) the application is made for a particular use of the product category with a

known exposure; and

(iv) they have been evaluated and found safe for use by the []SCCS in cosmetic

Specific labelling in order to avoid misuse of the cosmetic product shall be provided in

accordance with Article 3, taking into account possible risks linked to the presence of

hazardous substances and the routes of exposure.40

In order to implement this paragraph, the Commission shall amend the Annexes to this

Regulation in accordance with the procedure referred to in Article 27(3) within 15 months

at the latest after the inclusion of the substances concerned [in Annex I to Council

Directive 67/548/EEC] in part 3 of annex VI of Regulation (EC) No ... of the European

Parliament and of the Council of ... on Classification, Labelling and Packaging of

Substances and Mixtures.

On imperative grounds of urgency, the Commission may use the urgency procedure

referred to in Article 27(4).

The Commission shall mandate the [] SCCS to re-evaluate those substances as soon as

safety concerns arise and at the latest every 5 years after their inclusion in Annexes III to

VI.

41

42

(2a) By [add date: two years after the date of entry into force], the Commission shall ensure

that appropriate guidance is developed with the aim of enabling a harmonised

approach to the development and use of overall exposure estimates in assessing the safe

use of CMR substances. This guidance shall be developed in consultation with the

SCCS, the ECHA, the EFSA and other relevant stakeholders, drawing as appropriate

on relevant best practice.

(2b) When Community or internationally agreed criteria for identifying substances with

endocrine-disrupting properties are available, or at the latest 5 years after this

Regulation has entered into force, the Commission shall review the Regulation with

regard to substances with endocrine-disrupting properties.

Article 12 a

anomaterials

• 1. 

  For every product that contains nanomaterials as defined in Article 2, a high level of

protection of human health shall be ensured.

1a. The provisions of this Article do not apply to nanomaterials used as colorants, UV-filters

and preservatives regulated under Article 11, unless expressly specified.

• 2. 

  In addition to the notification in Article 10, cosmetic products containing nanomaterials

shall be notified by the responsible person to the Commission through electronic means

6 months prior to the placing on the market, except when these are in conformity with

the requirements set out in Annex III.

(a) The information notified to the Commission shall contain at least the following:

(i) the identification and specification of the nanomaterial including its chemical

name (IUPAC) and other descriptors as specified in paragraph 2 of the

Preamble to Annexes II to VI;

(ii) the specification of the nanomaterial including size of particles, physical and

chemical properties;

(iii) [] an estimate of the quantity intended to be placed on the market per year;

(iv) the toxicological profile of the nanomaterial;

• 3. 

  In case the Commission has concerns regarding the safety of the nanomaterial, the

Commission shall, without delay, request the SCCS to give its opinion on the safety of

these nanomaterials for the relevant categories of cosmetic products and the reasonably

foreseeable exposure conditions. The Commission shall make this information public

inform the responsible person and the Committee referred to in Article 27 (1). The

SCCS shall give its opinion within six months of the Commission request. If any missing

data are defined by the SCCS, the Commission shall require the responsible person to

provide them within one explicitly stated reasonable time, which shall not be extended.

The SCCS shall give its final opinion within six months of submission of additional data.

The opinion of the SCCS shall be made publicly available.

• 4. 

  The Commission may, at any time, invoke the procedure in the previous paragraph if it

has any safety concerns, for example due to new information supplied by a third party.

• 5. 

  Taking into account the opinion of the SCCS, and where there is a potential risk to

human health, including when there is insufficient data, the Commission shall make this

information public and may amend Annexes II and III of this Regulation. The

Commission shall immediately inform the responsible person, stating the grounds of its

decision.

5a. The Commission may, taking into account technical and scientific progress, amend

paragraph 2a by adding requirements.

• 8. 

  The following information shall be made available by the Commission:

(a) By [add date: forty two months after the date of entry into force of this

Regulation], the Commission shall make available a list of all nanomaterials used

in cosmetic products, including those used as colorants, UV-filters and

preservatives in a separate section, placed on the market, indicating the specific

categories of cosmetic products and the reasonably foreseeable exposure

conditions. This list shall be regularly updated thereafter and be made publicly

available.

(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 as

colorants, UV-filters and preservatives in a separate section. The first report will

be presented before the [add date: forty-eight months after date of entry into

force]. The report update shall summarise, in particular, the new nanomaterials in

new categories of cosmetic products, the number of notifications, the progress

made in developing nano-specific assessment methods and safety assessment

guides, and information on international cooperation programmes.

• 9. 

  The Commission shall regularly review the provisions of this Regulation concerning

nanomaterials in the light of scientific progress and, where necessary, shall propose

OE 82/368/EEC (adapted)

Article 13

Traces of prohibited substances

The non intended presence of small quantity of a prohibited substance[], stemming from

impurities of natural or synthetic ingredients, the manufacturing process, storage, migration

from transport facilities or packaging, which [cannot be eliminated by current technology or]

is technically unavoidable in good manufacturing practice, shall be allowed provided that such

presence is in conformity with Article 3.

OE 2003/15/EC Art. 1.2 (adapted)

new

Chapter V

Animal testing

Article 4a 1443

Animal testing

• 1. 

  Without prejudice to the general obligations deriving from Article 23, the following

shall not be allowed be prohibited Member States shall prohibit:

(a) the marketing placing on the market of cosmetic products where the final

formulation, in order to meet the requirements of this Regulation Directive, 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 development of validation within the OECD;

(b) the placing on the market marketing of cosmetic products containing ingredients or

combinations of ingredients which, in order to meet the requirements of this

Regulation Directive, have 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 development of validation within the OECD;

(d) the performance within the Community on their territory of animal testing of

ingredients or combinations of ingredients in order to meet the requirements of this

Regulation Directive, no later than the date on which such tests are required to be

replaced by one or more validated alternative methods listed in [Annex V to Council

Directive 67/548/EEC] 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)44of 27 June 1967 on the approximation of laws,

regulations and administrative provisions relating to the classification, packaging and

labelling of dangerous substances45 or in Annex VIIIIX to this Regulation

Directive.

No later than 11 September 2004 the Commission shall, in accordance with the procedure

referred to in Article 10(2) and after consultation of the Scientific Committee on Cosmetic

Products and Non-Food Products intended for consumers (SCCNFP) establish the contents

of Annex IX.

• 2. 

  The Commission, after consultation of the SCCNFP []SCCS and of the European

Centre for the Validation of Alternative Methods (ECVAM) and with due regard to the

development of validation within the OECD, shall establish has established

timetables for the implementation of the provisions under paragraph 1(a), (b) and (d),

including deadlines for the phasing-out of the various tests. The timetables shall be

were made available to the public on 1st October 2004 not later than 11

2.1. In relation to the tests concerning repeated-dose toxicity, reproductive toxicity and

toxicokinetics, 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 a

maximum of 10 years after the entry into force of Directive 2003/15/EC.

2.2. The Commission shall study possible technical difficulties in complying with the ban

in relation to tests, in particular those concerning repeated-dose toxicity, reproductive

toxicity and toxicokinetics, for which there are no alternatives yet under consideration.

Information about the provisional and final results of these studies should form part of the

yearly reports presented pursuant to Article 930.

On the basis of these annual reports, the timetables established in accordance with

paragraph 2 , first subparagraph, may be adapted up to 11 March 2009

within a maximum time limit of six years in relation to as referred to in the first

subparagraph paragraph 2 or 11 March 2013 10 years in relation to as

referred to in the second subparagraph paragraph 2.1 and after consultation of the entities

referred to in the first subparagraph paragraph 2.

2.3 The Commission shall study progress and compliance with the deadlines as well

as possible technical difficulties in complying with the ban. Information about the

provisional and final results of the Commission studies should form part of the yearly

reports presented pursuant to Article 930. If these studies conclude, at the latest two years

prior to the end of the maximum period referred to in the second subparagraph paragraph

2.4 In exceptional circumstances where serious concerns arise as regards the safety of

an existing cosmetic ingredient a Member State may request the Commission to grant a

derogation from paragraph 1. The request shall contain an evaluation of the situation and

indicate the measures necessary. On this basis, the Commission may, after consultation of

the []SCCS SCCNFP and by means of a reasoned decision, authorise the

derogation in accordance with the procedure referred to in Article 10(2). This authorisation

shall lay down the conditions associated with this derogation in terms of specific

objectives, duration and reporting of the results.

The measures referred to in the first subparagraph, designed to amend non-essential

elements of this Regulation, shall be adopted in accordance with the regulatory procedure

with scrutiny referred to in Article 27(3).

A derogation shall only be granted if:

(a) the ingredient is in wide use and cannot be replaced by another ingredient able to

-

perform 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 the basis 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 to be presented by the Commission in

OE 88/667/EEC (adapted)

Article 5

Member States shall allow the marketing of cosmetic products containing:

(a) the substances listed in Annex III, Part 2, within the limits and under the conditions laid

-

down, up to the dates in column (g) of that Annex;

(b) the colouring agents listed in Annex IV, Part 2, within the limits and under the

-

conditions laid down, until the admission dates given in that Annex;

(c) the preservatives listed in Annex VI, Part 2, within the limits and under the condition

laid down, until the dates given in column (f) of that Annex. However, some of these

substances may be used in other concentrations for specific purposes apparent from the

presentation of the product;

(d) the UV filters listed in Part 2 of Annex VII, within the limits and under the

conditions laid down, until the dates given in column (f) of that Annex.

At these dates, these substances, colouring agents, preservatives and UV filters shall be:

definitively allowed, or

definitively prohibited (Annex II), or

OE 93/35/EEC

Article 5a

• 1. 

  No later than 14 December 1994 the Commission shall, under the procedure laid down in Article

10, compile an inventory of ingredients employed in cosmetic products, on the basis in particular of

information supplied by the industry concerned.

For the purposes of this Article, `cosmetic ingredient' shall mean any chemical substance or

preparation of synthetic or natural origin, except for perfume and aromatic compositions, used in

the composition of cosmetic products.

The inventory shall be divided into two sections: one concerning perfume and aromatic raw

materials and the second concerning other substances.

• 2. 

  The inventory shall contain informtion on:

the identity of each ingredient, in particular its chemical name, the CTFA name, the European

Pharmacopoeia name, the international non-proprietary names recommended by the World

Health Organization, the Einecs, Iupac, CAS and colour index numbers, and the common

name referred to in Article 7 (2),

the usual function(s) of the ingredient in the final product,

OE 88/667/EEC (adapted)

Chapter VI

Consumer information

Article 615

Labelling47

OE 93/35/EEC (adapted)

• 1. 

  Member States shall take all measures necessary to ensure that cosmetic products may be

marketed only if the Without prejudice to other provisions in this Article, cosmetic

products shall only be made available on the market if [ the responsible person shall

label ] the container and packaging of cosmetic products shall bear the bear [

with ] the following information in indelible, easily legible and visible lettering; the

information mentioned in point (g) may, however, be indicated on the packaging alone:

OE 88/667/EEC (adapted)

new

(a) the name or style and the address or registered office of the manufacturer or the

responsible person responsible for marketing the cosmetic product who is

(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, free samples 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 information need not be given if the

number of items is easy to see from the outside or if the product is normally only sold

individually;

OE 2003/15/EC Art. 1.3 (adapted)

new

(c) the date of minimum durability date until which the cosmetic product, stored under

appropriate conditions, continues to fulfil its initial function and, in particular, remains in

conformity with Article 3 (hereinafter: "date of minimum durability");

The date itself or details of where it appears on the packaging shall be preceded

by

the symbol given in point 3 of Annex VII to this Regulation or indicated by

the words: `best used before the end of'. followed by either: the date itself, or

details of where it appears on the packaging;

Indication of the date of minimum durability shall not be mandatory for cosmetic

products with a minimum durability of more than 30 months49. For such products, there

shall be an indication of the period of time after opening for which the product is safe

and can be used without any harm to the consumer50. This information shall be

indicated, except when the concept of the durability after opening is not relevant, by

the symbol given in Annex VIIIa set out in point 2 of Annex VII to this Regulation

followed by the period (in months and/or years);

OE 93/35/EEC (adapted)

(d) particular precautions to be observed in use, and at least especially those listed in

the column `Conditions of use and warnings which must be printed on the label'

inAnnexes III to VI III, IV, VI and VII, which must appear on the container and packaging,

and as well as any special precautionary information on cosmetic products for

professional use.., in particular in hairdressing. Where this is impossible for practical

reasons, an enclosed leaflet, label, tape or card must contain that information to which the

consumer is referred either by abbreviated information or the symbol given in Annex VIII,

which must appear on the container and the packaging;

OE 88/667/EEC (adapted)

(e) the batch number of manufacture or the reference for identifying the cosmetic

product51 goods. Where this is impossible for practical reasons because the cosmetic

products are too small, such information need appear only on the packaging52;

OE 93/35/EEC (adapted)

(f) the function of the cosmetic product, unless it is clear from its the

presentation of the product;

OE 2003/15/EC Art. 1.4 (adapted)

new

(g) a list of ingredients in descending order of weight at the time they are added. This

information may be indicated on the packaging alone. The That list shall be preceded

by the term word`ingredients'. Where that is impossible for practical reasons, an

enclosed leaflet, label, tape or card must contain the ingredients to which the consumer is

referred either by abbreviated information or the symbol given in Annex VIII, which must

appear on the packaging.

For the purpose of this article 'ingredient' means any substance or mixture of

substances intentionally used [added] to 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 preparation but not present in the

final product,

(iii) - materials used in strictly necessary quantities as solvents or as carriers

for perfume and aromatic compositions.

Perfume and aromatic compositions and their raw materials shall be referred to by

the terms `parfum' word `perfume' or `aroma'. Moreover, the presence of

substances, the mention of which is required under the column `Other limitations and

requirements' in Annex III, shall be indicated in the list of ingredients in addition to the

said terms parfum or aroma.. irrespective of their function in the product.

[ Perfume and aromatic compositions and their raw materials shall be referred to by the

terms `parfum' word `perfume' or `aroma'53. However, allergenic fragrances,

listed in annex III, if added, as such, at concentrations exceeding 0,01 % by weight,

shall be explicitly listed in the list of ingredients. ]

The list of ingredients shall be established in descending order of weight of the

Colouring agents Colorants other than colorants intended to colour the hair may be

listed in any order after the other cosmetic ingredients, in accordance with the

colour index number or denomination adopted in Annex IV. For decorative cosmetic

products marketed in several colour shades, all colouring agents colorants other than

colorants intended to colour the hair used 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.

An ingredient must be identified by the common name referred to in Article 7(2) or, failing

that, by one of the names referred to in Article 5a(2), first indent.

In accordance with the procedure referred to in Article 10(2), the Commission may adapt

the criteria and conditions set out in Commission Directive 95/17/EC of 19 June 1995

laying down detailed rules for the application of Council Directive 76/768/EEC as regards

the non-inclusion of one or more ingredients on the list used for the labelling of cosmetic

products55 under which a manufacturer may, for reasons of trade secrecy, apply not to

include one or more ingredients on the abovementioned list.

OE 93/35/EEC (adapted)

• 2. 

  When it is impossible for practical reasons to label the information mentioned in

points (d) and (g) of paragraph 1 as provided, the following applies:

The information shall be mentioned on an enclosed or attached leaflet, label, tape, tag

or card;

Unless impracticable, this information shall be referred to by abbreviated information

or the symbol given in point 1 of Annex VII, which must appear on the container or

packaging for the information referred in point (d) of paragraph 1 and on packaging for

the information referred in point (g) of paragraph 1.

Where it is impracticable, for reasons of size or shape, for the particulars referred to in

points (d) and (g), to appear in an enclosed leaflet, those particulars shall appear on a label,

tape or card which is enclosed or attached to the cosmetic product.

• 3. 

  In the case of soap, bath balls and other small products where it is impossible for

practical reasons impracticable, for reasons of size or shape, for the particulars referred

to in point (g) of paragraph 1 point (g) to appear on a label, tag, tape or card or in

an enclosed leaflet, those particulars shall appear on a notice in immediate proximity to the

container in which the cosmetic product is exposed for sale.56

• 42. 

  For cosmetic products that are not pre-packaged, are packaged at the point of sale at the
• 5. 

  The language of the information mentioned in points (b), (c), (d) and (f) of paragraph 1

and in paragraphs (2) to (4) shall be determined by the law of the Member States in

which the product is made available to the end user.

• 6. 

  The distributors and persons making the product available to the end user [] have to

make sure/verify that the requirements set out in paragraphs [] 1 to 5 are fulfilled.

7 The information mentioned in point (g) of paragraph 1 shall be expressed by using the

common ingredient name set out in the glossary provided for in Article 28. In the absence

of a common ingredient name, a term as contained in a generally accepted nomenclature

shall be used.

OE 88/667/EEC (adapted)

L1 2003/15/EC Art. 1.5

Article 16

Product claims

3.1. Member States shall take all measures necessary to ensure that, iIn the labelling, putting up

for sale making available on the market and advertising of cosmetic products, text,

names, trade marks, pictures and figurative or other signs shall are not be

used to imply that these products have characteristics or functions 57 which they do not

have. L ---

• 2. 

  The Commission, in cooperation with Member States, shall establish an action plan

regarding claims used and fix priorities for determining common criteria justifying

the use of a claim.

After consultation of the SCCS or other relevant authorities, the Commission shall

adopt a list of common criteria for claims which may be used in respect of cosmetic

products, in accordance with the regulatory procedure with scrutiny referred to in

Article 27(3), taking into account provisions of Directive 2005/29/EC.

Three years after the date of application of the Regulation, 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 previous 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.

OE 2003/15/EC Art. 1.5 (adapted)

3[2]. Furthermore, the manufacturer or The responsible person responsible for placing

the product on the Community market may refer take advantage, on the product

packaging or in any document, notice, label, ring or collar accompanying or referring to

the cosmetic product, to of the fact that no animal tests have been carried

out only if the manufacturer and his suppliers have not carried out or commissioned any

OE 2003/15/EC Art. 1.7 (adapted)

Article 17

Access to information for the public

Without prejudice to the protection, in particular, of commercial secrecy and of intellectual property

rights, Member States the responsible person shall ensure that the qualitative and

quantitative composition of the cosmetic product and, in the case of perfume compositions and

perfumes, 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 is information required under (a) and (f) shall be made easily easily

accessible to the public by any appropriate means, including electronic means.

The quantitative information regarding composition of the cosmetic product required under

(a) to be made publicly accessible shall be limited to hazardous []substances [covered by Directive

67/548/EEC] in accordance with Article 3 of Regulation (EC) No ... of the European

Parliament and of the Council of ... on Classification, Labelling and Packaging of Substances

and Mixtures.

[]

new

Chapter VII

Market surveillance

Article 18

In-market control

Member States shall survey compliance with this Regulation via in-market controls of the cosmetic

products made available on the market. They shall perform appropriate checks of products and

on the economic operators on an adequate scale, through the product information file and,

where appropriate, physical and laboratory checks on the basis of adequate samples.

Member States shall also survey compliance with good manufacturing practices principles.59

Member States shall entrust market surveillance authorities with the necessary powers,

resources and knowledge in order 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 fourth year and the

results thereof shall be communicated to the other Member States and the Commission and

be made available to the public, by way of electronic communication and, where appropriate,

by other means.60

Article 1961

Communication of serious undesirable effects

• 1. 

  The responsible person62 and the distributors shall without delay notify the following to

the competent authority of the Member State where the serious undesirable effect

occurred where the product information file is readily accessible63:

(a) all serious undesirable effects which are known to him or which should reasonably be

expected to be known to him64,

(b) the [complete commercial] name of the product concerned, enabling its specific

-

identification;

(c) the corrective measures taken by him, if any;

• 2. 

  When the responsible person reports serious undesirable effects to the competent

authority of the Member State where the [serious undesirable] effect occurred, this

competent authority shall immediately transmit the information referred to in paragraph 1

[concerning the product] [, together with any other information available on serious

undesirable effects coming from consumer or health professionals,] to the competent

authorities of the other Member States [].

2a. When distributors report serious undesirable effects to the competent authority of the

Member State where the effect occurred, this competent authority shall immediately

2b. When end users or health professionals report serious undesirable effects to the

competent authority of the Member State where the effect occurred, this competent

authority shall immediately transmit the information on the product concerned to the

competent authorities of the other Member States and to the responsible person.

• 3. 

  Competent authorities may use the information referred to in this Article [only] for the

purposes of in-market surveillance, market analysis, evaluation and consumer

information in the context of Articles 21, 21a and 2265.

Article 20

Information on [concentration of] substances

In case of serious doubt regarding the safety of any substance contained in cosmetic products, the

competent authority of a Member State where a product containing such a substance is made

available 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 shall

indicate the concentration of this substance in the cosmetic products.66

Competent authorities may use the information referred to in this Article [only] for the purposes of

in-market surveillance, market analysis, evaluation and consumer information in the context of

Articles 21, 21a and 2267.

Chapter VIII

Non-compliance, safeguard clause

Article 21 68

on 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 product

into compliance69, 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:

70

(c) the good manufacturing practices referred to in Article 5;

-

(-a) the safety assessment referred to in Article 7;

(a) the requirements for the product information file referred to in Article 8;

-

(aa) the provisions on sampling and testing referred to in Article 9;

(b) the notification requirements referred to in Article 10;

(d) the restrictions for substances referred to in Articles 11, 12 and 13;

(g) the animal testing requirements referred to in Article 14.

(e) the labelling requirements referred to in Article 15(1), (2), (5) and (6);

(f) the requirements related to product claims set out in Article 16;

(h) the access to information for the public referred to in Article 17;

(i) the communication of serious undesirable effects referred to in Article 19;

(j) the information requirements on substances referred to in Article 20.

1a. Where applicable, the competent authority shall inform the competent authority of

the Member State where the responsible person is established of the measures which

it has required the responsible person to take.

• 2. 

  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.71

• 3. 

  In the case of serious risks for human health, where the competent authority considers that

the non-compliance is not limited to the territory of the Member State where the product is

made available on the market, it shall inform the Commission and the competent

authorities of the other Member States of the measures which it has required the

responsible person to take.

• 4. 

  The competent authority shall take all appropriate measures to prohibit or restrict the

making available on the market of the cosmetic product or to withdraw the product from

the market or to recall it in the following cases:

(a) where an immediate action is necessary in case of serious risk for human health; or

(b) where the responsible person, within the time limit referred to in paragraph 1, does

not take all appropriate measures.

In the case of serious risks for human health, that competent authority shall inform the

Commission and the competent authorities of the other Member States, without delay, of

the measures taken.

[]

4a. In the absence of a serious risk for human health, in the case where the responsible

person does not take all appropriate measures, the competent authority shall inform

without delay the competent authority of the Member State where the responsible

person is established of the measures taken.

• 5. 

  For the purposes of paragraphs 3 and 4 of this Article, the information exchange system

provided for in Article 12(1) of Directive 2001/95/EC of the European Parliament and of

the Council72 shall be used.

Article 12 (2), (3) and (4) of Directive 2001/95/EC and Article 23 of Regulation

765/2008/EC73 shall also apply.

Article 21 a

Non compliance by the distributors

Competent authorities shall require the distributors to take all appropriate measures,

including corrective actions bringing the product into compliance, the withdrawal of the

product from 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 provided by

Article 4b.

OE 76/768/EEC (new)

Article 12

• 1. 

  If a Member State notes, on the basis of a substantiated justification, that a cosmetic product,

although complying with the requirements of the Directive, represents a hazard to health, it may

provisionally prohibit the marketing of that product in its territory or subject it to special conditions.

It shall immediately inform the other Member States and the Commission thereof, stating the

grounds for its decision.

OE 88/667/EEC (new)

• 2. 

  The Commission shall as soon as possible consult the Member States concerned, following which

it shall deliver its opinion without delay and take the appropriate steps.

OE 76/768/EEC (new)

• 3. 

  If the Commission is of the opinion that technical adaptations to the Directive are necessary, such

adaptations shall be adopted by either the Commission or the Council in accordance with the

procedure laid down in Article 10. In that event, the Member State which has adopted safeguard

measures may maintain them until entry into force of the adaptations.

new

Article 22

Safeguard clause

• 1. 

  In the case of products meeting the requirements listed in Article 21 (1), where

[Where Article 21 does not apply, and] a competent authority ascertains, or has

reasonable grounds for concern, that a cosmetic product or products [placed] made

available on the market present or could present a serious risk for human health, it shall

take all appropriate provisional measures in order to ensure that the product or products

concerned are []withdrawn, recalled or their[] availability otherwise restricted.

• 2. 

  The competent authority shall immediately communicate to the Commission and the

competent authorities of the other Member States of the measures taken and any

supporting data.

For the purposes of the first subparagraph, the information exchange system provided for

in 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,74 whether the provisional measures

referred to in paragraph 1 are justified or not. For that purpose it shall, whenever possible,

consult the interested parties, the Member States and the []SCCS.

• 5. 

  If the provisional measures are not justified the Commission shall inform the Member

States thereof and the competent authority concerned shall repeal the provisional measures

in question.

OE 76/768/EEC (new)

Article 13

Precise reasons shall be stated for any individual measures placing a restriction or ban on the

marketing of cosmetic products taken pursuant to this Directive. It shall be notified to the party

concerned together with particulars of the remedies available to him under the laws in force in the

Member States and of the time limits allowed for the exercise of such remedies.

new

Article 23

Good administrative practices

• 1. 

  Any decision taken pursuant to Articles 21 and 22 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 the

law of the Member State concerned and of the time limits to which remedies are subject.

• 2. 

  Except in case where immediate action is necessary for reasons of serious risk for human

Chapter IX

Administrative cooperation

Article 24

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

Regulation and shall transmit to each other all information necessary in view of applying

this Regulation 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.

Article 25

Cooperation regarding verification of product information file

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 made

readily accessible to verify whether the product information file satisfies the requirements referred

to in Article 8(2) and whether the information set out therein provide evidence of the safety of the

cosmetic product.

The requesting competent authority shall provide a motivation for the request.

OE 76/768/EEC (new)

Article 8

• 1. 

  In accordance with the procedure laid down in Article 10 the following shall be determined:

the methods of analysis necessary for checking the composition of cosmetic products,

the criteria of microbiological and chemical purity for cosmetic products and methods for checking

compliance with those criteria.

OE 93/35/EEC (new)

L1 2003/15/EC Art. 1.8

• 2. 

  The common nomenclature of ingredients used in cosmetic products and, after consultation of the

L1 Scientific Committee for Cosmetic Products and Non-Food Products intended for

Consumers , the amendments necessary for the adaptation to technical progress of the Annexes

shall be adopted in accordance with the same procedure, as appropriate.

new

Chapter X

Implementing measures, final provisions

Article 26

Amendment of the Annexes

• 1. 

  Where there is a potential risk to human health, arising from the use of substances in

cosmetic products, which needs to be addressed on a Community-wide basis, the

Commission may, after consultation of the []SCCS, amend Annexes II to VI accordingly.

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

27(3).

On imperative grounds of urgency, the Commission may use the urgency procedure

referred to in Article 27(4).

• 2. 

  The Commission may, after consultation of 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

OE 2003/15/EC Art. 1.9 (adapted)

Article 10 27

Committee

• 1. 

  The Commission shall be assisted by the Standing Committee on Cosmetic Products.
• 2. 

  Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall

apply, having regard to the provisions of Article 8 thereof.

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

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• 3. 

  Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision

1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

• 4. 

  Where reference is made to this paragraph, Article 5a(1), (2), (4) and (6) and Article 7 of

Decision 1999/468/EC shall apply having regard to the provisions of Article 8 thereof.

OE 2003/15/EC Art. 1.9 (new)

• 3. 

  The Committee shall adopt its rules of procedure

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Article 28

Glossary of common ingredient names

The Commission shall compile and update a glossary of common ingredient names. To this end,

the Commission shall take account of internationally recognised nomenclatures including the

International Nomenclature of Cosmetic Ingredients (INCI). That glossary shall not constitute a

list of the substances authorised for use in cosmetic products.

The common ingredient name shall be applied for the purpose of labelling cosmetic products placed

on the market at the latest twelve months76 after publication of the glossary in the Official Journal

of the European Union.

Article 29

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 and

OE 82/368/EEC

L1 2003/15/EC Art. 1.8

Article 8a

• 1. 

  Notwithstanding Article 4 and without prejudice to Article 8 (2), a Member State may authorize

the use within its territory of other substances not contained in the lists of substances allowed, for

certain cosmetic products specified in its national authorization, subject to the following conditions:

(a) the authorization must be limited to a maximum period of three years;

(b) the Member State must carry out an official check on cosmetic products manufactured

-

from the substance or preparation use of which it has authorized;

(c) cosmetic products thus manufactured must bear a distinctive indication which will be

defined in the authorization.

• 2. 

  The Member Stats shall forward to the Commission and to the other Member States the next of

any authorization decision taken pursuant to paragraph 1 within two months of the date on which it

came into effect.

• 3. 

  Before expiry of the three-year period provided for in paragraph 1, the Member State may submit

to the Commission a request for the inclusion in a list of permitted substances of the substance

given national authorization in accordance with paragraph 1. At the same time, it shall supply

supporting documents setting out the grounds on which it deems such inclusion justified and shall

indicate the uses for which the substance or preparation is intended. Within 18 months of

submission of the request, a decision shall be taken on the basis of the latest scientific and technical

knowledge, after consultation, at the initiative of the Commission or of a Member State, of the

L1 Scientific Committee for Cosmetic Products and Non-Food Products intended for

Consumers and in accordance with the procedure laid down in Article 10 as to whether the

substance in question may be included in a list of permitted substances or whether the national

authorization should be revoked. Notwithstanding paragraph 1 (a), the national authorization shall

remain in force until a decision is taken on the request for inclusion in the list.

OE 2003/15/EC Art. 1.9 (adapted)

Article 930

Annual report on animal testing

Every year the Commission shall present a report to the European Parliament and the Council on:

(a1) 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 to

cosmetic products carried out on animals. The Member States shall be obliged to collect

that information in addition to collecting statistics as laid down by Council Directive

86/609/EEC of 24 November 1986 on the approximation of laws, regulations and

administrative provisions of the Member States regarding the protection of animals used

for experimental and other scientific purposes77. The Commission shall in particular ensure

the development, validation and legal acceptance of alternative test methods which do not

use live animals;

(b2) progress made by the Commission in its efforts to obtain acceptance by the OECD of

alternative methods validated at Community level and recognition by third non-

member countries of the results of the safety tests carried out in the Community using

alternative methods, in particular within the framework of cooperation agreements between

the Community and these countries;

(c3) the manner in which the specific needs of small and medium-sized enterprises have been

taken into account.

OE 76/768/EEC

Article 11

Without prejudice to Article 5 and not later than one year after expiry of the period laid down in

Article 14 (1) for implementation of this Directive by the Member States, the Commission shall, on

the basis of the results of the latest scientific and technical research, submit to the Council

appropriate proposals establishing lists of permitted substances.

Article 14

• 1. 

  Member States shall bring into force the provisions needed in order to comply with this Directive

within 18 months of its notification and shall forthwith inform the Commission thereof.

• 2. 

  Member States may, however, for a period of 36 months from notification of this Directive,

authorize the marketing in their territory of cosmetic products which do not conform to the

requirements of the Directive.

• 3. 

  Member States shall ensure that the texts of such provisions of national law as they adopt in the

field governed by this Directive are communicated to the Commission.

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• 2. 

  In the light of the Committee's opinion, the Commission shall decide to publish, not to

publish, to publish with restriction, to maintain, to maintain with restriction or to withdraw

the references to the harmonised standard concerned in the Official Journal of the

European Union.

• 3. 

  The Commission shall inform the Member States and the European standardisation body

concerned. It shall, if necessary, request the revision of the harmonised standards

concerned.

Article 32

Penalties

Member States shall lay down the provisions on penalties applicable for infringement of the

provisions of this Regulation and shall take all measures necessary to ensure that they are

implemented. The penalties provided for must be effective, proportionate and dissuasive. The

Member States shall notify those provisions to the Commission on [date to be added: 36 months

after publication of this Regulation in the Official Journal of the European Union] at the latest and

shall notify it without delay of any subsequent amendment affecting them.

Article 33

Repeal

Directive 76/768/EEC is repealed with effect from [date to be added: 36 months after publication of

this Regulation in the Official Journal of the European Union].

References to the repealed Directive shall be understood as references to this Regulation.

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 in Part B of Annex IX.

However, the competent authorities shall continue to keep available the information received

pursuant to Article 7(3) and Article 7a(4) of Directive 76/768/EEC and responsible persons

shall continue to keep readily accessible the information collected pursuant to Article 7a of

that Directive for [7 years] after the date referred to in Article 34(2).

Article 33a

Transitional provisions

By way of derogation from Directive 76/768/EEC, cosmetic products which comply with this

Regulation may be placed on the market before the date referred to in Article 34(2).

Article 34

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]

• 2. 

  It shall apply from [date to be added: 36 [date to be determined] months78 after

publication in the Official Journal of the European Union].

79

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

OE 76/768/EEC

Article 15

This Directive is addressed to the Member States.

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Done at Brussels, [...]

OE 76/768/EEC (adapted)

ANNEX I

ILLUSTRATIVE LIST BY CATEGORY OF COSMETIC PRODUCTS

• - 

  Creams, emulsions, lotions, gels and oils for the skin (hands, face, feet, etc.).
• - 

  Face masks (with the exception of peeling products).
• - 

  Tinted bases (liquids, pastes, powders).
• - 

  Make-up powders, after-bath powders, hygienic powders, etc.
• - 

  Toilet soaps, deodorant soaps, etc.
• - 

  Perfumes, toilet waters and eau de Cologne.
• - 

  Bath and shower preparations (salts, foams, oils, gels, etc.).
• - 

  Depilatories.
• - 

  Deodorants and anti-perspirants.
• - 

  Hair care products:
• - 

  hair tints and bleaches,
• - 

  products for waving, straightening and fixing,
• - 

  setting products,
• - 

  cleansing products (lotions, powders, shampoos),
• - 

  Shaving products (creams, foams, lotions, etc.).
• - 

  Products for making up and removing make-up from the face and the eyes.
• - 

  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.
• - 

  Anti-wrinkle products.

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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 product

Description of t The qualitative and quantitative composition of the product, including chemical

identity of the substances (incl. chemical name, INCI, CAS, EINECS/ELINCS, where possible)

and their intended function. In the case of [essential oils,] perfume and aromatic compositions

[and perfumes], description of the name and code number of the composition and the identity of

the supplier.

• 2. 

  Physical/chemical characteristics and stability of the cosmetic product

Description of t The physical and chemical characteristics of the substances or mixtures, [the raw-

material ] as well as the cosmetic product.

Description of t The stability of the cosmetics product under reasonably foreseeable storage

conditions.

• 3. 

  Microbiological quality

Description of t The microbiological specifications of the [raw material] substance or mixture and

the cosmetic product. Particular attention shall be paid to cosmetics used around the eyes, on

mucous membranes in general, on damaged skin, on children under three years of age, on elderly

people and persons showing compromised immune responses.

Results of preservation challenge test.

• 4. 

  Impurities, traces, information about the packaging material

Description of t The purity of the substances and [raw material] mixtures.

In the case of traces of prohibited substances, evidence for their technical unavoidability.

Description of t The relevant characteristics of packaging material, in particular purity and stability.

• 5. 

  ormal and reasonably foreseeable use

Description of t The normal and reasonably foreseeable use of the product. The reasoning shall be

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

• 6. 

  Exposure to the cosmetic product

Description of Data on the exposure to cosmetic product taking into consideration the findings

under Section 5 in relation to

(1) The site(s) of application;

(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 unit of 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 to particle sizes.

• 7. 

  Exposure to the substances

Description of 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 14, description of the toxicological profile of substance contained in

the cosmetic product for all relevant toxicological endpoints. A particular focus on local toxicity

evaluation (skin and eye irritation), skin 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 the and, systemic

Particular consideration shall be given to any possible impacts on the toxicological profile due to

particle sizes, including nanomaterials;

impurities of the substances and raw material used; and

interaction of substances.

Any read-across shall be duly substantiated and justified.

The source of information shall be clearly identified.

• 9. 

  Undesirable effects and serious undesirable effects

Description of 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. description of existing studies from human volunteers or the duly

confirmed and substantiated findings of risk assessments carried out in other relevant areas..

PART B Cosmetic product safety assessment

• 1. 

  Assessment conclusion

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

• 2. 

  Labelled warnings and instructions of use

Statement on the need to label any particular warnings and instructions of use in accordance with

Article 15(1)(d).

• 3. 

  Reasoning

Explanation of the scientific reasoning leading to the assessment conclusion set out under Section 1

and the statement set out under Section 2. This explanation shall be based on the descriptions set out

under Part A. Where relevant, margins of safety shall be calculated assessed and discussed.

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 in external intimate

hygiene.

Possible interactions of the substances contained in the cosmetic product shall be assessed. If such

interaction is not expected, this shall be duly justified.

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.

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 [not to stay in prolonged contact with] 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 hair

of 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 skin

of the face;

(g) `Nail product' means a cosmetic product which is intended to be applied on nails;

(h) `Oral product' means a cosmetic product which is intended to be applied on teeth or

the mucous membranes of the oral cavity;

of the oral cavity,

on the rim []of the eyes,

or of the external genital organs;

(j) `Eye product' means a cosmetic product which is intended to be applied in the

vicinity of the eyes;

(k) `Professional use' means the application and use of cosmetic products by persons in

the exercise of their professional activity.80

(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 and the European List of Notified

Chemical Substances (ELINCS) numbers or the registration81 number given under

Regulation (EC) No 1907/2006 of the European Parliament and of the Council on

the Registration, Evaluation, Authorisation and Restriction of Chemicals

(REACH);

(3) Substances listed in Annexes III to VI do not cover nanomaterials, except when

specifically mentioned.

OE 76/768/EEC