Corrigendum : Proposal for a Regulation of the European Parliament and of the Council on cosmetic products (recast) (SEC(2008)117) (SEC(2008)118)
Date: 2008-02-05
Institutions: European Commission
Subjects: approximation of laws, chemical product, consumer information, consumer protection, cosmetic product, product safety, technological change

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 14.4.2008 
COM(2008)49 final/2 

2008/0035 (COD) 

Corrigendum :  
annule et remplace le COM(2008)49 final. Il convient de lire la référence interinstitutionnelle 
2008/0035 (COD). Concerne toutes les versions linguistiques 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on cosmetic products 

(recast) 
(Text with EEA relevance) 

(SEC(2008)117) 

(SEC(2008)118) 

(presented by the Commission) 

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EXPLANATORY MEMORANDUM 

1. 

BACKGROUND TO THE PROPOSAL 

Simplification  of  Council  Directive  76/768/EEC  of  27  July  1976  on 
the 
approximation of the laws of the Member States relating to cosmetic products1 (the 
“Cosmetics  Directive”)  was  announced  in  the  Commission  Communication 
“Implementing the Community Lisbon programme: A strategy for the simplification 
of the regulatory environment”2 and in the Commission’s Annual Policy Strategy for 
2007.3 

This proposal pursues three objectives: 

–  Objective  1:  To  remove 

legal  uncertainties  and 

inconsistencies.  These 
inconsistencies can be explained by the high number of amendments (55 to date) 
and  the  complete  absence  of  any  set  of  definitions.  This  objective  also  includes 
several measures to facilitate management of the Cosmetics Directive with regard 
to implementing measures; 

–  Objective  2:  To  avoid  divergences  in  national  transposition  which  do  not 
contribute  to  product  safety  but  instead  add  to  the  regulatory  burden  and 
administrative costs; 

–  Objective 3: To ensure that cosmetic products placed on the EU market are safe in 

the light of innovation in this sector. 

2. 

PUBLIC CONSULTATION 

A stakeholder consultation was held from 12 January 2007 to 16 March 2007. The 
Commission  received  72  contributions  in  response  to  this  public  consultation.  Of 
these,  46  were  from  industry  (fine  chemicals,  cosmetics  and  others4),  18  from 
national  and  regional  authorities,  4  from  academia/health  professionals,  3  from 
consumers  and  consumer  organisations  and  1  from  an  animal  welfare  organisation. 
In  terms  of  regions,  7  contributions  were  received  from  EU-wide  associations,  15 
from  Germany,  9  from  France,  3  each  from  the  UK,  Austria  and  Sweden,  2  each 
from  Lithuania,  Belgium/Luxembourg,  Denmark,  Norway,  the  Czech  Republic, 
Spain,  Poland  and  Ireland,  1  each  from  Finland,  Malta,  Hungary,  the  Netherlands, 
Slovenia, Greece, Slovakia, Latvia and Switzerland and 7 from non-European Third 
Countries. 

Generally speaking, the consultation confirmed that the Cosmetics Directive needed 
to  be  recast  and  that  many  provisions  required  clarification.  The  stakeholder 
consultation also stressed that in order to ensure a high level of protection of human 

1 
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3 
4 

OJ L 262, 27.9.1976, p. 169, as amended. 
COM(2005) 535 of 25.10.2005. 
COM(2006) 122 of 14.3.2006. 
Including  retailers,  manufacturers  of  machinery/equipment,  chemists,  the  hairdressing  industry  and 
branding companies. 

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health  throughout  the  EU  and  to  ensure  an  internal  market  for  cosmetic  product,  a 
recast Cosmetics Directive should take the form of a Regulation. In terms of product 
safety,  responses  in  the  stakeholder  consultation  stressed  the  need  to  sharpen  the 
focus on the manufacturer’s responsibility for the safety of cosmetic products placed 
on the market. 

A summary of the responses is contained in Annex 1 to the impact assessment report. 

3. 

IMPACT ASSESSMENT 

The  Commission,  based  on  the  results  of  the  stakeholder  consultation  and  three 
studies  assessing  various  aspects  of  European  cosmetics  legislation5,  carried  out  an 
impact  assessment  of  the  various  policy  options  to  achieve  the  objectives  set  out 
above  (1.).  The  impact  assessment  board  of  the  European  Commission6  assessed  a 
draft  version  of  this  impact  assessment  in  August  2007  and  approved  it  subject  to 
some modifications.  

Analysis  and  comparison  of  the  various  options  and  their  impact  lead  to  the 
following conclusions:  

With  regard  to  objective  1,  the  impact  assessment  supports  amendment  of  the 
Cosmetics  Directive  as  the  only  effective  means  of  achieving  this  aim  thereby 
reducing  the  regulatory  burdens  considerably.  For  example,  the  impact  assessment 
shows  a  potential  to  reduce  administrative  costs  associated  with  notification  to 
poison control centres by approx. 80%. The clarification and streamlining of various 
provisions  –  including  those  on  labelling  –  facilitates  compliance  without 
compromising product safety. 

With regard to objective 2, the impact assessment supports a recast into the form of a 
Regulation. In particular, this is supported by the fact that the Cosmetics Directive is 
very  detailed  and  frequently  amended  (approximately  three  to  five  times  a  year  in 
recent years). Albeit minor, the differences in the 27 national transposing laws create 
additional costs for industry without contributing to product safety. 

With regard to objective 3, the impact assessment supports striking a better balance 
between  “manufacturer  responsibility”  and  “prescriptive  regulation  of  individual 
ingredients”: This is a crucial element, as the Cosmetics Directive is still shaped by 
the original concept – developed 30 years ago – of regulation of all substances used 
in cosmetic products “ingredient by ingredient”. Today it is acknowledged that this 
approach  alone  is  not  sufficient  to  ensure  that  cosmetic  products  placed  on  the 
market  are  safe.  Instead,  manufacturer  responsibility  and  in-market  control  aspects 
need to be strengthened to make sure that products from this innovative sector will 
be safe in the future. This includes: 

–  clear  minimum  requirements  for  the  cosmetics  safety  assessment  which  is  then 

controlled via in-market surveillance; 

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6 

These studies addressed the characteristics of the EU cosmetics industry, the impact of EU regulation 
on consumer safety, and the impact of EU regulation on industry’s competitiveness. 
http://ec.europa.eu/governance/impact/iab_en.htm 

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–  a  system  of  administrative  cooperation  of  competent  authorities:  this  entails  a 
system of coordination of Member States in the assessment of products and their 
supporting information, including rules for product withdrawal; 

–  an  obligation  of  industry  to  actively  report  serious  undesirable  effects  to 
competent authorities as part of an early detection mechanism for risks for human 
health caused by cosmetic products; and 

–  a notification requirement which provides information to all competent authorities 

of the internal market through one single notification portal. 

The most important element in terms of impact is the introduction of clear minimum 
requirements  for  the  cosmetics  safety  assessment.  Up  until  now,  the  Cosmetics 
Directive  did  not  contain  clear  legal  prerequisites  for  the  contents  of  a  cosmetics 
safety  assessment.  This  has  contributed  to  a  relatively  high  degree  of  non-
compliance. Clear minimum requirements increase the costs for companies which so 
far refrained from establishing a robust cosmetics safety assessment prior to placing 
the product on the market.  

However,  the  impact  assessment  shows  that  there  are  a  number  of  measures  which 
soften the impact of this requirement. For example, the increased costs can be largely 
outbalanced  by  the  considerable  decrease  in  administrative  costs.  Any  residual 
increase can be justified on the strength of the benefits to the consumer in terms of 
solid safety assessments brought about by this option. 

4. 

LEGAL BASIS AND SUBSIDIARITY 

The  Cosmetics  Directive  is  based  on  Article  95  of  the  EC  Treaty.  It  aims  at 
establishing an internal market for cosmetic products while ensuring a high level of 
protection of human health.  

Prior  to  the  adoption  of  the  Cosmetics  Directive,  the  provisions  laid  down  by  law, 
regulation or administrative action in force in the Member States differed from one 
Member State to another. These differences between these laws obliged the cosmetic 
industry  to  vary  their  production  according  to  the  Member  State  for  which  the 
products  are  intended.  Consequently,  the  different  national  rules  hindered  trade  in 
these  products  and,  as  a  result,  had  a  direct  effect  on  the  establishment  and 
functioning of the internal market. To respond to this, it was necessary to determine 
at  Community  level,  the  rules  which  must  be  observed  as  regards  the  composition, 
labelling and packaging of cosmetic products. This objective could only be achieved 
with a very limited efficiency at national level.  

This  rationale  is  still  valid  today:  Community  action  is  necessary  to  avoid  a 
fragmentation of the market and to ensure a high and equal level of protection of the 
European consumer.  

The  Cosmetics  Directive  exhaustively  harmonises  rules  on  protection  of  human 
health for cosmetic products placed on the Community market. Thus, changes to this 
legal framework can only be achieved by Community action and are in compliance 
with the principle of subsidiarity as established in Article 5 of the EC Treaty. 

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5. 

CODIFICATION  OF  THE  55  AMENDMENTS  OF  THE  COSMETICS  DIRECTIVE  AND 
ADOPTION OF TEXT AS REGULATION 

The  Cosmetics  Directive  has  been  amended  55  times.  The  proposal  joins  together 
these 55 amendments in one legal text. 

The choice of the legal form is that of a Regulation. This will facilitate a harmonised 
application and removes the need for transposition of the highly detailed provisions 
of the Cosmetics Directive. 

6. 

SUBSTANTIVE AMENDMENTS 

According  to  the  interinstitutional  agreement  of  28  November  2001  on  a  more 
structured  use  of  the  recasting  technique  for  legal  acts7,  substantive  amendments 
have been shaded in grey. 

The substantive changes can be summarised as follows: 

6.1. 

Facilitating the management of cosmetics legislation 

6.1.1. 

Introducing a set of definitions 

Article 2 as well as the preamble to Annexes II to VI of the proposal introduce a set 
of  definitions.  Until  now,  the  Cosmetics  Directive  contains  practically  no  legal 
definitions. This increases legal uncertainty and renders compliance more costly and 
burdensome 
than  necessary.  The  proposal  ensures  coherence  with  existing 
definitions  in  the  field  of  free  movement  of  goods  –  in  particular  with  view  to  the 
proposals for a common framework for new approach legislation.8 

6.1.2.  Glossary of ingredient names 

Article  28  of  the  proposal  introduces  a  facilitated  system  to  update  a  glossary  of 
ingredient names. This glossary takes up essentially the function of the “inventory of 
ingredient  names”,  which  was  already  provided  for  in  the  Cosmetics  Directive.9  It 
contains the names of all relevant cosmetic ingredients (approximately 10.000). The 
names used are independent of any national language and usually much shorter than 
the  chemical  name.  Thus  these  names  help  to  avoid  the  need  for  translation  of  the 
labelled  list  of  ingredients.  Moreover,  these  names  are  accepted  worldwide  which 
greatly  facilitates  exportation  for  EU  companies  and  thus  enhances  external 
competitiveness. 

6.2. 

Strengthening certain elements to ensure product safety in the future 

6.2.1.  Cosmetics safety assessment 

Annex  I  of  the  proposal  sets  out  the  requirements  for  the  cosmetic  product  safety 
assessment in terms of content. 

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OJ C 77, 28.03.2002, p. 1. 
COM (2007)53. 
Article 5a, 6 (1) (g), 7 (2) Cosmetics Directive. 

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The  concept  of  a  cosmetic  product  safety  assessment  is  not  new.  The  Cosmetics 
Directive already contained the requirement to undertake such an assessment prior to 
placing the product on the market.10 However, the information to be contained in this 
safety assessment was never specified, with the practical implication that the safety 
assessment  never  took  on  the  important  role  that  it  was  meant  to  play  within  the 
current legal framework. 

A  crucial  element  of  the  recast  is  clarification  as  to  what  information  has  to  be 
contained in the cosmetic product safety assessment to provide evidence of the safety 
of the cosmetic product placed on the market. 

6.2.2. 

Strengthening in-market control 

Cosmetics regulation in the EU is based on in-market controls. Therefore, it is crucial 
that  in-market  control  is  effective.  The  proposal  strengthens  the  role  and  improves 
the  functioning  of  in-market  control  –  in  particular,  in  view  of  ever  increasing 
imports from third countries. This entails the following: 

–  Article  4  of  the  proposal  defines  the  responsible  person  for  the  relevant  legal 
obligations.  This  provision  also  addresses  the  responsibility  in  cases  of  products 
supplied to the consumer from outside the EU, for example via internet. 

–  Article  10  of  the  proposal  introduces  a  simplified,  centralised  and  electronic 
notification  requirement:  Notification  of  certain  information  concerning  the 
product  placed  on  the  market  is  an  important  element  in  a  sector  based  on  in-
market  control.  Until  now,  the  Cosmetics  Directive  contains  two  notification 
requirements:  one  to  competent  authorities  and  one  to  poison  control  centres. 
Modalities differ considerably between Member States and multiple registrations 
are necessary. 

–  Article 19 of the proposal introduces a communication of information on certain 

undesirable effects to the competent authority. 

–  Article  20  of  the  proposal  introduces  the  possibility  for  competent  authority  to 

investigate on a broader basis the extent of the use of certain substances. 

–  Articles 21, 23, 24 and 25 of the proposal introduce and strengthen the rules that 
apply  to  non-compliant  products,  including  more  detailed  provisions  on 
administrative  cooperation  in  market  surveillance.  Presently,  the  Cosmetics 
Directive does not provide for any such rules. 

6.3. 

CMR Substances 

Article  12(2)  introduces  a  differentiated  regime  for  substances  classified  as 
carcinogenic, mutagenic or reprotoxic (“CMR”). 

CMR substances are classified based on their intrinsic properties (“hazard”) without 
taking into account exposure, i.e. future use. The difference between hazard and risk 
is  best  explained  with  an  example:  A  lion  is  a  “hazard”  (i.e.  a  lion  as  such  is 

10 

Article 7a (1) Cosmetics Directive. 

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dangerous for humans) but a lion is not necessarily a “risk” (e.g. if it is in a guarded 
zoo, behind a fence, and well-fed). 

CMR  substances  are  categorised  into  3  categories,  “1”,  “2”  and  “3“  based  on  the 
degree of evidence of their carcinogenic, mutagenic or reprotoxic properties.11 

Up  until  now,  CMR  1  and  2  substances  were  automatically  banned  in  cosmetic 
products.  CMR  3  substances  were  banned  unless  the  Scientific  Committee,  on  the 
basis of exposure-data, has found that the substance is safe for use in cosmetics.12 

The automatic ban without possibility of an exception for CMR 1 and 2 substances 
made  regulation  of  cosmetics  dependent  on  a  hazard-classification  without 
considering  exposure  and  actual  use  of  the  substance.  This  could  lead  to  absurd 
situations. A recent – but not the only – example is ethanol: Ethanol (i.e. alcohol) is 
widely  used  in  cosmetic  products.  It  was  considered  for  classification  as  CMR  1 
substance  in  2006.  The  dossier  is  pending.  A  classification  as  CMR  1  substance 
would  have  tremendous  impact  on  the  EU  cosmetics  industry,  without  ever  giving 
the  possibility  for  industry  to  prove  its  safe  use  in  cosmetic  products  based  on 
exposure data. On the other hand, this substance could be used in food with a much 
higher exposure. 

Article 12(2) of the proposal intends to propose a risk management regime for CMR 
1  and  2  substances  which  allows,  subject  to  rigid  conditions,  the  use  of  these 
substances  if  they  have  been  found  to  be  safe  by  the  Scientific  Committee  for 
Consumer Products. 

6.4. 

Other substantive changes 

Apart  from  the  amendments  set  out  under  points  6.1.  to  6.3.,  the  following 
substantive amendments have been made in the proposal: 

•  Article  7(1)  of  the  proposal  clarifies  the  obligation  for  the  responsible  person  to 

keep the cosmetic product safety report up to date. 

•  In Article 8 of the proposal, the reference to the appropriate level of qualification 
for  the  manufacturer  and  the  importer  has  been  deleted.  This  issue  is  now 
addressed by a strengthened role of the cosmetic product safety report as well as 
the adoption of a harmonised standard for GMP. 

•  Articles  5(2)  and  9  (2)  of  the  proposal  provide  for  clarification  of  the  role  of 
harmonised  standards  in  the  field  of  good  manufacturing  practices  and 
sampling/analysis of cosmetic products. 

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Category  1:  “Substances  known  to  be  carcinogenic/mutagenic/reprotoxic  to  man”;  Category  2: 
“Substances  which  should  be  regarded  as  if  they  are  carcinogenic/mutagenic/reprotoxic  to  man”; 
Category 
possible 
carcinogenic/mutagenic/reprotoxic  effects  but  in  respect  of  which  the  available  information  is  not 
adequate for making a satisfactory assessment.” 
Article 4b Cosmetics Directive. 

“Substances  which 

for  man 

concern 

owing 

cause 

to 

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•  Article  11(1)(d),  (f)  of  the  proposal  clarifies  that  the  restrictions  for  substances 
contained  in  Annex  IV  (colorants)  and  V  (preservatives)  also  apply  if  the 
substance is added to the product for another than a colorant/preservative purpose. 

•  Article 14(2) of the proposal introduces the  Comitology procedure with  scrutiny 

for granting a derogation from the animal testing regime. 

•  Article 15(1)(a) of the proposal introduces the possibility to highlight on the label 
the  relevant  address  for  competent  authorities  in  cases  where  several  addresses 
indicated. 

•  Article  15(1)(c)  and  point  3  under  Annex  VII  of  the  proposal  introduces  the 

possibility to label the date of minimum durability by way of a pictogram. 

•  In Article 15(1)(g) of the proposal, the possibility to suppress ingredients on the 
product labelling for reasons of trade secrecy has been deleted. This provision was 
practically never applied and did not play any role in practice. 

•  Article 16(1), sub-paragraph (2) of the proposal introduces the possibility to make 
use  of  harmonised  standards  to  address  issues  of  claims  relating  to  cosmetic 
products. 

•  Article 22 of the proposal introduces a clear procedure for the application of the 

safeguard clause (cf. Article 12 of the Cosmetics Directive). 

•  Article  26  of  the  proposal  introduces  and  clarifies  the  rules  applying  to  the 

amendment of the Annexes of the text. 

•  Article  27(3),(4)  of  the  proposal  introduces  the  Comitology  procedure  with 

scrutiny. 

•  Article  31  of  the  proposal  allows  for  the  formal  objection  against  harmonised 

standards. 

•  Article  32  of  the  proposal  introduces  the  obligation  for  Member  State  to  adopt 

provisions on penalties. 

•  Article  33  and  34  of  the  proposal  establish  the  rules  for  the  repeal  of  the 

Cosmetics Directive, and entry into force and application of the Regulation. 

•  Article 8a as well as Annex V of the Cosmetics Directive have been deleted. Both 
provisions contradicted the principle of exhaustiveness of the Cosmetics Directive 
and did not play a role in praxis. 

7. 

BUDGETARY IMPLICATION 

The  proposal  envisages  establishing  a  central  electronic  interface  for  the  product 
notification  to  the  competent  authorities  of  the  Member  States.  Budgetary 
implications  are  discussed  in  the  legislative  financial  statement  annexed  to  this 
proposal. 

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8. 

ADDITIONAL INFORMATION 

8.1. 

Repeal of legislation 

The  adoption  of  the  proposal  will  lead  to  repeal  of  one  basic  legal  act,  its  55 
amendments as well as one implementing Commission Directive. 

8.2. 

European Economic Area 

The proposal concerns an EEA matter and should therefore extend to the European 
Economic Area. 

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2008/0035 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on cosmetic products 

(recast) 
(Text with EEA relevance) 

(cid:208) 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 Commission13, 

Having regard to the opinion of the European Economic and Social Committee14, 

Having regard to the opinion of the Committee of the Regions15, 

Acting in accordance with the procedure laid down in Article 251 of the Treaty16, 

Whereas: 

(cid:216) new 

(1) 

Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the 
Member  States  relating  to  cosmetic  products17  has  been  significantly  amended  on 
several occasions. Since further amendments are to be made, it should be recast as one 
single text in the interests of clarity. 

13 
14 
15 
16 
17 

OJ C […], […], p. […]. 
OJ C […], […], p. […]. 
OJ C […], […], p. […]. 
OJ C […], […], p. […]. 
OJ L262, 27.9.1976, p. 169. Directive as last amended by […]. 

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(2) 

(3) 

(4) 

(5) 

(6) 

The  recast  aims  at  simplifying  procedures  and  streamlining  terminology  thereby 
reducing  administrative  burden  and  ambiguities.  Moreover,  the  recast  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. 

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. 

(cid:208) 76/768/EEC Recital 1 

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. 

(cid:208) 76/768/EEC Recital 2 

The  differences  between  these  laws  oblige  Community  cosmetic  producers  to  vary 
their production according to the Member State for which the products are intended. 
Consequently, they hinder trade in these products and, as a result, have a direct effect 
on the establishment and functioning of the common market. 

(cid:208) 76/768/EEC Recital 3 

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. 

(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. 

(cid:208) 76/768/EEC Recital 4 

(cid:208) 03/15/EC Recital 1 (adapted) 

(8) 

Council  Directive  76/768/EEC18  ⌦ 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. 

18 

OJ  L  262,  27.7.1976.  Directive  as  last  amended  by  Commission  Directive  2002/34/EC  (OJ  L  102, 
18.4.2002, p. 19). 

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(cid:208) 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. 

(cid:208) 76/768/EEC Annex I (adapted) 
(cid:214) new 

(10)  (cid:214) 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. 

(11) 

In the present state of research, it is advisable to exclude cosmetic products containing 
one of the substances listed in Annex V from the scope of this Directive. 

(cid:208) 76/768/EEC Recital 6 (new) 

(cid:208) 76/768/EEC Recital 7 (adapted) 
(cid:214) new 

(12)  Cosmetic  products  ⌦ should ⌫  must  not  be  ⌦ safe ⌫  harmful  under  normal  or 
⌦ reasonably ⌫  foreseeable  conditions  of  use.  In  particular,  ⌦ a  risk-benefit 
reasoning  should  not  justify  a  risk  to  human  health. ⌫  it  is  necessary  to  take  into 
account the possibility of danger to zones of the body that are contiguous to the area of 
application. 

EN 

12 

   EN 

 
 
 
 
 
(13)  ⌦ In order to establish clear responsibilities, each cosmetic product should be linked 
to  a  responsible  person  who  is  established  within  the  Community. ⌫  (cid:214) It  is  in 
particular necessary to determine who is the responsible person for cosmetic products 
which are sold directly to the consumer without recurring to an importer.  

(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. ⌫ 

(cid:208) 93/35/EEC Recital 4 (adapted) 
(cid:214) 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. ⌫ 

(cid:208) 93/35/EEC Recital 5 (adapted) 
(cid:214) new 

(19)  Whereas, however, Ffor reasons of monitoring ⌦ effective market surveillance ⌫ , 
the competent authorities should be ⌦ notified ⌫ apprised (cid:214) 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)  (cid:214) In order to keep administrative burdens to a minimum, both notifications should be 

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

EN 

13 

   EN 

 
 
 
(cid:208) 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; 

(23)  ⌦ The general principle of the responsibility of the manufacturer or importer for the 
safety  of  the  product  should  be  supported  by  restrictions  of  some  substances  in 
Annexes II and III. Moreover, substances which are intended to be used as colorants, 
preservatives  and  UV-filters  have  to  be  listed  in  the  Annexes  IV,  V  and  VI 
respectively in order to be allowed for these uses. ⌫ 

(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 substancess which colour through photoluminescence, interference, 
or chemical reaction. ⌫ 

(cid:216) 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  Products  (SCCP)  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. 

(cid:208) 03/15/EC Recital 13 (adapted) 
(cid:214) new 

(26)  Given  the  (cid:214) hazardous  properties  of   special  risks  that  substances  classified  as 
carcinogenic, mutagenic or toxic for reproduction ⌦ (CMR) ⌫ , 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  substances19 ⌫  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  3  substances  if,  in  view  of  exposure  and  concentration,  they  have  been  found 
safe for use in cosmetic products by the SCCP and are regulated by the Commission in 
the Annexes to this Regulation. ⌫ (cid:214) With regard to substances which are classified 
as CMR 1 or 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. Such substances should be continuously reviewed by the SCCP.  

19 

OJ 196, 16.8.1967, p. 1. Directive as last amended by […]. 

EN 

14 

   EN 

 
 
 
 
                                                 
(cid:208) 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; 

(cid:208) 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. 

(cid:208) 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  purposes20  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  States.  In  particular,  Article  7  of  that 
Directive requires that animal experiments be replaced by alternative methods, when 
such  methods  exist  and  are  scientifically  satisfactory.  In  order  to  facilitate  the 
development and use of alternative methods in the cosmetic sector which do not use 
live  animals,  specific  provisions  have  been  introduced  by  Council  Directive 
93/35/EEC of 14 June 1993 amending for the sixth time Directive 76/768/EEC on the 
approximation of the laws of the Member States relating to cosmetic products21. 

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. 

20 
21 

OJ L 358, 18.12.1986, p. 1. 
OJ L 151, 23.6.1993, p. 32. 

EN 

15 

   EN 

 
 
 
 
                                                 
(cid:208) 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. 

(cid:208) 03/15/EC Recital 6 (adapted) 
(cid:214) 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  (cid:214) 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  methods  which  do  not  involve  the  use  of 
animals for assessing the safety of finished cosmetic products ⌦ could be facilitated 
by Commission guidelines ⌫ . 

(cid:208) 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) 
⌦ SCCP ⌫  as  regards  the  applicability  of  the  validated  alternative  methods  to  the 
field of cosmetic products, the Commission should immediately publish the validated 
or  approved  methods  recognised  as  being  applicable  to  such  ingredients.  In  order  to 
achieve  the  highest  possible  degree  of  animal  protection,  a  deadline  must  be 
⌦ should be ⌫ set for the introduction of a definitive prohibition. 

(cid:208) 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 

EN 

16 

   EN 

 
 
 
 
 
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. 

(cid:208) 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 Council22. 

(cid:208) 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. 

(cid:208) 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 information.;  

(cid:208) 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 

22 

OJ L 232, 29.8.2002, p. 1. 

EN 

17 

   EN 

 
 
 
 
 
                                                 
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; 

(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. 

(cid:208) 03/15/EC Recital 14 (adapted) 

(cid:208) 03/15/EC Recital 15 (adapted) 
(cid:214) new 

(39)  ⌦ A  number  of  substances  have  been  identified  by  the  SCCP  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.  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. 

(40)  ⌦ The consumer should be protected from misleading claims concerning efficacy and 
other  characteristics  of  cosmetic  products. ⌫  (cid:214) In  order  to  address  specific  claims 
concerning  the  characteristics  of  cosmetic  products,  the  possibility  to  make  use  of 
harmonised standards should be provided.  

(cid:208) 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 
relevant  non-governmental 
majority  of 
organisations,  and  the  need  of  consumers  to  be  able  to  make  practical  distinctions 
between products on the basis of animal testing criteria. 

testing"  producers, 

the  "non-animal 

(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. ⌫ 

EN 

18 

   EN 

 
 
 
 
(cid:208) 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. 

(cid:216) 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. 

(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. 

(cid:208) 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. 

(cid:216) new 

(47) 

(48) 

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. 

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. 

(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  ultraviolet  filters,  taking  into  account  in  particular  the  problem  of 
sensitization. 

(cid:208) 76/768/EEC Recital 10 

EN 

19 

   EN 

 
 
 
 
 
 
(cid:208) 76/768/EEC Recital 9 (adapted) 

(50)  Technical progress necessitates rapid adaptation of the technical provisions defined in 
this  Directive  and  in  subsequent  Directives  in  this  field.  It  is  advisable,  in  order  to 
facilitate implementation of the measures necessary for this purpose, to provide for a 
procedure  establishing  close  cooperation  between  the  Member  States  and  the 
Commission within the Committee for adaptation to technical progress of Directives 
aimed at the removal of technical obstacles to trade in the cosmetic products sector. 

(cid:216) new 

(51)  The  Commission  should  be  assisted  by  the  SCCP,  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 Commission23. 

(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 
penalites 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. 

(56)  Directive 76/768/EEC should be repealed. 

(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. 

23 

OJ L184, 17.7.1999, p. 23. Decision as amended by Decision 2006/512/EC (OJ L200, 22.7.2006, p.11). 

EN 

20 

   EN 

 
 
 
                                                 
HAVE ADOPTED THIS DIRECTIVE ⌦ REGULATION ⌫ : 

(cid:208) 76/768/EEC (adapted) 

(cid:208) 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  preparation  ⌦ or  mixture ⌫  intended  to  be  placed  in  contact  with  the 
various  external  parts  of  the  human  body  (epidermis,  hair  system,  nails,  lips 
and external genital organs) or with the teeth and the mucous membranes of the 
oral  cavity  with  a  view  exclusively  or  mainly  to  cleaning  them,  perfuming 
them,  changing  their  appearance,  and/or  correcting  body  odours  and/or 
protecting  them,  or  keeping  them  in  good  condition  ⌦ or  correcting  body 
odours ⌫. 

2. The products to be considered as cosmetic products within the meaning of this definition 
are listed in Annex I. 

(cid:208) 76/768/EEC (adapted) 

EN 

21 

   EN 

 
 
 
 
(cid:208) 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. 

(cid:216) new  

(b) 

(c) 

(d) 

(e) 

(f) 

(g) 

(h) 

(i) 

‘manufacturer’ means any natural or legal person who designs or manufactures 
a cosmetic product or who has such a product designed or manufactured, under 
his name or trademark; 

‘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; 

‘placing  on  the  market’  means  the  first  making  available  of  a  product  on  the 
market; 

‘importer’  means  any  natural  or 
Community, who places a product from a third country on the market; 

legal  person  established  within 

the 

‘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 services24 in accordance with Article 6 of that Directive; 

‘traces’  means  the  non-intended  presence  of  a  substance  stemming  from 
impurities  of  natural  or  synthetic  ingredients,  the  manufacturing  process, 
storage, migration from transport facilities or packaging; 

‘preservatives’ means substances which are exclusively or mainly intended to 
inhibit the development of micro-organisms in the cosmetic product; 

‘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 UV radiation by absorbing, reflecting or scattering UV 
radiation; 

24 

OJ L 24, 21.7.1998, p. 37. Directive as last amended by […]. 

EN 

22 

   EN 

 
 
 
                                                 
(k) 

(l) 

‘undesirable effect’ means a harmful reaction for human health attributable to 
the normal or reasonably foreseeable use of a cosmetic product; 

’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; 

(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. 

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

(cid:208) 76/768/EEC, recital 5 (adapted) 

(cid:208) 93/35/EEC (adapted) 

⌦ Chapter II 
Safety, responsible person, 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  applied 
under  normal  or  reasonably  foreseeable  conditions  of  use,  taking  account,  in  particular,  of 
⌦ the following ⌫ : 

(a) 

the product’s presentation,; 

(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 person defined in Article 4. ⌫ 

The provision of such warnings shall not, in any event, exempt any person from compliance 
with the other requirements laid down in this Directive ⌦ Regulation ⌫. 

EN 

23 

   EN 

 
 
 
(cid:216) new 

Article 4 

Responsible person 

1. 

2. 

3. 

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’). 

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. 

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. 

4. 

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

The  importer  may,  by  written  mandate,  designate  a  person  established  within  the 
Community as the responsible person. 

5. 

For a cosmetic product made available on the market directly to the consumer 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. 

(cid:208) 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. 

(cid:208) 93/35/EEC (adapted) 

⌦ Article 5 
Good manufacturing practice ⌫ 

⌦ 1.  Manufacturing of cosmetic products shall comply with good manufacturing practice 

with a view to ensure the objectives of Article 1. ⌫ 

EN 

24 

   EN 

 
 
 
 
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. 

(cid:216) new 

(cid:208) 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 ⌫ . 

(cid:208) 93/35/EEC (adapted) 

(cid:214) new 

⌦ Chapter III 
Safety assessment, product information file, notification ⌫ 

Article 7a 7 

⌦ Safety assessment ⌫ 

⌦ 1.  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. ⌫ 

(cid:214) The responsible person shall ensure that the cosmetic product safety report is kept 
up-to-date in view of additional relevant information generated subsequent to placing 
the product on the market.  

⌦ 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,  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 discipline. ⌫ 

EN 

25 

   EN 

 
 
 
 
⌦ 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. ⌫ 

⌦ Article 8 

Product information file ⌫ 

1. 

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): 

⌦ 2.  The product information file shall contain the following information and data: ⌫ 

⌦ (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; ⌫ 

(a) 

the  qualitative  and  quantitative  composition  of  the  product;  in  the  case  of  perfume 
compositions and perfumes, the name and code number of the composition and the 
identity of the supplier; 

(b) the physico-chemical and microbiological specifications of the raw materials and 
the  finished  product  and  the  purity  and  microbiological  control  criteria  of  the 
cosmetic product; 

(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; 

(cid:208) 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 

EN 

26 

   EN 

 
 
 
 
 
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;  

(cid:208) 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; 

(cid:208) 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 

EN 

27 

   EN 

 
 
 
 
 
 
 
 
of  good  laboratory  practice  and  the  verification  of  their  application  for  tests  on 
chemical substances (25). 

3. 

⌦ The responsible person shall make the product information file readily accessible 
in electronic or other format at his address 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  the  national  language  or  languages  of  the 
Member  State  concerned  ⌦ where  the  product  file  is  made  available ⌫  ,  or  in  a 
language  readily  understood  by  the  competent  authorities  ⌦ of  that  Member 
State. ⌫ 

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 
the  European  Communities. 
Journal  of 
information 

the  Official 

in 

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. 

(cid:208) 82/368/EEC (adapted) 

⌦ Article 9 
Sampling and analysis ⌫ 

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

reproducible manner. ⌫ 

2. 

In  absence  of  any  applicable  Community  legislation,  compliance  with  paragraph  1 
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. 

(cid:216) new 

25 

OJ No L 15, 17.1.1987, p. 29. 

EN 

28 

   EN 

 
 
 
 
                                                 
(cid:208) 76/768/EEC (adapted) 

Article 710 
 ⌦ Notification ⌫ 

(cid:208) 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. 

(cid:216) new 

1. 

(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

The  responsible  person  shall  submit,  prior  to  placing  the  cosmetic  product  on  the 
market, the following information to the Commission: 

the category of cosmetic product and its complete commercial name; 

the name and address of the responsible person where the product information file is 
made readily accessible; 

the Member State where the cosmetic product is placed on the market; 

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

the presence of substances in the form of micronised particles other than substances 
listed in Annexe III to VI to this Regulation; 

the  presence  of  substances  classified  as  carcinogenic,  mutagenic  or  toxic  for 
reproduction, of category 1 or 2, under Annex I to Directive 67/548/EEC; 

EN 

29 

   EN 

 
 
 
 
(g) 

2. 

3. 

4. 

the frame formulation allowing for prompt and appropriate medical treatment in the 
event of difficulties; 

The  frame  formulation  referred  in  point  (g)  of  paragraph  1  shall  detail  the  type  of 
ingredients and their maximum concentration in the cosmetic product. If a cosmetic 
product is partially or not covered by a frame formulation, relevant quantitative and 
qualitative information shall be provided. 

The Commission shall transmit electronically the information referred to in points (a) 
to (f) of paragraph 1 to the competent authorities. 

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

The Commission shall transmit electronically the information referred to in points (a) 
to  (d)  and  in  points  (f)  and  (g)  of  paragraph  1  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. 

5. 

Where any of the information set out in paragraph 1 changes, the responsible person 
shall provide an update without delay. 

(cid:208) 93/35/EEC (new) 

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 

Communities. 

(cid:208) 82/368/EEC (adapted) 

(cid:214) 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  (cid:214) shall  not 
contain  containing ⌦ any of the following ⌫ : 

(a) 

substances listed in Annex II; 

EN 

30 

   EN 

 
 
 
(b) 

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 ⌫ ; 

(cid:208) 88/667/EEC (new) 
(cid:214) new 

(c)  ⌦ except  for  hair  colouring  products  referred  to  in  paragraph  2,  colorants ⌫ 
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; 

(cid:214) (d)  without prejudice to points (b), (e) and (g), 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.  

(cid:208) 82/368/EEC (adapted) 

(e) 

preservatives  other  than  those  listed  in  Annex  VI,  Part  1,  V  ⌦ and  preservatives 
which are not used in accordance with the conditions laid down in that Annex ⌫; 

(f) 

Without prejudice to points (b) (c) and (g), 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. 

(cid:216) new 

(cid:208) 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;  

(g) 

UV-filters other than those listed in Part 1 of Annex VII VI ⌦ and UV-filters which 
are not used in accordance with the conditions set out in that Annex ⌫; 

(cid:208) 83/574/EEC (adapted) 

EN 

31 

   EN 

 
 
 
 
 
 
 
⌦ (h)  without prejudice to points (b) (c) and (e), 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. 

(cid:216) 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. 

The  Commission  Decision  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). 

(cid:208) 2003/15/EC Art. 1.2 (adapted) 

(cid:214) new 

Article 4b12 
 ⌦ 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 and3, under Annex I to Directive 67/548/EEC 
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  3  may  be  used  in  ⌦ cosmetic  products ⌫ 
cosmetics  if  the  substance  has  been  evaluated  by  the  ⌦ SCCP ⌫  SCCNFP  and 
found  acceptable  (cid:214) 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) ⌫ . 

(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 
shall be prohibited. 

(cid:216) new 

However, such substances may be used in cosmetic products if, subsequent to their 
classification as carcinogenic, mutagenic or toxic for reproduction of category 1 or 2 
under Directive 67/548/EEC, all of the following conditions are fulfilled: 

–  they  have  been  evaluated  and  found  safe  for  use  by  the  SCCP  in  cosmetic 

products in particular in view of exposure; 

EN 

32 

   EN 

 
 
 
 
 
–  they  are  complying  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 safety26; 

–  there  are  no  suitable  alternative  substances  available,  as  documented  in  an 

analysis of alternatives. 

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. 

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. 

On imperative grounds of urgency, the Commission may use the urgency procedure 
referred to in Article 27(4). 

The Commission shall mandate the SCCP 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. 

(cid:208) 82/368/EEC (adapted) 

⌦ Article 13 
Traces ⌫ 

2.  ⌦ Without  prejudice  to  Article  3, ⌫  Tthe  presence  of  traces  of  the  ⌦ prohibited ⌫ 
substances  listed  in  Annex  II  shall  be  allowed  provided  that  such  presence  is  technically 
unavoidable in good manufacturing practice and that it conforms with Article 2. 

26 

OJ L 31, 1.2.2002, p. 1. Regulation as last amended by […]. 

EN 

33 

   EN 

 
 
                                                 
1. 

(a) 

(b) 

(c) 

(d) 

(cid:208) 2003/15/EC Art. 1.2 (adapted) 

(cid:214) new 

⌦ Chapter V 
Animal testing ⌫ 

Article 4a 14 

⌦ Animal testing ⌫ 

Without  prejudice  to  the  general  obligations  deriving  from  Article  23,  ⌦ the 
following shall not be allowed ⌫ Member States shall prohibit: 

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; 

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; 

the performance ⌦ within the Community ⌫ on their territory of animal testing of 
finished  cosmetic  products 
this 
⌦ Regulation ⌫ Directive; 

requirements  of 

in  order 

to  meet 

the 

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  of  27  June  1967  on  the  approximation  of  laws, 
regulations and administrative provisions relating to the classification, packaging and 
labelling  of  dangerous  substances27  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. 

27 

OJ 196, 16.8.1967, p. 1. Directive as last amended by Commission Directive 2001/59/EC (OJ L 225, 
21.8.2001, p. 1) ⌦ […] ⌫ . 

EN 

34 

   EN 

 
 
                                                 
2. 

The  Commission,  after  consultation  of  the  SCCNFP  ⌦ SCCP ⌫  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 September 2004 and  be sent to the  European  Parliament 
and  the  Council.  The  period  for  implementation  shall  be  limited  to  ⌦ 11  March 
2009 ⌫  a  maximum  of  six  years  after  the  entry  into  force  of  Directive 
2003/15/EC28 in relation to paragraph 1(a), (b) and (d). 

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 2.1, that for technical reasons one or more tests referred to in 
that  subparagraph  paragraph  2.1  will  not  be  developed  and  validated  before  the 
expiry of the period referred to therein in paragraph 2.1 it shall inform the European 
Parliament and the Council and shall put forward a legislative proposal in accordance 
with Article 251 of the Treaty. 

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  ⌦ SCCP ⌫  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. 

28 

OJ L66, 11.3.2003, p.26. 

EN 

35 

   EN 

 
                                                 
(cid:214) 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 accordance with Article 930. 

3. 

For the purposes of this Article ⌦ and Article 16: ⌫ 

(a) ‘finished cosmetic product’ means the cosmetic product in its final formulation, 
as placed on the market and made available to the final consumer, or its prototype.  

(b)‘prototype’ means a first model or design that has not been produced in batches, 
and from which the finished cosmetic product is copied or finally developed.  

(cid:208) 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. 

EN 

36 

   EN 

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

– 

– 

– 

– 

definitively allowed, or 

definitively prohibited (Annex II), or 

maintained for a given period specified in Part 2 of Annexes III, IV, VI and VII, or 

deleted  from  all  the  Annexes,  on  the  basis  of  available  scientific  information  or 
because they are no longer used. 

(cid:208) 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, 
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 

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

where  appropriate,  restrictions  and  conditions  of  use  and  warnings  which  must  be 
printed on the label by reference to the Annexes. 

3.  The  Commission  shall  publish  the  inventory  and  shall  update  it  periodically  under  the 

procedure provided for in Article 10. The inventory shall be indicative and shall not constitute 

a list of the substances authorized for use in cosmetic products 

EN 

37 

   EN 

 
 
(cid:208) 88/667/EEC (adapted) 

⌦ Chapter VI 
Consumer information ⌫ 

Article 615 

⌦ Labelling ⌫ 

(cid:208) 93/35/EEC (adapted) 

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, 
the ⌫ container and packaging ⌦ of cosmetic products shall ⌫ bear the following 
information  in  indelible,  easily  legible  and  visible  lettering;  the  information 
mentioned in point (g) may, however, be indicated on the packaging alone: 

(cid:208) 88/667/EEC (adapted) 

(cid:214) new 

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 
established within the Community. Such information may be abbreviated in so far as 
the  abbreviation  makes  it  generally  possible  to  identify  the  undertaking.⌦ that 
person ⌫.  (cid:214) If  several  addresses  are  indicated,  the  one  where  the  responsible 
person  makes 
shall  be 
highlighted; Member States may require that the country of origin be specified for 
goods manufactured outside the Community; 

readily  available 

the  product 

information 

file 

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; 

1. 

(a) 

(b) 

EN 

38 

   EN 

 
 
 
 
(cid:208) 2003/15/EC Art. 1.3 (adapted) 

(cid:214) new 

(c) 

the  date  of  minimum  durability  (cid:214) 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 ⌫  

–  (cid:214) 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; 

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

Indication  of  the  date  of  ⌦ minimum ⌫  durability  shall  not  be  mandatory  for 
cosmetic  products  with  a  minimum  durability  of  more  than  30  months.  For  such 
products, there shall be an indication  of  the  period  of  time  after  opening  for  which 
the  product  ⌦ is  safe ⌫  can  be  used  without  any  harm  to  the  consumer.  This 
information  shall  be  indicated  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); 

(cid:208) 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; 

(e) 

the  batch  number  of  manufacture  or  the  reference  for  identifying  the  ⌦ cosmetic 
product ⌫  goods.  Where  this  is  impossible  for  practical  reasons  because  the 

(cid:208) 88/667/EEC (adapted) 

EN 

39 

   EN 

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

(f) 

the  function  of  the  ⌦ cosmetic ⌫  product,  unless  it  is  clear  from  ⌦ its ⌫  the 
presentation of the product; 

(cid:208) 93/35/EEC (adapted) 

(cid:208) 2003/15/EC Art. 1.4 (adapted) 

(cid:214) 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. 

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’.  However,  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 irrespective of their function 
in the product. 

⌦ The list of ingredients shall be established in descending order of weight of the 
ingredients  at  the  time  they  are  added  to  the  cosmetic  product. ⌫  Ingredients  in 
concentrations  of  less  than  1 %  may  be  listed  in  any  order  after  those  in 
concentrations of more than 1 %. 

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. 

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. 

EN 

40 

   EN 

 
 
 
 
 
 
 
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 products29 under which a manufacturer may, for reasons 

of trade secrecy, apply not to include one or more ingredients on the abovementioned 

list. 

(cid:208) 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. 

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

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

⌦ 6.  The person making the product available to the end user is responsible for the respect 

of paragraphs 3 to 5. ⌫ 

29 

OJ L 140, 23.6.1995, p. 26. 

EN 

41 

   EN 

 
 
 
                                                 
⌦ 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. ⌫ 

(cid:208) 88/667/EEC (adapted) 

(cid:206)1 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 
which they do not have. (cid:206)1 ---  

Compliance with the  first  subparagraph shall be presumed  if  the cosmetic  products 
are  in  accordance  with  the  relevant  harmonised  standards,  the  references  of  which 
have been published in the Official Journal of the European Union. 

(cid:216) new 

(cid:208) 2003/15/EC Art. 1.5 (adapted) 

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  animal  tests  on  the  finished  ⌦ cosmetic ⌫  product,  or  its 
prototype, or any of the ingredients contained in it, or used any ingredients that have 
been  tested  on  animals  by  others  for  the  purpose  of  developing  new  cosmetic 
products. Guidelines shall be adopted in accordance with the procedure referred to in 
Article  10(2)  and  published  in  the  Official  Journal  of  the  European  Union.  The 
European  Parliament  shall  receive  copies  of  the  draft  measures  submitted  to  the 
Committee. 

EN 

42 

   EN 

 
 
 
 
(cid:208) 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  ⌦ publicly ⌫  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 dangerous substances covered by 
Directive 67/548/EEC30. 

(cid:216) 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. 

Article 19 
Communication of serious undesirable effects 

1. 

The  responsible  person  shall  without  delay  notify  the  following  to  the  competent 
authority where the product information file is readily accessible: 

all  serious  undesirable  effects  which  are  known  to  him  or  which  should 

(a) 
reasonably be expected to be known to him, 

(b) 

the complete commercial name of the product concerned, 

(c) 

the corrective measures taken by him, if any; 

30 

OJ 196, 16.8.1967, p. 1. Directive as last amended by […]. 

EN 

43 

   EN 

 
 
 
                                                 
2. 

3. 

The  competent  authority  concerned  shall  transmit  the  information  referred  to  in 
paragraph 1 to the competent authorities of the other Member States. 

Competent authorities may use the information referred to in this Article only for the 
purposes of in-market surveillance. 

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. 

Competent authorities may use the information referred to in this Article only for the purposes 
of in-market surveillance. 

Chapter VIII 

Non-compliance, safeguard clause 

Article 21 
Non compliance 

1. 

Competent  authorities  shall  require  the  responsible  person  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 any of the following:  

(a) 

the requirements for the product information file referred to in Article 8; 

(b) 

the notification requirements referred to in Article 10; 

(c) 

the good manufacturing practices referred to in Article 5; 

(d) 

the restrictions for substances referred to in Articles 11 and 12; 

(e) 

the labelling requirements referred to in Article 15(1), (2), and (7); 

(f) 

the requirements related to product claims set out in Article 16; 

(g) 

the animal testing requirements referred to in Article 14. 

EN 

44 

   EN 

 
2. 

3. 

4. 

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. 

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. 

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. 

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 Council31 shall be used. 

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

(cid:208) 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. 

31 

OJ L 11, 15.1.2002, p. 4. 

EN 

45 

   EN 

 
 
                                                 
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. 

(cid:208) 88/667/EEC (new) 

(cid:208) 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. 

(cid:216) new 

Article 22 
Safeguard clause 

1. 

2. 

3. 

4. 

5. 

Where  Article  21  does  not  apply,  and  a  competent  authority  ascertains  that  a 
cosmetic product placed on the market is liable to present a serious risk for human 
health,  it  shall  take  all  appropriate  provisional  measures  in  order  to  ensure  that  a 
cosmetic product is withdrawn, recalled or its availability otherwise restricted. 

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. 

The  Commission  shall  determine  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 SCCP. 

If the provisional measures are justified, Article 26(1) shall apply. 

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. 

EN 

46 

   EN 

 
 
 
 
(cid:208) 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. 

(cid:216) new 

Article 23 
Good administrative practices 

Any decision  taken pursuant to Articles 21 and 22 shall state the exact grounds on 
which  it  is  based.  It  shall  be  notified  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. 

Except  in  case  where  immediate  action  is  necessary  for  reasons  of  serious  risk  for 
human  health,  the  responsible  person  shall  have  the  opportunity  to  put  forward  his 
viewpoint before any decision is taken. 

Chapter IX 
Administrative cooperation 

Article 24 
Cooperation between competent authorities  

The competent authorities of the Member States shall cooperate with each other and 
with the Commission and transmit to each other all information necessary in view of 
applying this Regulation uniformly. 

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. 

1. 

2. 

1. 

2. 

3. 

Cooperation may be part of initiatives developed at international level. 

EN 

47 

   EN 

 
 
 
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. 

Upon that request, the competent authority requested shall, without undue delay, carry out the 
verification and shall inform the requesting competent authority of its finding. 

(cid:208) 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. 

(cid:208) 93/35/EEC (new) 

(cid:206)1 2003/15/EC Art. 1.8 

2. The common nomenclature of ingredients used in cosmetic products and, after consultation 

of the (cid:206)1 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. 

EN 

48 

   EN 

 
 
 
(cid:216) 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  SCCP,  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 SCCP, 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 27(3). 

3. 

Where it appears necessary, in order to ensure the safety of cosmetic products placed 
on the market, the Commission may, after consultation of the SCCP, amend Annex I. 

Those measures, designed to amend non-essential elements of this Regulation, shall 
be adopted in accordance with the regulatory procedure with scrutiny referred to in 
Article 27(3). 

(cid:208) 2003/15/EC Art. 1.9 (adapted) 

Article 10 27 

⌦ Committee ⌫ 

1. 

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

EN 

49 

   EN 

 
 
 
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. 

(cid:216) new 

3. 

4. 

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

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. 

3. 

The Committee shall adopt its rules of procedure 

(cid:208) 2003/15/EC Art. 1.9 (new) 

(cid:216) new 

Article 28 

Glossary of common ingredient names 

The  Commission  shall  compile  and  update  a  glossary  of  common  ingredient  names.  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  months  after  publication  of  the  glossary  in  the 
Official Journal of the European Union. 

Article 29 
Competent authorities, poison control centres or assimilated entities 

Member States shall designate their national competent authorities. 

Member States shall communicate the details of authorities referred to in paragraph 1 
and  of  the  bodies  referred  to  in  Article  10(4)  to  the  Commission.  They  shall 
communicate an update of these details when necessary. 

The Commission shall compile and update a list of the authorities and bodies referred 
to in paragraph 2 and make it available to the public. 

1. 

2. 

3. 

EN 

50 

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(cid:208) 82/368/EEC 

(cid:206)1 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  (cid:206)1 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. 

EN 

51 

   EN 

 
 
 
 
 
(cid:208) 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 purposes32. 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. 

(cid:208) 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. 

32 

OJ L 358, 18.12.1986, p. 1. 

EN 

52 

   EN 

 
 
 
                                                 
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. 

(cid:216) new 

Article 31 

Formal objection against harmonised standards 

1. 

2. 

3. 

When a Member State or the Commission considers that a harmonised standard does 
not  entirely  satisfy  the  requirements  set  out  in  the  relevant  provisions  of  this 
Regulation,  the  Commission  or  the  Member  State  concerned  shall  bring  the  matter 
before  the  Committee  set  up  by  Article  5  of  Directive  98/34/EC,  giving  its 
arguments. The Committee shall deliver its opinion without delay. 

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. 

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. 

EN 

53 

   EN 

 
 
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. 

Article 34 

Entry into force 

1. 

2. 

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

It  shall  apply  from  [date  to  be  added:  36  months  after  publication  in  the  Official 
Journal of the European Union]. 

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

(cid:208) 76/768/EEC 

Article 15 

This Directive is addressed to the Member States. 

Done at Brussels, […] 

(cid:216) new 

For the European Parliament 

For the Council 

The President 

[…] 

The President 

[…] 

EN 

54 

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(cid:208) 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), 

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. 

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. 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

EN 

55 

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– 

– 

– 

Products for tanning without sun. 

Skin-whitening products. 

Anti-wrinkle products. 

(cid:216) new 

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 the qualitative and quantitative composition of the product, including chemical 

identity  of  the  substances  (incl.  chemical  name,  INCI,  CAS,  EINECS/ELINCS)  and  their 

intended  function.  In  the  case  of  essential  oils,  perfume  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 the physical and chemical characteristics of the substances, the raw-material as 

well as the cosmetic product. 

Description  of  the  stability  of  the  cosmetics  product  under  reasonably  foreseeable  storage 

conditions. 

3. Microbiological quality 

Description  of  the  microbiological  specifications  of  the  raw  material  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. 

EN 

56 

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4. Impurities, traces, information about the packaging material 

Description of purity of the substances and raw material. 

In the case of traces of prohibited substances, evidence for their technical unavoidability. 

Description  of  the  relevant  characteristics  of  packaging  material,  in  particular  purity  and 
stability. 

5. Normal and reasonably foreseeable use 

Description of 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  exposure  to  cosmetic  product  taking  into  consideration  the  findings  under 

Section 5 in relation to 

(1) 

The site(s) of application; 

(2) 

The surface area(s) of application; 

(3) 

The amount of product applied; 

(4) 

The duration and frequency of use; 

(5) 

The normal and reasonably foreseeable exposure route(s); 

(6) 

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

The calculation of the exposure shall also take into consideration the toxicological effects to 

be considered (e.g. exposure might need to be calculated per unit area of skin or per 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. 

EN 

57 

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7. Exposure to the substances 

Description  of  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  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. 

In  case  of  significant  percutaneous  absorption,  systemic  effects  shall  be  considered  and 

NOAEL shall be assessed. The absence of these considerations shall be duly justified. 

Particular consideration shall be given to any possible impacts on the toxicological profile due 

to 

–  particle sizes; 

–  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 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. 

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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 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. 

EN 

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EN 

60 

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Preamble to Annexes II to VI 

(1) 

For the purposes of the Annexes II to VI: 

(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

(g) 

(h) 

(i) 

‘Rinse-off product’ means a cosmetic product which is intended not to stay in 
prolonged contact with the skin, the hair or the mucous membranes; 

‘Leave-on  product’  means  a  cosmetic  product  which  is  intended  to  stay  in 
prolonged contact with the skin, the hair or the mucous membranes; 

‘Hair product’ means a cosmetic product which is intended to be applied on the 
hair of head or face, except eye lashes; 

‘Skin product’ means a cosmetic product which is intended to be applied on the 
skin; 

‘Lip product’ means a cosmetic product which is intended to be applied on the 
lips; 

‘Face  product’  means  a  cosmetic  product  which  is  intended  to  be  applied  on 
the skin of the face; 

‘Nail  product’  means  a  cosmetic  product  which  is  intended  to  be  applied  on 
nails; 

‘Oral  product’  means  a  cosmetic  product  which  is  intended  to  be  applied  on 
teeth or the mucous membranes of the oral cavity; 

‘Product  applied  on  mucous  membranes’  means  a  cosmetic  product  which  is 
intended to be applied on the mucous membranes 

–  of the oral cavity, 

–  in the vicinity of the eyes, 

–  or of the external genital organs; 

(j) 

(k) 

‘Eye product’ means a cosmetic product which is intended to be applied in the 
vicinity of the eyes; 

‘Professional  use’  means  the  application  and  use  of  cosmetic  products  by 
persons in the exercise of their professional activity. 

(2) 

In order to facilitate substance identification, the following descriptors are used: 

–  The  Non-proprietary  Names  (INN)  for  pharmaceutical  products,  WHO,  Geneva, 

August 1975. 

–  The Chemical Abstracts Service numbers (CAS). 

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–  The European Inventory of Existing Commercial chemical Substances (EINECS) 
numbers  and  the  European  List  of  Notified  Chemical  Substances  (ELINCS) 
numbers. 

(cid:208) 76/768/EEC 

ANNEX II 

(cid:208) 82/368/EEC (adapted) 

LIST OF SUBSTANCES ⌦ PROHIBITED IN ⌫ WHICH MUST NOT FORM PART 
OF THE COMPOSITION OF COSMETIC PRODUCTS 

(cid:208) 76/768/EEC (adapted) 
(cid:206)1 82/368/EEC 
(cid:206)2 90/121/EEC 

⌦ 
Refe
renc
e 
num
ber 
⌫ 

⌫ 

⌦ Substance identification ⌫ 

⌦ Chemical name/INN ⌫ 

⌦ CAS 
number ⌫ 

⌦ EINECS/ELI
NCS number ⌫ 

⌦ b ⌫ 

⌦ c ⌫ 

⌦ d ⌫ 

1. 

N-5-Chlorobenzoxazol-2-ylacetamide  ⌦ 35783-57-

4 ⌫ 

2.  (cid:206)1 (2-

⌦51-84-3 ⌫  ⌦ 200-128-9 ⌫ 

Acetoxyethyl)trimethylammonium 
hydroxide (acetylcholine) and its salts  

3. 

Deanol aceglumate ⌦ (INN) ⌫ (33)  ⌦ 3342-61-

⌦ 222-085-5 ⌫ 

8 ⌫  

4. 

Spironolactone ⌦ (INN) ⌫ * 

⌦ 52-01-7 ⌫  ⌦ 200-133-6 ⌫ 

5.  (cid:206)1 [4-(4-Hydroxy-3-iodophenoxy)-3,5-
diiodophenyl]acetic acid and its salts  

⌦ 51-24-1 ⌫  ⌦ 200-086-1 ⌫ 

6. 

Methotrexate ⌦ (INN) ⌫ * 

⌦ 59-05-2 ⌫  ⌦ 200-413-8 ⌫ 

33 

In  this  Directive,  names  followed  by  an  asterisk  are  those  published  in  ‘Computer  print-out  1975, 
International Non-proprietary Names (INN) for pharmaceutical products, Lists 1-33 of proposed INN’, 
WHO, Geneva, August 1975. 

EN 

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7. 

8. 

9. 

Aminocaproic  acid  ⌦ (INN) ⌫  *  and 
its salts 

⌦ 60-32-2 ⌫  ⌦ 200-469-3 ⌫ 

Cinchophen  ⌦ (INN) ⌫  *,  its  salts, 
derivatives and salts of these derivatives 

⌦ 132-60-
5 ⌫ 

⌦ 205-067-1 ⌫ 

Thyropropic acid ⌦ (INN) ⌫ * and its 
salts 

⌦ 51-26-3 ⌫ 

10. 

Trichloroacetic acid 

⌦ 76-03-9 ⌫  ⌦ 200-927-2 ⌫ 

11. 

12. 

Aconitum  napellus  L.  (leaves,  roots  and 
galenical preparations) 

⌦ 84603-50-
9 ⌫ 

⌦ 283-252-6 ⌫ 

Aconitine 
Aconitum napellus L.)and its salts 

(principal 

alkaloid 

of 

⌦ 302-27-
2 ⌫ 

⌦ 206-121-7 ⌫ 

13. 

Adonis vernalis L. and its preparations  ⌦ 84649-73-

⌦ 283-458-6 ⌫ 

0 ⌫ 

14. 

Epinephrine ⌦ (INN) ⌫ * 

⌦ 51-43-4 ⌫  ⌦ 200-098-7 ⌫ 

15. 

16. 

Rauwolfia  serpentina  alkaloids  and  their 
salts 

⌦ 90106-13-
1 ⌫ 

⌦ 290-234-1 ⌫ 

Alkyne  alcohols,  their  esters,  ethers  and 
salts 

17. 

Isoprenaline ⌦ (INN) ⌫ * 

⌦ 7683-59-
2 ⌫ 

⌦ 231-687-7 ⌫ 

18. 

Allyl isothiocyanate 

⌦ 57-06-7 ⌫  ⌦ 200-309-2 ⌫ 

19. 

Alloclamide ⌦ (INN) ⌫ * and its salts  ⌦ 5486-77-

1 ⌫ 

20. 

21. 

Nalorphine ⌦ (INN) ⌫  *,  its  salts  and 
ethers 

⌦ 62-67-9 ⌫  ⌦ 200-546-1 ⌫ 

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

⌦ 300-62-
9 ⌫ 

⌦ 206-096-2 ⌫ 

22. 

Aniline, its salts and its halogenated and 
sulphonated derivatives 

⌦ 62-53-3 ⌫  ⌦ 200-539-3 ⌫ 

23. 

Betoxycaine ⌦ (INN) ⌫ * and its salts  ⌦ 3818-62-

EN 

0 ⌫ 

63 

   EN 

 
 
 
 
 
 
24. 

Zoxazolamine ⌦ (INN) ⌫ * 

⌦ 61-80-3 ⌫  ⌦ 200-519-4 ⌫ 

25. 

Procainamide  ⌦ (INN) ⌫  *,  its  salts 
and derivatives 

⌦ 51-06-9 ⌫  ⌦ 200-078-8 ⌫ 

26. 

Benzidine 

⌦ 92-87-5 ⌫  ⌦ 202-199-1 ⌫ 

27. 

Tuaminoheptane  ⌦ (INN) ⌫  *, 
isomers and salts 

its 

⌦ 123-82-
0 ⌫ 

⌦ 204-655-5 ⌫ 

28. 

Octodrine ⌦ (INN) ⌫ * and its salts  ⌦ 543-82-

⌦ 208-851-1 ⌫ 

29.  (cid:206)1 2-Amino-1,2-bis(4-

methoxyphenyl)ethanol and its salts  

8 ⌫ 

⌦ 530-34-
7 ⌫ 

30. 

1,3-dimethylpentylamine and its salts  ⌦ 105-41-

⌦ 203-296-1 ⌫ 

9 ⌫ 

31. 

4-Aminosalicylic acid and its salts 

⌦ 65-49-6 ⌫  ⌦ 200-613-5 ⌫ 

32. 

33. 

Toluidines, 
isomers,  salts  and 
halogenated and sulphonated derivatives 

their 

⌦ 26915-12-
8 ⌫ 

⌦ 248-105-2 ⌫ 

Xylidines, 
isomers,  salts  and 
halogenated and sulphonated derivatives 

their 

⌦ 1300-73-
8 ⌫ 

⌦ 215-091-4 ⌫ 

34.  (cid:206)1 Imperatorin 

(9-(3-methoxylbut-2-

enyloxy)furo[3,2-g]chromen-7-one)  

⌦ 482-44-
0 ⌫ 

⌦ 207-581-1 ⌫ 

35. 

Ammi  majus  ⌦ L. ⌫  and  its  galenical 
preparations 

⌦ 90320-46-
0 ⌫ 

⌦ 291-072-4 ⌫ 

36. 

2,3-Dichloro-2-methylbutane 

⌦ 507-45-
9 ⌫ 

37. 

Substances with androgenic effect 

38. 

Anthracene oil 

39. 

Antibiotics (cid:206)2 ---  

40. 

Antimony and its compounds 

⌦ 120-12-
7 ⌫ 

⌦ 204-371-1 ⌫ 

⌦ 7440-36-
0 ⌫ 

⌦ 231-146-5 ⌫ 

41. 

Apocynum  cannabinum  L.  and 
preparations 

its 

⌦ 84603-51-
0 ⌫ 

⌦ 283-253-1 ⌫ 

42.  (cid:206)1 Apomorphine 

(R 

5,6,6a, 

7-

⌦ 58-00-4 ⌫  ⌦ 200-360-0 ⌫ 

tetrahydro-6-methyl-4H-dibenzo 

EN 

64 

   EN 

 
 
 
 
 
 
 
[de,g]quinoline-10,11-diol) 
salts  

and 

its 

43. 

Arsenic and its compounds 

44. 

Atropa 
preparations 

belladonna 

L. 

and 

its 

⌦ 7440-38-
2 ⌫ 

⌦ 8007-93-
0 ⌫ 

⌦ 231-148-6 ⌫ 

⌦ 232-365-9 ⌫ 

45. 

Atropine, its salts and derivatives 

⌦ 51-55-8 ⌫  ⌦ 200-104-8 ⌫ 

(cid:208) 83/191/EEC (adapted) 

46. 

the  exception  of 
Barium  salts,  with 
barium  sulphate,  barium  sulphide  under 
the  conditions  laid  down  in  Annex  III, 
Part  1],  and  lakes,  salts  and  pigments 
prepared from the colouring agents listed 
with the reference (5) in Annex III , Part 2 
and Annex IV, Part 2 

(cid:208) 76/768/EEC (adapted) 
(cid:206)1 82/368/EEC 
(cid:206)2 85/391/EEC 

47. 

Benzene 

⌦ 71-43-2 ⌫  ⌦ 200-753-7 ⌫ 

48.  (cid:206)1 Benzimidazol-2(3H)-one  

⌦ 615-16-
7 ⌫ 

⌦ 210-412-4 ⌫ 

49.  (cid:206)1 Benzazepines 

benzodiazepines  

and 

⌦ 12794-10-
4 ⌫ 

50.  (cid:206)1 1-Dimethylaminomethyl-1-

methylpropyl  benzoate  (amylocaine)  and 
its salts  

51.  (cid:206)1 2,2,6-Trimethyl-4-piperidyl  benzoate 

(benzamine) and its salts  

⌦ 644-26-
8 ⌫ 

⌦ 500-34-
5 ⌫ 

⌦ 211-411-1 ⌫ 

52.  (cid:206)1 Isocarboxazid ⌦ (INN) ⌫ *   ⌦ 59-63-2 ⌫  ⌦ 200-438-4 ⌫ 

53. 

Bendroflumethiazide ⌦ (INN) ⌫ * and 
its derivatives 

⌦ 73-48-3 ⌫  ⌦ 200-800-1 ⌫ 

54. 

Beryllium and its compounds 

⌦ 7440-41- ⌦ 231-150-7 ⌫ 

EN 

65 

   EN 

 
 
 
 
 
 
 
 
 
 
 
55. 

Bromine, elemental 

7 ⌫ 

⌦ 7726-95-
6 ⌫ 

⌦ 231-778-1 ⌫ 

56. 

57. 

58. 

59. 

Bretylium tosilate ⌦ (INN) ⌫ * 

⌦ 61-75-6 ⌫  ⌦ 200-516-8 ⌫ 

Carbromal ⌦ (INN) ⌫ * 

⌦ 77-65-6 ⌫  ⌦ 201-046-6 ⌫ 

Bromisoval ⌦ (INN) ⌫ * 

Brompheniramine ⌦ (INN) ⌫ * and its 
salts 

⌦ 496-67-
3 ⌫ 

⌦ 207-825-7 ⌫ 

⌦ 86-22-6 ⌫  ⌦ 201-657-8 ⌫ 

60. 

Benzilonium bromide ⌦ (INN) ⌫ *  ⌦ 1050-48-

⌦ 213-885-5 ⌫ 

2 ⌫ 

61. 

Tetrylammonium  bromide  ⌦ (INN) ⌫ 
* 

⌦ 71-91-0 ⌫  ⌦ 200-769-4 ⌫ 

62. 

Brucine 

⌦ 357-57-
3 ⌫ 

⌦ 206-614-7 ⌫ 

63. 

64. 

65. 

66. 

67. 

68. 

Tetracaine ⌦ (INN) ⌫ * and its salts  ⌦ 94-24-6 ⌫  ⌦ 202-316-6 ⌫ 

Mofebutazone ⌦ (INN) ⌫ * 

⌦ 2210-63-
1 ⌫ 

⌦ 218-641-1 ⌫ 

Tolbutamide ⌦ (INN) ⌫ * 

⌦ 64-77-7 ⌫  ⌦ 200-594-3 ⌫ 

Carbutamide ⌦ (INN) ⌫ * 

⌦ 339-43-
5 ⌫ 

⌦ 206-424-4 ⌫ 

Phenylbutazone ⌦ (INN) ⌫ * 

⌦ 50-33-9 ⌫  ⌦ 200-029-0 ⌫ 

Cadmium and its compounds 

69. 

Cantharides, Cantharis vesicatoria 

70. 

(1R,2S)-Hexahydro-1,2-dimethyl-3,6-
epoxyphthalic anhydride (cantharidin) 

71. 

Phenprobamate ⌦ (INN) ⌫ * 

72.  (cid:206)1 Nitroderivatives of carbazole  

⌦ 7440-43-
9 ⌫ 

⌦ 92457-17-
5 ⌫ 

⌦ 231-152-8 ⌫ 

⌦ 296-298-7 ⌫ 

⌦ 56-25-7 ⌫  ⌦ 200-263-3 ⌫ 

⌦ 211-606-1 ⌫ 

⌦ 673-31-
4 ⌫ 

⌦ 31438-22-
9 ⌫ 

EN 

66 

   EN 

 
 
Carbon disulphide 

⌦ 75-15-0 ⌫  ⌦ 200-843-6 ⌫ 

73. 

74. 

Catalase 

75. 

Cephaeline and its salts 

⌦ 9001-05-
2 ⌫ 

⌦ 483-17-
0 ⌫ 

⌦ 232-577-1 ⌫ 

⌦ 207-591-6 ⌫ 

76. 

Chenopodium  ambrosioides  ⌦ L. ⌫ 
(essential oil) 

⌦ 8006-99-
3 ⌫ 

77. 

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

78. 

Chlorine 

⌦ 302-17-
0 ⌫ 

⌦ 7782-50-
5 ⌫ 

⌦ 206-117-5 ⌫ 

⌦ 231-959-5 ⌫ 

79. 

Chlorpropamide ⌦ (INN) ⌫ * 

⌦ 94-20-2 ⌫  ⌦ 202-314-5 ⌫ 

80.  (cid:206)1 Diphenoxylate  ⌦ (INN) ⌫ 

* 

hydrochloride  

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

⌦ 223-287-6 ⌫ 

⌦ 3810-80-
8 ⌫ 

⌦ 5909-04-
6 ⌫ 

Chlorzoxazone ⌦ (INN) ⌫ * 

⌦ 95-25-0 ⌫  ⌦ 202-403-9 ⌫ 

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

⌦ 535-89-
7 ⌫ 

⌦ 208-622-6 ⌫ 

Chlorprothixene  ⌦ (INN) ⌫  *  and  its 
salts 

⌦ 113-59-
7 ⌫ 

⌦ 204-032-8 ⌫ 

81. 

82. 

83. 

84. 

85. 

Clofenamide ⌦ (INN) ⌫ * 

86.  (cid:206)1 N,N-bis(2-chloroethyl)methylamine 

N-oxide and its salts  

⌦ 211-588-5 ⌫ 

⌦ 671-95-
4 ⌫ 

⌦ 126-85-
2 ⌫ 

87. 

88. 

89. 

Chlormethine  ⌦ (INN) ⌫  *  and  its 
salts 

⌦ 51-75-2 ⌫  ⌦ 200-120-5 ⌫ 

Cyclophosphamide  ⌦ (INN) ⌫  *  and 
its salts 

⌦ 50-18-0 ⌫  ⌦ 200-015-4 ⌫ 

Mannomustine  ⌦ (INN) ⌫  *  and  its 
salts 

⌦ 576-68-
1 ⌫ 

⌦ 209-404-3 ⌫ 

90. 

Butanilicaine ⌦ (INN) ⌫ * and its salts  ⌦ 3785-21-

EN 

5 ⌫ 

67 

   EN 

 
 
 
 
 
91.  (cid:206)1 Chlormezanone ⌦ (INN) ⌫ *   ⌦ 80-77-3 ⌫  ⌦ 201-307-4 ⌫ 

92. 

93. 

Triparanol ⌦ (INN) ⌫ * 

⌦ 78-41-1 ⌫  ⌦ 201-115-0 ⌫ 

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

⌦ 3691-35-
8 ⌫ 

⌦ 223-003-0 ⌫ 

94. 

Chlorphenoxamine ⌦ (INN) ⌫ * 

⌦ 77-38-3 ⌫ 

95.  (cid:206)1 2-[2-(4-Chlorophenyl)-2-
phenylacetyl]indan 
(chlorophacinone - ISO)  

1,3-dione 

⌦ Phenaglycodol (INN) ⌫ * 

⌦ 79-93-6 ⌫  ⌦ 201-235-3 ⌫ 

96. 

97. 

98. 

99. 

Chloroethane 

⌦ 75-00-3 ⌫  ⌦ 200-830-5 ⌫ 

Chromium; chromic acid and its salts  ⌦ 7440-47-

⌦ 231-157-5 ⌫ 

3 ⌫ 

Claviceps purpurea Tul., its alkaloids and 
galenical preparations 

⌦ 84775-56-
4 ⌫ 

⌦ 283-885-8 ⌫ 

Conium  maculatum  L  (fruit,  powder, 
galenical preparations) 

⌦ 85116-75-
2 ⌫ 

⌦ 285-527-6 ⌫ 

100. 

Glycyclamide ⌦ (INN) ⌫ * 

101. 

Cobalt benzenesulphonate 

⌦ 211-557-6 ⌫ 

⌦ 664-95-
9 ⌫ 

⌦ 23384-69-
2 ⌫ 

102. 

Colchicine, its salts and derivatives 

⌦ 64-86-8 ⌫  ⌦ 200-598-5 ⌫ 

103. 

Colchicoside and its derivatives 

⌦ 477-29-
2 ⌫ 

⌦ 207-513-0 ⌫ 

104. 

GColchicum  autumnale  L 
galenical preparations 

and 

its 

⌦ 84696-03-
7 ⌫ 

⌦ 283-623-2 ⌫ 

105. 

Convallatoxin 

⌦ 508-75-
8 ⌫ 

⌦ 208-086-3 ⌫ 

106. 

Anamirta cocculus L. (fruit) 

107. 

Croton tiglium (oil) 

⌦ 8001-28-
3 ⌫ 

108. 

1-Butyl-3-(N-crotonoylsulphanilyl)urea  ⌦ 52964-42-

EN 

8 ⌫ 

68 

   EN 

 
 
 
 
 
 
 
109. 

Curare and curarine 

110. 

Synthetic curarizants 

⌦ 8063-06-7; 
22260-42-0 ⌫ 

⌦ 232-511-1; 
244-880-6 ⌫ 

111. 

Hydrogen cyanide and its salts 

⌦ 74-90-8 ⌫  ⌦ 200-821-6 ⌫ 

112.  (cid:206)1 2-α-Cyclohexylbenzyl(N,N,N',N',-
tetraethyl)trimethylenediamine 
(phenetamine)  

113. 

Cyclomenol ⌦ (INN) ⌫ * and its salts  ⌦ 5591-47-

⌦ 227-002-6 ⌫ 

9 ⌫ 

114. 

Sodium hexacyclonate ⌦ (INN) ⌫ *  ⌦ 7009-49-

115. 

Hexapropymate ⌦ (INN) ⌫ * 

116. 

Dextropropoxyphene ⌦ (INN) ⌫ * 

117.  (cid:206)1 O,O'-Diacetyl-N-allyl-N-

normorphine  

6 ⌫ 

⌦ 358-52-
1 ⌫ 

⌦ 469-62-
5 ⌫ 

⌦ 2748-74-
5 ⌫ 

⌦ 206-618-9 ⌫ 

⌦ 207-420-5 ⌫ 

118. 

Pipazetate ⌦ (INN) ⌫ * and its salts  ⌦ 2167-85-

⌦ 218-508-8 ⌫ 

119.  (cid:206)1 5-(αβ-Dibromophenethyl)-5-

methylhydantoin  

120.  (cid:206)1 N,N'-Pentamethylenebis 
(trimethylammonium 
g. 
pentamethonium  bromide  ⌦ (INN) ⌫ 
*  

salts), 

e. 

3 ⌫ 

⌦ 511-75-
1 ⌫ 

⌦ 541-20-
8 ⌫ 

⌦ 208-133-8 ⌫ 

 ⌦ 208-771-7 ⌫ 

121.  (cid:206)1 N,N'-

[(Methylimino)diethylene]bis(ethyldimet
hylammonium) salts, e. g. azamethonium 
bromide ⌦ (INN) ⌫ *  

122. 

Cyclarbamate ⌦ (INN) ⌫ * 

⌦ 306-53-
6 ⌫ 

⌦ 206-186-1 ⌫ 

⌦ 5779-54-
4 ⌫ 

⌦ 227-302-7 ⌫ 

123. 

Clofenotane ⌦ (INN) ⌫ *; DDT (ISO)  ⌦ 50-29-3 ⌫  ⌦ 200-024-3 ⌫ 

124.  (cid:206)1 N,N'-

⌦ 55-97-0 ⌫  ⌦ 200-249-7 ⌫ 

Hexamethylenebis(trimethylammonium) 
salts,  e.  g.  hexamethonium  bromide 
⌦ (INN) ⌫ *  

EN 

69 

   EN 

 
 
 
 
 
 
 
125. 

Dichloroethanes (ethylene chlorides) 

126. 

Dichloroethylenes (acetylene chlorides) 

127. 

Lysergide ⌦ (INN) ⌫ * and its salts  ⌦ 50-37-3 ⌫  ⌦ 200-033-2 ⌫ 

128.  (cid:206)1 2-Diethylaminoethyl-3-hydroxy-4-
phenylbenzoate and its salts  

129. 

Cinchocaine ⌦ (INN) ⌫ * and its salts  ⌦ 85-79-0 ⌫  ⌦ 201-632-1 ⌫ 

130. 

3-Diethylaminopropyl cinnamate 

⌦ 538-66-
9 ⌫ 

131.  (cid:206)1 O,O'-Diethyl 

O-4-nitrophenyl 

⌦ 56-38-2 ⌫  ⌦ 200-271-7 ⌫ 

phosphorothioate (pParathion-lSO)  

132.  (cid:206)1 [Oxalylbisiminoethylene)]bis[(o-

chlorobenzyl)diethylammonium  salts],  e. 
g.  ambenonmium  chloride  ⌦ (INN) ⌫ 
*  

⌦ 115-79-
7 ⌫ 

⌦ 204-107-5 ⌫ 

133.  Methyprylon ⌦ (INN) ⌫ * and its salts  ⌦ 125-64-

⌦ 204-745-4 ⌫ 

4 ⌫ 

134. 

135. 

Digitaline and all heterosides of Digitalis 
purpurea L. 

⌦ 752-61-
4 ⌫ 

⌦ 212-036-6 ⌫ 

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

⌦ 2530-97-
4 ⌫ 

136. 

Dioxethedrin ⌦ (INN) ⌫ * and its salts  ⌦ 497-75-

⌦ 207-849-8 ⌫ 

6 ⌫ 

137. 

Piprocurarium iodide ⌦ (INN) ⌫ *  ⌦ 3562-55-

⌦ 222-627-0 ⌫ 

138. 

Propyphenazone ⌦ (INN) ⌫ * 

8 ⌫ 

⌦ 479-92-
5 ⌫ 

⌦ 207-539-2 ⌫ 

139. 

Tetrabenazine  ⌦ (INN) ⌫  *  and  its 
salts 

⌦ 58-46-8 ⌫  ⌦ 200-383-6 ⌫ 

140. 

Captodiame ⌦ (INN) ⌫ * 

141.  Mefeclorazine  ⌦ (INN) ⌫  *  and  its 

salts 

⌦ 207-629-1 ⌫ 

⌦ 486-17-
9 ⌫ 

⌦ 1243-33-
0 ⌫ 

142. 

Dimethylamine 

⌦ 124-40-

⌦ 204-697-4 ⌫ 

EN 

70 

   EN 

 
 
 
 
 
 
 
 
 
 
3 ⌫ 

143.  (cid:206)1 1,1-Bis(dimethylaminomethyl)propyl 
benzoate  (amydricaine,  alypine)  and  its 
salts  

⌦ 963-07-
5 ⌫ 

⌦ 213-512-6 ⌫ 

144.  Methapyrilene  ⌦ (INN) ⌫  *  and  its 

⌦ 91-80-5 ⌫  ⌦ 202-099-8 ⌫ 

salts 

145.  Metamfepramone ⌦ (INN) ⌫ * and its 

salts 

⌦ 15351-09-
4 ⌫ 

⌦ 239-384-1 ⌫ 

146. 

Amitriptyline ⌦ (INN) ⌫ * and its salts ⌦ 50-48-6 ⌫  ⌦ 200-041-6 ⌫ 

147.  Metformin ⌦ (INN) ⌫ * and its salts  ⌦ 657-24-

⌦ 211-517-8 ⌫ 

9 ⌫ 

148. 

Isosorbide dinitrate ⌦ (INN) ⌫ * 

⌦ 87-33-2 ⌫  ⌦ 201-740-9 ⌫ 

149.  Malononitrile 

150. 

Succinonitrile 

151. 

Dinitrophenol isomers 

152. 

Inproquone ⌦ (INN) ⌫ 

⌦ 203-703-2 ⌫ 

⌦ 203-783-9 ⌫ 

⌦ 109-77-
3 ⌫ 

⌦ 110-61-
2 ⌫ 

⌦ 436-40-
8 ⌫ 

153. 

Dimevamide ⌦ (INN) ⌫ * and its salts  ⌦ 60-46-8 ⌫  ⌦ 200-479-8 ⌫ 

154. 

Diphenylpyraline ⌦ (INN) ⌫  *  and  its 
salts 

⌦ 147-20-
6 ⌫ 

⌦ 205-686-7 ⌫ 

155. 

Sulfinpyrazone ⌦ (INN) ⌫ * 

⌦ 57-96-5 ⌫  ⌦ 200-357-4 ⌫ 

156.  (cid:206)1 N-(3-Carbamoyl-3,3-

⌦ 71-81-8 ⌫  ⌦ 200-766-8 ⌫ 

diphenylpropyl)-N,N-diisopropylmethyl-
ammonium  salts,  e.  g. 
iodide ⌦ (INN) ⌫ *  

isopropamide 

157. 

Benactyzine ⌦ (INN) ⌫ * 

⌦ 302-40-
9 ⌫ 

⌦ 206-123-8 ⌫ 

158. 

Benzatropine ⌦ (INN) ⌫ * and its salts  ⌦ 86-13-5 ⌫ 

159. 

Cyclizine ⌦ (INN) ⌫ * and its salts  ⌦ 82-92-8 ⌫  ⌦ 201-445-5 ⌫ 

160.  (cid:206)1 5,5-Diphenyl-4-imidazolidone   ⌦ 3254-93-

⌦ 221-851-6 ⌫ 

EN 

1 ⌫ 

71 

   EN 

 
 
 
 
 
161. 

Probenecid ⌦ (INN) ⌫ * 

⌦ 57-66-9 ⌫  ⌦ 200-344-3 ⌫ 

162. 

Disulfiram ⌦ (INN) ⌫ *; thiram (ISO) 
⌦ (INN) ⌫ 

⌦97-77-
8; 137-26-8 ⌫ 

⌦ 202-607-8; 
205-286-2 ⌫ 

163. 

Emetine, its salts and derivatives 

164. 

Ephedrine and its salts 

⌦ 483-18-
1 ⌫ 

⌦ 299-42-
3 ⌫ 

⌦ 207-592-1⌫ 

⌦ 206-080-5 ⌫ 

165. 

Oxanamide  ⌦ (INN) ⌫  *  and 
derivatives 

its 

⌦ 126-93-
2 ⌫ 

166. 

Eserine or physostigmine and its salts  ⌦ 57-47-6 ⌫  ⌦ 200-332-8 ⌫ 

167. 

Esters  of  4-aminobenzoic  acid,  with  the 
free  amino  group,  with  the  exception  of 
that given in (cid:206)2 Annex VIVII, Part 2  

168. 

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

⌦ 67-48-1 ⌫  ⌦ 200-655-4 ⌫ 

169. 

Caramiphen ⌦ (INN) ⌫ * and its salts  ⌦ 77-22-5 ⌫  ⌦ 201-013-6 ⌫ 

170. 

Diethyl 4-nitrophenyl phosphate 

171.  Metethoheptazine ⌦ (INN) ⌫ * and its 

salts 

⌦ 206-221-0 ⌫ 

⌦ 311-45-
5 ⌫ 

⌦ 509-84-
2 ⌫ 

172. 

173. 

Oxpheneridine  ⌦ (INN) ⌫  *  and  its 
salts 

⌦ 546-32-
7 ⌫ 

Ethoheptazine  ⌦ (INN) ⌫  *  and  its 
salts 

⌦ 77-15-6 ⌫  ⌦ 201-007-3 ⌫ 

174.  Metheptazine ⌦ (INN) ⌫ * and its salts ⌦ 469-78-

175.  Methylphenidate  ⌦ (INN) ⌫  *  and  its 

salts 

3 ⌫ 

⌦ 113-45-
1 ⌫ 

⌦ 204-028-6 ⌫ 

176. 

Doxylamine ⌦ (INN) ⌫ * and its salts  ⌦ 469-21-

⌦ 207-414-2 ⌫ 

177. 

Tolboxane ⌦ (INN) ⌫ * 

6 ⌫ 

⌦ 2430-46-
8 ⌫ 

EN 

72 

   EN 

 
 
 
 
 
 
 
 
(cid:208) 2003/83/EC Art. 1 and Annex 
.1(a) amended by Corrigendum, OJ 
L 058, 26.2.2004, p. 28 (adapted) 

178. 

4-Benzyloxyphenol and 4-ethoxyphenol  ⌦103-16-2; 
622-62-8 ⌫ 

⌦ 203-083-3; 
210-748-1 ⌫ 

(cid:208) 76/768/EEC (adapted) 

179. 

Parethoxycaine  ⌦ (INN) ⌫  *  and  its 
salts 

⌦ 136-46-
9 ⌫ 

⌦ 205-246-4 ⌫ 

180. 

Fenozolone ⌦ (INN) ⌫ * 

⌦ 15302-16-
6 ⌫ 

⌦ 239-339-6 ⌫ 

181. 

Glutethimide ⌦ (INN) ⌫ * and its salts  ⌦ 77-21-4 ⌫  ⌦ 201-012-0 ⌫ 

182. 

Ethylene oxide 

⌦ 75-21-8 ⌫  ⌦ 200-849-9 ⌫ 

183. 

Bemegride ⌦ (INN) ⌫ * and its salts  ⌦ 64-65-3 ⌫  ⌦ 200-588-0 ⌫ 

184. 

Valnoctamide ⌦ (INN) ⌫ * 

⌦ 4171-13-
5 ⌫ 

⌦ 224-033-7 ⌫ 

185. 

Haloperidol ⌦ (INN) ⌫ * 

⌦ 52-86-8 ⌫  ⌦ 200-155-6 ⌫ 

186. 

Paramethasone ⌦ (INN) ⌫ * 

⌦ 53-33-8 ⌫  ⌦ 200-169-2 ⌫ 

187. 

Fluanisone ⌦ (INN) ⌫ * 

188. 

Trifluperidol ⌦ (INN) ⌫ * 

189. 

Fluoresone ⌦ (INN) ⌫ * 

⌦ 1480-19-
9 ⌫ 

⌦ 749-13-
3 ⌫ 

⌦ 2924-67-
6 ⌫ 

⌦ 216-038-8 ⌫ 

⌦ 220-889-0 ⌫ 

190. 

Fluorouracil ⌦ (INN) ⌫ * 

⌦ 51-21-8 ⌫  ⌦ 200-085-6 ⌫ 

191. 

 Hydrofluoric  acid,  its  normal  salts,  its  ⌦ 7664-39- ⌦ 231-634-8 ⌫ 

(cid:208) 82/368/EEC (adapted) 

EN 

73 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
complexes  and  hydrofluorides  with  the 
exception  of  those  given  in  Annex  III, 
Part 1 

3 ⌫ 

(cid:208) 76/768/EEC (adapted) 
(cid:206)1 82/368/EEC 

192. 

Furfuryltrimethylammonium  salts,  e.  g. 
furtrethonium iodide ⌦ (INN) ⌫ * 

⌦ 541-64-
0 ⌫ 

⌦ 208-789-5 ⌫ 

193. 

Galantamine ⌦ (INN) ⌫ * 

⌦ 357-70-
0 ⌫ 

194. 

Progestogens 

195. 

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

⌦ 58-89-9 ⌫  ⌦ 200-401-2 ⌫ 

196.  (cid:206)1 (1R,4S,5R,8S)-1,2,3,4,10,10-

⌦ 72-20-8 ⌫  ⌦ 200-775-7 ⌫ 

Hexachloro-6,7-epoxy-1,4,4a,5,6,7,8,8a-
octahydro-1,4:5,8-dimethano-
naphthalene (endrin-ISO)  

197. 

Hexachloroethane 

⌦ 67-72-1 ⌫  ⌦ 200-666-4 ⌫ 

198. 

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

⌦ 465-73-
6 ⌫ 

⌦ 207-366-2 ⌫ 

199. 

Hydrastine, hydrastinine and their salts  ⌦ 118-08-1; 
6592-85-4 ⌫ 

⌦ 204-233-0; 
229-533-9 ⌫ 

200. 

Hydrazides and their salts 

⌦ 54-85-3 ⌫  ⌦ 200-214-6 ⌫ 

201. 

Hydrazine, its derivatives and their salts  ⌦ 302-01-

⌦ 206-114-9 ⌫ 

2 ⌫ 

202. 

Octamoxin ⌦ (INN) ⌫ * and its salts  ⌦ 4684-87-

1 ⌫ 

203.  Warfarin ⌦ (INN) ⌫ * and its salts  ⌦ 81-81-2 ⌫  ⌦ 201-377-6 ⌫ 

204.  (cid:206)1 Ethyl 

bis(4-hydroxy-2-oxo-1-
benzopyran-3-yl)  acetate  and  salts  of  the 
acid  

⌦ 548-00-
5 ⌫ 

⌦ 208-940-5 ⌫ 

205.  Methocarbamol ⌦ (INN) ⌫ * 

⌦ 532-03-

⌦ 208-524-3 ⌫ 

EN 

74 

   EN 

 
 
 
 
 
 
 
 
 
206. 

Propatylnitrate ⌦ (INN) ⌫ * 

207.  (cid:206)1 4,4'-Dihydroxy-3,3'-(3-

methylthiopropylidene) dicoumarin  

208. 

Fenadiazole ⌦ (INN) ⌫ * 

6 ⌫ 

⌦ 2921-92-
8 ⌫ 

⌦ 1008-65-
7 ⌫ 

⌦ 220-866-5 ⌫ 

209. 

Nitroxoline ⌦ (INN) ⌫ * and its salts  ⌦ 4008-48-

⌦ 223-662-4 ⌫ 

4 ⌫ 

210. 

Hyoscyamine, its salts and derivatives  ⌦ 101-31-

⌦ 202-933-0 ⌫ 

5 ⌫ 

211. 

Hyoscyamus  niger  L.  (leaves,  seeds, 
powder and galenical preparations) 

⌦ 84603-65-
6 ⌫ 

⌦ 283-265-7 ⌫ 

212. 

Pemoline ⌦ (INN) ⌫ * and its salts  ⌦ 2152-34-

⌦ 218-438-8 ⌫ 

213. 

Iodine 

214.  (cid:206)1 Decamethylenebis(trimethylammoniu
decamethonium 
e. 

g. 

salts, 
m) 
bromide  

3 ⌫ 

⌦ 7553-56-
2 ⌫ 

⌦ 541-22-
0 ⌫ 

⌦ 231-442-4 ⌫ 

⌦ 208-772-2 ⌫ 

215. 

Ipecacuanha 
ipecacuanha 
(Cephaelis 
Brot  and  related  species)  (roots,  powder 
and galenical preparations) 

⌦ 8012-96-
2 ⌫ 

⌦ 232-385-8 ⌫ 

216. 

(2-Isopropylpent4-enoyl)urea 
(apronalide) 

217.  (cid:206)1 α-Santonin 

[(3S,5aR,9bS)-

3,3a,4,5,5a,9b-hexahydro-3,5a,9-
trimethylnaphto 
dione]  

[1,2-b] 

furan-2,8-

⌦ 528-92-
7 ⌫ 

⌦ 481-06-
1 ⌫ 

⌦ 208-443-3 ⌫ 

⌦ 207-560-7 ⌫ 

218. 

Lobelia 
preparations 

inflata  L.  and 

its  galenical 

⌦ 84696-23-
1 ⌫ 

⌦ 283-642-6 ⌫ 

219. 

Lobeline ⌦ (INN) ⌫ * and its salts 

⌦ 90-69-7 ⌫  ⌦ 202-012-3 ⌫ 

220. 

Barbiturates 

EN 

75 

   EN 

 
 
 
 
 
 
(cid:208) 86/199/EEC (adapted) 
(cid:206)1 91/184/EEC 

221.  Mercury and its compounds, except those 
special cases included (cid:206)1 in Annex VVI, 
Part 1  

⌦ 7439-97-
6 ⌫ 

⌦ 231-106-7 ⌫ 

(cid:208) 76/768/EEC (adapted) 
(cid:206)1 82/368/EEC 
(cid:206)2 89/174/EEC 

222. 

3,4,5-Trimethoxyphenethylamine  and  its 
salts 

⌦ 54-04-6 ⌫  ⌦ 200-190-7 ⌫ 

223.  Metaldehyde 

⌦ 9002-91-
9 ⌫ 

224. 

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

⌦ 305-13-
5 ⌫ 

225. 

Coumetarol ⌦ (INN) ⌫ * 

⌦ 4366-18-
1 ⌫ 

⌦ 224-455-1 ⌫ 

226. 

Dextromethorphan  ⌦ (INN) ⌫  *  and 
its salts 

⌦ 125-71-
3 ⌫ 

⌦ 204-752-2 ⌫ 

227. 

2-Methylheptylamine and its salts 

⌦ 540-43-
2 ⌫ 

228. 

Isometheptene  ⌦ (INN) ⌫  *  and  its 
salts 

⌦ 503-01-
5 ⌫ 

⌦ 207-959-6 ⌫ 

229.  Mecamylamine ⌦ (INN) ⌫ * 

⌦ 60-40-2 ⌫  ⌦ 200-476-1 ⌫ 

230. 

Guaifenesin ⌦ (INN) ⌫ * 

⌦ 93-14-1 ⌫  ⌦ 202-222-5 ⌫ 

231. 

Dicoumarol ⌦ (INN) ⌫ * 

⌦ 66-76-2 ⌫  ⌦ 200-632-9 ⌫ 

232. 

Phenmetrazine  ⌦ (INN) ⌫  *, 
derivatives and salts 

its 

⌦ 134-49-
6 ⌫ 

⌦ 205-143-4 ⌫ 

233. 

Thiamazole ⌦ (INN) ⌫ * 

⌦ 60-56-0 ⌫  ⌦ 200-482-4 ⌫ 

234.  (cid:206)1 3,4-Dihydro-2-methoxy-2-methyl-4-

⌦ 518-20-

⌦ 208-248-3 ⌫ 

phenyl-2H,5H-pyrano 

[3,2-c]-[1] 

EN 

76 

   EN 

 
 
 
 
 
 
 
 
 
 
 
benzopyran-5-one (cyclocoumarol)  

7 ⌫ 

235. 

Carisoprodol ⌦ (INN) ⌫ * 

⌦ 78-44-4 ⌫  ⌦ 201-118-7 ⌫ 

236.  Meprobamate ⌦ (INN) ⌫ * 

⌦ 57-53-4 ⌫  ⌦ 200-337-5 ⌫ 

237. 

Tefazoline ⌦ (INN) ⌫ * and its salts  ⌦ 1082-56-

0 ⌫ 

238. 

Arecoline 

⌦ 63-75-2 ⌫  ⌦ 200-565-5 ⌫ 

239. 

Poldine metilsulfate ⌦ (INN) ⌫ * 

⌦ 545-80-
2 ⌫ 

⌦ 208-894-6 ⌫ 

240. 

Hydroxyzine ⌦ (INN) ⌫ * 

⌦ 68-88-2 ⌫  ⌦ 200-693-1 ⌫ 

241. 

2-Naphthol 

⌦ 135-19-
3 ⌫ 

⌦ 205-182-7 ⌫ 

242. 

1-and 2-Naphthylamines and their salts  ⌦ 134-32-7; 

243.  (cid:206)1 3-(1-Naphthyl)-4-
hydroxycoumarin  

91-59-8 ⌫ 

⌦ 39923-41-
6 ⌫ 

⌦ 205-138-7; 202-
080-4 ⌫ 

244. 

Naphazoline ⌦ (INN) ⌫ * and its salts  ⌦ 835-31-

⌦ 212-641-5 ⌫ 

245. 

Neostigmine 
neostigmine bromide ⌦ (INN) ⌫ *) 

salts 

and 

its 

(e.  g. 

4 ⌫ 

⌦ 114-80-
7 ⌫ 

⌦ 204-054-8 ⌫ 

246. 

Nicotine and its salts 

⌦ 54-11-5 ⌫  ⌦ 200-193-3 ⌫ 

247. 

Amyl nitrites 

⌦ 110-46-
3 ⌫ 

⌦ 203-770-8 ⌫ 

248. 

Inorganic  nitrites,  with  the  exception  of 
sodium nitrite 

⌦ 14797-65-
0 ⌫ 

249. 

Nitrobenzene 

⌦ 98-95-3 ⌫  ⌦ 202-716-0 ⌫ 

250. 

Nitrocresols and their alkali metal salts  ⌦ 12167-20-

3 ⌫ 

251. 

Nitrofurantoin ⌦ (INN) ⌫ * 

⌦ 67-20-9 ⌫  ⌦ 200-646-5 ⌫ 

252. 

Furazolidone ⌦ (INN) ⌫ * 

⌦ 67-45-8 ⌫  ⌦ 200-653-3 ⌫ 

253. 

Propane-1,2,3-triyl trinitrate 

⌦ 55-63-0 ⌫  ⌦ 200-240-8 ⌫ 

254. 

Acenocoumarol ⌦ (INN) ⌫ * 

⌦ 152-72-
7 ⌫ 

⌦ 205-807-3 ⌫ 

EN 

77 

   EN 

 
 
 
 
 
255. 

Alkali pentacyanonitrosylferrate (2-) 

256. 

Nitrostilbenes, 
their derivatives 

their  homologues  and 

257. 

Noradrenaline and its salts 

⌦ 51-41-2 ⌫  ⌦ 200-096-6 ⌫ 

258. 

Noscapine ⌦ (INN) ⌫ * and its salts  ⌦ 128-62-

⌦ 204-899-2 ⌫ 

1 ⌫ 

259. 

Guanethidine ⌦ (INN) ⌫ * and its salts ⌦ 55-65-2 ⌫  ⌦ 200-241-3 ⌫ 

260. 

Oestrogens (cid:206)2 ---  

261. 

Oleandrin 

⌦ 465-16-
7 ⌫ 

⌦ 207-361-5 ⌫ 

262. 

Chlortalidone ⌦ (INN) ⌫ * 

⌦ 77-36-1 ⌫  ⌦ 201-022-5 ⌫ 

263. 

Pelletierine and its salts 

⌦ 2858-66-
4 ⌫ 

⌦ 220-673-6 ⌫ 

264. 

Pentachloroethane 

⌦ 76-01-7 ⌫  ⌦ 200-925-1 ⌫ 

265. 

Pentaerithrityl tetranitrate ⌦ (INN) ⌫ * ⌦ 78-11-5 ⌫  ⌦ 201-084-3 ⌫ 

266. 

Petrichloral ⌦ (INN) ⌫ * 

⌦ 78-12-6 ⌫ 

267. 

Octamylamine  ⌦ (INN) ⌫  *  and  its 
salts 

⌦ 502-59-
0 ⌫ 

⌦ 207-947-0 ⌫ 

268. 

Picric acid 

⌦ 88-89-1 ⌫  ⌦ 201-865-9 ⌫ 

(cid:208) 82/368/EEC (adapted) 

(cid:208) 76/768/EEC (adapted) 
(cid:206)1 82/368/EEC 

269. 

Phenacemide ⌦ (INN) ⌫ * 

⌦ 63-98-9 ⌫  ⌦ 200-570-2 ⌫ 

270. 

Difencldoxazine ⌦ (INN) ⌫ * 

⌦ 5617-26-
5 ⌫ 

EN 

78 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
271.  (cid:206)1 2-Phenylindan-1,3-dione 

(phenindione)  ⌦ (INN) ⌫ 

⌦ 83-12-5 ⌫  ⌦ 201-454-4 ⌫ 

272. 

Ethylphenacemide  ⌦ (pheneturide) 
(INN) ⌫ * 

⌦ 90-49-3 ⌫  ⌦ 201-998-2 ⌫ 

273. 

Phenprocoumon ⌦ (INN) ⌫ * 

274. 

Fenyramidol ⌦ (INN) ⌫ * 

⌦ 435-97-
2 ⌫ 

⌦ 553-69-
5 ⌫ 

⌦ 207-108-9 ⌫ 

⌦ 209-044-7 ⌫ 

275. 

Triamterene ⌦ (INN) ⌫ * and its salts  ⌦ 396-01-

⌦ 206-904-3 ⌫ 

276.  (cid:206)1 Tetraethyl 

pyrophosphate;  TEPP 

(ISO)  

277. 

Tritolyl phosphate 

278. 

Psilocybine ⌦ (INN) ⌫ * 

279. 

Phosphorus and metal phosphides 

0 ⌫ 

⌦ 107-49-
3 ⌫ 

⌦ 1330-78-
5 ⌫ 

⌦ 520-52-
5 ⌫ 

⌦ 7723-14-
0 ⌫ 

⌦ 203-495-3 ⌫ 

⌦ 215-548-8 ⌫ 

⌦ 208-294-4 ⌫ 

⌦ 231-768-7 ⌫ 

280. 

Thalidomide ⌦ (INN) ⌫ * and its salts  ⌦ 50-35-1 ⌫  ⌦ 200-031-1 ⌫ 

281. 

Physostigma venenosum Balf. 

282. 

Picrotoxin 

⌦ 89958-15-
6 ⌫ 

⌦ 124-87-
8 ⌫ 

⌦ 289-638-0 ⌫ 

⌦ 204-716-6 ⌫ 

283. 

Pilocarpine and its salts 

⌦ 92-13-7 ⌫  ⌦ 202-128-4 ⌫ 

284.  (cid:206)1 α-Piperidin-2-ylbenzyl  acette  (SIC! 
threoform 
laevorotatory 
acetate) 
(levofphacetoperane)  ⌦ (INN) ⌫  and 
its salts  

, 

⌦ 24558-01-
8 ⌫ 

285. 

Pipradrol ⌦ (INN) ⌫ * and its salts  ⌦ 467-60-

⌦ 207-394-5 ⌫ 

7 ⌫ 

286. 

Azacyclonol ⌦ (INN) ⌫ * and its salts  ⌦ 115-46-

⌦ 204-092-5 ⌫ 

287. 

Bietamiverine ⌦ (INN) ⌫ * 

8 ⌫ 

⌦ 479-81-
2 ⌫ 

⌦ 207-538-7 ⌫ 

EN 

79 

   EN 

 
 
288. 

Butopiprine ⌦ (INN) ⌫ * and its salts  ⌦ 55837-15-

⌦ 259-848-7 ⌫ 

5 ⌫ 

(cid:208) 2004/93/EC Art. 1 and Annex .1 
(adapted) 

289. 

Lead and its compounds 

⌦ 7439-92-
1 ⌫ 

⌦ 231-100-4 ⌫ 

(cid:208) 76/768/EEC (adapted) 

290. 

Coniine 

⌦ 458-88-
8 ⌫ 

⌦ 207-282-6 ⌫ 

291. 

Prunus  laurocerasus  L.  (‘cherry  laurel 
water’) 

⌦ 89997-54-
6 ⌫ 

⌦ 289-689-9 ⌫ 

292.  Metyrapone ⌦ (INN) ⌫ * 

⌦ 54-36-4 ⌫  ⌦ 200-206-2 ⌫ 

293. 

Radioactive  substances,  as  defined  by 
Directive  96/29/Euratom34  laying  down 
basic  safety  standards  for  the  protection 
of  the  health  of  workers  and  the  general 
public  against  the  dangers  arising  from 
ionising radiation 

(cid:208) 2002/34/EC Art. 1 and Annex 
.1(i) 

(cid:208) 76/768/EEC (adapted) 

34 

OJ L 159, 29.6.1996, p. 1. 

EN 

80 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
294. 

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

⌦ 90046-04-
1 ⌫ 

⌦ 289-971-1 ⌫ 

295. 

Hyoscine, its salts and derivatives 

⌦ 51-34-3 ⌫  ⌦ 200-090-3 ⌫ 

296. 

Gold salts 

(cid:208) 85/391/EEC (adapted) 

297. 

Selenium  and  its  compounds  with  the 
exception  of 
selenium  disulphideele 
under 
the  conditions  set  out  under 
reference No 49 in Annex III, Part 1 

⌦ 7782-49-
2 ⌫ 

⌦ 231-957-4 ⌫ 

(cid:208) 76/768/EEC (adapted) 
(cid:206)1 82/368/EEC 

298. 

Solanum  nigrum  L.  and  its  galenical 
preparations 

⌦ 84929-77-
1 ⌫ 

⌦ 284-555-6 ⌫ 

299. 

Sparteine ⌦ (INN) ⌫ and its salts 

⌦ 90-39-1 ⌫  ⌦ 201-988-8 ⌫ 

300. 

Glucocorticoids 

301. 

302. 

303. 

Datura  stramonium  L.  and  its  galenical 
preparations 

⌦ 84696-08-
2 ⌫ 

⌦ 283-627-4 ⌫ 

Strophantines,  their  aglucones  and  their 
respective derivatives 

⌦ 11005-63-
3 ⌫ 

⌦ 234-239-9 ⌫ 

Strophantus  species  and  their  galenical 
preparations 

304. 

Strychnine and its salts 

⌦ 57-24-9 ⌫  ⌦ 200-319-7 ⌫ 

305. 

306. 

Strychnos  species  and  their  galenical 
preparations 

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

307.  (cid:206)1 Sulphonamides  (sulphanilamide  and 
its derivatives…) and their salts obtained 

EN 

81 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
by  substitution  of  one  or  more  H-atoms 
of the -NH2 groups) and their salts  

308. 

Sultiame ⌦ (INN) ⌫ * 

⌦ 61-56-3 ⌫  ⌦ 200-511-0 ⌫ 

309. 

Neodymium and its salts 

⌦ 7440-00-
8 ⌫ 

⌦ 231-109-3 ⌫ 

310. 

Thiotepa ⌦ (INN) ⌫ * 

⌦ 52-24-4 ⌫  ⌦ 200-135-7 ⌫ 

311. 

Pilocarpus  jaborandi  Holmes  and  its 
galenical preparations 

⌦ 84696-42-
4 ⌫ 

⌦ 283-649-4 ⌫ 

312. 

Tellurium and its compounds 

313.  (cid:206)1 Xylometazoline  ⌦ (INN) ⌫  *  and 

its salts  

314. 

Tetrachloroethylene 

⌦ 13494-80-
9 ⌫ 

⌦ 236-813-4 ⌫ 

⌦ 526-36-
3 ⌫ 

⌦ 127-18-
4 ⌫ 

⌦ 208-390-6 ⌫ 

⌦ 204-825-9 ⌫ 

315. 

Carbon tetrachloride 

⌦ 56-23-5 ⌫  ⌦ 200-262-8 ⌫ 

316. 

Hexaethyl tetraphosphate 

317. 

Thallium and its compounds 

318. 

Thevetia  neriifolia 
extract 

Juss.,  glycoside 

319. 

Ethionamide ⌦ (INN) ⌫ * 

⌦ 757-58-
4 ⌫ 

⌦ 7440-28-
0 ⌫ 

⌦ 90147-54-
9 ⌫ 

⌦ 536-33-
4 ⌫ 

⌦ 212-057-0 ⌫ 

⌦ 231-138-1 ⌫ 

⌦ 290-446-4 ⌫ 

⌦ 208-628-9 ⌫ 

320. 

Phenothiazine  ⌦ (INN) ⌫  *  and  its 
compounds 

⌦ 92-84-2 ⌫  ⌦ 202-196-5 ⌫ 

(cid:208) 82/368/EEC (adapted) 

321. 

Thiourea  and  its  derivatives,  with  the 
exception  of  the  one  listed  in  Annex  III, 
Part 1 

⌦ 62-56-6 ⌫  ⌦ 200-543-5 ⌫ 

EN 

82 

   EN 

 
 
 
 
 
 
(cid:208) 76/768/EEC (adapted) 
(cid:214) new 

322.  Mephenesin ⌦ (INN) ⌫ * and its esters  ⌦ 59-47-2 ⌫  ⌦ 200-427-4 ⌫ 

323. 

Vaccines, toxins or serums ⌦ defined as 
immunological  medicinal 
products 
pursuant  to  Article  1(4)  of  Directive 
2001/83/EC ⌫ listed in the Annex to the 
second  Council  Directive  of  20  May 
1975  on  the  approximation  of  provisions 
regulation  or 
laid  down  by 
law, 
administrative 
to 
action 
proprietary medicinal products (OJ No L 
147, 9. 6. 1975, p. 13)  

relating 

324. 

Tranylcypromine  ⌦ (INN) ⌫  *  and  its 
salts 

⌦ 155-09-
9 ⌫ 

⌦ 205-841-9 ⌫ 

325. 

Trichloronitromethane (chloropicrine)  ⌦ 76-06-2 ⌫  ⌦ 200-930-9 ⌫ 

326. 

327. 

2,2,2-Tribromoethanol 
alcohol) 

(tribromoethyl 

⌦ 75-80-9 ⌫  ⌦ 200-903-1 ⌫ 

Trich ⌦ l ⌫ iormethine ⌦ (INN) ⌫ * 
and its salts 

⌦ 817-09-
4 ⌫ 

⌦ 212-442-3 ⌫ 

328. 

Tretamine ⌦ (INN) ⌫ * 

⌦ 51-18-3 ⌫  ⌦ 200-083-5 ⌫ 

329. 

Gallamine triethiodide ⌦ (INN) ⌫ *  ⌦ 65-29-2 ⌫  ⌦ 200-605-1 ⌫ 

330. 

331. 

332. 

Urginea scilla Steinhrn. and its galenical 
preparations 

⌦ 84650-62-
4 ⌫ 

⌦ 283-520-2 ⌫ 

Veratrine, 
preparations 

its 

salts 

and 

galenical 

⌦ 8051-02-
3 ⌫ 

⌦ 613-062-00-
4 ⌫ 

Schoenocaulon  o  ⌦ f ⌫  lficinale  Lind 
(seeds and galenical preparations) 

⌦ 84604-18-
2 ⌫ 

⌦ 283-296-6 ⌫ 

(cid:208) 84/415/EEC (adapted) 

333. 

Veratrum Spp and their preparations 

⌦ 90131-91-
2 ⌫ 

⌦ 290-407-1 ⌫ 

EN 

83 

   EN 

 
 
 
 
 
 
 
 
 
 
(cid:208) 76/768/EEC (adapted) 
(cid:206)1 82/368/EEC 

334. 

Vinyl chloride monomer 

⌦ 75-01-4 ⌫  ⌦ 200-831-

0 ⌫ 

335. 

Ergocalciferol  ⌦ (INN) ⌫  * 
cholecalciferol (vitamins D2 and D3) 

and 

⌦ 50-14-6;  67-
97-0 ⌫ 

⌦ 200-014-9: 
200-673-2 ⌫ 

336. 

Salts of O-alkyldithiocarbonic acids 

337. 

Yohbimbine and its salts 

⌦ 146-48-5 ⌫  ⌦ 205-672-

0 ⌫ 

338. 

Dimethyl sulfoxide ⌦ (INN) ⌫ * 

⌦ 67-68-5 ⌫  ⌦ 200-664-

3 ⌫ 

339. 

Diphenhydramine ⌦ (INN) ⌫ * and its 
salts 

⌦ 58-73-1 ⌫  ⌦ 200-396-

7 ⌫ 

340. 

4-tert-Butylphenol 

⌦ 98-54-4 ⌫  ⌦ 202-679-

0 ⌫ 

341. 

4-tert-Butylpyrocatechol 

⌦ 98-29-3 ⌫  ⌦ 202-653-

9 ⌫ 

342. 

Dihydrotachysterol ⌦ (INN) ⌫ 

⌦ 67-96-9 ⌫  ⌦ 200-672-

343. 

Dioxane 

7 ⌫ 

⌦ 123-91-1 ⌫  ⌦ 204-661-

8 ⌫ 

344.  Morpholine and its salts 

⌦ 110-91-8 ⌫  ⌦ 203-815-

1 ⌫ 

345. 

Pyretbhrum  album  L.  and  its  galenical 
preparations 

346.  (cid:206)1 2-[4-Methoxybenzyl-N-(2-

⌦ 59-33-6 ⌫  ⌦ 200-422-

pyridyl)amino]ethyldimethylamine 
maleate  

7 ⌫ 

347. 

Tripelennamine ⌦ (INN) ⌫ * 

⌦ 91-81-6 ⌫  ⌦ 202-100-

1 ⌫ 

348. 

Tetrachlorosalicylanilides 

⌦ 7426-07-5 ⌫ 

EN 

84 

   EN 

 
 
 
 
 
 
 
 
 
 
349. 

Dichlorosalicylanilides 

⌦ 1147-98-4 ⌫ 

350. 

Tetrabromosalicylanilides 

351. 

Dibromosalicylanilides 

(cid:208) 82/368/EEC (adapted) 

⌦ 24556-64-
7 ⌫ 

⌦ 246-310-1 ⌫ 

(cid:208) 76/768/EEC (adapted) 

352. 

Bithionol ⌦ (INN) ⌫ * 

⌦ 97-18-7 ⌫  ⌦ 202-565-0 ⌫ 

353. 

Thiuram monosulphides 

⌦ 97-74-5 ⌫  ⌦ 202-605-7 ⌫ 

354. 

Thiuram disulphides 

⌦ 137-26-8 ⌫  ⌦ 205-286-2 ⌫ 

355. 

Dimethylformamide 

⌦ 68-12-2 ⌫  ⌦ 200-679-5 ⌫ 

356. 

4-Phenylbut-3-en-2-one 

⌦ 122-57-6 ⌫  ⌦ 204-555-1 ⌫ 

357. 

Benzoates 
of 
methoxycinnamyl  alcohol  except 
normal content in natural essences used 

4-hydroxy-3-
for 

(cid:208) 95/34/EC (adapted) 

358. 

(e.  g. 

trioxyysalean 
Furocoumarines 
⌦ (INN) ⌫  *,  8-methoxypsoralen,  5-
methoxypsoralen)  except 
for  normal 
content in natural essences used. 

⌦ 3902-71-4; 
298-81-7; 484-20-
8 ⌫ 

⌦ 223-459-0; 
206-066-9;  207-
604-5 ⌫ 

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

(cid:208) 76/768/EEC (adapted) 

359. 

Oil from the seeds of Laurus nobilis L.  ⌦ 84603-73-

⌦ 283-272-5 ⌫ 

EN 

6 ⌫ 

85 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
(cid:208) 82/368/EEC (adapted) 

360. 

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

⌦ 94-59-7⌫  ⌦ 202-345-4 ⌫ 

100 ppm in the finished product, 50 ppm 
in  products  for  dental  and  oral  hygiene, 
and provided that Safrole is not present in 
for 
toothpastes 
children 

specifically 

intended 

(cid:208) 76/768/EEC (adapted) 

361. 

5,5'-Di-isopropyl-2,2'-dimethylbiphenyl-
4,4'-diyl dihypoiodite 

⌦ 552-22-7 ⌫  ⌦ 209-007-5 ⌫ 

362. 

3'-Ethyl-5',6',7',8'-tetrahydro-5',5',8',8'-
tetramethyl-2'-acetonaphthone 
acetyl-6-ethyl-1,1,4,4-tetramethyl-
1,2,3,4-tetrahydronaphtalen 

or 

7-

(cid:208) 2000/11/EC Art. 1 and Annex 
.II (adapted) 

⌦ 88-29-9 ⌫  ⌦ 201-817-7 ⌫ 

(cid:208) 83/341/EEC (adapted) 

363. 

Oo-phenylenediamine and its salts 

⌦ 95-54-5 ⌫  ⌦ 202-430-6 ⌫ 

364. 

4-methyl-m-phenylenediamine  and 
salts 

its 

⌦ 95-80-7 ⌫  ⌦ 202-453-1 ⌫ 

EN 

86 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
365. 

Aristolochic 
Aristolochia spp. and their preparations 

acid 

and 

its 

salts; 

(cid:208) 2000/11/EC Art. 1 and Annex 
.II (adapted) 

⌦ 475-80-9; 
313-67-7;  15918-
62-4 ⌫ 

⌦ 202-499-6; 
206-238-3; - ⌫  

(cid:208) 86/179/EEC (adapted) 

366. 

Chloroform 

⌦ 67-66-3 ⌫  ⌦ 200-663-8 ⌫ 

(cid:208) 2000/11/EC Art. 1 and Annex 
.II (adapted) 

367. 

2,3,7,8-Tetra chlorodibenzo-p-dioxin 

⌦ 1746-01-6 ⌫  ⌦ 217-122-7 ⌫ 

(cid:208) 86/179/EEC (adapted) 

368. 

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

acetate 

⌦ 828-00-2 ⌫  ⌦ 212-579-9 ⌫ 

369. 

Pyrithione sodium (INNM) 

⌦ 3811-73-2 ⌫  ⌦ 223-296-5 ⌫ 

(cid:208) 87/137/EEC (adapted) 

370. 

371. 

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

⌦ 133-06-2 ⌫  ⌦ 205-087-0 ⌫ 

2,2'-Dihydroxy-3,3',5,5',6,6'-
hexachlorodiphenylmethane 
(hexachlorophene) ⌦ (INN) ⌫ 

⌦ 70-30-4 ⌫  ⌦ 200-733-8 ⌫ 

EN 

87 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
(cid:208) 2000/11/EC Art. 1 and Annex 
.II (adapted) 

372. 

373. 

374. 

375. 

376. 

6-(Piperidinyl)-2,4-pyrimidinediamine  3-
oxide  (minoxidil)  ⌦ (INN) ⌫  and  its 
salts 

⌦ 38304-91-
5 ⌫ 

⌦ 253-874-2 ⌫ 

3,4',5-Tribromosalicylanilide 
⌦ tribromsalan) (INN) ⌫ 

⌦ 87-10-5 ⌫  ⌦ 201-723-6 ⌫ 

Phytolacca spp and their preparations  ⌦ 65497-07-6; 
60820-94-2 ⌫ 

(cid:208) 88/233/EEC (adapted) 
(cid:206)1 90/121/EEC 

Tretinoin ⌦ (INN) ⌫ (retinoic acid and 
its salts) 

⌦ 302-79-4 ⌫  ⌦ 206-129-0 ⌫ 

1-Methoxy-2,4-diaminobenzene 
(2,4-
diaminoanisole - CI 76050) (cid:206)1 and their 
salts  

⌦ 615-05-4 ⌫  ⌦ 210-406-1 ⌫ 

377. 

1-Methoxy-2,5-diaminobenzene 
diaminoanisole) (cid:206)1 and their salts  

(2,5-

⌦ 5307-02-8 ⌫  ⌦ 226-161-9 ⌫ 

378. 

Colouring agent CI 12140 

⌦ 3118-97-6 ⌫  ⌦ 221-490-4 ⌫ 

379. 

Colouring agent CI 26105 

⌦ 85-83-6 ⌫  ⌦ 201-635-8 ⌫ 

380. 

Colouring agent CI 42555 

⌦ 548-62-9 

⌦ 208-953-6 

Colouring agent CI 42555:1 

467-63-0 ⌫ 

207-396-6 ⌫ 

Colouring agent CI 42555:2 

(cid:208) 89/174/EEC (adapted) 

381. 

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

⌦ 14779-78-
3 ⌫ 

⌦ 238-849-6 ⌫ 

EN 

88 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
(cid:208) 89/174/EEC (adapted) 

383. 

2-Amino-4-nitrophenol 

⌦ 99-57-0 ⌫  ⌦ 202-767-9 ⌫ 

384. 

2-Amino-5-nitrophenol 

⌦ 121-88-0 ⌫  ⌦ 204-503-8 ⌫ 

(cid:208) 90/121/EEC (adapted) 

385. 

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

⌦ 80-75-1 ⌫  ⌦ 201-306-9 ⌫ 

385. 11α-Hydroxypregn-4-ene-3, 20-dione) and its esters 

(cid:208) 2000/11/EC Art. 1 and Annex 
.II (adapted) 

(cid:208) 2000/11/EC Art. 1 and Annex 
.II (adapted) 

386. 

Colouring agent CI 42640 

⌦ 1694-09-3 ⌫  ⌦ 216-901-9 ⌫ 

(cid:208) 90/121/EEC (adapted) 

387. 

Colouring agent CI 13065 

⌦ 587-98-4 ⌫  ⌦ 209-608-2 ⌫ 

388. 

Colouring agent CI 42535 

⌦ 8004-87-3 ⌫ 

389. 

Colouring agent CI 61554 

⌦ 17354-14-2 ⌫  ⌦ 241-379-4 ⌫ 

(cid:208) 2000/11/EC Art. 1 and Annex 
.II (adapted) 

390. 

Anti-androgens of steroidal structure 

391. 

Zirconium  and  its  compounds,  with  the 
exception  of  the  substances  listed  under 
reference  number  50  in  Annex  III,  Part 

⌦ 7440-67-7 ⌫  ⌦ 231-176-9 ⌫ 

EN 

89 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
One,  and  the  zirconium  lakes,  pigments 
or  salts  of  the  colouring  agents  listed  in 
Annex  IV,  Part  One,  with  reference 
number 3 

393. 

Acetonitrile 

⌦ 75-05-8 ⌫ 

⌦ 200-835-2 ⌫ 

394. 

Tetrahydrozoline 
(INN) ⌫ and its salts 

⌦ Tetryzoline 

⌦ 84-22-0 ⌫ 

⌦ 201-522-3 ⌫ 

(cid:208) 91/184/EEC (adapted) 

395. 

396. 

397. 

398. 

Hydroxy-8-quinoline  and  its  sulphate, 
except for the uses provided for in No 51 
in Annex III, Part 1 

⌦ 148-24-3;  134-
31-6 ⌫ 

⌦ 205-711-1; 
205-137-1 ⌫ 

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

Colouring  agent  CI  12075  and  its  lakes, 
pigments and salts 

⌦ 43143-11-9 ⌫  ⌦ 256-115-3 ⌫ 

⌦ 3468-63-1 ⌫  ⌦ 222-429-4 ⌫ 

Colouring  agent  CI  45170  and  CI 
45170:1 

⌦ 81-88-9; 
34-2 ⌫ 

509-

⌦ 201-383-9; 
208-096-8 ⌫ 

399. 

Lidocaine ⌦ (INN) ⌫ 

⌦ 137-58-6 ⌫  ⌦ 205-302-8 ⌫ 

(cid:208) 92/86/EEC (adapted) 

400. 

1,2-epoxybutane 

⌦ 106-88-7 ⌫  ⌦ 203-438-2 ⌫ 

401. 

Colouring agent CI 15585 

⌦ 5160-02-1; 
2092-56-0 ⌫ 

⌦ 225-935-3; 
218-248-5 ⌫ 

402. 

Strontium lactate 

⌦ 29870-99-3 ⌫  ⌦ 249-915-9 ⌫ 

403. 

Strontium nitrate 

⌦ 10042-76-9 ⌫  ⌦ 233-131-9 ⌫ 

404. 

Strontium polycarboxylate 

405. 

Pramocaine ⌦ (INN) ⌫ 

⌦ 140-65-8 ⌫  ⌦ 205-425-7 ⌫ 

406. 

4-ethoxy-m-phenylenediamine  and 

its  ⌦ 5862-77-1 ⌫ 

EN 

90 

   EN 

 
 
 
 
 
 
 
 
 
 
 
salts 

407. 

2,4-diaminophenylethanol and its salts  ⌦ 14572-93-1 ⌫ 

408. 

Catechol 

409. 

Pyrogallol 

410. 

Nitrosamines 

⌦ 120-80-9 ⌫  ⌦ 204-427-5 ⌫ 

⌦ 87-66-1 ⌫  ⌦ 201-762-9 ⌫ 

(cid:208) 2003/83/EC Art. 1 and Annex 
.1(c) 

411. 

Secondary  alkyl-  and  alkanolamines  and 

their salts 

(cid:208) 93/47/EEC (adapted) 

412. 

4-Amino-2-nitrophenol 

⌦ 119-34-6 ⌫  ⌦ 204-316-1 ⌫ 

(cid:208) 94/32/EC (adapted) 

413. 

2-Methyl-m-phenylenediamine 

⌦ 823-40-5 ⌫  ⌦ 212-513-9 ⌫ 

(cid:208) 95/34/EC (adapted) 

414. 

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

⌦ 83-66-9 ⌫ 

⌦ 201-493-7 ⌫ 

(cid:208) 95/34/EC (adapted) 

416. 

Cells, tissues or products of human origin 

417. 

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

⌦ 77-09-8 ⌫  ⌦ 201-004-7 ⌫ 

EN 

91 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
(cid:208) 96/41/EC (adapted) 

418. 

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

⌦ 104-98-3, 
27538-35-8 ⌫ 

⌦ 203-258-4, 
248-515-1 ⌫ 

419. 

Category  1  material  and  Category  2 
material  as  defined  in  Articles  4  and  5 
respectively  of  Regulation 
(EC)  No 
1774/2002 of the European Parliament and 
of  the  Council35,  and  ingredients  derived 
therefrom 

(cid:208) 2006/78/EC Art. 1 

(cid:208) 97/45/EC (adapted) 

420. 

Crude and refined coal tars 

⌦ 8007-45-2 ⌫  ⌦ 232-361-7 ⌫ 

(cid:208) 98/62/EC (adapted) 

421. 

422. 

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

⌦ 116-66-5 ⌫  ⌦ 204-149-4 ⌫ 

5-tert-Butyl-1,2,3-trimethyl-4,6-
dinitrobenzene (musk tibetene) 

⌦ 145-39-1 ⌫  ⌦ 205-651-6 ⌫ 

(cid:208) 2002/34/EC Art. 1 and Annex 
.1(ii) (adapted) 
(cid:206)1 2002/34/EC Art. 1 and Annex 
.1(ii) amended by Corrigendum, 
OJ L 341, 17.12.2002, p. 71 

35 

OJ L 273, 10.10.2002, p. 1. 

EN 

92 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
423. 

424. 

425. 

426. 

427. 

428. 

429. 

430. 

431. 

432. 

433. 

434. 

435. 

436. 

Alanroot  oil  (Inula  helenium)  (CAS  No 
97676-35-2),  when  used  as  a  fragrance 
ingredient 

⌦ 97676-35-
2 ⌫ 

Benzyl cyanide (CAS No 140-29-4), when 
used as a fragrance ingredient 

⌦ 140-29-4 ⌫  ⌦ 205-410-5 ⌫ 

Cyclamen  alcohol  (CAS  No  4756-19-8), 
when used as a fragrance ingredient 

⌦ 4756-19-8 ⌫  ⌦ 225-289-2 ⌫ 

Diethyl maleate (CAS No 141-05-9), when 
used as a fragrance ingredient 

⌦ 141-05-9 ⌫  ⌦ 205-451-9 ⌫ 

Dihydrocoumarine  (CAS  No  119-84-6), 
when used as a fragrance ingredient 

⌦ 119-84-6 ⌫  ⌦ 204-354-9 ⌫ 

2,4-Dihydroxy-3-methylbenzaldehyde 
(CAS  No  6248-20-0),  when  used  as  a 
fragrance ingredient 

⌦ 6248-20-0 ⌫  ⌦ 228-369-5 ⌫ 

 3,7-Dimethyl-2-octen-1-ol 
(6,7-
Dihydrogeraniol)  (CAS  No  40607-48-5), 
when used as a fragrance ingredient 

⌦ 40607-48-
5 ⌫ 

⌦ 254-999-5 ⌫ 

4,6-Dimethyl-8-tert-butylcoumarin 
(CAS 
No 17874-34-9), when used as a fragrance 
ingredient 

⌦ 17874-34-
9 ⌫ 

⌦ 241-827-9 ⌫ 

Dimethyl  citraconate  (CAS  No  617-54-9), 
when used as a fragrance ingredient 

⌦ 617-54-9 ⌫ 

7,11-Dimethyl-4,6,10-dodecatrien-3-one 
(CAS  No  26651-96-7),  when  used  as  a 
fragrance ingredient 

⌦ 26651-96-
7 ⌫ 

⌦ 247-878-3 ⌫ 

6,10-Dimethyl-3,5,9-undecatrien-2-one 
(CAS  No  141-10-6),  when  used  as  a 
fragrance ingredient 

⌦ 141-10-6 ⌫  ⌦ 205-457-1 ⌫ 

Diphenylamine  (CAS  No  122-39-4),  when 
used as a fragrance ingredient 

⌦ 122-39-4 ⌫  ⌦ 204-539-4 ⌫ 

Ethyl  acrylate  (CAS  No  140-88-5),  when 
used as a fragrance ingredient 

⌦ 140-88-5 ⌫  ⌦ 205-438-8 ⌫ 

Fig  leaf  absolute  (Ficus  carica)  (CAS  No 
68916-52-9),  when  used  as  a  fragrance 
ingredient 

⌦ 68916-52-
9 ⌫ 

437. 

trans-2-Heptenal  (CAS  No  18829-55-5), 
when used as a fragrance ingredient 

⌦ 18829-55-
5 ⌫ 

⌦ 242-608-0 ⌫ 

EN 

93 

   EN 

 
 
 
 
438. 

439. 

440. 

441. 

442. 

443. 

444. 

trans-2-Hexenal  diethyl  acetal  (CAS  No 
67746-30-9),  when  used  as  a  fragrance 
ingredient 

⌦ 67746-30-
9 ⌫ 

⌦ 266-989-8 ⌫ 

trans-2-Hexenal  dimethyl  acetal  (CAS  No 
18318-83-7),  when  used  as  a  fragrance 
ingredient 

⌦ 18318-83-
7 ⌫ 

⌦ 242-204-4 ⌫ 

Hydroabietyl  alcohol  (CAS  No  13393-93-
6), when used as a fragrance ingredient 

⌦ 13393-93-
6 ⌫ 

⌦ 236-476-3 ⌫ 

6-Isopropyl-2-decahydronaphthalenol 
(CAS  No  34131-99-2),  when  used  as  a 
fragrance ingredient 

⌦ 34131-99-
2 ⌫ 

⌦ 251-841-7 ⌫ 

7-Methoxycoumarin  (CAS  No  531-59-9), 
when used as a fragrance ingredient 

⌦ 531-59-9 ⌫  ⌦ 208-513-3 ⌫ 

4-(4-Methoxyphenyl)-3-butene-2-one 
(CAS  No  943-88-4),  when  used  as  a 
fragrance ingredient 

1-(4-Methoxyphenyl)-1-penten-3-one 
(CAS  No  104-27-8),  when  used  as  a 
fragrance ingredient 

⌦ 943-88-4 ⌫  ⌦ 213-404-9 ⌫ 

⌦ 104-27-8 ⌫  ⌦ 203-190-5 ⌫ 

445.  Methyl  trans-2-butenoate  (CAS  No  623-
43-8), when used as a fragrance ingredient 

⌦ 623-43-8 ⌫  ⌦ 210-793-7 ⌫ 

446. 

447. 

448. 

449. 

450. 

7-Methylcoumarin  (CAS  No  2445-83-2), 
when used as a fragrance ingredient 

⌦ 2445-83-2 ⌫  ⌦ 219-499-3 ⌫ 

5-Methyl-2,3-hexanedione 
(CAS  No 
13706-86-0),  when  used  as  a  fragrance 
ingredient 

⌦ 13706-86-
0 ⌫ 

⌦ 237-241-8 ⌫ 

2-Pentylidenecyclohexanone 
(CAS  No 
25677-40-1),  when  used  as  a  fragrance 
ingredient 

⌦ 25677-40-
1 ⌫ 

⌦ 247-178-8 ⌫ 

3,6,10-Trimethyl-3,5,9-undecatrien-2-one 
(CAS  No  1117-41-5),  when  used  as  a 
fragrance ingredient 

⌦ 1117-41-5 ⌫  ⌦ 214-245-8 ⌫ 

Verbena  oil  (Lippia  citriodora  Kunth.) 
(CAS  No  8024-12-2),  when  used  as  a 
fragrance ingredient 

⌦ 8024-12-2 ⌫ 

451.  (cid:206)1Methyleugenol  (CAS  No  93-15-2)  
except  for  normal  content  in  the  natural 
the 
essences  used  and  provided 

that 

EN 

94 

   EN 

 
 
 
 
concentration does not exceed: 

(a) 0,01 % in fine fragrance 

(b) 0,004 % in eau de toilette 

(c) 0,002 % in fragrance cream 

(d) 0,001 % in rinse-off products 

(e)  0,0002 %  in  other  leave-on  products 
and oral hygiene products 

. 

(cid:208) 2004/93/EC Art. 1 and Annex .2 
(adapted) 

452. 

6-(2-Chloroethyl)-6-(2-methoxyethoxy)-
2,5,7,10-tetraoxa-6-silaundecane  (Cas  No 
37894-46-5) 

⌦ 37894-46-
5 ⌫ 

⌦ 253-704-7 ⌫ 

453. 

Cobalt dichloride (Cas No 7646-79-9) 

⌦ 7646-79-9 ⌫  ⌦ 231-589-4 ⌫ 

454. 

Cobalt sulphate (Cas No 10124-43-3) 

⌦ 10124-43-
3 ⌫ 

⌦ 233-334-2 ⌫ 

455. 

Nickel monoxide (Cas No 1313-99-1) 

⌦ 1313-99-1 ⌫  ⌦ 215-215-7 ⌫ 

456. 

Dinickel trioxide (Cas No 1314-06-3) 

⌦ 1314-06-3 ⌫  ⌦ 215-217-8 ⌫ 

457. 

Nickel dioxide (Cas No 12035-36-8) 

⌦ 12035-36-
8 ⌫ 

⌦ 234-823-3 ⌫ 

458. 

Trinickel disulphide (Cas No 12035-72-2)  ⌦ 12035-72-

⌦ 234-829-6 ⌫ 

2 ⌫ 

459. 

Tetracarbonylnickel (Cas No 13463-39-3)  ⌦ 13463-39-

⌦ 236-669-2 ⌫ 

460. 

Nickel sulphide (Cas No 16812-54-7) 

3 ⌫ 

⌦ 16812-54-
7 ⌫ 

⌦ 240-841-2 ⌫ 

461. 

Potassium bromate (Cas No 7758-01-2)  ⌦ 7758-01-2 ⌫  ⌦ 231-829-8 ⌫ 

462. 

Carbon monoxide (Cas No 630-08-0) 

⌦ 630-08-0 ⌫  ⌦ 211-128-3 ⌫ 

463. 

Buta-1,3-diene (Cas No 106-99-0) 

⌦ 106-99-0 ⌫  ⌦ 203-450-8 ⌫ 

464. 

Isobutane (Cas No 75-28-5), if it contains  ⌦ 75-28-5 ⌫  ⌦ 200-857-2 ⌫ 

EN 

95 

   EN 

 
 
 
 
465. 

466. 

467. 

468. 

469. 

470. 

471. 

472. 

473. 

474. 

475. 

≥ 0,1 % w/w Butadiene 

Butane  (Cas  No  106-97-8),  if  it  contains 
≥ 0,1 % w/w Butadiene 

⌦ 106-97-8 ⌫  ⌦ 203-448-7 ⌫ 

Gases  (petroleum),  C3-4  (Cas  No  68131-
75-9), 
they  contain  > 0,1 %  w/w 
if 
Butadiene 

⌦ 68131-75-
9 ⌫ 

⌦ 268-629-5 ⌫ 

Tail  gas  (petroleum),  catalytic  cracked 
distillate  and  catalytic  cracked  naphtha 
fractionation absorber  (Cas  No 68307-98-
2), if it contains > 0,1 % w/w Butadiene 

Tail  gas  (petroleum),  catalytic  polymn. 
naphtha  fractionation  stabiliser  (Cas  No 
68307-99-3),  if  it  contains  > 0,1 %  w/w 
Butadiene 

Tail  gas  (petroleum),  catalytic  reformed 
naphtha  fractionation  stabiliser,  hydrogen 
sulfide-free  (Cas  No  68308-00-9),  if  it 
contains > 0,1 % w/w Butadiene 

⌦ 68307-98-
2 ⌫ 

⌦ 269-617-2 ⌫ 

⌦ 68307-99-
3 ⌫ 

⌦ 269-618-8 ⌫ 

⌦ 68308-00-
9 ⌫ 

⌦ 269-619-3 ⌫ 

Tail  gas  (petroleum),  cracked  distillate 
hydrotreater  stripper  (Cas  No  68308-01-
0), if it contains > 0,1 % w/w Butadiene 

⌦ 68308-01-
0 ⌫ 

Tail  gas  (petroleum),  gas  oil  catalytic 
cracking absorber (Cas No 68308-03-2), if 
it contains > 0,1 % w/w Butadiene 

⌦ 68308-03-
2 ⌫ 

Tail  gas  (petroleum),  gas  recovery  plant 
(Cas  No  68308-04-3), 
it  contains 
> 0,1 % w/w Butadiene 

if 

⌦ 68308-04-
3 ⌫ 

Tail  gas  (petroleum),  gas  recovery  plant 
deethaniser  (Cas  No  68308-05-4),  if  it 
contains > 0,1 % w/w Butadiene 

⌦ 68308-05-
4 ⌫ 

⌦ 269-620-9 ⌫ 

⌦ 269-623-5 ⌫ 

⌦ 269-624-0 ⌫ 

⌦ 269-625-6 ⌫ 

Tail  gas  (petroleum),  hydrodesulfurised 
distillate  and  hydrodesulfurised  naphtha 
fractionator,  acid-free  (Cas  No  68308-06-
5), if it contains > 0,1 % w/w Butadiene 

Tail  gas  (petroleum),  hydrodesulfurised 
vacuum gas oil stripper, hydrogen sulfide-
free  (Cas  No  68308-07-6),  if  it  contains 
> 0,1 % w/w Butadiene 

⌦ 68308-06-
5 ⌫ 

⌦ 269-626-1 ⌫ 

⌦ 68308-07-
6 ⌫ 

⌦ 269-627-7 ⌫ 

476. 

 Tail  gas  (petroleum),  isomerised  naphtha  ⌦ 68308-08-

⌦ 269-628-2 ⌫ 

EN 

96 

   EN 

 
fractionation stabiliser (Cas No 68308-08-
7), if it contains > 0,1 % w/w Butadiene 

7 ⌫ 

Tail  gas  (petroleum),  light  straight-run 
naphtha  stabiliser,  hydrogen  sulfide-free 
(Cas  No  68308-09-8), 
it  contains 
> 0,1 % w/w Butadiene 

if 

Tail gas (petroleum), straight-run distillate 
hydrodesulferised,  hydrogen  sulfide-free 
(Cas  No  68308-10-1), 
it  contains 
> 0,1 % w/w Butadiene 

if 

Tail  gas  (petroleum),  propane-propylene 
alkylation  feed  prep  deethaniser  (Cas  No 
68308-11-2),  if  it  contains  > 0,1 %  w/w 
Butadiene 

Tail  gas  (petroleum),  vacuum  gas  oil 
hydrodesulferised,  hydrogen  sulfide-free 
(Cas  No  68308-12-3), 
it  contains 
> 0,1 % w/w Butadiene 

if 

⌦ 68308-09-
8 ⌫ 

⌦ 269-629-8 ⌫ 

⌦ 68308-10-
1 ⌫ 

⌦ 269-630-3 ⌫ 

⌦ 68308-11-
2 ⌫ 

⌦ 269-631-9 ⌫ 

⌦ 68308-12-
3 ⌫ 

⌦ 269-632-4 ⌫ 

(petroleum),  catalytic  cracked 
Gases 
overheads  (Cas  No  68409-99-4),  if  they 
contain > 0,1 % w/w Butadiene 

⌦ 68409-99-
4 ⌫ 

⌦ 270-071-2 ⌫ 

Alkanes,  C1-2  (Cas  No  68475-57-0),  if 
they contain > 0,1 % w/w Butadiene 

⌦ 68475-57-
0 ⌫ 

⌦ 270-651-5 ⌫ 

Alkanes,  C2-3  (Cas  No  68475-58-1),  if 
they contain > 0,1 % w/w Butadiene 

⌦ 68475-58-
1 ⌫ 

⌦ 270-652-0 ⌫ 

Alkanes,  C3-4  (Cas  No  68475-59-2),  if 
they contain > 0,1 % w/w Butadiene 

⌦ 68475-59-
2 ⌫ 

⌦ 270-653-6 ⌫ 

Alkanes,  C4-5  (Cas  No  68475-60-5),  if 
they contain > 0,1 % w/w Butadiene 

⌦ 68475-60-
5 ⌫ 

⌦ 270-654-1 ⌫ 

Fuel-gases  (Cas  No  68476-26-6),  if  they 
contain > 0,1 % w/w Butadiene 

⌦ 68476-26-
6 ⌫ 

⌦ 270-667-2 ⌫ 

Fuel  gases,  crude  oil  distillates  (Cas  No 
68476-29-9),  if  they  contain  > 0,1 %  w/w 
Butadiene 

⌦ 68476-29-
9 ⌫ 

⌦ 270-670-9 ⌫ 

Hydrocarbons, C3-4 (Cas  No 68476-40-4), 
if they contain > 0,1 % w/w Butadiene 

⌦ 68476-40-
4 ⌫ 

⌦ 270-681-9 ⌫ 

Hydrocarbons, C4-5 (Cas  No 68476-42-6), 
if they contain > 0,1 % w/w Butadiene 

⌦ 68476-42-
6 ⌫ 

⌦ 270-682-4 ⌫ 

477. 

478. 

479. 

480. 

481. 

482. 

483. 

484. 

485. 

486. 

487. 

488. 

489. 

EN 

97 

   EN 

 
490. 

491. 

492. 

493. 

494. 

495. 

496. 

497. 

498. 

499. 

500. 

501. 

Hydrocarbons,  C2-4,  C3-rich  (Cas  No 
68476-49-3),  if  they  contain  > 0,1 %  w/w 
Butadiene 

⌦ 68476-49-
3 ⌫ 

(Cas  No 
Petroleum  gases, 
68476-85-7),  if  they  contain  > 0,1 %  w/w 
Butadiene 

liquefied 

⌦ 68476-85-
7 ⌫ 

liquefied,  sweetened 
Petroleum  gases, 
(Cas  No  68476-86-8),  if  they  contain 
> 0,1 % w/w Butadiene 

⌦ 68476-86-
8 ⌫ 

Gases  (petroleum),  C3-4,  isobutane-rich 
(Cas  No  68477-33-8),  if  they  contain 
> 0,1 % w/w Butadiene 

⌦ 68477-33-
8 ⌫ 

Distillates  (petroleum),  C3-6,  piperylene-
rich (Cas No 68477-35-0), if they contain 
> 0,1 % w/w Butadiene 

⌦ 68477-35-
0 ⌫ 

Gases  (petroleum),  amine  system  feed 
(Cas  No  68477-65-6),  if  they  contain 
> 0,1 % w/w Butadiene 

⌦ 68477-65-
6 ⌫ 

⌦ 270-689-2 ⌫ 

⌦ 270-704-2 ⌫ 

⌦ 270-705-8 ⌫ 

⌦ 270-724-1 ⌫ 

⌦ 270-726-2 ⌫ 

⌦ 270-746-1 ⌫ 

(petroleum), 

Gases 
unit 
hydrodesulferised  off  (Cas  No  68477-66-
7), if they contain > 0,1 % w/w Butadiene 

benzene 

⌦ 68477-66-
7 ⌫ 

⌦ 270-747-7 ⌫ 

Gases  (petroleum),  benzene  unit  recycle, 
hydrogen-rich  (Cas  No  68477-67-8),  if 
they contain > 0,1 % w/w Butadiene 

⌦ 68477-67-
8 ⌫ 

Gases  (petroleum),  blend  oil,  hydrogen-
nitrogen-rich  (Cas  No  68477-68-9),  ,if 
they contain > 0,1 % w/w Butadiene 

⌦ 68477-68-
9 ⌫ 

⌦ 270-748-2 ⌫ 

⌦ 270-749-8 ⌫ 

(petroleum), 

Gases 
splitter 
overheads  (Cas  No  68477-69-0),  if  they 
contain > 0,1 % w/w Butadiene 

butane 

⌦ 68477-69-
0 ⌫ 

⌦ 270-750-3 ⌫ 

Gases  (petroleum),  C2-3  (Cas  No  68477-
they  contain  > 0,1 %  w/w 
if 
70-3), 
Butadiene 

⌦ 68477-70-
3 ⌫ 

⌦ 270-751-9 ⌫ 

Gases  (petroleum),  catalytic-cracked  gas 
oil depropaniser bottoms, C4-rich acid-free 
(Cas  No  68477-71-4),  if  they  contain 
> 0,1 % w/w Butadiene 

⌦ 68477-71-
4 ⌫ 

⌦ 270-752-4 ⌫ 

502. 

catalytic-cracked 
Gases 
naphtha  debutaniser  bottoms,  C3-5-rich 

(petroleum), 

⌦ 68477-72-

⌦ 270-754-5 ⌫ 

EN 

98 

   EN 

 
503. 

504. 

505. 

506. 

507. 

508. 

509. 

510. 

511. 

512. 

513. 

(Cas  No  68477-72-5),  if  they  contain 
> 0,1 % w/w Butadiene 

5 ⌫ 

Gases 
(petroleum),  catalytic  cracked 
naphtha  depropaniser  overhead,  C3-rich 
acid-free  (Cas  No  68477-73-6),  if  they 
contain > 0,1 % w/w Butadiene 

⌦ 68477-73-
6 ⌫ 

⌦ 270-755-0 ⌫ 

Gases  (petroleum),  catalytic  cracker  (Cas 
No  68477-74-7),  if  they  contain  > 0,1 % 
w/w Butadiene 

⌦ 68477-74-
7 ⌫ 

Gases (petroleum), catalytic cracker, C1-5-
rich (Cas No 68477-75-8), if they contain 
> 0,1 % w/w Butadiene 

⌦ 68477-75-
8 ⌫ 

⌦ 270-756-6 ⌫ 

⌦ 270-757-1 ⌫ 

(petroleum),  catalytic  polymd. 
Gases 
naphtha stabiliser overhead, C2-4-rich (Cas 
No  68477-76-9),  if  they  contain  > 0,1 % 
w/w Butadiene 

reformed 
Gases 
(petroleum),  catalytic 
naphtha  stripper  overheads 
(Cas  No 
68477-77-0),  if  they  contain  > 0,1 %  w/w 
Butadiene 

⌦ 68477-76-
9 ⌫ 

⌦ 270-758-7 ⌫ 

⌦ 68477-77-
0 ⌫ 

⌦ 270-759-2 ⌫ 

Gases  (petroleum),  catalytic  reformer,  C1-
they 
4-rich  (Cas  No  68477-79-2), 
contain > 0,1 % w/w Butadiene 

if 

⌦ 68477-79-
2 ⌫ 

Gases (petroleum), C6-8 catalytic reformer 
recycle  (Cas  No  68477-80-5),  if  they 
contain > 0,1 % w/w Butadiene 

⌦ 68477-80-
5 ⌫ 

Gases (petroleum), C6-8 catalytic reformer 
(Cas  No  68477-81-6),  if  they  contain 
> 0,1 % w/w Butadiene 

⌦ 68477-81-
6 ⌫ 

Gases (petroleum), C6-8 catalytic reformer 
recycle, hydrogen-rich (Cas No 68477-82-
7), if they contain > 0,1 % w/w Butadiene 

⌦ 68477-82-
7 ⌫ 

Gases (petroleum), C3-5 olefinic-paraffinic 
alkylation  feed,  (Cas  No  68477-83-8),  if 
they contain > 0,1 % w/w Butadiene 

⌦ 68477-83-
8 ⌫ 

Gases  (petroleum),  C2-return  stream  (Cas 
No  68477-84-9),  if  they  contain  > 0,1 % 
w/w Butadiene 

⌦ 68477-84-
9 ⌫ 

⌦ 270-760-8 ⌫ 

⌦ 270-761-3 ⌫ 

⌦ 270-762-9 ⌫ 

⌦ 270-763-4 ⌫ 

⌦ 270-765-5 ⌫ 

⌦ 270-766-0 ⌫ 

514. 

Gases 

(petroleum),  C4-rich 

(Cas  No  ⌦ 68477-85-

⌦ 270-767-6 ⌫ 

EN 

99 

   EN 

 
515. 

516. 

517. 

518. 

519. 

520. 

521. 

522. 

523. 

524. 

525. 

68477-85-0),  if  they  contain  > 0,1 %  w/w 
Butadiene 

0 ⌫ 

Gases  (petroleum),  deethaniser  overheads 
(Cas  No  68477-86-1),  if  they  contain 
> 0,1 % w/w Butadiene 

⌦ 68477-86-
1 ⌫ 

Gases  (petroleum),  deisobutaniser  tower 
overheads  (Cas  No  68477-87-2),  if  they 
contain > 0,1 % w/w Butadiene 

⌦ 68477-87-
2 ⌫ 

Gases 
(petroleum),  depropaniser  dry, 
propene-rich (Cas No 68477-90-7), if they 
contain > 0,1 % w/w Butadiene 

⌦ 68477-90-
7 ⌫ 

(petroleum), 

Gases 
depropaniser 
overheads  (Cas  No  68477-91-8),  if  they 
contain > 0,1 % w/w Butadiene 

⌦ 68477-91-
8 ⌫ 

Gases  (petroleum),  dry  sour,  gas-concn.  -
unit-off  (Cas  No  68477-92-9),  if  they 
contain > 0,1 % w/w Butadiene 

⌦ 68477-92-
9 ⌫ 

Gases  (petroleum),  gas  concn.  reabsorber 
distn.  (Cas  No  68477-93-0), 
they 
contain > 0,1 % w/w Butadiene 

if 

⌦ 68477-93-
0 ⌫ 

⌦ 270-768-1 ⌫ 

⌦ 270-769-7 ⌫ 

⌦ 270-772-3 ⌫ 

⌦ 270-773-9 ⌫ 

⌦ 270-774-4 ⌫ 

⌦ 270-776-5 ⌫ 

Gases  (petroleum),  gas  recovery  plant 
depropaniser  overheads  (Cas  No  68477-
94-1), 
they  contain  > 0,1 %  w/w 
if 
Butadiene 

⌦ 68477-94-
1 ⌫ 

⌦ 270-777-0 ⌫ 

Gases (petroleum), Girbatol unit feed (Cas 
No  68477-95-2),  if  they  contain  > 0,1 % 
w/w Butadiene 

⌦ 68477-95-
2 ⌫ 

Gases  (petroleum),  hydrogen  absorber  off 
(Cas  No  68477-96-3),  if  they  contain 
> 0,1 % w/w Butadiene 

⌦ 68477-96-
3 ⌫ 

Gases (petroleum), hydrogen-rich (Cas No 
68477-97-4),  if  they  contain  > 0,1 %  w/w 
Butadiene 

⌦ 68477-97-
4 ⌫ 

⌦ 270-778-6 ⌫ 

⌦ 270-779-1 ⌫ 

⌦ 270-780-7 ⌫ 

Gases  (petroleum),  hydrotreater  blend  oil 
recycle,  hydrogen-nitrogen-rich  (Cas  No 
68477-98-5),  if  they  contain  > 0,1 %  w/w 
Butadiene 

⌦ 68477-98-
5 ⌫ 

⌦ 270-781-2 ⌫ 

526. 

Gases  (petroleum),  isomerised  naphtha 
fractionator,  C4-rich,  hydrogen  sulfide-

⌦ 68477-99-
6 ⌫ 

⌦ 270-782-8 ⌫ 

EN 

100 

   EN 

 
527. 

528. 

529. 

530. 

531. 

532. 

533. 

534. 

535. 

536. 

free (Cas No 68477-99-6), if they contain 
> 0,1 % w/w Butadiene 

Gases (petroleum), recycle, hydrogen-rich 
(Cas  No  68478-00-2),  if  they  contain 
> 0,1 % w/w Butadiene 

⌦ 68478-00-
2 ⌫ 

Gases  (petroleum),  reformer  make-up, 
hydrogen-rich,  (Cas  No  68478-01-3),  if 
they contain > 0,1 % w/w Butadiene 

⌦ 68478-01-
3 ⌫ 

Gases (petroleum), reforming hydrotreater 
(Cas  No  68478-02-4),  if  they  contain 
> 0,1 % w/w Butadiene 

⌦ 68478-02-
4 ⌫ 

⌦ 270-783-3 ⌫ 

⌦ 270-784-9 ⌫ 

⌦ 270-785-4 ⌫ 

(petroleum), 

Gases 
reforming 
hydrotreater,  hydrogen-methane-rich  (Cas 
No  68478-03-5),  if  they  contain  > 0,1 % 
w/w Butadiene 

Gases (petroleum), reforming hydrotreater 
make-up,  hydrogen-rich  (Cas  No  68478-
04-6), 
they  contain  > 0,1 %  w/w 
if 
Butadiene 

⌦ 68478-03-
5 ⌫ 

⌦ 270-787-5 ⌫ 

⌦ 68478-04-
6 ⌫ 

⌦ 270-788-0 ⌫ 

(petroleum), 

Gases 
distn.,  (Cas  No  68478-05-7), 
contain > 0,1 % w/w Butadiene 

thermal  cracking 
they 

if 

Tail  gas  (petroleum),  catalytic  cracked 
clarified  oil  and  thermal  cracked  vacuum 
residue fractionation reflux drum (Cas No 
68478-21-7),  if  it  contains  > 0,1 %  w/w 
Butadiene 

Tail  gas  (petroleum),  catalytic  cracked 
naphtha  stabilisation  absorber  (Cas  No 
68478-22-8),  if  it  contains  > 0,1 %  w/w 
Butadiene 

Tail  gas  (petroleum),  catalytic  cracker, 
catalytic  reformer  and  hydrodesulferised 
combined  fractionater  (Cas  No  68478-24-
0), if it contains > 0,1 % w/w Butadiene 

Tail  gas  (petroleum),  catalytic  cracker 
refractionation  absorber  (Cas  No  68478-
25-1), 
it  contains  > 0,1 %  w/w 
if 
Butadiene 

⌦ 68478-05-
7 ⌫ 

⌦ 68478-21-
7 ⌫ 

⌦ 270-789-6 ⌫ 

⌦ 270-802-5 ⌫ 

⌦ 68478-22-
8 ⌫ 

⌦ 270-803-0 ⌫ 

⌦ 68478-24-
0 ⌫ 

⌦ 270-804-6 ⌫ 

⌦ 68478-25-
1 ⌫ 

⌦ 270-805-1 ⌫ 

537. 

 Tail  gas  (petroleum),  catalytic  reformed  ⌦ 68478-26-

⌦ 270-806-7 ⌫ 

EN 

101 

   EN 

 
538. 

539. 

540. 

541. 

542. 

543. 

544. 

545. 

546. 

547. 

548. 

naphtha  fractionation  stabiliser  (Cas  No 
68478-26-2),  if  it  contains  > 0,1 %  w/w 
Butadiene 

2 ⌫ 

Tail  gas  (petroleum),  catalytic  reformed 
naphtha separator (Cas No 68478-27-3), if 
it contains > 0,1 % w/w Butadiene 

⌦ 68478-27-
3 ⌫ 

Tail  gas  (petroleum),  catalytic  reformed 
naphtha  stabiliser,  (Cas  No  68478-28-4), 
if it contains > 0,1 % w/w Butadiene 

⌦ 68478-28-
4 ⌫ 

 Tail  gas  (petroleum),  cracked  distillate 
hydrotreater separator  (Cas  No 68478-29-
5), if it contains > 0,1 % w/w Butadiene 

⌦ 68478-29-
5 ⌫ 

⌦ 270-807-2 ⌫ 

⌦ 270-808-8 ⌫ 

⌦ 270-809-3 ⌫ 

Tail  gas  (petroleum),  hydrodesulfurised 
straight-run  naphtha  separator  (Cas  No 
68478-30-8),  if  it  contains  > 0,1 %  w/w 
Butadiene 

⌦ 68478-30-
8 ⌫ 

⌦ 270-810-9 ⌫ 

Tail  gas  (petroleum),  saturate  gas  plant 
mixed stream, C4-rich (Cas No 68478-32-
0), if it contains > 0,1 % w/w Butadiene 

⌦ 68478-32-
0 ⌫ 

Tail gas (petroleum), saturate gas recovery 
plant, C1-2-rich (Cas No 68478-33-1), if it 
contains > 0,1 % w/w Butadiene 

⌦ 68478-33-
1 ⌫ 

Tail  gas  (petroleum),  vacuum  residues 
thermal  cracker,  (Cas  No  68478-34-2),  if 
it contains > 0,1 % w/w Butadiene 

⌦ 68478-34-
2 ⌫ 

Hydrocarbons, 
petroleum 
distillate  (Cas  No  68512-91-4),  if  they 
contain > 0,1 % w/w Butadiene 

C3-4-rich, 

⌦ 68512-91-
4 ⌫ 

⌦ 270-813-5 ⌫ 

⌦ 270-814-0 ⌫ 

⌦ 270-815-6 ⌫ 

⌦ 270-990-9 ⌫ 

(petroleum),  catalytic 

Gases 
reformed 
straight-run  naphtha  stabiliser  overheads, 
(Cas  No  68513-14-4),  if  they  contain 
> 0,1 % w/w Butadiene 

Gases  (petroleum),  full-range  straight-run 
naphtha  dehexaniser  off  (Cas  No  68513-
15-5), 
they  contain  > 0,1 %  w/w 
if 
Butadiene 

(petroleum), 

Gases 
hydrocracking 
depropaniser  off,  hydrocarbon-rich  (Cas 
No  68513-16-6),  if  they  contain  > 0,1 % 
w/w Butadiene 

⌦ 68513-14-
4 ⌫ 

⌦ 270-999-8 ⌫ 

⌦ 68513-15-
5 ⌫ 

⌦ 271-000-8 ⌫ 

⌦ 68513-16-
6 ⌫ 

⌦ 271-001-3 ⌫ 

EN 

102 

   EN 

 
549. 

550. 

551. 

552. 

553. 

554. 

555. 

556. 

557. 

558. 

559. 

560. 

(petroleum), 

straight-run 
Gases 
naphtha  stabiliser  off  (Cas  No  68513-17-
7), if they contain > 0,1 % w/w Butadiene 

light 

Gases (petroleum), reformer effluent high-
pressure  flash  drum  off  (Cas  No  68513-
18-8), 
they  contain  > 0,1 %  w/w 
if 
Butadiene 

Gases (petroleum), reformer effluent low-
pressure  flash  drum  off  (Cas  No  68513-
they  contain  > 0,1 %  w/w 
if 
19-9), 
Butadiene 

⌦ 68513-17-
7 ⌫ 

⌦ 68513-18-
8 ⌫ 

⌦ 271-002-9 ⌫ 

⌦ 271-003-4 ⌫ 

⌦ 68513-19-
9 ⌫ 

⌦ 271-005-5 ⌫ 

Residues  (petroleum),  alkylation  splitter, 
C4-rich  (Cas  No  68513-66-6),  if  they 
contain > 0,1 % w/w Butadiene 

⌦ 68513-66-
6 ⌫ 

⌦ 271-010-2 ⌫ 

Hydrocarbons, C1-4 (Cas  No 68514-31-8), 
if they contain > 0,1 % w/w Butadiene 

⌦ 68514-31-
8 ⌫ 

⌦ 271-032-2 ⌫ 

Hydrocarbons,  C1-4,  sweetened  (Cas  No 
68514-36-3) , if they contain > 0,1 % w/w 
Butadiene 

⌦ 68514-36-
3 ⌫ 

Gases  (petroleum),  oil  refinery  gas  distn. 
off  (Cas  No  68527-15-1),  if  they  contain 
> 0,1 % w/w Butadiene 

⌦ 68527-15-
1 ⌫ 

⌦ 271-038-5 ⌫ 

⌦ 271-258-1 ⌫ 

Hydrocarbons, C1-3 (Cas  No 68527-16-2), 
if they contain > 0,1 % w/w Butadiene 

⌦ 68527-16-
2 ⌫ 

⌦ 271-259-7 ⌫ 

Hydrocarbons,  C1-4,  debutanizer  fraction 
(Cas  No  68527-19-5),  if  they  contain 
> 0,1 % w/w Butadiene 

⌦ 68527-19-
5 ⌫ 

⌦ 271-261-8 ⌫ 

(petroleum), 

Gases 
unit 
hydrotreater  depentaniser  overheads  (Cas 
No  68602-82-4),  if  they  contain  > 0,1 % 
w/w Butadiene 

benzene 

⌦ 68602-82-
4 ⌫ 

⌦ 271-623-5 ⌫ 

Gases  (petroleum),  C1-5,  wet  (Cas  No 
68602-83-5),  if  they  contain  > 0,1 %  w/w 
Butadiene 

⌦ 68602-83-
5 ⌫ 

⌦ 271-624-0 ⌫ 

Gases  (petroleum),  secondary  absorber 
off,  fluidised  catalytic  cracker  overheads 
fractionator  (Cas  No  68602-84-6),  if  they 
contain > 0,1 % w/w Butadiene 

⌦ 68602-84-
6 ⌫ 

⌦ 271-625-6 ⌫ 

EN 

103 

   EN 

 
561. 

562. 

563. 

564. 

565. 

566. 

567. 

568. 

569. 

570. 

571. 

572. 

573. 

Hydrocarbons, C2-4 (Cas  No 68606-25-7), 
if they contain > 0,1 % w/w Butadiene 

⌦ 68606-25-
7 ⌫ 

⌦ 271-734-9 ⌫ 

Hydrocarbons, C3 (Cas No 68606-26-8), if 
they contain > 0,1 % w/w Butadiene 

⌦ 68606-26-
8 ⌫ 

⌦ 271-735-4 ⌫ 

Gases  (petroleum),  alkylation  feed  (Cas 
No  68606-27-9),  if  they  contain  > 0,1 % 
w/w Butadiene 

⌦ 68606-27-
9 ⌫ 

Gases  (petroleum),  depropaniser  bottoms 
fractionation  off  (Cas  No  68606-34-8),  if 
they contain > 0,1 % w/w Butadiene 

⌦ 68606-34-
8 ⌫ 

Petroleum  products,  refinery  gases  (Cas 
No  68607-11-4),  if  they  contain  > 0,1 % 
w/w Butadiene 

⌦ 68607-11-
4 ⌫ 

Gases  (petroleum),  hydrocracking  low-
pressure separator (Cas No 68783-06-2), if 
they contain > 0,1 % w/w Butadiene 

⌦ 68783-06-
2 ⌫ 

Gases (petroleum), refinery blend (Cas No 
68783-07-3),  if  they  contain  > 0,1 %  w/w 
Butadiene 

⌦ 68783-07-
3 ⌫ 

Gases (petroleum), catalytic cracking (Cas 
No  68783-64-2),  if  they  contain  > 0,1 % 
w/w Butadiene 

⌦ 68783-64-
2 ⌫ 

Gases  (petroleum),  C2-4,  sweetened  (Cas 
No  68783-65-3),  if  they  contain  >  0,1  % 
w/w Butadiene 

⌦ 68783-65-
3 ⌫ 

Gases  (petroleum),  refinery  (Cas  No 
68814-67-5),  if  they  contain  > 0,1 %  w/w 
Butadiene 

⌦ 68814-67-
5 ⌫ 

Gases  (petroleum),  platformer  products 
separator off (Cas No 68814-90-4), if they 
contain > 0,1 % w/w Butadiene 

⌦ 68814-90-
4 ⌫ 

⌦ 271-737-5 ⌫ 

⌦ 271-742-2 ⌫ 

⌦ 271-750-6 ⌫ 

⌦ 272-182-1 ⌫ 

⌦ 272-183-7 ⌫ 

⌦ 272-203-4 ⌫ 

⌦ 272-205-5 ⌫ 

⌦ 272-338-9 ⌫ 

⌦ 272-343-6 ⌫ 

Gases 
(petroleum),  hydrotreated  sour 
kerosine  depentaniser  stabiliser  off  (Cas 
No  68911-58-0),  if  they  contain  > 0,1 % 
w/w Butadiene 

⌦ 68911-58-
0 ⌫ 

⌦ 272-775-5 ⌫ 

Gases 
(petroleum),  hydrotreated  sour 
kerosine flash drum (Cas No 68911-59-1), 
if they contain > 0,1 % w/w Butadiene 

⌦ 68911-59-
1 ⌫ 

⌦ 272-776-0 ⌫ 

EN 

104 

   EN 

 
574. 

575. 

576. 

577. 

578. 

579. 

580. 

581. 

582. 

583. 

584. 

Gases  (petroleum),  crude  oil  fractionation 
off  (Cas  No  68918-99-0),  if  they  contain 
> 0,1 % w/w Butadiene 

⌦ 68918-99-
0 ⌫ 

Gases  (petroleum),  dehexaniser  off  (Cas 
No  68919-00-6),  if  they  contain  > 0,1 % 
w/w Butadiene 

⌦ 68919-00-
6 ⌫ 

⌦ 272-871-7 ⌫ 

⌦ 272-872-2 ⌫ 

(petroleum),  distillate  unifiner 
Gases 
desulfurisation tripper off (Cas No 68919-
01-7), 
they  contain  > 0,1 %  w/w 
if 
Butadiene 

(petroleum), 

Gases 
fluidised  catalytic 
cracker  fractionation  off  (Cas  No  68919-
they  contain  > 0,1 %  w/w 
if 
02-8) 
Butadiene 

(petroleum), 

Gases 
fluidised  catalytic 
cracker  scrubbing  secondary  absorber  off 
(Cas  No  68919-03-9),  if  they  contain 
> 0,1 % w/w Butadiene 

heavy 

(petroleum), 

Gases 
distillate 
hydrotreater  desulfurisation  stripper  off 
(Cas  No  68919-04-0),  if  they  contain 
> 0,1 % w/w Butadiene 

Gases  (petroleum), 
light  straight  run 
gasoline  fractionation  stabiliser  off  (Cas 
No  68919-05-1),  if  they  contain  > 0,1 % 
w/w Butadiene 

Gases 
(petroleum),  naphtha  unifiner 
(Cas  No 
desulfurisation  stripper  off 
68919-06-2),  if  they  contain  > 0,1 %  w/w 
Butadiene 

Gases  (petroleum),  platformer  stabiliser 
off,  light  ends  fractionation  (Cas  No 
68919-07-3),  if  they  contain  > 0,1 %  w/w 
Butadiene 

⌦ 68919-01-
7 ⌫ 

⌦ 272-873-8 ⌫ 

⌦ 68919-02-
8 ⌫ 

⌦ 272-874-3 ⌫ 

⌦ 68919-03-
9 ⌫ 

⌦ 272-875-9 ⌫ 

⌦ 68919-04-
0 ⌫ 

⌦ 272-876-4 ⌫ 

⌦ 68919-05-
1 ⌫ 

⌦ 272-878-5 ⌫ 

⌦ 68919-06-
2 ⌫ 

⌦ 272-879-0 ⌫ 

⌦ 68919-07-
3 ⌫ 

⌦ 272-880-6 ⌫ 

Gases  (petroleum),  preflash  tower  off, 
crude  distn.  (Cas  No  68919-08-4),  if  they 
contain > 0,1 % w/w Butadiene 

⌦ 
4 ⌫ 

68919-08-

⌦ 272-881-1 ⌫ 

Gases  (petroleum),  straight-run  naphtha 
catalytic reforming off (Cas No 68919-09-
5), if they contain > 0,1 % w/w Butadiene 

⌦ 68919-09-
5 ⌫ 

⌦ 272-882-7 ⌫ 

EN 

105 

   EN 

 
585. 

586. 

587. 

588. 

589. 

590. 

591. 

592. 

593. 

594. 

595. 

Gases  (petroleum),  straight-run  stabiliser 
off  (Cas  No  68919-10-8),  if  they  contain 
> 0,1 % w/w Butadiene 

⌦ 68919-10-
8 ⌫ 

Gases  (petroleum),  tar  stripper  off  (Cas 
No  68919-11-9),  if  they  contain  > 0,1 % 
w/w Butadiene 

⌦ 68919-11-
9 ⌫ 

Gases  (petroleum),  unifiner  stripper  off 
(Cas  No  68919-12-0),  if  they  contain 
> 0,1 % w/w Butadiene 

⌦ 68919-12-
0 ⌫ 

⌦ 272-883-2 ⌫ 

⌦ 272-884-8 ⌫ 

⌦ 272-885-3 ⌫ 

(petroleum), 

Gases 
fluidised  catalytic 
cracker splitter overheads (Cas No 68919-
20-0), 
they  contain  > 0,1 %  w/w 
if 
Butadiene 

⌦ 68919-20-
0 ⌫ 

⌦ 272-893-7 ⌫ 

Gases 
(petroleum),  catalytic  cracked 
naphtha debutanizer (Cas No 68952-76-1), 
if they contain > 0,1 % w/w Butadiene 

⌦ 68952-76-
1 ⌫ 

⌦ 273-169-3 ⌫ 

Tail  gas  (petroleum),  catalytic  cracked 
distillate  and  naphtha  stabiliser  (Cas  No 
68952-77-2),  if  it  contains  > 0,1 %  w/w 
Butadiene 

⌦ 68952-77-
2 ⌫ 

⌦ 273-170-9 ⌫ 

gas 

(petroleum), 

catalytic 
Tail 
hydrodesulfurised  naphtha  separator  (Cas 
No  68952-79-4),  if  it  contains  > 0,1 % 
w/w Butadiene 

⌦ 68952-79-
4 ⌫ 

⌦ 273-173-5 ⌫ 

Tail  gas  (petroleum),  straight-run  naphtha 
hydrodesulferised (Cas No 68952-80-7), if 
it contains > 0,1 % w/w Butadiene 

⌦ 68952-80-
7 ⌫ 

⌦ 273-174-0 ⌫ 

(petroleum), 

Tail  gas 
thermal-cracked 
distillate,  gas  oil  and  naphtha  absorber 
it  contains 
(Cas  No  68952-81-8), 
> 0,1 % w/w Butadiene 

if 

⌦ 68952-81-
8 ⌫ 

⌦ 273-175-6 ⌫ 

Tail  gas  (petroleum),  thermal  cracked 
stabiliser, 
hydrocarbon 
petroleum coking (Cas No 68952-82-9), if 
it contains > 0,1 % w/w Butadiene 

fractionation 

⌦ 68952-82-
9 ⌫ 

⌦ 273-176-1 ⌫ 

Gases  (petroleum),  light  steam-cracked, 
butadiene  conc.  (Cas  No  68955-28-2),  if 
they contain > 0,1 % w/w Butadiene 

⌦ 68955-28-
2 ⌫ 

⌦ 273-265-5 ⌫ 

596. 

Gases  (petroleum),  sponge  absorber  off, 
fluidised  catalytic  cracker  and  gas  oil 

⌦ 68955-33-

⌦ 273-269-7 ⌫ 

EN 

106 

   EN 

 
desulfuriser  overhead  fractionation  (Cas 
No  68955-33-9),  if  they  contain  > 0,1 % 
w/w Butadiene 

9 ⌫ 

Gases  (petroleum),  straight-run  naphtha 
catalytic reformer stabiliser overhead (Cas 
No  68955-34-0),  if  they  contain  > 0,1 % 
w/w Butadiene 

⌦ 68955-34-
0 ⌫ 

⌦ 273-270-2 ⌫ 

Gases 
(petroleum),  crude  distn.  and 
catalytic cracking (Cas No 68989-88-8), if 
they contain > 0,1 % w/w Butadiene 

⌦ 68989-88-
8 ⌫ 

⌦ 273-563-5 ⌫ 

Hydrocarbons, C4 (Cas No 87741-01-3), if 
they contain > 0,1 % w/w Butadiene 

⌦ 87741-01-
3 ⌫ 

⌦ 289-339-5 ⌫ 

Alkanes, C1-4, C3-rich (Cas No 90622-55-
2), if they contain > 0,1 % w/w Butadiene 

⌦ 90622-55-
2 ⌫ 

⌦ 292-456-4 ⌫ 

Gases (petroleum), gas oil diethanolamine 
scrubber off (Cas No 92045-15-3), if they 
contain > 0,1 % w/w Butadiene 

⌦ 92045-15-
3 ⌫ 

⌦ 295-397-2 ⌫ 

(petroleum), 

oil 
Gases 
hydrodesulfurisation  effluent  (Cas  No 
92045-16-4), if they contain > 0,1 % w/w 
Butadiene 

gas 

(petroleum), 

oil 
Gases 
hydrodesulfurisation  purge 
(Cas  No 
92045-17-5),  if  they  contain  > 0,1 %  w/w 
Butadiene 

gas 

⌦ 92045-16-
4 ⌫ 

⌦ 295-398-8 ⌫ 

⌦ 92045-17-
5 ⌫ 

⌦ 295-399-3 ⌫ 

Gases  (petroleum),  hydrogenator  effluent 
flash  drum  off  (Cas  No  92045-18-6),  if 
they contain > 0,1 % w/w Butadiene 

⌦ 92045-18-
6 ⌫ 

⌦ 295-400-7 ⌫ 

naphtha 

(petroleum), 

Gases 
steam 
cracking  high-pressure  residual  (Cas  No 
92045-19-7),  if  they  contain  > 0,1 %  w/w 
Butadiene 

⌦ 92045-19-
7 ⌫ 

⌦ 295-401-2 ⌫ 

Gases (petroleum), residue visbreaking off 
(Cas  No  92045-20-0),  if  they  contain 
> 0,1 % w/w Butadiene 

⌦ 92045-20-
0 ⌫ 

Gases  (petroleum),  steam-cracker  C3-rich 
(Cas  No  92045-22-2),  if  they  contain 
> 0,1 % w/w Butadiene 

⌦ 92045-22-
2 ⌫ 

⌦ 295-402-8 ⌫ 

⌦ 295-404-9 ⌫ 

597. 

598. 

599. 

600. 

601. 

602. 

603. 

604. 

605. 

606. 

607. 

608. 

Hydrocarbons, C4, steam-cracker distillate  ⌦ 92045-23-

⌦ 295-405-4 ⌫ 

EN 

107 

   EN 

 
609. 

610. 

611. 

612. 

613. 

614. 

617. 

618. 

619. 

620. 

621. 

(Cas  No  92045-23-3),  if  they  contain 
> 0,1 % w/w Butadiene 

3 ⌫ 

Petroleum  gases,  liquefied,  sweetened,  C4 
fraction  (Cas  No  92045-80-2),  if  they 
contain > 0,1 % w/w Butadiene 

⌦ 92045-80-
2 ⌫ 

Hydrocarbons,  C4,  1,3-butadiene-  and 
isobutene-free  (Cas  No  95465-89-7),  if 
they contain > 0,1 % w/w Butadiene 

⌦ 95465-89-
7 ⌫ 

⌦ 295-463-0 ⌫ 

⌦ 306-004-1 ⌫ 

Raffinates  (petroleum),  steam-cracked  C4 
fraction cuprous ammonium acetate extn. , 
C3-5 and C3-5 unsatd. , butadiene-free (Cas 
No  97722-19-5),  if  they  contain  > 0,1 % 
w/w Butadiene 

⌦ 97722-19-
5 ⌫ 

⌦ 307-769-4 ⌫ 

Benzo[def]chrysene 
(Cas No 50-32-8) 

(=benzo[a]pyrene) 

⌦ 50-32-8 ⌫  ⌦ 200-028-5 ⌫ 

Pitch,  coal  tar-petroleum  (Cas  No  68187-
57-5), 
it  contains  > 0,005 %  w/w 
if 
benzo[a]pyrene 

⌦ 68187-57-
5 ⌫ 

Distillates  (coal-petroleum),  condensed-
ring  arom.  (Cas  No  68188-48-7),  if  they 
contain > 0,005 % w/w benzo[a]pyrene 

⌦ 68188-48-
7 ⌫ 

⌦ 269-109-0 ⌫ 

⌦ 269-159-3 ⌫ 

acenaphthene 

Creosote  oil, 
fraction, 
acenaphthene-free  (Cas  No  90640-85-0), 
w/w 
if 
benzo[a]pyrene 

> 0,005 % 

contains 

it 

⌦ 90640-85-
0 ⌫ 

⌦ 292-606-9 ⌫ 

Pitch, coal tar, low-temp. (Cas No 90669-
it  contains  > 0,005 %  w/w 
if 
57-1), 
benzo[a]pyrene 

⌦ 90669-57-
1 ⌫ 

Pitch,  coal  tar,  low-temp.,  heat-treated 
it  contains 
(Cas  No  90669-58-2), 
> 0,005 % w/w benzo[a]pyrene 

if 

⌦ 90669-58-
2 ⌫ 

Pitch,  coal  tar,  low-temp.,  oxidised  (Cas 
No  90669-59-3),  if  it  contains  > 0,005 % 
w/w benzo[a]pyrene 

⌦ 90669-59-
3 ⌫ 

Extract  residues  (coal),  brown  (Cas  No 
91697-23-3),  if  they  contain  > 0,005 % 
w/w benzo[a]pyrene 

⌦ 91697-23-
3 ⌫ 

⌦ 292-651-4 ⌫ 

⌦ 292-653-5 ⌫ 

⌦ 292-654-0 ⌫ 

⌦ 294-285-0 ⌫ 

622. 

Paraffin  waxes  (coal),  brown-coal  high-
temp.  tar  (Cas  No  92045-71-1),  if  they 

⌦ 92045-71-
1 ⌫ 

⌦ 295-454-1 ⌫ 

EN 

108 

   EN 

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

623. 

Paraffin  waxes  (coal),  brown-coal  high-
temp. tar, hydrotreated (Cas No 92045-72-
they  contain  > 0,005 %  w/w 
2), 
benzo[a]pyrene 

if 

⌦ 92045-72-
2 ⌫ 

⌦ 295-455-7 ⌫ 

624.  Waste  solids,  coal-tar  pitch  coking  (Cas 
No 92062-34-5), if they contain > 0,005 % 
w/w benzo[a]pyrene 

⌦ 92062-34-
5 ⌫ 

Pitch,  coal  tar,  high-temp.  ,  secondary 
it  contains 
(Cas  No  94114-13-3), 
> 0,005 % w/w benzo[a]pyrene 

if 

⌦ 94114-13-
3 ⌫ 

Residues (coal), liq. solvent extn. (Cas No 
94114-46-2),  if  they  contain  > 0,005 % 
w/w benzo[a]pyrene 

⌦ 94114-46-
2 ⌫ 

Coal  liquids,  liq.  solvent  extn.  soln.  (Cas 
No 94114-47-3), if they contain > 0,005 % 
w/w benzo[a]pyrene 

⌦ 94114-47-
3 ⌫ 

Coal  liquids,  liq.  solvent  extn.  (Cas  No 
94114-48-4),  if  they  contain  > 0,005 % 
w/w benzo[a]pyrene 

⌦ 94114-48-
4 ⌫ 

⌦ 295-549-8 ⌫ 

⌦ 302-650-3 ⌫ 

⌦ 302-681-2 ⌫ 

⌦ 302-682-8 ⌫ 

⌦ 302-683-3 ⌫ 

Paraffin  waxes  (coal),  brown-coal  high-
temp.  tar,  carbon-treated  (Cas  No  97926-
76-6),  if  they  contain  > 0,005 %  w/w 
benzo[a]pyrene 

Paraffin  waxes  (coal),  brown-coal  high-
temp  tar,  clay-treated  (Cas  No  97926-77-
they  contain  > 0,005 %  w/w 
7), 
benzo[a]pyrene 

if 

Paraffin  waxes  (coal),  brown-coal  high-
temp  tar,  silicic  acid-treated  (Cas  No 
97926-78-8),  if  they  contain  > 0,005 % 
w/w benzo[a]pyrene 

⌦ 97926-76-
6 ⌫ 

⌦ 308-296-6 ⌫ 

⌦ 97926-77-
7 ⌫ 

⌦ 308-297-1 ⌫ 

⌦ 97926-78-
8 ⌫ 

⌦ 308-298-7 ⌫ 

Absorption  oils,  bicyclo  arom.  and 
heterocylic  hydrocarbon  fraction  (Cas  No 
101316-45-4),  if  they  contain  > 0,005 % 
w/w benzo[a]pyrene 

⌦ 
4 ⌫ 

101316-45-

⌦ 309-851-5 ⌫ 

Aromatic hydrocarbons, C20-28, polycyclic, 
mixed 
pitch-polyethylene 
polypropylene  pyrolysis-derived  (Cas  No 
101794-74-5),  if  they  contain  > 0,005 % 

coal-tar 

⌦ 101794-74-
5 ⌫ 

⌦ 309-956-6 ⌫ 

625. 

626. 

627. 

628. 

629. 

630. 

631. 

632. 

633. 

EN 

109 

   EN 

 
634. 

635. 

w/w benzo[a]pyrene 

coal-tar 

Aromatic hydrocarbons, C20-28, polycyclic, 
mixed 
pitch-polyethylene 
pyrolysis-derived  (Cas  No  101794-75-6), 
if 
> 0,005 %  w/w 
they 
benzo[a]pyrene 

contain 

coal-tar 

Aromatic hydrocarbons, C20-28, polycyclic, 
mixed 
pitch-polystyrene 
pyrolysis-derived  (Cas  No  101794-76-7), 
if 
> 0,005 %  w/w 
they 
benzo[a]pyrene 

contain 

⌦ 101794-75-
6 ⌫ 

⌦ 309-957-1 ⌫ 

⌦ 101794-76-
7 ⌫ 

⌦ 309-958-7 ⌫ 

636. 

Pitch,  coal  tar,  high-temp.  ,  heat-treated 
(Cas  No  121575-60-8),  if  it  contains 
> 0,005 % w/w benzo[a]pyrene 

⌦ 121575-60-
8 ⌫ 

⌦ 310-162-7 ⌫ 

637. 

Dibenz[a,h]anthracene (Cas No 53-70-3)  ⌦ 53-70-3 ⌫  ⌦ 200-181-8 ⌫ 

638. 

Benz[a]anthracene (Cas No 56-55-3) 

⌦ 56-55-3 ⌫  ⌦ 200-280-6 ⌫ 

639. 

Benzo[e]pyrene (Cas No 192-97-2) 

⌦ 192-97-2 ⌫  ⌦ 205-892-7 ⌫ 

640. 

Benzo[j]fluoranthene (Cas No 205-82-3)  ⌦ 205-82-3 ⌫  ⌦ 205-910-3 ⌫ 

641. 

Benz(e)acephenanthrylene  (Cas  No  205-
99-2) 

⌦ 205-99-2 ⌫  ⌦ 205-911-9 ⌫ 

642. 

Benzo(k)fluoranthene (Cas No 207-08-9)  ⌦ 207-08-9 ⌫  ⌦ 205-916-6 ⌫ 

643. 

Chrysene (Cas No 218-01-9) 

⌦ 218-01-9 ⌫  ⌦ 205-923-4 ⌫ 

644. 

2-Bromopropane (Cas No 75-26-3) 

⌦ 75-26-3 ⌫  ⌦ 200-855-1 ⌫ 

645. 

Trichloroethylene (Cas No 79-01-6) 

⌦ 79-01-6 ⌫  ⌦ 201-167-4 ⌫ 

646. 

647. 

1,2-Dibromo-3-chloropropane 
96-12-8) 

(Cas  No 

⌦ 96-12-8 ⌫  ⌦ 202-479-3 ⌫ 

2,3-Dibromopropan-1-ol  (Cas  No  96-13-
9) 

⌦ 96-13-9 ⌫  ⌦ 202-480-9 ⌫ 

648. 

1,3-Dichloropropan-2-ol (Cas No 96-23-1) ⌦ 96-23-1 ⌫  ⌦ 202-491-9 ⌫ 

649. 

α,α,α-Trichlorotoluene (Cas No 98-07-7)  ⌦ 98-07-7 ⌫  ⌦ 202-634-5 ⌫ 

650. 

α-Chlorotoluene (Cas No 100-44-7) 

⌦ 100-44-7 ⌫  ⌦ 202-853-6 ⌫ 

651. 

1,2-Dibromoethane (Cas No 106-93-4)  ⌦ 106-93-4 ⌫  ⌦ 203-444-5 ⌫ 

EN 

110 

   EN 

 
652. 

Hexachlorobenzene (Cas No 118-74-1)  ⌦ 118-74-1 ⌫  ⌦ 204-273-9 ⌫ 

653. 

Bromoethylene (Cas No 593-60-2) 

⌦ 593-60-2 ⌫  ⌦ 209-800-6 ⌫ 

654. 

1,4-Dichlorobut-2-ene (Cas No 764-41-0)  ⌦ 764-41-0 ⌫  ⌦ 212-121-8 ⌫ 

655.  Methyloxirane (Cas No 75-56-9) 

⌦ 75-56-9 ⌫  ⌦ 200-879-2 ⌫ 

656. 

(Epoxyethyl)benzene (Cas No 96-09-3)  ⌦ 96-09-3 ⌫  ⌦ 202-476-7 ⌫ 

657. 

658. 

659. 

1-Chloro-2,3-epoxypropane  (Cas  No  106-
89-8) 

⌦ 106-89-8 ⌫  ⌦ 203-439-8 ⌫ 

R-1-Chloro-2,3-epoxypropane 
51594-55-9) 

(Cas  No 

⌦ 51594-55-
9 ⌫ 

⌦ 603-166-00-
8 ⌫ 

1,2-Epoxy-3-phenoxypropane 
122-60-1) 

(Cas  No 

⌦ 122-60-1 ⌫  ⌦ 204-557-2 ⌫ 

660. 

2,3-Epoxypropan-1-ol (Cas No 556-52-5)  ⌦ 556-52-5 ⌫  ⌦ 209-128-3 ⌫ 

661. 

R-2,3-Epoxy-1-propanol  (Cas  No  57044-
25-4) 

⌦ 57044-25-
4 ⌫ 

⌦ 603-143-00-
2 ⌫ 

662. 

2,2′-Bioxirane (Cas No 1464-53-5) 

⌦ 1464-53-5 ⌫  ⌦ 215-979-1 ⌫ 

(cid:208) 2007/1/EC Art. 1 and Annex pt. 
3 (adapted) 

663. 

 (2RS,3RS)-3-(2-Chlorophenyl)-2-(4-
fluorophenyl)-[1H-1,2,4-triazol-1-
yl)methyl]oxirane;  Eepoxiconazole  (CAS 
No 133855-98-8) 

⌦ 133855-98-
8 ⌫ 

⌦ 613-175-00-
9 ⌫ 

(cid:208) 2004/93/EC Art. 1 and Annex .2 
(adapted) 

664. 

Chloromethyl  methyl  ether  (Cas  No  107-
30-2) 

⌦ 107-30-2 ⌫  ⌦ 203-480-1 ⌫ 

665. 

2-Methoxyethanol (Cas No 109-86-4) 

⌦ 109-86-4 ⌫  ⌦ 203-713-7 ⌫ 

EN 

111 

   EN 

 
 
 
 
 
 
 
 
 
666. 

2-Ethoxyethanol (Cas No 110-80-5) 

⌦ 110-80-5 ⌫  ⌦ 203-804-1 ⌫ 

667. 

Oxybis[chloromethane], 
(Chloromethyl) ether (Cas No 542-88-1) 

bis 

⌦ 542-88-1 ⌫  ⌦ 208-832-8 ⌫ 

668. 

2-Methoxypropanol (Cas No 1589-47-5)  ⌦ 1589-47-5 ⌫  ⌦ 216-455-5 ⌫ 

669. 

Propiolactone (Cas No 57-57-8) 

⌦ 57-57-8 ⌫  ⌦ 200-340-1 ⌫ 

670. 

Dimethylcarbamoyl  chloride  (Cas  No  79-
44-7) 

⌦ 79-44-7 ⌫  ⌦ 201-208-6 ⌫ 

671. 

Urethane (Cas No 51-79-6) 

⌦ 51-79-6 ⌫  ⌦ 200-123-1 ⌫ 

672. 

2-Methoxyethyl acetate (Cas No 110-49-6)  ⌦ 110-49-6 ⌫  ⌦ 203-772-9 ⌫ 

673. 

2-Ethoxyethyl acetate (Cas No 111-15-9)  ⌦ 111-15-9 ⌫  ⌦ 203-839-2 ⌫ 

674.  Methoxyacetic acid (Cas No 625-45-6)  ⌦ 625-45-6 ⌫  ⌦ 210-894-6 ⌫ 

675. 

Dibutyl phthalate (Cas No 84-74-2) 

⌦ 84-74-2 ⌫  ⌦ 201-557-4 ⌫ 

676. 

677. 

678. 

679. 

680. 

681. 

bis(2-Methyoxyethyl)  ether  (Cas  No  111-
96-6) 

⌦ 111-96-6 ⌫  ⌦ 203-924-4 ⌫ 

bis(2-Ethylhexyl)  phthalate  (Cas  No  117-
81-7) 

⌦ 117-81-7 ⌫  ⌦ 204-211-0 ⌫ 

bis(2-Methoxyethyl)  phthalate  (Cas  No 
117-82-8) 

⌦ 117-82-8 ⌫  ⌦ 204-212-6 ⌫ 

2-Methoxypropyl  acetate  (Cas  No  70657-
70-4) 

⌦ 70657-70-
4 ⌫ 

⌦ 274-724-2 ⌫ 

2-Ethylhexyl[[[3,5-bis(1,1-dimethylethyl)-
4-hydroxyphenyl]-methyl]thio]acetate 
(Cas No 80387-97-9) 

⌦ 80387-97-
9 ⌫ 

⌦ 279-452-8 ⌫ 

Acrylamide,  unless  regulated  elsewhere  in 
this  ⌦ Regulation ⌫  Directive  (Cas  No 
79-06-1) 

⌦ 79-06-1 ⌫  ⌦ 201-173-7 ⌫ 

682. 

Acrylonitrile (Cas No 107-13-1) 

⌦ 107-13-1 ⌫  ⌦ 203-466-5 ⌫ 

683. 

2-Nitropropane (Cas No 79-46-9) 

⌦ 79-46-9 ⌫  ⌦ 201-209-1 ⌫ 

684. 

Dinoseb  (Cas  No  88-85-7),  its  salts  and 
esters with the exception of those specified 
elsewhere in this list 

⌦ 88-85-7 ⌫  ⌦ 201-861-7 ⌫ 

685. 

2-Nitroanisole (Cas No 91-23-6) 

⌦ 91-23-6 ⌫  ⌦ 202-052-1 ⌫ 

EN 

112 

   EN 

 
686. 

4-Nitrobiphenyl (Cas No 92-93-3) 

⌦ 92-93-3 ⌫  ⌦ 202-204-7 ⌫ 

(cid:208) 2005/80/EC Art. 1 and Annex 
.1(b) (adapted) 

687. 

dinitrotoluene,  technical  grade  (Cas  No 
121-14-2) 

⌦ 121-14-2 ⌫  ⌦ 204-450-0 ⌫ 

(cid:208) 2004/93/EC Art. 1 and Annex .2 
(adapted) 
(cid:206)1 2004/93/EC Art. 1 and Annex 
.2 amended by Corrigendum, OJ L 
097, 15.4.2005, p. 63 

688. 

Binapacryl (Cas No 485-31-4) 

⌦ 485-31-4 ⌫  ⌦ 207-612-9 ⌫ 

689. 

2-Nitronaphthalene (Cas No 581-89-5)  ⌦ 581-89-5 ⌫  ⌦ 209-474-5 ⌫ 

690. 

2,3-Dinitrotoluene (Cas No 602-01-7) 

⌦ 602-01-7 ⌫  ⌦ 210-013-5 ⌫ 

691. 

5-Nitroacenaphthene (Cas No 602-87-9)  ⌦ 602-87-9 ⌫  ⌦ 210-025-0 ⌫ 

692. 

2,6-Dinitrotoluene (Cas No 606-20-2) 

⌦ 606-20-2 ⌫  ⌦ 210-106-0 ⌫ 

693. 

3,4-Dinitrotoluene (Cas No 610-39-9) 

⌦ 610-39-9 ⌫  ⌦ 210-222-1 ⌫ 

694. 

3,5-Dinitrotoluene (Cas No 618-85-9) 

⌦ 618-85-9 ⌫  ⌦ 210-566-2 ⌫ 

695. 

2,5-Dinitrotoluene (Cas No 619-15-8) 

⌦ 619-15-8 ⌫  ⌦ 210-581-4 ⌫ 

696. 

Dinoterb (Cas No 1420-07-1), its salts and 
esters 

⌦ 1420-07-1 ⌫  ⌦ 215-813-8 ⌫ 

697. 

Nitrofen (Cas No 1836-75-5) 

⌦ 1836-75-5 ⌫  ⌦ 217-406-0 ⌫ 

698. 

Dinitrotoluene (Cas No 25321-14-6) 

⌦ 25321-14-
6 ⌫ 

⌦ 246-836-1 ⌫ 

699. 

Diazomethane (Cas No 334-88-3) 

⌦ 334-88-3 ⌫  ⌦ 206-382-7 ⌫ 

700. 

1,4,5,8-Tetraaminoanthraquinone 
(Disperse Blue 1) (Cas No 2475-45-8) 

⌦ 2475-45-8 ⌫  ⌦ 219-603-7 ⌫ 

701. 

Dimethylnitrosoamine (Cas No 62-75-9)  ⌦ 62-75-9 ⌫  ⌦ 200-549-8 ⌫ 

EN 

113 

   EN 

 
 
 
 
 
 
 
 
702. 

1-Methyl-3-nitro-1-nitrosoguanidine  (Cas 
No 70-25-7) 

⌦ 70-25-7 ⌫  ⌦ 200-730-1 ⌫ 

703. 

Nitrosodipropylamine (Cas No 621-64-7)  ⌦ 621-64-7 ⌫  ⌦ 210-698-0 ⌫ 

704. 

2,2′-(Nitrosoimino)bisethanol 
1116-54-7) 

(Cas  No 

⌦ 1116-54-7 ⌫  ⌦ 214-237-4 ⌫ 

705. 

4,4′-Methylenedianiline (Cas No 101-77-9) ⌦ 101-77-9 ⌫  ⌦ 202-974-4 ⌫ 

706. 

4,4′-(4-Iminocyclohexa-2,5-
dienylidenemethylene) 
hydrochloride (Cas No 569-61-9) 

dianiline 

⌦ 569-61-9 ⌫  ⌦ 209-321-2 ⌫ 

707. 

4,4′-Methylenedi-o-toluidine (Cas No 838-
88-0) 

⌦ 838-88-0 ⌫  ⌦ 212-658-8 ⌫ 

708. 

o-Anisidine (Cas No 90-04-0) 

⌦ 90-04-0 ⌫  ⌦ 201-963-1 ⌫ 

709. 

3,3′-Dimethoxybenzidine (Cas No 119-90-
4) 

⌦ 119-90-4 ⌫  ⌦ 204-355-4 ⌫ 

710. 

Salts of o-dianisidine 

711. 

o-Dianisidine based azo dyes 

712. 

3,3′-Dichlorobenzidine (Cas No 91-94-1)  ⌦ 91-94-1 ⌫  ⌦ 202-109-0 ⌫ 

713. 

714. 

715. 

Benzidine  dihydrochloride  (Cas  No  531-
85-1) 

⌦ 531-85-1 ⌫  ⌦ 208-519-6 ⌫ 

[[1,1′-Biphenyl]-4,4′-diyl]diammonium 
sulphate (Cas No 531-86-2) 

⌦ 531-86-2 ⌫  ⌦ 208-520-1 ⌫ 

3,3′-Dichlorobenzidine 
(Cas No 612-83-9) 

dihydrochloride 

⌦ 612-83-9 ⌫  ⌦ 210-323-0 ⌫ 

716. 

Benzidine sulphate (Cas No 21136-70-9)  ⌦ 21136-70-

⌦ 244-236-4 ⌫ 

9 ⌫ 

717. 

Benzidine acetate (Cas No 36341-27-2)  ⌦ 36341-27-

⌦ 252-984-8 ⌫ 

2 ⌫ 

718. 

719. 

3,3′-Dichlorobenzidine 
bis(sulphate) (Cas No 64969-34-2) 

dihydrogen 

⌦ 64969-34-
2 ⌫ 

⌦ 265-293-1 ⌫ 

3,3′-Dichlorobenzidine  sulphate  (Cas  No 
74332-73-3) 

⌦ 74332-73-
3 ⌫ 

⌦ 277-822-3 ⌫ 

720. 

Benzidine based azo dyes 

EN 

114 

   EN 

 
 
 
 
 
 
 
721. 

4,4′-Bi-o-toluidine (Cas No 119-93-7) 

⌦ 119-93-7 ⌫  ⌦ 204-358-0 ⌫ 

722. 

723. 

4,4′-Bi-o-toluidine  dihydrochloride  (Cas 
No 612-82-8) 

⌦ 612-82-8 ⌫  ⌦ 210-322-5 ⌫ 

[3,3′-Dimethyl[1,1′-biphenyl]-4,4′-
diyl]diammonium  bis(hydrogen  sulphate) 
(Cas No 64969-36-4) 

⌦ 64969-36-
4 ⌫ 

⌦ 265-294-7 ⌫ 

724. 

4,4′-Bi-o-toluidine 
74753-18-7) 

sulphate 

(Cas  No 

⌦ 74753-18-
7 ⌫ 

⌦ 277-985-0 ⌫ 

725. 

o-Toluidine based dyes 

726. 

Biphenyl-4-ylamine (Cas No 92-67-1) and 
its salts 

⌦ 92-67-1 ⌫  ⌦ 202-177-1 ⌫ 

727. 

Azobenzene (Cas No 103-33-3) 

⌦ 103-33-3 ⌫  ⌦ 203-102-5 ⌫ 

728. 

(Methyl-ONN-azoxy)methyl  acetate  (Cas 
No 592-62-1) 

⌦ 592-62-1 ⌫  ⌦ 209-765-7 ⌫ 

729. 

Cycloheximide (Cas No 66-81-9) 

⌦ 66-81-9 ⌫  ⌦ 200-636-0 ⌫ 

730. 

2-Methylaziridine (Cas No 75-55-8) 

⌦ 75-55-8 ⌫  ⌦ 200-878-7 ⌫ 

731. 

Imidazolidine-2-thione (Cas No 96-45-7)  ⌦ 96-45-7 ⌫  ⌦ 202-506-9 ⌫ 

732. 

Furan (Cas No 110-00-9) 

⌦ 110-00-9 ⌫  ⌦ 203-727-3 ⌫ 

733. 

Aziridine (Cas No 151-56-4) 

⌦ 151-56-4 ⌫  ⌦ 205-793-9 ⌫ 

734. 

Captafol (2425-06-1) 

⌦ 2425-06-1 ⌫  ⌦ 219-363-3 ⌫ 

735. 

Carbadox (Cas No 6804-07-5) 

⌦ 6804-07-5 ⌫  ⌦ 229-879-0 ⌫ 

736. 

Flumioxazin (Cas No 103361-09-7) 

⌦ 103361-09-
7 ⌫ 

⌦ 613-166-00-
X ⌫ 

737. 

Tridemorph (Cas No 24602-86-6) 

738. 

Vinclozolin (Cas No 50471-44-8) 

739. 

Fluazifop-butyl (Cas No 69806-50-4) 

⌦ 24602-86-
6 ⌫ 

⌦ 50471-44-
8 ⌫ 

⌦ 69806-50-
4 ⌫ 

⌦ 246-347-3 ⌫ 

⌦ 256-599-6 ⌫ 

⌦ 274-125-6 ⌫ 

740. 

Flusilazole (Cas No 85509-19-9) 

⌦ 85509-19-
9 ⌫ 

⌦ 014-017-00-
6 ⌫ 

EN 

115 

   EN 

 
 
 
741. 

1,3,5-Tris(oxiranylmethyl)-1,3,5-triazine-
2,4,6(1H,3H,5H)-trione  (Cas  No  2451-62-
9) 

⌦ 2451-62-9 ⌫  ⌦ 219-514-3 ⌫ 

742. 

Thioacetamide (Cas No 62-55-5) 

⌦ 62-55-5 ⌫  ⌦ 200-541-4 ⌫ 

743. 

N,N-Dimethylformamide  (Cas  No  68-12-
2) 

⌦ 68-12-2 ⌫  ⌦ 200-679-5 ⌫ 

744. 

Formamide (Cas No 75-12-7) 

⌦ 75-12-7 ⌫  ⌦ 200-842-0 ⌫ 

745. 

N-Methylacetamide (Cas No 79-16-3) 

⌦ 79-16-3 ⌫  ⌦ 201-182-6 ⌫ 

746. 

N-Methylformamide (Cas No 123-39-7)  ⌦ 123-39-7 ⌫  ⌦ 204-624-6 ⌫ 

747. 

748. 

N,N-Dimethylacetamide  (Cas  No  127-19-
5) 

⌦ 127-19-5 ⌫  ⌦ 204-826-4 ⌫ 

Hexamethylphosphoric-triamide  (Cas  No 
680-31-9) 

⌦ 680-31-9 ⌫  ⌦ 211-653-8 ⌫ 

749. 

Diethyl sulphate (Cas No 64-67-5) 

⌦ 64-67-5 ⌫  ⌦ 200-589-6 ⌫ 

750. 

Dimethyl sulphate (Cas No 77-78-1) 

⌦ 77-78-1 ⌫  ⌦ 201-058-1 ⌫ 

751. 

1,3-Propanesultone (Cas No 1120-71-4)  ⌦ 1120-71-4 ⌫  ⌦ 214-317-9 ⌫ 

752. 

Dimethylsulphamoyl-chloride 
13360-57-1) 

(Cas  No 

⌦ 13360-57-
1 ⌫ 

⌦ 236-412-4 ⌫ 

753. 

Sulfallate (Cas No 95-06-7) 

⌦ 95-06-7 ⌫  ⌦ 202-388-9 ⌫ 

754. 

755. 

756. 

757. 

of: 

mixture 

A 
Fluorophenyl)methylsilyl]methyl]-4H-
1,2,4-triazole 
fluorophenyl)methylsilyl]methyl]-1H-
1,2,4-triazole (EC No 403-250-2) 

and 

4-[[bis-(4-

1-[[bis-(4-

⌦ 403-250-2 ⌫ 

(+/–)-Tetrahydrofurfuryl 
chloroquinoxalin-2-
yloxy)phenyloxy]propionate 
119738-06-6) 

–(R)-2-[4-(6-

⌦ 119738-06-
6 ⌫ 

⌦ 607-373-00-
4 ⌫ 

(Cas  No 

6-Hydroxy-1-(3-Isopropoxypropyl)-4-
methyl-2-oxo-5-[4-(phenylazo)phenylazo]-
1,2-dihydro-3-pyridinecarbonitrile (Cas No 
85136-74-9) 

⌦ 85136-74-
9 ⌫ 

⌦ 611-057-00-
1 ⌫ 

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

⌦ 108225-03-
2 ⌫ 

⌦ 611-058-00-
7 ⌫ 

EN 

116 

   EN 

 
 
758. 

759. 

methylethyl)ammonium]  formate  (Cas  No 
108225-03-2) 

[4′-(8-acetylamino-3,6-

Trisodium 
disulfonato-2-naphthylazo)-4″-(6-
benzoylamino-3-Sulfonato-2-
naphthylazo)-biphenyl-1,3′,3″,1″′-
tetraolato-O,O′,O″,O″′]copper(II)  (EC  No 
413-590-3) 

A  mixture 
of:  N-[3-Hydroxy-2-(2-
methylacryloylaminomethoxy)propoxymet
hyl]-2-methylacrylamide  and  N-[2,3-bis-
(2-
Methylacryloylaminomethoxy)propoxymet
and 
hyl]-2-methylacrylamide 
methacrylamide 
2-methyl-N-(2-
and 
methylacryloylaminomethoxymethyl)-
acrylamide 
dihydroxypropoxymethyl)-2-
methylacrylamide (EC No 412-790-8) 

N-(2,3-

and 

⌦ 413-590-3 ⌫ 

⌦ 412-790-8 ⌫ 

760. 

1,3,5-tris-[(2S  and  2R)-2,3-Epoxypropyl]-
1,3,5-triazine-2,4,6-(1H,3H,5H)-trione 
(Cas No 59653-74-6) 

⌦ 59653-74-
6 ⌫ 

⌦ 616-091-00-
0 ⌫ 

761. 

Erionite (Cas No 12510-42-8) 

762. 

Asbestos (Cas No 12001-28-4) 

⌦ 12510-42-
8 ⌫ 

⌦ 650-012-00-
0 ⌫ 

⌦ 12001-28-
4 ⌫ 

⌦ 650-013-00-
6 ⌫ 

763. 

Petroleum (Cas No 8002-05-9) 

⌦ 8002-05-9 ⌫  ⌦ 232-298-5 ⌫ 

764. 

765. 

766. 

767. 

heavy 
Distillates 
hydrocracked (Cas No 64741-76-0), if they 
contain > 3 % w/w DMSO extract 

(petroleum), 

⌦ 64741-76-
0 ⌫ 

⌦ 265-077-7 ⌫ 

(petroleum), 

solvent-refined 
Distillates 
heavy  paraffinic  (Cas  No  64741-88-4),  if 
they contain > 3 % w/w DMSO extract 

⌦ 64741-88-
4 ⌫ 

⌦ 265-090-8 ⌫ 

(petroleum), 

Distillates 
solvent-refined 
light  paraffinic  (Cas  No  64741-89-5),  if 
they contain > 3 % w/w DMSO extract 

⌦ 64741-89-
5 ⌫ 

⌦ 265-091-3 ⌫ 

oils 

Residual 
solvent 
deasphalted  (Cas  No  64741-95-3),  if  they 
contain > 3 % w/w DMSO extract 

(petroleum), 

⌦ 64741-95-
3 ⌫ 

⌦ 265-096-0 ⌫ 

768. 

Distillates 

(petroleum), 

solvent-refined  ⌦ 64741-96-

⌦ 265-097-6 ⌫ 

EN 

117 

   EN 

 
 
 
769. 

770. 

771. 

772. 

773. 

774. 

775. 

776. 

777. 

778. 

779. 

780. 

heavy naphthenic (Cas No 64741-96-4), if 
they contain > 3 % w/w DMSO extract 

4 ⌫ 

(petroleum), 

Distillates 
solvent-refined 
light  naphthenic  (Cas  No  64741-97-5),  if 
they contain > 3 % w/w DMSO extract 

⌦ 64741-97-
5 ⌫ 

⌦ 265-098-1 ⌫ 

Residual  oils  (petroleum),  solvent-refined 
(Cas  No  64742-01-4),  if  they  contain 
> 3 % w/w DMSO extract 

⌦ 64742-01-
4 ⌫ 

⌦ 265-101-6 ⌫ 

Distillates  (petroleum),  clay-treated  heavy 
paraffinic  (Cas  No  64742-36-5),  if  they 
contain > 3 % w/w DMSO extract 

⌦ 64742-36-
5 ⌫ 

⌦ 265-137-2 ⌫ 

Distillates  (petroleum),  clay-treated  light 
paraffinic  (Cas  No  64742-37-6),  if  they 
contain > 3 % w/w DMSO extract 

⌦ 64742-37-
6 ⌫ 

⌦ 265-138-8 ⌫ 

(petroleum),  clay-treated 
Residual  oils 
(Cas  No  64742-41-2),  if  they  contain 
> 3 % w/w DMSO extract 

⌦ 64742-41-
2 ⌫ 

⌦ 265-143-5 ⌫ 

Distillates  (petroleum),  clay-treated  heavy 
naphthenic  (Cas  No  64742-44-5),  if  they 
contain > 3 % w/w DMSO extract 

⌦ 64742-44-
5 ⌫ 

⌦ 265-146-1 ⌫ 

Distillates  (petroleum),  clay-treated  light 
naphthenic  (Cas  No  64742-45-6),  if  they 
contain > 3 % w/w DMSO extract 

⌦ 64742-45-
6 ⌫ 

⌦ 265-147-7 ⌫ 

Distillates (petroleum), hydrotreated heavy 
naphthenic  (Cas  No  64742-52-5),  if  they 
contain > 3% w/w DMSO extract 

⌦ 64742-52-
5 ⌫ 

⌦ 265-155-0 ⌫ 

Distillates  (petroleum),  hydrotreated  light 
naphthenic  (Cas  No  64742-53-6),  if  they 
contain > 3 % w/w DMSO extract 

⌦ 64742-53-
6 ⌫ 

⌦ 265-156-6 ⌫ 

Distillates (petroleum), hydrotreated heavy 
paraffinic  (Cas  No  64742-54-7),  if  they 
contain > 3 % w/w DMSO extract 

⌦ 64742-54-
7 ⌫ 

⌦ 265-157-1 ⌫ 

Distillates  (petroleum),  hydrotreated  light 
paraffinic  (Cas  No  64742-55-8),  if  they 
contain > 3 % w/w DMSO extract 

⌦ 64742-55-
8 ⌫ 

⌦ 265-158-7 ⌫ 

Distillates  (petroleum),  solvent-dewaxed 
light  paraffinic  (Cas  No  64742-56-9),  if 
they contain > 3 % w/w DMSO extract 

⌦ 64742-56-
9 ⌫ 

⌦ 265-159-2 ⌫ 

EN 

118 

   EN 

 
781. 

782. 

783. 

784. 

785. 

786. 

787. 

788. 

789. 

790. 

791. 

792. 

793. 

Residual  oils  (petroleum),  hydrotreated 
(Cas  No  64742-57-0),  if  they  contain 
> 3 % w/w DMSO extract 

⌦ 64742-57-
0 ⌫ 

⌦ 265-160-8 ⌫ 

oils 

solvent-
Residual 
dewaxed,  (Cas  No  64742-62-7),  if  they 
contain > 3 % w/w DMSO extract 

(petroleum), 

⌦ 64742-62-
7 ⌫ 

⌦ 265-166-0 ⌫ 

Distillates  (petroleum),  solvent-dewaxed 
heavy naphthenic (Cas No 64742-63-8), if 
they contain > 3 % w/w DMSO extract 

⌦ 64742-63-
8 ⌫ 

⌦ 265-167-6 ⌫ 

Distillates  (petroleum),  solvent-dewaxed 
light  naphthenic  (Cas  No  64742-64-9),  if 
they contain > 3 % w/w DMSO extract 

⌦ 64742-64-
9 ⌫ 

⌦ 265-168-1 ⌫ 

Distillates  (petroleum),  solvent-dewaxed 
heavy  paraffinic  (Cas  No  64742-65-0),  if 
they contain > 3 % w/w DMSO extract 

⌦ 64742-65-
0 ⌫ 

⌦ 265-169-7 ⌫ 

Foots  oil  (petroleum)  (Cas  No  64742-67-
2), if it contains > 3 % w/w DMSO extract 

⌦ 64742-67-
2 ⌫ 

⌦ 265-171-8 ⌫ 

(petroleum),  catalytic 
Naphthenic  oils 
dewaxed  heavy  (Cas  No  64742-68-3),  if 
they contain > 3 % w/w DMSO extract 

⌦ 64742-68-
3 ⌫ 

⌦ 265-172-3 ⌫ 

Naphthenic  oils 
(petroleum),  catalytic 
dewaxed  light  (Cas  No  64742-69-4),  if 
they contain > 3 % w/w DMSO extract 

⌦ 64742-69-
4 ⌫ 

⌦ 265-173-9 ⌫ 

oils 

Paraffin 
catalytic 
dewaxed  heavy  (Cas  No  64742-70-7),  if 
they contain > 3 % w/w DMSO extract 

(petroleum), 

oils 

Paraffin 
catalytic 
dewaxed  light  (Cas  No  64742-71-8),  if 
they contain > 3 % w/w DMSO extract 

(petroleum), 

⌦ 64742-70-
7 ⌫ 

⌦ 64742-71-
8 ⌫ 

⌦ 265-174-4 ⌫ 

⌦ 265-176-5 ⌫ 

Naphthenic  oils 
(petroleum),  complex 
dewaxed  heavy,  (Cas  No  64742-75-2),  if 
they contain > 3 % w/w DMSO extract 

⌦ 64742-75-
2 ⌫ 

⌦ 265-179-1 ⌫ 

Naphthenic  oils 
(petroleum),  complex 
dewaxed  light  (Cas  No  64742-76-3),  if 
they contain > 3 % w/w DMSO extract 

⌦ 64742-76-
3 ⌫ 

⌦ 265-180-7 ⌫ 

Extracts  (petroleum),  heavy  naphthenic 
distillate  solvent,  arom.  Conc.  (Cas  No 
68783-00-6),  if  they  contain  > 3 %  w/w 

⌦ 68783-00-
6 ⌫ 

⌦ 272-175-3 ⌫ 

EN 

119 

   EN 

 
794. 

795. 

796. 

797. 

798. 

799. 

800. 

801. 

802. 

803. 

804. 

DMSO extract 

(petroleum), 

Extracts 
solvent-refined 
heavy paraffinic distillate solvent (Cas No 
68783-04-0),  if  they  contain  > 3 %  w/w 
DMSO extract 

Extracts 
(petroleum),  heavy  paraffinic 
distillates,  solvent-deasphalted  (Cas  No 
68814-89-1),  if  they  contain  > 3 %  w/w 
DMSO extract 

oils 

(petroleum),  C20-50, 
Lubricating 
hydrotreated  neutral  oil-based,  high-
viscosity  (Cas  No  72623-85-9),  if  they 
contain > 3 % w/w DMSO extract 

⌦ 68783-04-
0 ⌫ 

⌦ 272-180-0 ⌫ 

⌦ 68814-89-
1 ⌫ 

⌦ 272-342-0 ⌫ 

⌦ 72623-85-
9 ⌫ 

⌦ 276-736-3 ⌫ 

oils 

Lubricating 
(petroleum),  C15-30, 
hydrotreated  neutral  oil-based  (Cas  No 
72623-  86-0),  if  they  contain  > 3 %  w/w 
DMSO extract 

⌦ 72623- 
0 ⌫ 

oils 

Lubricating 
(petroleum),  C20-50, 
hydrotreated  neutral  oil-based  (Cas  No 
72623-  87-1),  if  they  contain  > 3 %  w/w 
DMSO extract 

⌦ 72623- 
1 ⌫ 

86-

⌦ 276-737-9 ⌫ 

87-

⌦ 276-738-4 ⌫ 

Lubricating  oils,  (Cas  No  74869-22-0),  if 
they contain > 3 % w/w DMSO extract 

⌦ 74869-22-
0 ⌫ 

⌦ 278-012-2 ⌫ 

Distillates  (petroleum),  complex  dewaxed 
heavy  paraffinic  (Cas  No  90640-91-8),  if 
they contain > 3 % w/w DMSO extract 

⌦ 90640-91-
8 ⌫ 

⌦ 292-613-7 ⌫ 

Distillates  (petroleum),  complex  dewaxed 
light  paraffinic  (Cas  No  90640-92-9),  if 
they contain > 3 % w/w DMSO extract 

⌦ 90640-92-
9 ⌫ 

⌦ 292-614-2 ⌫ 

Distillates  (petroleum),  solvent  dewaxed 
heavy  paraffinic,  clay-treated  (Cas  No 
90640-94-1),  if  they  contain  > 3 %  w/w 
DMSO extract 

Hydrocarbons,  C20-50,  solvent  dewaxed 
heavy  paraffinic,  hydrotreated  (Cas  No 
90640-95-2),  if  they  contain  > 3 %  w/w 
DMSO extract 

⌦ 90640-94-
1 ⌫ 

⌦ 292-616-3 ⌫ 

⌦ 90640-95-
2 ⌫ 

⌦ 292-617-9 ⌫ 

Distillates  (petroleum),  solvent  dewaxed 
light  paraffinic,  clay-treated  (Cas  No 
90640-96-3),  if  they  contain  > 3 %  w/w 

⌦ 90640-96-
3 ⌫ 

⌦ 292-618-4 ⌫ 

EN 

120 

   EN 

 
805. 

806. 

807. 

808. 

809. 

810. 

811. 

812. 

813. 

814. 

DMSO extract 

Distillates  (petroleum),  solvent  dewaxed 
light  paraffinic,  hydrotreated  (Cas  No 
90640-97-4),  if  they  contain  > 3 %  w/w 
DMSO extract 

Extracts  (petroleum),  heavy  naphthenic 
distillate  solvent,  hydrotreated  (Cas  No 
90641-07-9),  if  they  contain  > 3 %  w/w 
DMSO extract 

(petroleum),  heavy  paraffinic 
Extracts 
distillate  solvent,  hydrotreated  (Cas  No 
90641-08-0),  if  they  contain  > 3 %  w/w 
DMSO extract 

(petroleum), 

Extracts 
light  paraffinic 
distillate  solvent,  hydrotreated  (Cas  No 
90641-09-1),  if  they  contain  > 3 %  w/w 
DMSO extract 

⌦ 90640-97-
4 ⌫ 

⌦ 292-620-5 ⌫ 

⌦ 90641-07-
9 ⌫ 

⌦ 292-631-5 ⌫ 

⌦ 90641-08-
0 ⌫ 

⌦ 292-632-0 ⌫ 

⌦ 90641-09-
1 ⌫ 

⌦ 292-633-6 ⌫ 

Residual  oils  (petroleum),  hydrotreated 
solvent  dewaxed  (Cas  No  90669-74-2),  if 
they contain > 3 % w/w DMSO extract 

⌦ 90669-74-
2 ⌫ 

⌦ 292-656-1 ⌫ 

oils 

Residual 
catalytic 
dewaxed  (Cas  No  91770-57-9),  if  they 
contain > 3 % w/w DMSO extract 

(petroleum), 

Distillates  (petroleum),  dewaxed  heavy 
paraffinic,  hydrotreated,  (Cas  No  91995-
39-0)  if  they  contain  > 3 %  w/w  DMSO 
extract 

(petroleum),  dewaxed 

Distillates 
light 
paraffinic,  hydrotreated  (Cas  No  91995-
40-3),  if  they  contain  > 3 %  w/w  DMSO 
extract 

(petroleum), 

Distillates 
hydrocracked 
solvent-refined,  dewaxed  (Cas  No  91995-
45-8),  if  they  contain  > 3 %  w/w  DMSO 
extract 

(petroleum), 

solvent-refined 
Distillates 
light  naphthenic,  hydrotreated  (Cas  No 
91995-54-9),  if  they  contain  > 3 %  w/w 
DMSO extract 

⌦ 91770-57-
9 ⌫ 

⌦ 91995-39-
0 ⌫ 

⌦ 294-843-3 ⌫ 

⌦ 295-300-3 ⌫ 

⌦ 91995-40-
3 ⌫ 

⌦ 295-301-9 ⌫ 

⌦ 91995-45-
8 ⌫ 

⌦ 295-306-6 ⌫ 

⌦ 91995-54-
9 ⌫ 

⌦ 295-316-0 ⌫ 

815. 

Extracts  (petroleum),  hydrotreated  light  ⌦ 91995- 

73- ⌦ 295-335-4 ⌫ 

EN 

121 

   EN 

 
816. 

817. 

818. 

819. 

820. 

821. 

822. 

823. 

824. 

825. 

paraffinic distillate solvent (Cas No 91995- 
73-2),  if  they  contain  > 3 %  w/w  DMSO 
extract 

2 ⌫ 

(petroleum), 

light  naphthenic 
Extracts 
distillate  solvent,  hydrodesulfurised  (Cas 
No 91995-75-4), if they contain > 3 % w/w 
DMSO extract 

(petroleum), 

Extracts 
light  paraffinic 
distillate  solvent,  acid-treated  (Cas  No 
91995-76-5),  if  they  contain  > 3 %  w/w 
DMSO extract 

(petroleum), 

Extracts 
light  paraffinic 
distillate  solvent,  hydrodesulfurised  (Cas 
No 91995-77-6), if they contain > 3 % w/w 
DMSO extract 

Extracts  (petroleum),  light  vacuum  gas  oil 
solvent,  hydrotreated  (Cas  No  91995-79-
8),  if  they  contain  > 3 %  w/w  DMSO 
extract 

⌦ 91995-75-
4 ⌫ 

⌦ 295-338-0 ⌫ 

⌦ 91995-76-
5 ⌫ 

⌦ 295-339-6 ⌫ 

⌦ 91995-77-
6 ⌫ 

⌦ 295-340-1 ⌫ 

⌦ 91995-79-
8 ⌫ 

⌦ 295-342-2 ⌫ 

Foots  oil  (petroleum),  hydrotreated  (Cas 
No  92045-12-0),  if  it  contains  > 3 %  w/w 
DMSO extract 

⌦ 92045-12-
0 ⌫ 

⌦ 295-394-6 ⌫ 

oils 

Lubricating 
(petroleum),  C17-35, 
solvent-extd. , dewaxed, hydrotreated (Cas 
No 92045-42-6), if they contain > 3 % w/w 
DMSO extract 

Lubricating oils (petroleum), hydrocracked 
nonarom  solvent-deparaffined  (Cas  No 
92045-43-7),  if  they  contain  > 3 %  w/w 
DMSO extract 

Residual  oils  (petroleum),  hydrocracked 
acid-treated  solvent-dewaxed 
(Cas  No 
92061-86-4),  if  they  contain  > 3 %  w/w 
DMSO extract 

⌦ 92045-42-
6 ⌫ 

⌦ 295-423-2 ⌫ 

⌦ 92045-43-
7 ⌫ 

⌦ 295-424-8 ⌫ 

⌦ 92061-86-
4 ⌫ 

⌦ 295-499-7 ⌫ 

Paraffin  oils  (petroleum),  solvent-refined 
dewaxed  heavy  (Cas  No  92129-09-4),  if 
they contain > 3 % w/w DMSO extract 

⌦ 92129-09-
4 ⌫ 

⌦ 295-810-6 ⌫ 

Extracts 
(petroleum),  heavy  paraffinic 
distillate  solvent,  clay-treated  (Cas  No 
92704-  08-0),  if  they  contain  > 3 %  w/w 
DMSO extract 

⌦ 92704- 
0 ⌫ 

08-

⌦ 296-437-1 ⌫ 

EN 

122 

   EN 

 
826. 

827. 

828. 

829. 

830. 

831. 

832. 

833. 

834. 

835. 

836. 

Lubricating  oils  (petroleum),  base  oils, 
paraffinic  (Cas  No  93572-43-1),  if  they 
contain > 3 % w/w DMSO extract 

⌦ 93572-42-
1 ⌫ 

⌦ 297-474-6 ⌫ 

Extracts  (petroleum),  heavy  naphthenic 
distillate  solvent,  hydrodesulfurised  (Cas 
No 93763-10-1), if they contain > 3 % w/w 
DMSO extract 

⌦ 93763-10-
1 ⌫ 

⌦ 297-827-4 ⌫ 

(petroleum), 

solvent-dewaxed 
Extracts 
heavy 
solvent, 
hydrodesulfurised (Cas No 93763-11-2), if 
they contain > 3 % w/w DMSO extract 

paraffinic 

distillate 

⌦ 93763-11-
2 ⌫ 

⌦ 297-829-5 ⌫ 

Hydrocarbons,  hydrocracked  paraffinic 
distn.  residues,  solvent-dewaxed  (Cas  No 
93763-38-3),  if  they  contain  > 3 %  w/w 
DMSO extract 

⌦ 93763-38-
3 ⌫ 

⌦ 297-857-8 ⌫ 

Foots oil (petroleum), acid-treated (Cas No 
93924-31-3),  if  it  contains  > 3 %  w/w 
DMSO extract 

⌦ 93924-31-
3 ⌫ 

⌦ 300-225-7 ⌫ 

Foots oil (petroleum), clay-treated (Cas No 
93924-32-4),  if  it  contains  > 3 %  w/w 
DMSO extract 

⌦ 93924-32-
4 ⌫ 

⌦ 300-226-2 ⌫ 

Hydrocarbons, 
oil 
C20-50, 
hydrogenation  vacuum  distillate  (Cas  No 
93924-61-9),  if  they  contain  > 3 %  w/w 
DMSO extract 

residual 

(petroleum), 

Distillates 
solvent-refined 
hydrotreated heavy, hydrogenated (Cas No 
94733-08-1),  if  they  contain  > 3 %  w/w 
DMSO extract 

⌦ 93924-61-
9 ⌫ 

⌦ 300-257-1 ⌫ 

⌦ 94733-08-
1 ⌫ 

⌦ 305-588-5 ⌫ 

(petroleum), 

solvent-refined 
Distillates 
hydrocracked  light  (Cas  No  94733-09-2), 
if they contain > 3 % w/w DMSO extract 

⌦ 94733-09-
2 ⌫ 

⌦ 305-589-0 ⌫ 

oils 

(petroleum),  C18-40, 
Lubricating 
solvent-dewaxed  hydrocracked  distillate-
based (Cas No 94733-15-0), if they contain 
> 3 % w/w DMSO extract 

oils 

Lubricating 
(petroleum),  C18-40, 
solvent-dewaxed  hydrogenated  raffinate-
based (Cas No 94733-16-1), if they contain 
> 3 % w/w DMSO extract 

⌦ 94733-15-
0 ⌫ 

⌦ 305-594-8 ⌫ 

⌦ 94733-16-
1 ⌫ 

⌦ 305-595-3 ⌫ 

EN 

123 

   EN 

 
837. 

838. 

839. 

840. 

841. 

842. 

843. 

844. 

845. 

846. 

847. 

Hydrocarbons, C13-30, arom. -rich, solvent-
extd. naphthenic distillate (Cas No 95371-
04-3),  if  they  contain  > 3 %  w/w  DMSO 
extract 

Hydrocarbons,  C16-32,  arom.  rich,  solvent-
extd. naphthenic distillate (Cas No 95371-
05-4),  if  they  contain  > 3 %  w/w  DMSO 
extract 

C37-68, 

Hydrocarbons, 
dewaxed 
deasphalted  hydrotreated  vacuum  distn. 
Residues  (Cas  No  95371-07-6),  if  they 
contain > 3 % w/w DMSO extract 

hydrotreated 
C37-65, 
Hydrocarbons, 
deasphalted  vacuum  distn.  Residues  (Cas 
No 95371-08-7), if they contain > 3 % w/w 
DMSO extract 

⌦ 95371-04-
3 ⌫ 

⌦ 305-971-7 ⌫ 

⌦ 95371-05-
4 ⌫ 

⌦ 305-972-2 ⌫ 

⌦ 95371-07-
6 ⌫ 

⌦ 305-974-3 ⌫ 

⌦ 95371-08-
7 ⌫ 

⌦ 305-975-9 ⌫ 

(petroleum), 

Distillates 
hydrocracked 
solvent-refined light (Cas No 97488-73-8), 
if they contain > 3 % w/w DMSO extract 

⌦ 97488-73-
8 ⌫ 

⌦ 307-010-7 ⌫ 

(petroleum), 

Distillates 
solvent-refined 
hydrogenated heavy (Cas No 97488-74-9), 
if they contain > 3 % w/w DMSO extract 

⌦ 97488-74-
9 ⌫ 

⌦ 307-011-2 ⌫ 

oils 

Lubricating 
(petroleum),  C18-27, 
hydrocracked  solvent-dewaxed  (Cas  No 
97488-95-4),  if  they  contain  > 3 %  w/w 
DMSO extract 

Hydrocarbons, 
hydrotreated 
C17-30, 
solvent-deasphalted  atm.  distn.  residue, 
distn.  lights  (Cas  No  97675-87-1),  if  they 
contain > 3 % w/w DMSO extract 

Hydrocarbons, 
hydrotreated 
C17-40, 
solvent-deasphalted distn. residue, vacuum 
distn.  lights  (Cas  No  97722-06-0),  if  they 
contain > 3 % w/w DMSO extract 

⌦ 97488-95-
4 ⌫ 

⌦ 307-034-8 ⌫ 

⌦ 97675-87-
1 ⌫ 

⌦ 307-661-7 ⌫ 

⌦ 97722-06-
0 ⌫ 

⌦ 307-755-8 ⌫ 

Hydrocarbons,  C13-27,  solvent-extd.  light 
naphthenic  (Cas  No  97722-09-3),  if  they 
contain > 3 % w/w DMSO extract 

⌦ 97722-09-
3 ⌫ 

⌦ 307-758-4 ⌫ 

Hydrocarbons,  C14-29,  solvent-extd.  light 
naphthenic  (Cas  No  97722-10-6),  if  they 
contain > 3 % w/w DMSO extract 

⌦ 97722-10-
6 ⌫ 

⌦ 307-760-5 ⌫ 

EN 

124 

   EN 

 
848. 

849. 

850. 

851. 

852. 

853. 

854. 

855. 

856. 

857. 

858. 

859. 

Foots  oil  (petroleum),  carbon-treated  (Cas 
No  97862-76-5),  if  it  contains  > 3 %  w/w 
DMSO extract 

⌦ 97862-76-
5 ⌫ 

⌦ 308-126-0 ⌫ 

Foots  oil  (petroleum),  silicic  acid-treated 
(Cas  No  97862-77-6),  if  it  contains  > 3 % 
w/w DMSO extract 

⌦ 97862-77-
6 ⌫ 

⌦ 308-127-6 ⌫ 

Hydrocarbons,  C27-42,  dearomatised  (Cas 
No 97862-81-2), if they contain > 3 % w/w 
DMSO extract 

⌦ 97862-81-
2 ⌫ 

⌦ 308-131-8 ⌫ 

C17-30, 

Hydrocarbons, 
hydrotreated 
distillates, distn. Lights (Cas No 97862-82-
3),  if  they  contain  > 3 %  w/w  DMSO 
extract 

⌦ 97862-82-
3 ⌫ 

⌦ 308-132-3 ⌫ 

Hydrocarbons,  C27-45,  naphthenic  vacuum 
distn. (Cas No 97862-83-4), if they contain 
> 3 % w/w DMSO extract 

⌦ 97862-83-
4 ⌫ 

⌦ 308-133-9 ⌫ 

Hydrocarbons,  C27-45,  dearomatised  (Cas 
No 97926-68-6), if they contain > 3 % w/w 
DMSO extract 

⌦ 97926-68-
6 ⌫ 

⌦ 308-287-7 ⌫ 

Hydrocarbons,  C20-58,  hydrotreated  (Cas 
No 97926-70-0), if they contain > 3 % w/w 
DMSO extract 

⌦ 97926-70-
0 ⌫ 

⌦ 308-289-8 ⌫ 

Hydrocarbons,  C27-42,  naphthenic  (Cas  No 
97926-71-1),  if  they  contain  > 3 %  w/w 
DMSO extract 

⌦ 97926-71-
1 ⌫ 

⌦ 308-290-3 ⌫ 

(petroleum), 

Extracts 
light  paraffinic 
distillate  solvent,  carbon-treated  (Cas  No 
100684-02-4),  if  they  contain  > 3 %  w/w 
DMSO extract 

(petroleum), 

Extracts 
light  paraffinic 
distillate  solvent,  clay-treated  (Cas  No 
100684-  03-5),  if  they  contain  > 3 %  w/w 
DMSO extract 

Extracts (petroleum), light vacuum, gas oil 
solvent,  carbon-treated  (Cas  No  100684-
04-6),  if  they  contain  > 3 %  w/w  DMSO 
extract 

⌦ 100684-02-
4 ⌫ 

⌦ 309-672-2 ⌫ 

⌦ 100684-  03-
5 ⌫ 

⌦ 309-673-8 ⌫ 

⌦ 100684-04-
6 ⌫ 

⌦ 309-674-3 ⌫ 

Extracts  (petroleum),  light  vacuum  gas  oil 
solvent,  clay-treated  (Cas  No  100684-05-
7),  if  they  contain  > 3 %  w/w  DMSO 

⌦ 100684-05-
7 ⌫ 

⌦ 309-675-9 ⌫ 

EN 

125 

   EN 

 
860. 

861. 

862. 

863. 

864. 

865. 

866. 

867. 

868. 

extract 

Residual  oils  (petroleum),  carbon-treated 
solvent-dewaxed (Cas No 100684-37-5), if 
they contain > 3 % w/w DMSO extract 

⌦ 100684-37-
5 ⌫ 

⌦ 309-710-8 ⌫ 

Residual  oils 
(petroleum),  clay-treated 
solvent-dewaxed (Cas No 100684-38-6), if 
they contain > 3 % w/w DMSO extract 

⌦ 100684-38-
6 ⌫ 

⌦ 309-711-3 ⌫ 

Lubricating oils (petroleum), C>25, solvent-
extd., deasphalted, dewaxed, hydrogenated 
(Cas  No  101316-69-2),  if  they  contain 
> 3 % w/w DMSO extract 

Lubricating 
oils 
(petroleum),  C17-32, 
,  dewaxed,  hydrogenated 
solvent-extd. 
(Cas  No  101316-70-5),  if  they  contain 
> 3 % w/w DMSO extract 

oils 
(petroleum),  C20-35, 
Lubricating 
solvent-extd. 
,  dewaxed,  hydrogenated 
(Cas  No  101316-71-6),  if  they  contain 
> 3 % w/w DMSO extract 

oils 
(petroleum),  C24-50, 
Lubricating 
solvent-extd. 
,  dewaxed,  hydrogenated 
(Cas  No  101316-72-7),  if  they  contain 
> 3 % w/w DMSO extract 

Distillates  (petroleum),  sweetened  middle 
(Cas  No  64741-86-2),  except  if  the  full 
refining  history  is  known  and  it  can  be 
shown  that  the  substance  from  which  it  is 
produced is not a carcinogen 

Gas  oils  (petroleum),  solvent-refined  (Cas 
No 64741-90-8), except if the full refining 
history is known and it can be shown that 
the substance from which it is produced is 
not a carcinogen 

(petroleum), 

Distillates 
solvent-refined 
middle (Cas No 64741-91-9), except if the 
full refining history is known and it can be 
shown  that  the  substance  from  which  it  is 
produced is not a carcinogen 

⌦ 101316-69-
2 ⌫ 

⌦ 309-874-0 ⌫ 

⌦ 101316-70-
5 ⌫ 

⌦ 309-875-6 ⌫ 

⌦ 101316-71-
6 ⌫ 

⌦ 309-876-1 ⌫ 

⌦ 101316-72-
7 ⌫ 

⌦ 309-877-7 ⌫ 

⌦ 64741-86-
2 ⌫ 

⌦ 265-088-7 ⌫ 

⌦ 64741-90-
8 ⌫ 

⌦ 265-092-9 ⌫ 

⌦ 64741-91-
9 ⌫ 

⌦ 265-093-4 ⌫ 

869. 

Gas oils (petroleum), acid-treated (Cas No 
64742-12-7),  except  if  the  full  refining 
history is known and it can be shown that 

⌦ 64742-12-
7 ⌫ 

⌦ 265-112-6 ⌫ 

EN 

126 

   EN 

 
870. 

871. 

872. 

873. 

874. 

875. 

876. 

877. 

the substance from which it is produced is 
not a carcinogen 

Distillates (petroleum), acid-treated middle 
(Cas  No  64742-13-8),  except  if  the  full 
refining  history  is  known  and  it  can  be 
shown  that  the  substance  from  which  it  is 
produced is not a carcinogen 

Distillates  (petroleum),  acid-treated  light 
(Cas  No  64742-14-9),  except  if  the  full 
refining  history  is  known  and  it  can  be 
shown  that  the  substance  from  which  it  is 
produced is not a carcinogen 

oils 

chemically 
(petroleum), 
Gas 
neutralised (Cas No 64742-29-6), except if 
the full refining history is known and it can 
be shown that the substance from which it 
is produced is not a carcinogen 

Distillates 
chemically 
(petroleum), 
neutralised  middle  (Cas  No  64742-30-9), 
except if the full refining history is known 
and  it  can  be  shown  that  the  substance 
from  which 
is  not  a 
carcinogen 

is  produced 

it 

⌦ 64742-13-
8 ⌫ 

⌦ 265-113-1 ⌫ 

⌦ 64742-14-
9 ⌫ 

⌦ 265-114-7 ⌫ 

⌦ 64742-29-
6 ⌫ 

⌦ 265-129-9 ⌫ 

⌦ 64742-30-
9 ⌫ 

⌦ 265-130-4 ⌫ 

Distillates (petroleum), clay-treated middle 
(Cas  No  64742-38-7),  except  if  the  full 
refining  history  is  known  and  it  can  be 
shown  that  the  substance  from  which  it  is 
produced is not a carcinogen 

(petroleum), 

hydrotreated 
Distillates 
middle (Cas No 64742-46-7), except if the 
full refining history is known and it can be 
shown  that  the  substance  from  which  it  is 
produced is not a carcinogen 

Gas  oils  (petroleum),  hydrodesulfurised 
(Cas  No  64742-79-6),  except  if  the  full 
refining  history  is  known  and  it  can  be 
shown  that  the  substance  from  which  it  is 
produced is not a carcinogen 

Distillates  (petroleum),  hydrodesulfurised 
middle (Cas No 64742-80-9), except if the 
full refining history is known and it can be 
shown  that  the  substance  from  which  it  is 

⌦ 64742-38-
7 ⌫ 

⌦ 265-139-3 ⌫ 

⌦ 64742-46-
7 ⌫ 

⌦ 265-148-2 ⌫ 

⌦ 64742-79-
6 ⌫ 

⌦ 265-182-8 ⌫ 

⌦ 64742-80-
9 ⌫ 

⌦ 265-183-3 ⌫ 

EN 

127 

   EN 

 
878. 

879. 

880. 

881. 

882. 

883. 

884. 

produced is not a carcinogen 

Distillates  (petroleum),  catalytic  reformer 
fractionator  residue,  high-boiling  (Cas  No 
68477-29-2),  except  if  the  full  refining 
history is known and it can be shown that 
the substance from which it is produced is 
not a carcinogen 

Distillates  (petroleum),  catalytic  reformer 
fractionator  residue,  intermediate-boiling 
(Cas  No  68477-30-5),  except  if  the  full 
refining  history  is  known  and  it  can  be 
shown  that  the  substance  from  which  it  is 
produced is not a carcinogen 

Distillates  (petroleum),  catalytic  reformer 
fractionator  residue,  low-boiling  (Cas  No 
68477-31-6),  except  if  the  full  refining 
history is known and it can be shown that 
the substance from which it is produced is 
not a carcinogen 

Alkanes,  C12-26-branched  and  linear  (Cas 
No 90622-53-0), except if the full refining 
history is known and it can be shown that 
the substance from which it is produced is 
not a carcinogen 

(petroleum),  highly 

Distillates 
refined 
middle (Cas No 90640-93-0), except if the 
full refining history is known and it can be 
shown  that  the  substance  from  which  it  is 
produced is not a carcinogen 

Distillates  (petroleum),  catalytic  reformer, 
heavy  arom.  conc.  Cas  No  91995-34-5), 
except if the full refining history is known 
and  it  can  be  shown  that  the  substance 
from  which 
is  not  a 
carcinogen 

is  produced 

it 

Gas  oils,  paraffinic  (Cas  No  93924-33-5), 
except if the full refining history is known 
and  it  can  be  shown  that  the  substance 
is  not  a 
from  which 
carcinogen 

is  produced 

it 

⌦ 68477-29-
2 ⌫ 

⌦ 270-719-4 ⌫ 

⌦ 68477-30-
5 ⌫ 

⌦ 270-721-5 ⌫ 

⌦ 68477-31-
6 ⌫ 

⌦ 270-722-0 ⌫ 

⌦ 90622-53-
0 ⌫ 

⌦ 292-454-3 ⌫ 

⌦ 90640-93-
0 ⌫ 

⌦ 292-615-8 ⌫ 

⌦ 91995-34-
5 ⌫ 

⌦ 295-294-2 ⌫ 

⌦ 93924-33-
5 ⌫ 

⌦ 300-227-8 ⌫ 

885. 

(petroleum), 

Naphtha 
solvent-refined 
hydrodesulfurised  heavy  (Cas  No  97488-
96-5),  except  if  the  full  refining  history  is 

⌦ 97488-96-
5 ⌫ 

⌦ 307-035-3 ⌫ 

EN 

128 

   EN 

 
886. 

887. 

888. 

889. 

890. 

891. 

892. 

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

Hydrocarbons,  C16-20,  hydrotreated  middle 
distillate, distn. Lights (Cas No 97675- 85-
9),  except  if  the  full  refining  history  is 
known  and  it  can  be  shown  that  the 
substance from which it is produced is not 
a carcinogen 

C12-20, 

Hydrocarbons, 
hydrotreated 
paraffinic, distn. lights (Cas No 97675-86-
0),  except  if  the  full  refining  history  is 
known  and  it  can  be  shown  that  the 
substance from which it is produced is not 
a carcinogen 

Hydrocarbons,  C11-17,  solvent-extd.  light 
naphthenic (Cas No 97722-08-2), except if 
the full refining history is known and it can 
be shown that the substance from which it 
is produced is not a carcinogen 

Gas  oils,  hydrotreated  (Cas  No  97862-78-
7),  except  if  the  full  refining  history  is 
known  and  it  can  be  shown  that  the 
substance from which it is produced is not 
a carcinogen 

Distillates (petroleum), carbon-treated light 
paraffinic (Cas No 100683-97-4), except if 
the full refining history is known and it can 
be shown that the substance from which it 
is produced is not a carcinogen 

Distillates 
intermediate 
(petroleum), 
paraffinic, carbon-treated (Cas No 100683-
98-5),  except  if  the  full  refining  history  is 
known  and  it  can  be  shown  that  the 
substance from which it is produced is not 
a carcinogen 

Distillates 
intermediate 
(petroleum), 
paraffinic,  clay-treated  (Cas  No  100683-
99-6),  except  if  the  full  refining  history  is 
known  and  it  can  be  shown  that  the 
substance from which it is produced is not 
a carcinogen 

⌦ 97675- 
9 ⌫ 

85-

⌦ 307-659-6 ⌫ 

⌦ 97675-86-
0 ⌫ 

⌦ 307-660-1 ⌫ 

⌦ 97722-08-
2 ⌫ 

⌦ 307-757-9 ⌫ 

⌦ 97862-78-
7 ⌫ 

⌦ 308-128-1 ⌫ 

⌦ 100683-97-
4 ⌫ 

⌦ 309-667-5 ⌫ 

⌦ 100683-98-
5 ⌫ 

⌦ 309-668-0 ⌫ 

⌦ 100683-99-
6 ⌫ 

⌦ 309-669-6 ⌫ 

EN 

129 

   EN 

 
893. 

894. 

895. 

896. 

897. 

898. 

899. 

900. 

Lubricating  greases  (Cas  No  74869-21-9), 
except if the full refining history is known 
and  it  can  be  shown  that  the  substance 
from  which 
is  not  a 
carcinogen 

is  produced 

it 

Slack wax (petroleum) (Cas No 64742-61-
6),  except  if  the  full  refining  history  is 
known  and  it  can  be  shown  that  the 
substance from which it is produced is not 
a carcinogen 

Slack  wax  (petroleum),  acid-treated  (Cas 
No 90669-77-5), except if the full refining 
history is known and it can be shown that 
the substance from which it is produced is 
not a carcinogen 

Slack  wax  (petroleum),  clay-treated  (Cas 
No 90669-78-6), except if the full refining 
history is known and it can be shown that 
the substance from which it is produced is 
not a carcinogen 

Slack  wax  (petroleum),  hydrotreated  (Cas 
No 92062-09-4), except if the full refining 
history is known and it can be shown that 
the substance from which it is produced is 
not a carcinogen 

Slack  wax  (petroleum),  low-melting  (Cas 
No 92062-10-7), except if the full refining 
history is known and it can be shown that 
the substance from which it is produced is 
not a carcinogen 

Slack  wax 
low-melting, 
(petroleum), 
hydrotreated  (Cas  No  92062-11-8),  except 
if  the  full  refining  history  is  known  and  it 
can  be  shown  that  the  substance  from 
which it is produced is not a carcinogen 

(petroleum), 

low-melting, 
Slack  wax 
carbon-treated 
(Cas  No  97863-04-2), 
except if the full refining history is known 
and  it  can  be  shown  that  the  substance 
from  which 
is  not  a 
carcinogen 

is  produced 

it 

⌦ 74869-21-
9 ⌫ 

⌦ 278-011-7 ⌫ 

⌦ 64742-61-
6 ⌫ 

⌦ 265-165-5 ⌫ 

⌦ 90669-77-
5 ⌫ 

⌦ 292-659-8 ⌫ 

⌦ 90669-78-
6 ⌫ 

⌦ 292-660-3 ⌫ 

⌦ 92062-09-
4 ⌫ 

⌦ 295-523-6 ⌫ 

⌦ 92062-10-
7 ⌫ 

⌦ 295-524-1 ⌫ 

⌦ 92062-11-
8 ⌫ 

⌦ 295-525-7 ⌫ 

⌦ 97863-04-
2 ⌫ 

⌦ 308-155-9 ⌫ 

901. 

Slack  wax  (petroleum),  low-melting,  clay- ⌦ 97863-05-

⌦ 308-156-4 ⌫ 

EN 

130 

   EN 

 
treated (Cas No 97863-05-3), except if the 
full refining history is known and it can be 
shown  that  the  substance  from  which  it  is 
produced is not a carcinogen 

3 ⌫ 

902. 

903. 

904. 

905. 

906. 

907. 

908. 

909. 

Slack wax (petroleum), low-melting, silicic 
acid-treated  (Cas  No  97863-06-4),  except 
if  the  full  refining  history  is  known  and  it 
can  be  shown  that  the  substance  from 
which it is produced is not a carcinogen 

Slack  wax 
(petroleum),  carbon-treated 
(Cas  No  100684-49-9),  except  if  the  full 
refining  history  is  known  and  it  can  be 
shown  that  the  substance  from  which  it  is 
produced is not a carcinogen 

Petrolatum  (Cas  No  8009-03-8),  except  if 
the full refining history is known and it can 
be shown that the substance from which it 
is produced is not a carcinogen 

Petrolatum  (petroleum),  oxidised  (Cas  No 
64743-01-7),  except  if  the  full  refining 
history is known and it can be shown that 
the substance from which it is produced is 
not a carcinogen 

Petrolatum  (petroleum),  alumina-treated 
(Cas  No  85029-74-9),  except  if  the  full 
refining  history  is  known  and  it  can  be 
shown  that  the  substance  from  which  it  is 
produced is not a carcinogen 

Petrolatum  (petroleum),  hydrotreated  (Cas 
No 92045-77-7), except if the full refining 
history is known and it can be shown that 
the substance from which it is produced is 
not a carcinogen 

(petroleum), 

Petrolatum 
carbon-treated 
(Cas  No  97862-97-0),  except  if  the  full 
refining  history  is  known  and  it  can  be 
shown  that  the  substance  from  which  it  is 
produced is not a carcinogen 

Petrolatum (petroleum), silicic acid-treated 
(Cas  No  97862-98-1),  except  if  the  full 
refining  history  is  known  and  it  can  be 
shown  that  the  substance  from  which  it  is 

⌦ 97863-06-
4 ⌫ 

⌦ 308-158-5 ⌫ 

⌦ 100684-49-
9 ⌫ 

⌦ 309-723-9 ⌫ 

⌦ 8009-03-8 ⌫  ⌦ 232-373-2 ⌫ 

⌦ 64743-01-
7 ⌫ 

⌦ 265-206-7 ⌫ 

⌦ 85029-74-
9 ⌫ 

⌦ 285-098-5 ⌫ 

⌦ 92045-77-
7 ⌫ 

⌦ 295-459-9 ⌫ 

⌦ 97862-97-
0 ⌫ 

⌦ 308-149-6 ⌫ 

⌦ 97862-98-
1 ⌫ 

⌦ 308-150-1 ⌫ 

EN 

131 

   EN 

 
910. 

911. 

912. 

913. 

914. 

915. 

916. 

917. 

918. 

919. 

920. 

921. 

922. 

produced is not a carcinogen 

Petrolatum  (petroleum),  clay-treated  (Cas 
No  100684-33-1),  except 
full 
refining  history  is  known  and  it  can  be 
shown  that  the  substance  from  which  it  is 
produced is not a carcinogen 

the 

if 

Distillates 
cracked (Cas No 64741-59-9) 

(petroleum), 

light  catalytic 

⌦ 100684-33-
1 ⌫ 

⌦ 309-706-6 ⌫ 

⌦ 64741-59-
9 ⌫ 

⌦ 265-060-4 ⌫ 

Distillates 
(petroleum), 
catalytic cracked (Cas No 64741-60-2) 

intermediate 

⌦ 64741-60-
2 ⌫ 

⌦ 265-062-5 ⌫ 

Distillates 
cracked (Cas No 64741-82-8) 

(petroleum), 

light 

thermal 

⌦ 64741-82-
8 ⌫ 

⌦ 265-084-5 ⌫ 

Distillates  (petroleum),  hydrodesulfurised 
light  catalytic  cracked  (Cas  No  68333-25-
5) 

⌦ 68333-25-
5 ⌫ 

⌦ 269-781-5 ⌫ 

Distillates (petroleum), light steam-cracked 
naphtha (Cas No 68475-80-9) 

⌦ 68475-80-
9 ⌫ 

⌦ 270-662-5 ⌫ 

Distillates  (petroleum),  cracked  steam-
cracked  petroleum  distillates  (Cas  No 
68477-38-3) 

⌦ 68477-38-
3 ⌫ 

⌦ 270-727-8 ⌫ 

Gas  oils  (petroleum),  steam-cracked  (Cas 
No 68527-18-4) 

⌦ 68527-18-
4 ⌫ 

⌦ 271-260-2 ⌫ 

Distillates  (petroleum),  hydrodesulfurised 
thermal  cracked  middle  (Cas  No  85116-
53-6) 

⌦ 85116-53-
6 ⌫ 

⌦ 285-505-6 ⌫ 

Gas  oils  (petroleum), 
hydrodesulfurised (Cas No 92045-29-9) 

thermal-cracked, 

⌦ 92045-29-
9 ⌫ 

⌦ 295-411-7 ⌫ 

(petroleum), 

hydrogenated 
Residues 
steam-cracked naphtha (Cas No 92062-00-
5) 

⌦ 92062-00-
5 ⌫ 

⌦ 295-514-7 ⌫ 

(petroleum), 
Residues 
naphtha distn. (Cas No 92062-04-9) 

steam-cracked 

⌦ 92062-04-
9 ⌫ 

⌦ 295-517-3 ⌫ 

Distillates 
cracked, 
92201-60-0) 

(petroleum), 

light  catalytic 
thermally  degraded  (Cas  No 

⌦ 92201-60-
0 ⌫ 

⌦ 295-991-1 ⌫ 

923. 

Residues  (petroleum),  steam-cracked heat-
soaked naphtha (Cas No 93763-85-0) 

⌦ 93763-85-
0 ⌫ 

⌦ 297-905-8 ⌫ 

EN 

132 

   EN 

 
924. 

925. 

926. 

927. 

928. 

929. 

930. 

931. 

932. 

933. 

934. 

935. 

936. 

937. 

938. 

939. 

940. 

(petroleum), 
Gas  oils 
thermal-cracked  hydrodesulfurised 
No 97926-59-5) 

light  vacuum, 
(Cas 

⌦ 97926-59-
5 ⌫ 

⌦ 308-278-8 ⌫ 

Distillates  (petroleum),  hydrodesulfurised 
middle coker (Cas No 101316-59-0) 

⌦ 101316-59-
0 ⌫ 

⌦ 309-865-1 ⌫ 

Distillates 
cracked (Cas No 101631-14-5) 

(petroleum),  heavy 

steam-

⌦ 101631-14-
5 ⌫ 

⌦ 309-939-3 ⌫ 

Residues (petroleum), atm. Tower (Cas No 
64741-45-3) 

⌦ 64741-45-
3 ⌫ 

⌦ 265-045-2 ⌫ 

Gas  oils  (petroleum),  heavy  vacuum  (Cas 
No 64741-57-7) 

⌦ 64741-57-
7 ⌫ 

⌦ 265-058-3 ⌫ 

Distillates  (petroleum),  heavy  catalytic 
cracked (Cas No 64741-61-3) 

⌦ 64741-61-
3 ⌫ 

⌦ 265-063-0 ⌫ 

oils 
Clarified 
cracked (Cas No 64741-62-4) 

(petroleum), 

catalytic 

⌦ 64741-62-
4 ⌫ 

⌦ 265-064-6 ⌫ 

Residues  (petroleum),  catalytic  reformer 
fractionator (Cas No 64741-67-9) 

⌦ 64741-67-
9 ⌫ 

⌦ 265-069-3 ⌫ 

Residues  (petroleum),  hydrocracked  (Cas 
No 64741-75-9) 

⌦ 64741-75-
9 ⌫ 

⌦ 265-076-1 ⌫ 

Residues  (petroleum), 
(Cas No 64741-80-6) 

thermal  cracked 

⌦ 64741-80-
6 ⌫ 

⌦ 265-081-9 ⌫ 

Distillates 
cracked (Cas No 64741-81-7) 

(petroleum),  heavy 

thermal 

⌦ 64741-81-
7 ⌫ 

⌦ 265-082-4 ⌫ 

Gas oils (petroleum), hydrotreated vacuum 
(Cas No 64742-59-2) 

⌦ 64742-59-
2 ⌫ 

⌦ 265-162-9 ⌫ 

Residues  (petroleum),  hydrodesulfurised 
atmospheric tower (Cas No 64742-78-5) 

⌦ 64742-78-
5 ⌫ 

⌦ 265-181-2 ⌫ 

Gas  oils  (petroleum),  hydrodesulfurised 
heavy vacuum (Cas No 64742-86-5) 

⌦ 64742-86-
5 ⌫ 

⌦ 265-189-6 ⌫ 

Residues  (petroleum),  steam-cracked  (Cas 
No 64742-90-1) 

⌦ 64742-90-
1 ⌫ 

⌦ 265-193-8 ⌫ 

Residues  (petroleum),  atmospheric  (Cas 
No 68333-22-2) 

⌦ 68333-22-
2 ⌫ 

⌦ 269-777-3 ⌫ 

(petroleum), 
Clarified 
hydrodesulfurised  catalytic  cracked  (Cas 

oils 

⌦ 68333-26-
6 ⌫ 

⌦ 269-782-0 ⌫ 

EN 

133 

   EN 

 
No 68333-26-6) 

941. 

942. 

Distillates  (petroleum),  hydrodesulfurised 
intermediate  catalytic  cracked  (Cas  No 
68333-27-7) 

⌦ 68333-27-
7 ⌫ 

⌦ 269-783-6 ⌫ 

Distillates  (petroleum),  hydrodesulfurised 
heavy catalytic cracked (Cas No 68333-28-
8) 

⌦ 68333-28-
8 ⌫ 

⌦ 269-784-1 ⌫ 

943. 

Fuel  oil,  residues-straight-run  gas  oils, 
high-sulfur (Cas No 68476-32-4) 

⌦ 68476-32-
4 ⌫ 

⌦ 270-674-0 ⌫ 

944. 

Fuel oil, residual (Cas No 68476-33-5) 

Residues  (petroleum),  catalytic  reformer 
fractionator  residue  distn.  (Cas  No  68478-
13-7) 

⌦ 68476-33-
5 ⌫ 

⌦ 68478-13-
7 ⌫ 

⌦ 270-675-6 ⌫ 

⌦ 270-792-2 ⌫ 

Residues  (petroleum),  heavy  coker  gas  oil 
and vacuum gas oil (Cas No 68478-17-1) 

⌦ 68478-17-
1 ⌫ 

⌦ 270-796-4 ⌫ 

Residues  (petroleum),  heavy  coker  and 
light vacuum (Cas No 68512-61-8) 

⌦ 68512-61-
8 ⌫ 

⌦ 270-983-0 ⌫ 

Residues  (petroleum),  light  vacuum  (Cas 
No 68512-62-9) 

⌦ 68512-62-
9 ⌫ 

⌦ 270-984-6 ⌫ 

Residues  (petroleum),  steam-cracked  light 
(Cas No 68513-69-9) 

⌦ 68513-69-
9 ⌫ 

⌦ 271-013-9 ⌫ 

945. 

946. 

947. 

948. 

949. 

950. 

Fuel oil, No 6 (Cas No 68553-00-4) 

⌦ 68553-00-
4 ⌫ 

⌦ 271-384-7 ⌫ 

951. 

952. 

953. 

954. 

955. 

Residues  (petroleum),  topping  plant,  low-
sulfur (Cas No 68607-30-7) 

⌦ 68607-30-
7 ⌫ 

⌦ 271-763-7 ⌫ 

Gas  oils  (petroleum),  heavy  atmospheric 
(Cas No 68783-08-4) 

⌦ 68783-08-
4 ⌫ 

⌦ 272-184-2 ⌫ 

Residues 
condensed-ring-arom. 
68783-13-1) 

(petroleum),  coker  scrubber, 
(Cas  No 
-contg 

⌦ 68783-13-
1 ⌫ 

⌦ 272-187-9 ⌫ 

Distillates  (petroleum),  petroleum  residues 
vacuum (Cas No 68955-27-1) 

⌦ 68955-27-
1 ⌫ 

⌦ 273-263-4 ⌫ 

Residues 
resinous (Cas No 68955-36-2) 

(petroleum), 

steam-cracked, 

⌦ 68955-36-
2 ⌫ 

⌦ 273-272-3 ⌫ 

EN 

134 

   EN 

 
956. 

957. 

958. 

959. 

960. 

961. 

962. 

963. 

964. 

965. 

966. 

967. 

968. 

969. 

970. 

971. 

972. 

Distillates 
vacuum (Cas No 70592-76-6) 

(petroleum), 

intermediate 

⌦ 70592-76-
6 ⌫ 

⌦ 274-683-0 ⌫ 

Distillates  (petroleum),  light  vacuum  (Cas 
No 70592-77-7) 

⌦ 70592-77-
7 ⌫ 

⌦ 274-684-6 ⌫ 

Distillates  (petroleum),  vacuum  (Cas  No 
70592-78-8) 

⌦ 70592-78-
8 ⌫ 

⌦ 274-685-1 ⌫ 

Gas  oils  (petroleum),  hydrodesulfurised 
coker heavy vacuum (Cas No 85117-03-9) 

⌦ 85117-03-
9 ⌫ 

⌦ 285-555-9 ⌫ 

Residues 
distillates (Cas No 90669-75-3) 

(petroleum), 

steam-cracked, 

⌦ 90669-75-
3 ⌫ 

⌦ 292-657-7 ⌫ 

Residues  (petroleum),  vacuum,  light  (Cas 
No 90669-76-4) 

⌦ 90669-76-
4 ⌫ 

⌦ 292-658-2 ⌫ 

Fuel  oil,  heavy,  high-sulfur  (Cas  No 
92045-14-2) 

⌦ 92045-14-
2 ⌫ 

⌦ 295-396-7 ⌫ 

Residues  (petroleum),  catalytic  cracking 
(Cas No 92061-97-7) 

⌦ 92061-97-
7 ⌫ 

⌦ 295-511-0 ⌫ 

Distillates 
intermediate 
(petroleum), 
catalytic cracked, thermally degraded (Cas 
No 92201-59-7) 

⌦ 92201-59-
7 ⌫ 

⌦ 295-990-6 ⌫ 

Residual  oils  (petroleum)  (Cas  No  93821-
66-0) 

⌦ 93821-66-
0 ⌫ 

⌦ 298-754-0 ⌫ 

Residues, steam cracked, thermally treated 
(Cas No 98219-64-8) 

⌦ 98219-64-
8 ⌫ 

⌦ 308-733-0 ⌫ 

Distillates  (petroleum),  hydrodesulfurised 
full-range middle (Cas No 101316-57-8) 

⌦ 101316-57-
8 ⌫ 

⌦ 309-863-0 ⌫ 

Distillates  (petroleum), 
(Cas No 64741-50-0) 

light  paraffinic 

⌦ 64741-50-
0 ⌫ 

⌦ 265-051-5 ⌫ 

Distillates  (petroleum),  heavy  paraffinic 
(Cas No 64741-51-1) 

⌦ 64741-51-
1 ⌫ 

⌦ 265-052-0 ⌫ 

Distillates  (petroleum),  light  naphthenic 
(Cas No 64741-52-2) 

⌦ 64741-52-
2 ⌫ 

⌦ 265-053-6 ⌫ 

Distillates  (petroleum),  heavy  naphthenic 
(Cas No 64741-53-3) 

⌦ 64741-53-
3 ⌫ 

⌦ 265-054-1 ⌫ 

Distillates  (petroleum),  acid-treated  heavy 
naphthenic (Cas No 64742-18-3) 

⌦ 64742-18-
3 ⌫ 

⌦ 265-117-3 ⌫ 

EN 

135 

   EN 

 
973. 

974. 

975. 

976. 

977. 

978. 

979. 

980. 

981. 

982. 

983. 

984. 

985. 

986. 

987. 

Distillates  (petroleum),  acid-treated  light 
naphthenic (Cas No 64742-19-4) 

⌦ 64742-19-
4 ⌫ 

⌦ 265-118-9 ⌫ 

Distillates  (petroleum),  acid-treated  heavy 
paraffinic (Cas No 64742-20-7) 

⌦ 64742-20-
7 ⌫ 

⌦ 265-119-4 ⌫ 

Distillates  (petroleum),  acid-treated  light 
paraffinic (Cas No 64742-21-8) 

⌦ 64742-21-
8 ⌫ 

⌦ 265-121-5 ⌫ 

(petroleum), 

Distillates 
neutralised  heavy  paraffinic 
64742-27-4) 

chemically 
(Cas  No 

⌦ 64742-27-
4 ⌫ 

⌦ 265-127-8 ⌫ 

Distillates 
chemically 
(petroleum), 
neutralised light paraffinic (Cas No 64742-
28-5) 

⌦ 64742-28-
5 ⌫ 

⌦ 265-128-3 ⌫ 

Distillates 
chemically 
(petroleum), 
neutralised  heavy  naphthenic  (Cas  No 
64742-34-3) 

⌦ 64742-34-
3 ⌫ 

⌦ 265-135-1 ⌫ 

Distillates 
neutralised 
64742-35-4) 

(petroleum), 
light  naphthenic 

chemically 
(Cas  No 

⌦ 64742-35-
4 ⌫ 

⌦ 265-136-7 ⌫ 

Extracts 
distillate solvent (Cas No 64742-03-6) 

(petroleum), 

light  naphthenic 

⌦ 64742-03-
6 ⌫ 

⌦ 265-102-1 ⌫ 

Extracts 
distillate solvent (Cas No 64742-04-7) 

(petroleum),  heavy  paraffinic 

⌦ 64742-04-
7 ⌫ 

⌦ 265-103-7 ⌫ 

Extracts 
distillate solvent (Cas No 64742-05-8) 

(petroleum), 

light  paraffinic 

⌦ 64742-05-
8 ⌫ 

⌦ 265-104-2 ⌫ 

Extracts  (petroleum),  heavy  naphthenic 
distillate solvent (Cas No 64742-11-6) 

⌦ 64742-11-
6 ⌫ 

⌦ 265-111-0 ⌫ 

Extracts  (petroleum),  light  vacuum  gas  oil 
solvent (Cas No 91995-78-7) 

⌦ 91995-78-
7 ⌫ 

⌦ 295-341-7 ⌫ 

Hydrocarbons,  C26-55,  arom.  rich  (Cas  No 
97722-04-8) 

⌦ 97722-04-
8 ⌫ 

⌦ 307-753-7 ⌫ 

Disodium 
diylbis(azo)] 
sulphonate) (Cas No 573-58-0) 

3,3′-[[1,1′-biphenyl]-4,4′-
bis(4-aminonaphthalene-1- 

Disodium 
diaminophenyl)azo] 
yl]azo]-5-hydroxy-6-
(phenylazo)naphthalene-2,7-disulphonate 

4-amino-3-[[4′-[(2,4-
[1,1′-biphenyl]-4-

⌦ 573-58-0 ⌫  ⌦ 209-358-4 ⌫ 

⌦ 1937-37-7 ⌫  ⌦ 217-710-3 ⌫ 

EN 

136 

   EN 

 
(Cas No 1937-37-7) 

988. 

3,3′-[[1,1′-biphenyl]-4,4′-

Tetrasodium 
diylbis(azo)]bis[5-amino-4- 
hydroxynaphthalene-2,7-disulphonate] 
(Cas No 2602-46-2) 

⌦ 2602-46-2 ⌫  ⌦ 220-012-1 ⌫ 

989. 

4-o-Tolylazo-o-toluidine (Cas No 97-56-3)  ⌦ 97-56-3 ⌫  ⌦ 202-591-2 ⌫ 

990. 

4-Aminoazobenzene (Cas No 60-09-3)  ⌦ 60-09-3 ⌫  ⌦ 200-453-6 ⌫ 

991. 

Disodium[5-[[4′-[[2,6-dihydroxy-3-[(2-
hydroxy-5-
sulphophenyl)azo]phenyl]azo][1,1′-
biphenyl]-4-yl]azo]salicylato(4-
)]cuprate(2-) (Cas No 16071-86-6) 

⌦ 16071-86-
6 ⌫ 

⌦ 240-221-1 ⌫ 

992. 

Resorcinol  diglycidyl  ether  (Cas  No  101-
90-6) 

⌦ 101-90-6 ⌫  ⌦ 202-987-5 ⌫ 

993. 

1,3-Diphenylguanidine (Cas No 102-06-7)  ⌦ 102-06-7 ⌫  ⌦ 203-002-1 ⌫ 

994. 

Heptachlor-epoxide (Cas No 1024-57-3)  ⌦ 1024-57-3 ⌫  ⌦ 213-831-0 ⌫ 

995. 

4-Nitrosophenol (Cas No 104-91-6) 

⌦ 104-91-6 ⌫  ⌦ 203-251-6 ⌫ 

996. 

Carbendazim (Cas No 10605-21-7) 

⌦ 10605-21-
7 ⌫ 

⌦ 234-232-0 ⌫ 

997. 

Allyl glycidyl ether (Cas No 106-92-3)  ⌦ 106-92-3 ⌫  ⌦ 203-442-4 ⌫ 

998. 

Chloroacetaldehyde (Cas No 107-20-0)  ⌦ 107-20-0 ⌫  ⌦ 203-472-8 ⌫ 

999. 

Hexane (Cas No 110-54-3) 

⌦ 110-54-3 ⌫  ⌦ 203-777-6 ⌫ 

1000. 

2-(2-Methoxyethoxy)ethanol (Cas No 111-
77-3) 

⌦ 111-77-3 ⌫  ⌦ 203-906-6 ⌫ 

1001. 

1002. 

1003. 

(+/–)-2-(2,4-Dichlorophenyl)-3-(1H-1,2,4-
triazol-1-yl)propyl-1,1,2,2-
tetrafluoroethylether  (Cas  No  112281-77-
3) 

⌦ 112281-77-
3 ⌫ 

⌦ 613-174-00-
3 ⌫ 

4-[4-(1,3-Dihydroxyprop-2-
yl)phenylamino]-1,8-dihydroxy-5-
nitroanthraquinone (Cas No 114565-66-1) 

⌦ 114565-66-
1 ⌫ 

⌦ 603-121-00-
2 ⌫ 

5,6,12,13-Tetrachloroanthra(2,1,9-
def:6,5,10-d’e’f’)diisoquinoline-
1,3,8,10(2H,9H)-tetrone  (Cas  No  115662-
06-1) 

⌦ 115662-06-
1 ⌫ 

⌦ 616-066-00-
4 ⌫ 

EN 

137 

   EN 

 
1004. 

tris(2-Chloroethyl)  phosphate  (Cas  No 
115-96-8) 

⌦ 115-96-8 ⌫  ⌦ 204-118-5 ⌫ 

1005. 

4′-Ethoxy-2-benzimidazoleanilide (Cas No 
120187-29-3) 

⌦ 120187-29-
3 ⌫ 

⌦ 616-073-00-
2 ⌫ 

1006.  Nickel dihydroxide (Cas No 12054-48-7)  ⌦ 12054-48-

⌦ 235-008-5 ⌫ 

7 ⌫ 

1007.  N,N-Dimethylaniline (Cas No 121-69-7)  ⌦ 121-69-7 ⌫  ⌦ 204-493-5 ⌫ 

1008.  Simazine (Cas No 122-34-9) 

⌦ 122-34-9 ⌫  ⌦ 204-535-2 ⌫ 

1009.  Bis(cyclopentadienyl)-bis(2,6-difluoro-3-

(pyrrol-1-yl)-phenyl)titanium 
125051-32-3) 

(Cas  No 

⌦ 125051-32-
3 ⌫ 

⌦ 022-003-00-
6 ⌫ 

1010.  N,N,N′,N′-Tetraglycidyl-4,4′-diamino-3,3′-
diethyldiphenylmethane  (Cas  No  130728-
76-6) 

⌦ 130728-76-
6 ⌫ 

⌦ 612-171-00-
4 ⌫ 

1011.  Divanadium pentaoxide (Cas No 1314-62-

⌦ 1314-62-1 ⌫  ⌦ 215-239-8 ⌫ 

1) 

1012.  Alkali salts of pentachlorophenol (Cas Nos 

131-52-2 and 7778-73-6) 

⌦ 131-52-2; 
7778-73-6 ⌫ 

⌦ 205-025-2; 
231-911-3 ⌫ 

1013.  Phosphamidon (Cas No 13171-21-6) 

⌦ 13171-21-
6 ⌫ 

⌦ 236-116-5 ⌫ 

1014.  N-(Trichloromethylthio)phthalimide 

(Cas 

⌦ 133-07-3 ⌫  ⌦ 205-088-6 ⌫ 

No 133-07-3) 

1015.  N-2-Naphthylaniline (Cas No 135-88-6)  ⌦ 135-88-6 ⌫  ⌦ 205-223-9 ⌫ 

1016.  Ziram (Cas No 137-30-4) 

⌦ 137-30-4 ⌫  ⌦ 205-288-3 ⌫ 

1017. 

1-Bromo-3,4,5-trifluorobenzene  (Cas  No 
138526-69-9)  

⌦ 138526-69-
9 ⌫ 

⌦ 602-092-00-
3 ⌫ 

1018.  Propazine (Cas No 139-40-2) 

⌦ 139-40-2 ⌫  ⌦ 205-359-9 ⌫ 

1019. 

3-(4-Chlorophenyl)-1,1-dimethyluronium 
trichloroacetate;  monuron-TCA  (Cas  No 
140-41-0) 

⌦ 140-41-0 ⌫  ⌦ 006-043-00-

1 ⌫ 

1020. 

Isoxaflutole (Cas No 141112-29-0) 

⌦ 141112-29-
0 ⌫ 

⌦ 606-054-00-
7 ⌫ 

1021.  Kresoxim-methyl (Cas No 143390-89-0)  ⌦ 143390-89-

EN 

0 ⌫ 

138 

⌦ 607-310-00-
0 ⌫ 

   EN 

 
1022.  Chlordecone (Cas No 143-50-0) 

⌦ 143-50-0 ⌫  ⌦ 205-601-3 ⌫ 

1023. 

9-Vinylcarbazole (Cas No 1484-13-5) 

⌦ 1484-13-5 ⌫  ⌦ 216-055-0 ⌫ 

1024. 

2-Ethylhexanoic acid (Cas No 149-57-5)  ⌦ 149-57-5 ⌫  ⌦ 205-743-6 ⌫ 

1025.  Monuron (Cas No 150-68-5) 

⌦ 150-68-5 ⌫  ⌦ 205-766-1 ⌫ 

1026.  Morpholine-4-carbonyl  chloride  (Cas  No 

15159-40-7) 

⌦ 15159-40-
7 ⌫ 

⌦ 239-213-0 ⌫ 

1027.  Daminozide (Cas No 1596-84-5) 

⌦ 1596-84-5 ⌫  ⌦ 216-485-9 ⌫ 

1028.  Alachlor (Cas No 15972-60-8) 

1029.  UVCB  condensation  product  of:  tetrakis-
hydroxymethylphosphonium chloride, urea 
and  distilled  hydrogenated  C16-18  tallow 
alkylamine (Cas No 166242-53-1) 

⌦ 15972-60-
8 ⌫ 

⌦ 240-110-8 ⌫ 

⌦ 166242-53-
1 ⌫ 

⌦ 015-179-00-
0 ⌫ 

1030. 

Ioxynil (Cas No 1689-83-4) 

⌦ 1689-83-4 ⌫  ⌦ 216-881-1 ⌫ 

1031. 

3,5-Dibromo-4-hydroxybenzonitrile 
No 1689-84-5) 

(Cas 

⌦ 1689-84-5 ⌫  ⌦ 216-882-7 ⌫ 

1032. 

2,6-Dibromo-4-cyanophenyl 
(Cas No 1689-99-2) 

octanoate 

⌦ 1689-99-2 ⌫  ⌦ 216-885-3 ⌫ 

1033. 

[4-[[4-(Dimethylamino)phenyl][4-[ethyl(3-
sulphonatobenzyl)amino]phenyl]methylen
e]cyclohexa-2,5-dien-1-ylidene](ethyl)(3-
sulphonatobenzyl)ammonium,  sodium  salt 
(Cas No 1694-09-3) 

⌦ 1694-09-3 ⌫  ⌦ 216-901-9 ⌫ 

1034. 

5-Chloro-1,3-dihydro-2H-indol-2-one  (Cas 
No 17630-75-0) 

⌦ 17630-75-
0 ⌫ 

⌦ 613-172-00-
2 ⌫ 

1035.  Benomyl (Cas No 17804-35-2) 

⌦ 17804-35-
2 ⌫ 

⌦ 241-775-7 ⌫ 

1036.  Chlorothalonil (Cas No 1897-45-6) 

⌦ 1897-45-6 ⌫  ⌦ 217-588-1 ⌫ 

1037.  N′-(4-Chloro-o-tolyl)-N,N-

dimethylformamidine  monohydrochloride 
(Cas No 19750-95-9) 

⌦ 19750-95-
9 ⌫ 

⌦ 243-269-1 ⌫ 

1038. 

4,4′-Methylenebis(2-ethylaniline)  (Cas  No 
19900-65-3) 

⌦ 19900-65-
3 ⌫ 

⌦ 243-420-1 ⌫ 

1039.  Valinamide (Cas No 20108-78-5) 

⌦ 20108-78-

⌦ 616-025-00-

EN 

139 

   EN 

 
1040. 

[(p-Tolyloxy)methyl]oxirane 
2186-24-5) 

1041. 

[(m-Tolyloxy)methyl]oxirane 
2186-25-6) 

5 ⌫ 

0 ⌫ 

(Cas  No 

⌦ 2186-24-5 ⌫  ⌦ 218-574-8 ⌫ 

(Cas  No 

⌦ 2186-25-6 ⌫  ⌦ 218-575-3 ⌫ 

1042. 

2,3-Epoxypropyl  o-tolyl  ether  (Cas  No 
2210-79-9) 

⌦ 2210-79-9 ⌫  ⌦ 218-645-3 ⌫ 

1043. 

[(Tolyloxy)methyl]oxirane,  cresyl  glycidyl 
ether (Cas No 26447-14-3) 

⌦ 26447-14-
3 ⌫ 

⌦ 247-711-4 ⌫ 

1044.  Di-allate (Cas No 2303-16-4) 

⌦ 2303-16-4 ⌫  ⌦ 218-961-1 ⌫ 

1045.  Benzyl  2,4-dibromobutanoate  (Cas  No 

23085-60-1) 

⌦ 23085-60-
1 ⌫ 

⌦ 607-376-00-
0 ⌫ 

1046.  Trifluoroiodomethane (Cas No 2314-97-8)  ⌦ 2314-97-8 ⌫  ⌦ 219-014-5 ⌫ 

1047.  Thiophanate-methyl (Cas No 23564-05-8)  ⌦ 23564-05-

⌦ 245-740-7 ⌫ 

1048.  Dodecachloropentacyclo[5.2.1. 

03,905,8]decane (Cas No 2385-85-5) 

1049.  Propyzamide (Cas No 23950-58-5) 

8 ⌫ 

02,6. 

⌦ 2385-85-5 ⌫  ⌦ 219-196-6 ⌫ 

⌦ 23950-58-
5 ⌫ 

⌦ 245-951-4 ⌫ 

1050.  Butyl glycidyl ether (Cas No 2426-08-6)  ⌦ 2426-08-6 ⌫  ⌦ 219-376-4 ⌫ 

1051. 

2,3,4-Trichlorobut-1-ene  (Cas  No  2431-
50-7) 

⌦ 2431-50-7 ⌫  ⌦ 219-397-9 ⌫ 

1052.  Chinomethionate (Cas No 2439-01-2) 

⌦ 2439-01-2 ⌫  ⌦ 219-455-3 ⌫ 

1053. 

(R)-α-Phenylethylammonium  (-)-(1R,2S)-
(1,2-epoxypropyl)phosphonate 
monohydrate (Cas No 25383-07-7) 

⌦ 25383-07-
7 ⌫ 

⌦ 015-178-00-
5 ⌫ 

1054. 

5-Ethoxy-3-trichloromethyl-1,2,4-
thiadiazole (Cas No 2593-15-9) 

⌦ 2593-15-9 ⌫  ⌦ 219-991-8 ⌫ 

1055.  Disperse Yellow 3 (Cas No 2832-40-8)  ⌦ 2832-40-8 ⌫  ⌦ 220-600-8 ⌫ 

1056. 

1,2,4-Triazole (Cas No 288-88-0) 

⌦ 288-88-0 ⌫  ⌦ 206-022-9 ⌫ 

1057.  Aldrin (Cas No 309-00-2) 

⌦ 309-00-2 ⌫  ⌦ 206-215-8 ⌫ 

1058.  Diuron (Cas No 330-54-1) 

⌦ 330-54-1 ⌫  ⌦ 206-354-4 ⌫ 

EN 

140 

   EN 

 
1059.  Linuron (Cas No 330-55-2) 

⌦ 330-55-2 ⌫  ⌦ 206-356-5 ⌫ 

1060.  Nickel carbonate (Cas No 3333-67-3) 

⌦ 3333-67-3 ⌫  ⌦ 222-068-2 ⌫ 

1061. 

3-(4-Isopropylphenyl)-1,1-dimethylurea 
(Cas No 34123-59-6) 

⌦ 34123-59-
6 ⌫ 

⌦ 251-835-4 ⌫ 

1062. 

Iprodione (Cas No 36734-19-7) 

1063. 

4-Cyano-2,6-diiodophenyl  octanoate  (Cas 
No 3861-47-0) 

1064. 

5-(2,4-Dioxo-1,2,3,4-
tetrahydropyrimidine)-3-fluro-2-
hydroxymethylterahydrofuran 
41107-56-6) 

(Cas  No 

⌦ 36734-19-
7 ⌫ 

⌦ 253-178-9 ⌫ 

⌦ 3861-47-0 ⌫  ⌦ 223-375-4 ⌫ 

⌦ 41107-56-
6 ⌫ 

⌦ 616-089-00-
X ⌫ 

1065.  Crotonaldehyde (Cas No 4170-30-3) 

⌦ 4170-30-3 ⌫  ⌦ 224-030-0 ⌫ 

1066.  Hexahydrocyclopenta(c)pyrrole-1-(1H)-

⌦ 418-350-1 ⌫ 

ammonium 
olylsulfonyl)azanide (EC No 418-350-1) 

N-ethoxycarbonyl-N-(p-

1067. 

4,4′-Carbonimidoylbis[N,N-
dimethylaniline] (Cas No 492-80-8) 

⌦ 492-80-8 ⌫  ⌦ 207-762-5 ⌫ 

1068.  DNOC (Cas No 534-52-1) 

⌦ 534-52-1 ⌫  ⌦ 208-601-1 ⌫ 

1069.  Toluidinium chloride (Cas No 540-23-8)  ⌦ 540-23-8 ⌫  ⌦ 208-740-8 ⌫ 

1070.  Toluidine  sulphate  (1:1)  (Cas  No  540-25-

⌦ 540-25-0 ⌫  ⌦ 208-741-3 ⌫ 

0) 

1071. 

2-(4-tert-Butylphenyl)ethanol 
5406-86-0) 

(Cas  No 

⌦ 5406-86-0 ⌫  ⌦ 603-152-00-

1 ⌫ 

1072.  Fenthion (Cas No 55-38-9) 

⌦ 55-38-9 ⌫  ⌦ 200-231-9 ⌫ 

1073.  Chlordane, pur (Cas No 57-74-9) 

⌦ 57-74-9 ⌫  ⌦ 200-349-0 ⌫ 

1074.  Hexan-2-one (Cas No 591-78-6) 

⌦ 591-78-6 ⌫  ⌦ 209-731-1 ⌫ 

1075.  Fenarimol (Cas No 60168-88-9) 

⌦ 60168-88-
9 ⌫ 

⌦ 262-095-7 ⌫ 

1076.  Acetamide (Cas No 60-35-5) 

⌦ 60-35-5 ⌫  ⌦ 200-473-5 ⌫ 

1077.  N-cyclohexyl-N-methoxy-2,5-dimethyl-3-
furamide (Cas No 60568-05-0) 

⌦ 60568-05-
0 ⌫ 

⌦ 262-302-0 ⌫ 

EN 

141 

   EN 

 
 
1078.  Dieldrin (Cas No 60-57-1) 

⌦ 60-57-1 ⌫  ⌦ 200-484-5 ⌫ 

1079. 

4,4′-  Isobutylethylidenediphenol  (Cas  No 
6807-17-6) 

⌦ 6807-17-6 ⌫  ⌦ 604-024-00-

8 ⌫ 

1080.  Chlordimeform (Cas No 6164-98-3) 

⌦ 6164-98-3 ⌫  ⌦ 228-200-5 ⌫ 

1081.  Amitrole (Cas No 61-82-5) 

⌦ 61-82-5 ⌫  ⌦ 200-521-5 ⌫ 

1082.  Carbaryl (Cas No 63-25-2) 

⌦ 63-25-2 ⌫  ⌦ 200-555-0 ⌫ 

1083.  Distillates  (petroleum),  light  hydrocracked 

(Cas No 64741-77-1) 

⌦ 64741-77-
1 ⌫ 

⌦ 265-078-2 ⌫ 

1084. 

1-Ethyl-1-methylmorpholinium 
(Cas No 65756-41-4) 

bromide 

⌦ 65756-41-
4 ⌫ 

⌦ 612-182-00-
4 ⌫ 

1085. 

(3-Chlorophenyl)-(4-methoxy-3-
nitrophenyl)methanone (Cas No 66938-41-
8) 

⌦ 66938-41-
8 ⌫ 

⌦ 606-061-00-
5 ⌫ 

1086.  Fuels,  diesel (Cas No 68334-30-5), except 
if  the  full  refining  history  is  known  and  it 
can  be  shown  that  the  substance  from 
which it is produced is not a carcinogen 

1087.  Fuel oil, no. 2 (Cas No 68476-30-2) 

1088.  Fuel oil, no. 4 (Cas No 68476-31-3) 

⌦ 68334-30-
5 ⌫ 

⌦ 269-822-7 ⌫ 

⌦ 68476-30-
2 ⌫ 

⌦ 68476-31-
3 ⌫ 

⌦ 270-671-4 ⌫ 

⌦ 270-673-5 ⌫ 

1089.  Fuels, diesel, no. 2 (Cas No 68476-34-6)  ⌦ 68476-34-

⌦ 270-676-1 ⌫ 

6 ⌫ 

1090. 

2,2-Dibromo-2-nitroethanol 
69094-18-4) 

(Cas  No 

⌦ 69094-18-
4 ⌫ 

⌦ 609-056-00-
6 ⌫ 

1091. 

1-Ethyl-1-methylpyrrolidinium 
(Cas No 69227-51-6) 

bromide 

⌦ 69227-51-
6 ⌫ 

⌦ 612-183-00-
X ⌫ 

1092.  Monocrotophos (Cas No 6923-22-4) 

⌦ 6923-22-4 ⌫  ⌦ 230-042-7 ⌫ 

1093.  Nickel (Cas No 7440-02-0) 

⌦ 7440-02-0 ⌫  ⌦ 231-111-4 ⌫ 

1094.  Bromomethane (Cas No 74-83-9) 

⌦ 74-83-9 ⌫  ⌦ 200-813-2 ⌫ 

1095.  Chloromethane (Cas No 74-87-3) 

⌦ 74-87-3 ⌫  ⌦ 200-817-4 ⌫ 

1096. 

Iodomethane (Cas No 74-88-4) 

⌦ 74-88-4 ⌫  ⌦ 200-819-5 ⌫ 

EN 

142 

   EN 

 
1097.  Bromoethane (Cas No 74-96-4) 

⌦ 74-96-4 ⌫  ⌦ 200-825-8 ⌫ 

1098.  Heptachlor (Cas No 76-44-8) 

⌦ 76-44-8 ⌫  ⌦ 200-962-3 ⌫ 

1099.  Fentin hydroxide (Cas No 76-87-9) 

⌦ 76-87-9 ⌫  ⌦ 200-990-6 ⌫ 

1100.  Nickel sulphate (Cas No 7786-81-4) 

⌦ 7786-81-4 ⌫  ⌦ 232-104-9 ⌫ 

1101. 

3,5,5-Trimethylcyclohex-2-enone  (Cas  No 
78-59-1) 

⌦ 78-59-1 ⌫  ⌦ 201-126-0 ⌫ 

1102. 

2,3-Dichloropropene (Cas No 78-88-6)  ⌦ 78-88-6 ⌫  ⌦ 201-153-8 ⌫ 

1103.  Fluazifop-P-butyl (Cas No 79241-46-6)  ⌦ 79241-46-

6 ⌫ 

⌦ 607-305-00-
3 ⌫ 

1104. 

(S)-2,3-Dihydro-1H-indole-carboxylic  acid 
(Cas No 79815-20-6) 

⌦ 79815-20-
6 ⌫ 

⌦ 607-330-00-
X ⌫ 

1105.  Toxaphene (Cas No 8001-35-2) 

⌦ 8001-35-2 ⌫  ⌦ 232-283-3 ⌫ 

1106. 

(4-Hydrazinophenyl)-N-
methylmethanesulfonamide  hydrochloride 
(Cas No 81880-96-8) 

⌦ 81880-96-
8 ⌫ 

⌦ 007-025-00-
6 ⌫ 

1107.  (cid:206)1 CI. Solvent yYellow 14 (CAS No 842-

⌦ 842-07-9 ⌫  ⌦ 212-668-2 ⌫ 

07-9)  

1108.  Chlozolinate (Cas No 84332-86-5) 

1109.  Alkanes, C10-13, chloro (Cas No 85535-84-

8) 

⌦ 84332-86-
5 ⌫ 

⌦ 85535-84-
8 ⌫ 

⌦ 282-714-4 ⌫ 

⌦ 287-476-5 ⌫ 

1110.  Pentachlorophenol (Cas No 87-86-5) 

⌦ 87-86-5 ⌫  ⌦ 201-778-6 ⌫ 

1111. 

2,4,6-Trichlorophenol (Cas No 88-06-2)  ⌦ 88-06-2 ⌫  ⌦ 201-795-9 ⌫ 

1112.  Diethylcarbamoyl-chloride (Cas No 88-10-

⌦ 88-10-8 ⌫  ⌦ 201-798-5 ⌫ 

8) 

1113. 

1-Vinyl-2-pyrrolidone (Cas No 88-12-0)  ⌦ 88-12-0 ⌫  ⌦ 201-800-4 ⌫ 

1114.  Myclobutanil;  2-(4-chlorophenyl)-2-(1H-
1,2,4-triazol-1-ylmethyl)hexanenitrile  (Cas 
No 88671-89-0) 

⌦ 88671-89-
0 ⌫ 

⌦ 613-134-00-
5 ⌫ 

1115.  Fentin acetate (Cas No 900-95-8) 

⌦ 900-95-8 ⌫  ⌦ 212-984-0 ⌫ 

1116.  Biphenyl-2-ylamine (Cas No 90-41-5) 

⌦ 90-41-5 ⌫  ⌦ 201-990-9 ⌫ 

EN 

143 

   EN 

 
1117.  Trans-4-cyclohexyl-L-proline  monohydro-

chloride (Cas No 90657-55-9) 

⌦ 90657-55-
9 ⌫ 

⌦ 607-377-00-
6 ⌫ 

1118. 

2-Methyl-m-phenylene  diisocyanate  (Cas 
No 91-08-7) 

⌦ 91-08-7 ⌫  ⌦ 202-039-0 ⌫ 

1119. 

4-Methyl-m-phenylene  diisocyanate  (Cas 
No 584-84-9) 

⌦ 584-84-9 ⌫  ⌦ 209-544-5 ⌫ 

1120.  m-Tolylidene diisocyanate (Cas No 26471-

62-5) 

1121.  Fuels,  jet  aircraft,  coal  solvent  extn.  , 
(Cas  No 

hydrocracked  hydrogenated 
94114-58-6) 

1122.  Fuels,  diesel,  coal 

hydrocracked  hydrogenated 
94114-59-7) 

solvent  extn. 

, 
(Cas  No 

⌦ 26471-62-
5 ⌫ 

⌦ 94114-58-
6 ⌫ 

⌦ 94114-59-
7 ⌫ 

⌦ 247-722-4 ⌫ 

⌦ 302-694-3 ⌫ 

⌦ 302-695-9 ⌫ 

1123.  Pitch (Cas No 61789-60-4), if it contains > 

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

⌦ 61789-60-
4 ⌫ 

⌦ 263-072-4 ⌫ 

1124. 

2-Butanone oxime (Cas No 96-29-7) 

⌦ 96-29-7 ⌫  ⌦ 202-496-6 ⌫ 

1125.  Hydrocarbons,  C16-20, 

solvent-dewaxed 
hydrocracked  paraffinic  distn.  Residue 
(Cas No 97675-88-2) 

⌦ 97675-88-
2 ⌫ 

⌦ 307-662-2 ⌫ 

1126.  α,α-Dichlorotoluene (Cas No 98-87-3) 

⌦ 98-87-3 ⌫  ⌦ 202-709-2 ⌫ 

1127.  (cid:206)1 Mineral  wool,  with  the  exception  of 
those  specified  elsewhere  in  this  Annex; 
[Man-made  vitreous  (silicate)fibres  with 
random orientation with alkaline oxide and 
alkali  earth  oxide  (Na2O  +  K2O  +  CaO  + 
MgO + BaO) content greater than 18 % by 
weight]  

1128.  (cid:206)1 Reaction  product  of  acetophenone, 
formaldehyde,  cyclohexylamine,  methanol 
and acetic acid (EC No 406-230-1)  

1129.  Salts 

of 

4,4′-carbonimidoylbis[N,N-

dimethylaniline] 

1130. 

1,2,3,4,5,6-Hexachlorcyclohexanes  with 
the exception of those specified  elsewhere 
in this Annex 

⌦ 406-230-1 ⌫ 

⌦ 602-042-00-
0 ⌫ 

1131.  (cid:206)1 Trisodium  bis(7-acetamido-2-(4-nitro-

⌦ 400-810-8 ⌫ 

EN 

144 

   EN 

 
 
 
 
 
 
 
 
⌦ 417-470-1 ⌫ 

2-oxidophenylazo)-3-sulfonato-1-
naphtholato)chromate(1-) 
810-8 )  

(EC  No 400-

1132.  (cid:206)1 A  mixture  of:  4-allyl-2,6-bis(2,3-
epoxypropyl)phenol,  4-allyl-6-(3-(6-(3-(6-
(3-(4-allyl-2,6-bis(2,3-epoxypropyl)-
phenoxy)2-hydroxypropyl)-4-allyl-2-(2,3-
epoxypropyl)phenoxy)-2-hydroxypropyl)-
4-allyl-2-(2,3-epoxypropyl)-phenoxy-2-
hydroxypropyl-2-(2,3-epoxypropyl)phenol, 
4-allyl-6-(3-(4-allyl-2,6-bis(2,3-
epoxypropyl)phenoxy)-2-  hydroxypropyl)-
2-(2,3-epoxypropyl)phenoxy)phenol 
and 
4-allyl-6-(3-(6-(3-(4-allyl-2,6-bis(2,3-
epoxypropyl)-phenoxy)-2-hydroxypropyl)-
4-allyl-2-(2,3-epoxypropyl)phenoxy)2-
hydroxypropyl)-2-(2,3-
epoxypropyl)phenol 
1)  

(EC  No  417-470-

(cid:208) 2005/42/EC Art. 1 and Annex .1 
(adapted) 

1133.  Costus  root  oil  (Saussurea  lappa  Clarke) 
(CAS  No  8023-88-9),  when  used  as  a 
fragrance ingredient 

⌦ 8023-88-9 ⌫ 

1134. 

7-Ethoxy-4-methylcoumarin  (CAS  No  87-
05-8), when used as a fragrance ingredient 

⌦ 87-05-8 ⌫  ⌦ 201-721-5 ⌫ 

1135.  Hexahydrocoumarin  (CAS  No  700-82-3), 
when used as a fragrance ingredient 

⌦ 700-82-3 ⌫  ⌦ 211-851-4 ⌫ 

1136.  Peru  balsam  (INCI  name:  Myroxylon 
pereirae;  CAS  No  8007-00-9),  when  used 
as a fragrance ingredient 

⌦ 8007-00-9 ⌫  ⌦ 232-352-8 ⌫ 

(cid:208) 2005/80/EC Art. 1 and Annex 
.1(c) (adapted) 
(cid:206)1 2006/65/EC Art. 1 and Annex 
.1 
(cid:206)2 2007/1/EC Art. 1 and Annex 
pt. 1 

1137 

isobutyl nitrite 

542-56-2  

⌦ 208-819-7 ⌫ 

1138 

isoprene (stabilized) 

78-79-5  

⌦ 201-143-3 ⌫ 

EN 

145 

   EN 

 
 
 
 
 
 
 
(2-methyl-1,3-butadiene) 

1139 

1-bromopropane 

106-94-5  

⌦ 203-445-0 ⌫ 

n-propyl bromide 

1140 

chloroprene (stabilized) 

126-99-8 

⌦ 204-818-0 ⌫ 

(2-chlorobuta-1,3-diene) 

1141 

1,2,3-trichloropropane 

96-18-4  

⌦ 202-486-1 ⌫ 

1142 

ethylene glycol dimethyl ether 

110-71-4  

⌦ 203-794-9 ⌫ 

(EGDME) 

1143 

dinocap (ISO) 

39300-45-3  

⌦ 254-408-0 ⌫ 

1144 

diaminotoluene, technical product -mixture 
of [4-methyl-m-phenylene diamine]36 and 
[2-methyl-m-phenylene diamine]37 

methyl-phenylenediamine 

25376-45-8 

⌦ 246-910-3 ⌫ 

1145 

p-chlorobenzotrichloride 

5216-25-1 

⌦ 226-009-1 ⌫ 

1146 

diphenylether; octabromo derivate 

32536-52-0 

⌦ 251-087-9 ⌫ 

1147 

1,2-bis(2-methoxyethoxy)ethane 

112-49-2  

⌦ 203-977-3 ⌫ 

triethylene glycol dimethyl ether 
(TEGDME) 

1148 

tetrahydrothiopyran-3-carboxaldehyde 

61571-06-0  

1149 

4,4′-bis(dimethylamino)benzophenone 

90-94-8  

⌦ 202-027-5 ⌫ 

(Michler's ketone) 

1150 

oxiranemethanol, 4-methylbenzene-
sulfonate, (S)- 

70987-78-9  

1151 

1,2-benzenedicarboxylic acid, 
dipentylester, branched and linear [1] 

84777-06-0 [1]   ⌦ 284-032-2 ⌫ 

n-pentyl-isopentylphthalate [2] 
di-n-pentyl phthalate [3] 
diisopentylphthalate [4] 

 -[2]  
131-18-0 [3]  
605-50-5 [4]  

⌦ 205-017-9 ⌫ 
⌦ 210-088-4 ⌫ 

36 
37 

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

EN 

146 

   EN 

 
 
 
 
                                                 
1152 

benzyl butyl phthalate (BBP) 

85-68-7  

⌦ 201-622-7 ⌫ 

1153 

1,2-benzenedicarboxylic acid di-C7-11, 
branched and linear alkylesters 

68515-42-4  

⌦ 271-084-6 ⌫ 

1154 

1155 

1156 

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

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

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

⌦ EC No 402-
660-9 ⌫ 

⌦ EC No 401-
500-5 ⌫ 

⌦ EC No 420-
580-2 ⌫ 

1157 

azafenidin 

68049-83-2  

1158 

2,4,5-trimethylaniline [1] 

137-17-7 [1]  

⌦ 205-282-0 ⌫ 

2,4,5-trimethylaniline hydrochloride [2] 

21436-97-5 [2]  

1159 

4,4′-thiodianiline and its salts 

139-65-1  

⌦ 205-370-9 ⌫ 

1160 

4,4′-oxydianiline (p-aminophenyl ether) 
and its salts 

101-80-4  

⌦ 202-977-0 ⌫ 

1161  N,N,N′,N′-tetramethyl-4,4′-
methylendianiline 

101-61-1 

⌦ 202-959-2 ⌫ 

1162 

6-methoxy-m-toluidine 

120-71-8 

⌦ 204-419-1 ⌫ 

(p-cresidine) 

1163 

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

143860-04-2 

1164 

a mixture of: 1,3,5-tris(3-
aminomethylphenyl)-1,3,5-(1H,3H,5H)-

⌦ EC No 421-

EN 

147 

   EN 

 
 
 
 
 
 
 
 
triazine-2,4,6-trione and a mixture of 
oligomers of 3,5-bis(3-
aminomethylphenyl)-1-poly[3,5-bis(3-
aminomethylphenyl)-2,4,6-trioxo-1,3,5-
(1H,3H,5H)-triazin-1-yl]-1,3,5-
(1H,3H,5H)-triazine-2,4,6-trione 

550-1 ⌫ 

1165 

2-nitrotoluene 

88-72-2 

⌦ 201-853-3 ⌫ 

1166 

tributyl phosphate 

126-73-8 

⌦ 204-800-2 ⌫ 

1167 

naphthalene 

91-20-3 

⌦ 202-049-5 ⌫ 

1168 

nonylphenol [1] 

25154-52-3 [1] 

⌦ 246-672-0 ⌫ 

4-nonylphenol, branched [2] 

84852-15-3 [2] 

⌦ 284-325-5 ⌫ 

1169 

1,1,2-trichloroethane 

1170 

pentachloroethane 

1171 

vinylidene chloride 

(1,1-dichloroethylene) 

79-00-5 

76-01-7 

75-35-4 

⌦ 201-166-9 ⌫ 

200-925-1  

⌦ 200-864-0 ⌫ 

1172 

allyl chloride 

107-05-1 

⌦ 203-457-6 ⌫ 

(3-chloropropene) 

1173 

1,4-dichlorobenzene 

106-46-7 

⌦ 203-400-5 ⌫ 

(p-dichlorobenzene) 

1174 

bis(2-chloroethyl) ether 

1175 

Phenol 

1176 

bisphenol A 

(4,4′-isopropylidenediphenol) 

111-44-4 

108-95-2 

80-05-7 

⌦ 203-870-1 ⌫ 

⌦ 203-632-7 ⌫ 

⌦ 201-245-8 ⌫ 

1177 

trioxymethylene 

110-88-3 

⌦ 203-812-5 ⌫ 

(1,3,5-trioxan) 

1178 

propargite (ISO) 

2312-35-8 

⌦ 219-006-1 ⌫ 

1179 

1-chloro-4-nitrobenzene 

100-00-5 

⌦ 202-809-6 ⌫ 

1180  molinate (ISO) 

1181 

fenpropimorph 

2212-67-1 

⌦ 218-661-0 ⌫ 

67564-91-4 

⌦ 266-719-9 ⌫ 

EN 

148 

   EN 

 
1183  methyl isocyanate 

624-83-9 

⌦ 210-866-3 ⌫ 

1184  N,N-dimethylanilinium 

118612-00-3 

tetrakis(pentafluorophenyl)borate 

1185  O,O′-(ethenylmethylsilylene) di[(4-
methylpentan-2-one) oxime] 

EC No 421-870-1  ⌦ 421-870-1 ⌫ 

140698-96-0 

EC No 417-980-4  ⌦ 417-980-4 ⌫ 

1186 

1187 

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

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

1188 

malachite green hydrochloride [1] 

569-64-2 [1] 

⌦ 209-322-8 ⌫ 

malachite green oxalate [2] 

18015-76-4 [2] 

⌦ 241-922-5 ⌫ 

1189 

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

107534-96-3 

1190 

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

138164-12-2 

1191 

trans-4-phenyl-L-proline 

96314-26-0 

1192 

bromoxynil heptanoate (ISO) 

56634-95-8 

⌦ 260-300-4 ⌫ 

1193 

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

1194 

2-{4-(2-ammoniopropylamino)-6-[4-
hydroxy-3-(5-methyl-2-methoxy-4-
sulfamoylphenylazo)-2-sulfonatonaphth-7-

163879-69-4 

EC No 424-260-3  ⌦ 424-260-3 ⌫ 

EN 

149 

   EN 

 
 
 
 
 
 
 
ylamino]-1,3,5-triazin-2-ylamino}-2-
aminopropyl formate 

1195 

5-nitro-o-toluidine [1] 

99-55-8 [1] 

⌦ 202-765-8 ⌫ 

5-nitro-o-toluidine hydrochloride [2] 

51085-52-0 [2] 

⌦ 256-960-8 ⌫ 

1196 

1-(1-naphthylmethyl)quinolinium 

65322-65-8 

1197 

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

143322-57-0 

1198 

pymetrozine (ISO) 

123312-89-0 

1199 

oxadiargyl (ISO) 

39807-15-3 

⌦ 254-637-6 ⌫ 

1200  Chlorotoluron (3-(3-chloro-p-tolyl)-1,1-

15545-48-9 

⌦ 239-592-2 ⌫ 

dimethylurea) 

1201  N-[2-(3-acetyl-5-nitrothiophen-2-ylazo)-5-
diethylaminophenyl] acetamide 

EC No 416-860-9  ⌦ 416-860-9 ⌫ 

1202 

1,3-bis(vinylsulfonylacetamido)-propane 

93629-90-4 

1203 

p-phenetidine (4-ethoxyaniline) 

1204  m-phenylenediamine and its salts 

156-43-4 

108-45-2 

⌦ 616-142-00-
7 ⌫ 

⌦ 205-855-5 ⌫ 

⌦ 203-584-7 ⌫ 

1205 

residues (coal tar), creosote oil distn., if it 
contains > 0,005 % w/w benzo[a]pyrene 

92061-93-3 

⌦ 295-506-3 ⌫ 

1206 

creosote oil, acenaphthene fraction, wash 
oil, if it contains > 0,005 % w/w 
benzo[a]pyrene 

90640-84-9 

⌦ 292-605-3 ⌫ 

1207 

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

61789-28-4 

⌦ 263-047-8 ⌫ 

1208 

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

8001-58-9 

⌦ 232-287-5 ⌫ 

1209 

1210 

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

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

70321-79-8 

⌦ 274-565-9 ⌫ 

122384-77-4 

⌦ 310-189-4 ⌫ 

1211 

creosote oil, low-boiling distillate, wash 
oil, if it contains > 0,005 % w/w 

70321-80-1 

⌦ 274-566-4 ⌫ 

EN 

150 

   EN 

 
 
 
 
benzo[a]pyrene 

(cid:206)1 6-Methoxy-2,3-Pyridinediamine and 
its HCl salt, when used as a substance in 
hair dye products  

(cid:206)1 2,3-Naphthalenediol, when used as a 
substance in hair dye products  

(cid:206)1 2,4-Diaminodiphenylamine, when 
used as a substance in hair dye products  

(cid:206)1 2,6-Bis(2-Hydroxyethoxy)-3,5-
Pyridinediamine and its HCl salt, when 
used as a substance in hair dye products  

(cid:206)1 2-Methoxymethyl-p-Aminophenol and 
its HCl salt, when used as a substance in 
hair dye products  

(cid:206)1 4,5-Diamino-1-Methylpyrazole and its 
HCl salt, when used as a substance in hair 
dye products  

(cid:206)1 4,5-Diamino-1-((4-
Chlorophenyl)Methyl)-1H-Pyrazole 
Sulfate, when used as a substance in hair 
dye products  

(cid:206)1 4-Chloro-2-Aminophenol, when used 
as a substance in hair dye products  

(cid:206)1 4-Hydroxyindole, when used as a 
substance in hair dye products  

(cid:206)1 4-Methoxytoluene-2,5-Diamine and its 
HCl salt, when used as a substance in hair 
dye products  

(cid:206)1 5-Amino-4-Fluoro-2-Methylphenol 
Sulfate, when used as a substance in hair 
dye products  

(cid:206)1 N,N-Diethyl-m-Aminophenol, when 
used as a substance in hair dye products  

(cid:206)1 1
212 
 

(cid:206)1 1
213 
 

(cid:206)1 1
214 
 

(cid:206)1 1
215 
 

(cid:206)1 1
216 
 

(cid:206)1 1
217 
 

(cid:206)1 1
218 
 

(cid:206)1 1
219 
 

(cid:206)1 1
220 
 

(cid:206)1 1
221 
 

(cid:206)1 1
222 
 

(cid:206)1 1
223 
 

EN 

151 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
(cid:206)1 N,N-Dimethyl-2,6-Pyridinediamine 
and its HCl salt, when used as a substance 
in hair dye products  

(cid:206)1 N-Cyclopentyl-m-Aminophenol, when 
used as a substance in hair dye products  

(cid:206)1 N-(2-Methoxyethyl)-p-
phenylenediamine and its HCl salt, when 
used as a substance in hair dye products  

(cid:206)1 2,4-Diamino-5-methylphenetol and its 
HCl salt, when used as a substance in hair 
dye products  

(cid:206)1 1,7-Naphthalenediol, when used as a 
substance in hair dye products  

(cid:206)1 3,4-Diaminobenzoic acid, when used 
as a substance in hair dye products  

(cid:206)1 2-Aminomethyl-p-aminophenol and its 
HCl salt, when used as a substance in hair 
dye products  

(cid:206)1 Solvent Red 1 (CI 12150), when used 
as a substance in hair dye products  

(cid:206)1 Acid Orange 24 (CI 20170), when 
used as a substance in hair dye products  

(cid:206)1 Acid Red 73 (CI 27290), when used as 
a substance in hair dye products  

(cid:206)2 PEG-3,2′,2′-di-p-Phenylenediamine  

(cid:206)2 6-Nitro-o-Toluidine  

(cid:206)2 HC Yellow No 11  

(cid:206)1 1
224 
 

(cid:206)1 1
225 
 

(cid:206)1 1
226 
 

(cid:206)1 1
227 
 

(cid:206)1 1
228 
 

(cid:206)1 1
229 
 

(cid:206)1 1
230 
 

(cid:206)1 1
231 
 

(cid:206)1 1
232 
 

(cid:206)1 1
233 
 

(cid:206)2 1
234 
 

(cid:206)2 1
235 
 

(cid:206)2 1
236 
 

EN 

152 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
(cid:206)2 1
237 
 

(cid:206)2 1
238 
 

(cid:206)2 1
239 
 

(cid:206)2 1
240 
 

(cid:206)2 1
241 
 

(cid:206)2 1
242 
 

(cid:206)2 1
243 
 

1244 

1245 

1246 

1247 

1248 

(cid:206)2 HC Orange No 3  

(cid:206)2 HC Green No 1  

(cid:206)2 HC Red No 8 and its salts  

(cid:206)2 Tetrahydro-6-nitroquinoxaline and its 
salts  

(cid:206)2 Disperse Red 15, except as impurity in 
Disperse Violet 1  

(cid:206)2 4-amino-3-fluorophenol  

(cid:206)2 N,N′-dihexadecyl-N,N′-bis(2-
hydroxyethyl)propanediamide 

Bishydroxyethyl Biscetyl Malonamide  

(cid:208) 2007/54/EC Art1 and Annex 1 
pt. 1 (adapted) 

1-Methyl-2,4,5-trihydroxybenzene (CAS 
No 1124-09-0) and its salts, when used as a 
substance in hair dye products 
2,6-Dihydroxy-4-methylpyridine (CAS No 
4664-16-8) and its salts, when used as a 
substance in hair dye products 
5-Hydroxy-1,4-benzodioxane (CAS No 
10288-36-5) and its salts, when used as a 
substance in hair dye products 
3,4-Methylenedioxyphenol (CAS No 533-
31-3) and its salts, when used as a 
substance in hair dye products 
3,4-Methylenedioxyaniline (CAS No 
14268-66-7) and its salts, when used as a 
substance in hair dye products 

⌦ 1124-09-0 ⌫ 

⌦ 4664-16-8 ⌫ 

⌦ 10288-36-
5 ⌫ 

⌦ 533-31-3 ⌫ 

⌦ 14268-66-
7 ⌫ 

EN 

153 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1250 

1249  Hydroxypyridinone (CAS No 822-89-9) 
and its salts, when used as a substance in 
hair dye products 
3-Nitro-4-aminophenoxyethanol (CAS No 
50982-74-6) and its salts, when used as a 
substance in hair dye products 
2-methoxy-4-nitrophenol (CAS No 3251-
56-7) (4-Nitroguaiacol) and its salts, when 
used as a substance in hair dye products 

1251 

1252  C.I. Acid Black 131 (CAS No 12219-01-1) 

1253 

1254 

and its salts, when used as a substance in 
hair dye products 
1,3,5-Trihydroxybenzene (CAS No 108-73-
6) (Phloroglucinol) and its salts, when used 
as a substance in hair dye products 
1,2,4-Benzenetriacetate (CAS No 613-03-
6) and its salts, when used as a substance in 
hair dye products 

1255  Ethanol, 2,2'-iminobis-, reaction products 

with epichlorohydrin and 2-nitro-1,4-
benzenediamine (CAS No 68478-64-8) 
(CAS 158571-58-5) (HC Blue No. 5) and 
its salts, when used as a substance in hair 
dye products 

1256  N-Methyl-1,4-diaminoanthraquinone, 

1257 

1258 

1259 

1260 

reaction products with epichlorohydrin and 
monoethanolamine (CAS No 158571-57-4) 
(HC Blue No. 4) and its salts, when used as 
a substance in hair dye products 
4-Aminobenzenesulfonic acid (CAS No 
121-57-3) and its salts, when used as a 
substance in hair dye products 
3,3'-(Sulfonylbis(2-nitro-4,1-
phenylene)imino)bis(6-(phenylamino)) 
benzenesulfonic acid and its salts, when 
used as a substance in hair dye products 
3(or5)-((4-
(Benzylmethylamino)phenyl)azo)-1,2-
(or1,4)-dimethyl-1H-1,2,4-triazolium and 
its salts, when used as a substance in hair 
dye products 
2,2'-((3-Chloro-4-((2,6-dichloro-4-
nitrophenyl)azo)phenyl)imino)bisethanol 
(CAS No 23355-64-8) (Disperse Brown 1) 
and its salts, when used as a substance in 
hair dye products 

⌦ 822-89-9 ⌫ 

⌦ 50982-74-
6 ⌫ 

⌦ 3251-56-7 ⌫ 

⌦ 12219-01-
1 ⌫ 

⌦ 108-73-6 ⌫ 

⌦ 613-03-6 ⌫ 

⌦ 68478-64-
8158571-58-5 ⌫ 

⌦ 158571-57-
4 ⌫ 

⌦ 121-57-3 ⌫ 

⌦ 23355-64-
8 ⌫ 

EN 

154 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1261  Benzothiazolium, 2-[[4-[ethyl(2-

1262 

1263 

1264 

1265 

1266 

1267 

1268 

1269 

1270 

hydroxyethyl)amino]phenyl]azo]-6-
methoxy-3-methyl- and its salts, when used 
as a substance in hair dye products 
2-[(4-Chloro-2-nitrophenyl)azo]-N-(2-
methoxyphenyl)-3-oxobutanamide (CAS 
No 13515-40-7) (Pigment Yellow 73) and 
its salts, when used as a substance in hair 
dye products 
2,2'-[(3,3'-Dichloro[1,1'-biphenyl]-4,4'-
diyl)bis(azo)]bis[3-oxo-N-
phenylbutanamide] (CAS No 6358-85-6) 
(Pigment Yellow 12) and its salts, when 
used as a substance in hair dye products 
2,2'-(1,2-Ethenediyl)bis[5-((4-
ethoxyphenyl)azo]benzenesulfonic acid) 
and its salts, when used as a substance in 
hair dye products 
2,3-Dihydro-2,2-dimethyl-6-[(4-
(phenylazo)-1-naphthalenyl)azo]-1H-
pyrimidine (CAS No 4197-25-5) (Solvent 
Black 3) and its salts, when used as a 
substance in hair dye products  
3(or5)-[[4-[(7-amino-1-hydroxy-3-
sulphonato-2-naphthyl)azo]-1-
naphthyl]azo]salicylic acid and its salts, 
when used as a substance in hair dye 
products 
2-Naphthalenesulfonic acid, 7-
(benzoylamino)-4-hydroxy-3-[[4-[(4-
sulfophenyl)azo]phenyl]azo]- and its salts, 
when used as a substance in hair dye 
products 
(µ-((7,7'-Iminobis(4-hydroxy-3-((2-
hydroxy-5-(N-
methylsulphamoyl)phenyl)azo)naphthalene
-2-sulphonato))(6-)))dicuprate(2-) and its 
salts, when used as a substance in hair dye 
products 
3-[(4-(Acetylamino)phenyl)azo]-4-
hydroxy-7-[[[[5-hydroxy-6-(phenylazo)-7-
sulfo-2-
naphthalenyl]amino]carbonyl]amino]-2-
naphthalenesulfonic acid and its salts, when 
used as a substance in hair dye products  
2-Naphthalenesulfonic acid, 7,7'-
(carbonyldiimino)bis(4-hydroxy-3-[[2-
sulfo-4-[(4-sulfophenyl)azo]phenyl]azo]-, 
(CAS No 25188-41-4) and its salts, when 
used as a substance in hair dye products 

⌦ 13515-40-
7 ⌫ 

⌦ 6358-85-6 ⌫ 

⌦ 4197-25-5 ⌫ 

⌦ 25188-41-
4 ⌫ 

EN 

155 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1271  Ethanaminium, N-(4-[bis[4-

1272 

1273 

(diethylamino)phenyl]methylene]-2,5-
cyclohexadien-1-ylidene)-N-ethyl- and its 
salts, when used as a substance in hair dye 
products 
3H-Indolium, 2-[[(4-
methoxyphenyl)methylhydrazono]methyl]-
1,3,3-trimethyl- and its salts, when used as 
a substance in hair dye products 
3H-Indolium, 2-(2-((2,4-
dimethoxyphenyl)amino)ethenyl)-1,3,3-
trimethyl- and its salts, when used as a 
substance in hair dye products 
1274  Nigrosine spirit soluble (CAS No 11099-
03-9) (Solvent Black 5), when used as a 
substance in hair dye products 
Phenoxazin-5-ium, 3,7-bis(diethylamino)-, 
(CAS No 47367-75-9) and its salts, when 
used as a substance in hair dye products  

1275 

1276  Benzo[a]phenoxazin-7-ium, 9-

1277 

1278 

(dimethylamino)-, and its salts, when used 
as a substance in hair dye products 
6-Amino-2-(2,4-dimethylphenyl)-1H-
benz[de]isoquinoline-1,3(2H)-dione (CAS 
No 2478-20-8) (Solvent Yellow 44) and its 
salts, when used as a substance in hair dye 
products 
1-Amino-4-[[4-
[(dimethylamino)methyl]phenyl]amino]ant
hraquinone (CAS No 12217-43-5) and its 
salts, when used as a substance in hair dye 
products 

1279  Laccaic Acid (CI Natural Red 25 ) (CAS 

No 60687-93-6) and its salts, when used as 
a substance in hair dye products 

1280  Benzenesulfonic acid, 5-[(2,4-

dinitrophenyl)amino]-2-(phenylamino)-, 
(CAS No 15347-52-1) and its salts, when 
used as a substance in hair dye products 
4-[(4-Nitrophenyl)azo]aniline (CAS No 
730-40-5) (Disperse Orange 3) and its salts, 
when used as a substance in hair dye 
products 
4-Nitro-m-phenylenediamine (CAS No 
5131-58-8) and its salts, when used as a 
substance in hair dye products 
1-Amino-4-(methylamino)-9,10-
anthracenedione (CAS No 1220-94-6) 
(Disperse Violet 4) and its salts, when used 

1281 

1282 

1283 

⌦ 11099-03-
9 ⌫ 

⌦ 47367-75-
9 ⌫ 

⌦ 2478-20-8 ⌫ 

⌦ 12217-43-
5 ⌫ 

⌦ 60687-93-
6 ⌫ 

⌦ 15347-52-
1 ⌫ 

⌦ 730-40-5 ⌫ 

⌦ 5131-58-8 ⌫ 

⌦ 1220-94-6 ⌫ 

EN 

156 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
⌦ 2973-21-9 ⌫ 

⌦ 56932-44-
6 ⌫ 

⌦ 56932-45-
7 ⌫ 

⌦ 57524-53-
5 ⌫ 

⌦ 10228-03-
2 ⌫ 

⌦ 93633-79-
5 ⌫ 

⌦ 2788-74-1 ⌫ 

⌦ 495-54-5 ⌫ 

as a substance in hair dye products 

1284  N-Methyl-3-nitro-p-phenylenediamine 

(CAS No 2973-21-9) and its salts, when 
used as a substance in hair dye products 

1285  N1-(2-Hydroxyethyl)-4-nitro-o-

phenylenediamine (CAS No 56932-44-6) 
(HC Yellow No. 5) and its salts, when used 
as a substance in hair dye products 
1286  N1-(Tris(hydroxymethyl))methyl-4-nitro-

1287 

1289 

1,2-phenylenediamine (CAS No 56932-45-
7) (HC Yellow No. 3) and its salts, when 
used as a substance in hair dye products 
2-Nitro-N-hydroxyethyl-p-anisidine (CAS 
No 57524-53-5) and its salts, when used as 
a substance in hair dye products 
1288  N,N'-Dimethyl-N-Hydroxyethyl-3-nitro-p-
phenylenediamine (CAS No 10228-03-2) 
and its salts, when used as a substance in 
hair dye products 
3-(N-Methyl-N-(4-methylamino-3-
nitrophenyl)amino)propane-1,2-diol (CAS 
No 93633-79-5) and its salts, when used as 
a substance in hair dye products  
4-Ethylamino-3-nitrobenzoic acid (CAS No 
2788-74-1) (N-Ethyl-3-Nitro PABA) and 
its salts, when used as a substance in hair 
dye products 
(8-[(4-Amino-2-nitrophenyl)azo]-7-
hydroxy-2-naphthyl)trimethylammonium 
and its salts, except Basic Red 118 (CAS 
71134-97-9) as impurity in Basic Brown 
17), when used as a substance in hair dye 
products 
5-((4-(Dimethylamino)phenyl)azo)-1,4-
dimethyl-1H-1,2,4-triazolium and its salts, 
when used as a substance in hair dye 
products 

1292 

1290 

1291 

1294 

1293  m-Phenylenediamine, 4-(phenylazo)-, 
(CAS No 495-54-5) and its salts, when 
used as a substance in hair dye products 
1,3-Benzenediamine, 4-methyl-6-
(phenylazo)- and its salts, when used as a 
substance in hair dye products 
2,7-Naphthalenedisulfonic acid, 5-
(acetylamino)-4-hydroxy-3-((2-
methylphenyl)azo)- and its salts, when used 
as a substance in hair dye products 

1295 

EN 

157 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
⌦ 4482-25-1 ⌫ 

⌦ 86722-66-
9 ⌫ 

⌦ 2872-48-2 ⌫ 

⌦ 3179-90-6 ⌫ 

1296 

4,4'-[(4-Methyl-1,3-
phenylene)bis(azo)]bis[6-methyl-1,3-
benzenediamine] (CAS No 4482-25-1) 
(Basic Brown 4) and its salts, when used as 
a substance in hair dye products 

1297  Benzenaminium, 3-[[4-

[[diamino(phenylazo)phenyl]azo]-2-
methylphenyl]azo]-N,N,N-trimethyl- and 
its salts, when used as a substance in hair 
dye products 
1298  Benzenaminium, 3-[[4-

[[diamino(phenylazo)phenyl]azo]-1-
naphthalenyl]azo]-N,N,N-trimethyl- and its 
salts, when used as a substance in hair dye 
products 

1299  Ethanaminium, N-[4-[(4-

(diethylamino)phenyl)phenylmethylene]-
2,5-cyclohexadien-1-ylidene]-N-ethyl- and 
its salts, when used as a substance in hair 
dye products 
9,10-Anthracenedione, 1-[(2-
hydroxyethyl)amino]-4-(methylamino)-
(CAS No 86722-66-9) and its derivatives 
and salts, when used as a substance in hair 
dye products 
1,4-Diamino-2-methoxy-9,10-
anthracenedione (CAS No 2872-48-2) 
(Disperse Red 11) and its salts, when used 
as a substance in hair dye products 
1,4-Dihydroxy-5,8-bis[(2-
hydroxyethyl)amino]anthraquinone (CAS 
No 3179-90-6) (Disperse Blue 7) and its 
salts, when used as a substance in hair dye 
products 
1-[(3-Aminopropyl)amino]-4-
(methylamino)anthraquinone and its salts, 
when used as a substance in hair dye 
products 

1300 

1301 

1302 

1303 

1304  N-[6-[(2-Chloro-4-hydroxyphenyl)imino]-

1305 

4-methoxy-3-oxo-1,4-cyclohexadien-1-
yl]acetamide (CAS No 66612-11-1) (HC 
Yellow No. 8) and its salts, when used as a 
substance in hair dye products 
[6-[[3-Chloro-4-
(methylamino)phenyl]imino]-4-methyl-3-
oxocyclohexa-1,4-dien-1-yl]urea (CAS No 
56330-88-2) (HC Red No. 9) and its salts, 
when used as a substance in hair dye 
products 

⌦ 66612-11-
1 ⌫ 

⌦ 56330-88-
2 ⌫ 

EN 

158 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1306 

1307 

1308 

1309 

1310 

Phenothiazin-5-ium, 3,7-
bis(dimethylamino)- and its salts, when 
used as a substance in hair dye products  
4,6-Bis(2-Hydroxyethoxy)-m-
Phenylenediamine and its salts, when used 
as a substance in hair dye products 
5-Amino-2,6-Dimethoxy-3-
Hydroxypyridine (CAS No 104333-03-1) 
and its salts, when used as a substance in 
hair dye products 
4,4'-Diaminodiphenylamine (CAS No 537-
65-5) and its salts, when used as a 
substance in hair dye products 
4-Diethylamino-o-toluidine (CAS No 148-
71-0) and its salts, when used as a 
substance in hair dye products 

⌦ 104333-03-
1 ⌫ 

⌦ 537-65-5 ⌫ 

⌦ 148-71-0 ⌫ 

1311  N,N-Diethyl-p-phenylenediamine (CAS No 
93-05-0) and its salts, when used as a 
substance in hair dye products 
1312  N,N-Dimethyl-p-phenylenediamine (CAS 
No 99-98-9) and its salts, when used as a 
substance in hair dye products 

⌦ 93-05-0 ⌫ 

⌦ 99-98-9 ⌫ 

1314 

1313  Toluene-3,4-Diamine (CAS No 496-72-0) 
and its salts, when used as a substance in 
hair dye products 
2,4-Diamino-5-methylphenoxyethanol 
(CAS No 141614-05-3) and its salts, when 
used as a substance in hair dye products 
6-Amino-o-cresol (CAS No 17672-22-9) 
and its salts, when used as a substance in 
hair dye products 

1315 

1317 

1316  Hydroxyethylaminomethyl-p-aminophenol 
(CAS No 110952-46-0) and its salts, when 
used as a substance in hair dye products 
2-Amino-3-nitrophenol (CAS No 603-85-0) 
and its salts, when used as a substance in 
hair dye products 
2-Chloro-5-nitro-N-hydroxyethyl-p-
phenylenediamine (CAS No 50610-28-1) 
and its salts, when used as a substance in 
hair dye products 
2-Nitro-p-phenylenediamine (CAS No 
5307-14-2) and its salts, when used as a 
substance in hair dye products 

1319 

1318 

⌦ 496-72-0 ⌫ 

⌦ 141614-05-
3 ⌫ 

⌦ 17672-22-
9 ⌫ 

⌦ 110952-46-
0 ⌫ 

⌦ 603-85-0 ⌫ 

⌦ 50610-28-
1 ⌫ 

⌦ 5307-14-2 ⌫ 

1320  Hydroxyethyl-2,6-dinitro-p-anisidine (CAS 

No 122252-11-3) and its salts, when used 
as a substance in hair dye products 

⌦ 122252-11-
3 ⌫ 

EN 

159 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1321 

1322 

1323 

1324 

1325 

1326 

1327 

6-Nitro-2,5-pyridinediamine (CAS No 
69825-83-8) and its salts, when used as a 
substance in hair dye products 
Phenazinium, 3,7-diamino-2,8-dimethyl-5-
phenyl- and its salts, when used as a 
substance in hair dye products 
3-Hydroxy-4-[(2-hydroxynaphthyl)azo]-7-
nitronaphthalene-1-sulphonic acid (CAS 
No 16279-54-2) and its salts, when used as 
a substance in hair dye products 
3-[(2-nitro-4-
(trifluoromethyl)phenyl)amino]propane-
1,2-diol (CAS No 104333-00-8) (HC 
Yellow No. 6) and its salts, when used as a 
substance in hair dye products 
2-[(4-chloro-2-nitrophenyl)amino]ethanol 
(CAS No 59320-13-7) (HC Yellow No. 12) 
and its salts, when used as a substance in 
hair dye products 
3-[[4-[(2-Hydroxyethyl)Methylamino]-2-
Nitrophenyl]Amino]-1,2-Propanediol (CAS 
No 173994-75-7) and its salts, when used 
as a substance in hair dye products 
3-[[4-[Ethyl(2-Hydroxyethyl)Amino]-2-
Nitrophenyl]Amino]-1,2-Propanediol (CAS 
No 114087-41-1) and its salts, when used 
as a substance in hair dye products 

⌦ 69825-83-
8 ⌫ 

⌦ 16279-54-
2 ⌫ 

⌦ 104333-00-
8 ⌫ 

⌦ 59320-13-
7 ⌫ 

⌦ 173994-75-
7 ⌫ 

⌦ 114087-41-
1 ⌫ 

1328  Ethanaminium, N-[4-[[4-

(diethylamino)phenyl][4-(ethylamino)-1-
naphthalenyl]methylene]-2,5-
cyclohexadien-1-ylidene]-N-ethyl- and its 
salts, when used as a substance in hair dye 
products” 

EN 

160 

   EN 

 
 
 
 
 
 
 
 
 
 
 
(cid:208) 76/768/EEC 

ANNEX III 

(cid:208) 82/368/EEC (adapted) 

PART 1 

LIST OF SUBSTANCES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS AND 

CONDITIONS LAID DOWN 

Refer
ence 
numb
er 

⌦ Chemical 
name/INN ⌫  

Substance ⌦ identification ⌫  

⌦ Name of Common 
Ingredients 
glossary ⌫ 

⌦ CAS 
number 
⌫  

⌦ EINECS
/ELINCS 
number ⌫  

⌦ Product type, 
body parts ⌫ 
Field of 
application 
and/or use 

Restrictions 

Maximum 
authorized 
concentration 
in the finished 
cosmetic 
product 

Other 
limitations and 
requirements 

⌦ Wording 
of ⌫ 
Cconditions of 
use and warnings 
which must be 
printed on the 
label 

a 

b 

c 

d 

e 

f 

gd 

eh 

fi 

EN 

161 

EN 

 
  
 
 
(cid:208) 76/768/EEC (adapted) 
(cid:206)1 82/368/EEC 
(cid:206)2 2000/6/EC Art. 1 and Annex .2(I) 
(cid:206)3 2005/80/EC Art. 1 and Annex .2(b) 
(cid:206)4 88/233/EEC 
(cid:206)5 2005/80/EC Art. 1 and Annex .2(c) 
(cid:206)6 92/86/EEC 
(cid:206)7 93/47/EEC 
(cid:206)8 83/341/EEC 
(cid:206)9 87/137/EEC 
(cid:206)10 2003/83/EC Art. 1 and Annex .2(a) 
(cid:206)11 96/41/EC 
(cid:206)12 2002/34/EC Art. 1 and Annex .2(ii) 
(cid:206)13 2002/34/EC Art. 1 and Annex .2(iii) 
(cid:206)14 2005/80/EC Art. 1 and Annex .2(a) 
(cid:206)15 86/179/EEC 
(cid:206)16 83/191/EEC 
(cid:206)17 84/415/EEC 
(cid:206)18 85/391/EEC 
(cid:206)19 2004/93/EC Art. 1 and Annex .3 
(cid:206)20 91/184/EEC 
(cid:206)21 98/62/EC 
(cid:206)22 94/32/EC 
(cid:206)23 94/32/EC amended by Corrigendum, OJ L 273, 25.10.1994, p. 38 
(cid:206)24 2003/83/EC Art. 1 and Annex .2(b) 
(cid:206)25 2000/6/EC Art. 1 and Annex .2(III) 
(cid:206)26 2002/34/EC Art. 1 and Annex .2(iv) 
(cid:206)27 2003/15/EC Art. 1.10 
(cid:206)28 2003/83/EC Art. 1 and Annex .2(c) 
(cid:206)29 2004/88/EC Art. 1 and Annex .2 

EN 

162 

EN 

 
  
 
(cid:206)30 2007/17/EC Art. 1 and Annex pt. 1 
(cid:206)31 2007/53/EC Art. 1 and Annex 
(cid:206)32 2007/54/EC Art. 1 and Annex .2 

(cid:214) new 

(cid:206)31a
 

(cid:206)3 Boric acid, borates 
and tetraborates with 
the exception of 
substance No […] in 
Annex II  

⌦ Boric acid ⌫ 

(cid:206)2 (a) 
Talc  

(cid:206)2 (a) 5 % 
(by mass/mass 
as boric 
acid)  

(cid:206)2 (a) 

(cid:206)2 (a) 

Not to be used for 
children  under  3 
years of age 

Not  to  be  used  on 
peeling or irritated 
skin  

Not  to  be  used 
in  products  for 
children under 3 
years of age 

Not  to  be  used 
on  peeling  or 
irritated  skin  if 
the 
concentration of 
soluble 
free 
borates  exceeds 
(by 
1,5 % 
mass/mass 
as 
boric acid)  

(cid:206)2 (b) 
Products for 
all hygiène  

⌦ Oral 
products ⌫ 

(cid:206)2 (b) 0,1 % 
(by mass/mass 
as boric 
acid)  

(cid:206)2 (b) 

(cid:206)2 (b) 

Not to be used 
in products for 
children under 3 
years of age  

Not to be 
swallowed 

Not to be used for 
children under 3 

EN 

163 

EN 

 
  
 
 
 
 
(cid:206)2 (c) 3 % 
(by mass/mass 
as boric 
acid)  

(cid:206)2 (c) Other 
products 
(excluding 
bath products 
and hair 
waving 
products)  

(cid:206)2 (a) Bath 
products  

(cid:206)2 (b) Hair 
waving 
products  

(cid:206)4 (a) Hair 

(cid:206)2 (a) 18 % 
(by mass/mass 
as boric 
acid)  

(cid:206)2 (b) 8 % 
(by mass/mass 
as boric 
acid)  

years of age  

(cid:206)2 (c) 

(cid:206)2 (c) 

Not to be used 
in products for 
children under 3 
years of age 

Not to be used 
on peeling or 
irritated skin if 
the 
concentration of 
free soluble 
borates exceeds 
1,5 % (by 
mass/mass as 
boric acid)  

(cid:206)2 (a) Not to 
be used in 
products for 
children under 3 
years of age  

Not to be used for 
children under 3 
years of age 

Not to be used on 
peeling or irritated 
skin  

(cid:206)2 (a) Not to be 
used of bathing for 
children under 3 
years of age  

(cid:206)2 (b) Rinse 
well  

(cid:206)4 

EN 

(cid:206)2 1
b  

(cid:206)2 Tetraborates   ⌦ Sodium borate ⌫ 

(cid:206)4 2 (cid:206)4 Thioglycollic acid  ⌦ Thioglycollic 

EN 

164 

 
  
 
 
 
 
 
 
 
a  

and its salts  

acid ⌫ 

waving or 
straightening 
products:  

(cid:206)4 — 8 % 
ready for use 
pH 7 to 9,5  

(cid:206)4 — general 
use  

(cid:206)4 — 11 % 
ready for use 
pH 7 to 9,5  

(cid:206)4 — 
professional 
use  

(cid:206)4 (b) 
Depilatories 
 

(cid:206)4 (c) Other 
hair-caire 
products 
which are 
removed after 
application  

⌦ Hair rinse-
off 
products ⌫ 

(cid:206)4 — 5 % 
ready for 
usepH 7 to 
12,7  

(cid:206)4 — 2 % 
ready for use 
pH to 9,5 

The 
abovemention
ed percentages 
are calculated 
as 
thioglycollic 
acid  

⌦ Conditions of 
use: 

(a), (b), (c): 

Avoid contact 
with eyes 

In the event of 
contact with eyes, 
rinse immediately 
with plenty of 
water and seek 
medical advice 

(a) and (c): 

Wear suitable 
gloves ⌫((a) and 
(c) only)  

⌦ Warnings: ⌫ 

(a) Contains 
thioglycolate 

Follow the 
instructions 

Keep out of reach 
of children 

EN 

165 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
(cid:206)4 2
b  

(cid:206)4 Thioglycollic acid 
esters  

⌦ Glyceryl 
thioglycolate ⌫ 

(cid:206)4 Hair 
waving or 
straightening 
products:  

(cid:206)4 — 8 % 
ready for use 
pH 6 to 9,5  

(cid:206)4 —  general 
use  

For professional 
use only 

(b) and (c): 

Contains 
thioglycolate 

Follow the 
instructions 

Keep out of reach 
of children  

⌦ Conditions of 
use: 

- May cause 
sensitization in the 
event of skin 
contact 

- Avoid contact 
with eyes 

- In the event of 
contact with eyes, 
rinse immediately 
with plenty of 
water and seek 

EN 

166 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
medical advice 

- Wear suitable 
gloves ⌫ 

⌦ Warnings: ⌫ 

(cid:206)4 - Contains 
thioglycolate 

- Follow the 
instructions 

- Keep out of 
reach of 
children  

(cid:206)4 — For 
professional use 
only  

EN 

167 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
(cid:206)4 — 11 % 
ready for use 
pH 6 to 9,5  

(cid:206)4 — 
professional 
use  

(cid:206)4 The 
abovemention
ed percentages 
are calculated 
as 
thioglycollic 
acid  

(cid:206)4 The 
directions for 
use drawn up in 
the national or 
official 
language(s) 
must 
obligatorily 
incorporate the 
following 
sentences: 

- May cause 
sensitization in 
the event of 
skin contact 

- Avoid contact 
with eyes 

EN 

168 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
(cid:206)1 3 
 

(cid:206)1 4 
 

(cid:206)1 Oxalic acid, its 
esters and alcaline 
salts  

⌦ Oxalic acid ⌫ 

(cid:206)1 Ammonia  

⌦ Ammonia ⌫ 

(cid:206)1 5 
 

(cid:206)1 Tosylchloramide 
sodium (INN) (*)  

⌦ Chloramine-t ⌫ 

(cid:206)1 6 
 

(cid:206)1 Chlorates of alkali 
metals  

⌦ Sodium chlorate, 
potassium chlorate ⌫ 

- In the event of 
contact with 
eyes, rinse 
immediately 
with plenty of 
water and seek 
medical advice 

- Wear suitable 
gloves  

(cid:206)1 For 
professional use 
only  

(cid:206)1 Above 2 %: 
contains 
ammonia  

(cid:206)1 Hair care 
products  

(cid:206)1 5 %   ⌦professional 

use ⌫  

(cid:206)1 6 % 
calculated as 
(as NH3)  

(cid:206)1 0·2 %  

(cid:206)1 (a) 5 % 

(b) 3 %  

(cid:206)1 (a) 
Toothpaste 

(b) Other 
uses ⌦ produ
cts ⌫  

(cid:206)1 7 
 

(cid:206)1 Dichloromethane 
 

⌦ Dichloromethane 
⌫ 

(cid:206)1 35 % 

(when mixed 

(cid:206)1 0,·2 % as 
maximum 
impurity 

EN 

169 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
⌦ p-
Phenylenediamine, p-
Phenylenediamine 
HCI, p-
Phenylenediamine 
sulfate ⌫ 

(cid:206)1 8 
 

(cid:206)5 

(cid:206)32 p-
Phenylenediamine, its 
N-substituted 
derivatives and its salts; 
Nsubstituted 
derivatives of o-
Phenylenediamine42, 
with the exception of 
those derivatives listed 
elsewhere in this 
Annex and under 
reference numbers 
1309, 1311, and 1312 
in Annex II  

content  

with 1,1,1-
trichloroethane
, total 
concentration 
must not 
exceed 
35 %)  

(cid:206)1 6 % 
calculated (as 
free base)  

(cid:206)1 Oxidizing 
colouring 
agents for hair 
dyeing  

(cid:206)1 (a) general 
use  

⌦ No use on 
eyebrows ⌫ 

(cid:206)1 (b) 
professional 
use  

(cid:206)1 (a) Can cause 
an allergic 
reaction. (cid:206)6 ---
  Contains 
phenylenediamine
s. Do not use to 
dye eyelashes or 
eyebrows  

(cid:206)1 (b) For 
professional use 
only. Contains 
phenylenediamine
s. Can cause an 
allergic reaction. 
(cid:206)6 ---
 (cid:206)7 Wear 
suitable 

EN 

170 

EN 

 
  
 
 
 
 
 
 
 
 
 
⌦ Toluene-2,2-
diamine; toluene-2,5-
diamine sulphate ⌫ 

(cid:206)1 Oxidizing 
colouring 
agents for hair 
dyeing  

(cid:206)1 10 % 
calculated (as 
free base)  

(cid:206)1 9 
 

(cid:206)8 

(cid:206)32 Methylphenylened
iamines, their N-
substituted derivatives 
and their salts38 with 
the exception of 
substances under 
reference numbers 364, 
1310 and 1313 in 
Annex II  

(cid:206)1 (a) general 
use  

⌦ No use on 
eyelashes or 
eyebrows ⌫  

(cid:206)1 (b) 
professional 
use  

gloves.   

(cid:206)1 (a) Can cause 
an allergic 
reaction. (cid:206)6 ---
  Contains 
phenylenediamine
s. Do not use to 
dye eyelashes or 
eyebrows  

(cid:206)1 (b) For 
professional use 
only. Contains 
phenylenediamine
s. Can cause en 
allergic reaction. 
(cid:206)6 ---
 (cid:206)7 Wear 
suitable 
gloves.   

EN 

171 

EN 

 
  
 
 
 
 
 
 
 
 
 
(cid:206)1 1
0  

(cid:206)1 Diaminophenols38 
 

⌦ 2,4-
Diaminophenol, 2,4-
diaminophenol 
HCL ⌫ 

(cid:206)1 Oxidizing 
colouring 
agents for hair 
dyeing  

(cid:206)1 10 % 
calculated (as 
free base)  

(cid:206)9 1
1  

(cid:206)9 Dichlorophen 
(*)  

⌦ Dichlorophene ⌫ 

(cid:206)9 0,5 %  

(cid:206)1 (a) general 
use  

(cid:206)1 (b) 
professional 
use  

(cid:206)1 (a) Can cause 
an allergic 
reaction. (cid:206)6 ---
  Contains 
diaminophenols. 
Do not use to dye 
eyelashes or 
eyebrows  

(cid:206)1 (b) For 
professional use 
only. Contains 
diaminophenols. 
Can cause allergic 
reaction. (cid:206)6 ---
  

(cid:206)7 Wear suitable 
gloves.   

(cid:206)9 Contains 
dichlorophen  
⌦ Dichlorophene

38 

EN 

These substances may be used singly or in combination provided that the sum of the ratios of the levels of each of them in the cosmetic product expressed with reference to 
the maximum level authorized for each of them does not exceed 1. 

172 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
⌦ Hydrogen 
peroxide ⌫ 

(cid:206)6 1
2  

(cid:206)6 Hydrogen 
peroxide, and other 
compounds or mixtures 
that release hydrogen 
peroxide, including 
carbamide peroxide 
and zinc peroxide  

(cid:206)6 (a) Hair- 
⌦ products 
⌫ caire 
preparations 
 

(cid:206)6 (b) Skin- 
⌦ products 
⌫ care 
preparations 
 

(cid:206)6 (c) Nail 
⌦ products 
⌫ hardening 
preparations 
 

(cid:206)6 12 % of 
H2O2 (40 
volumes), 
present or 
released  

(cid:206)6 4 % of 
H2O2, present 
or released  

(cid:206)6 2 % of 
H2O2, present 
or released  

(cid:206)6 (d) Oral 
hygiene 
products  

(cid:206)6 0,1 % of 
H2O2, present 
or released  

 ⌫ 

(cid:206)7 (a): Wear 
suitable gloves  

(cid:206)6 (a) (b) (c): 
Contains hydrogen 
peroxide.  

(cid:206)6 Avoid contact 
with eyes. 

Rinse immediately 
if product comes 
into contact with 
them  

(cid:206)1 1 (cid:206)1 Formaldehyde   ⌦ Formaldehyde ⌫ 

(cid:206)1 Nail 

(cid:206)1 5 % 

⌦ For 

(cid:206)1 Protect 

EN 

173 

EN 

 
  
 
 
 
 
 
 
 
 
 
3  
⌦ 39 
⌫ 

⌦ products 
⌫ 
hardeners  

calculated (as 
formaldehyde)
  

cuticles with 
grease or oil. 
Contains 
formaldehyde40. 
 

purposes other 
than inhibiting 
the 
development of 
micro-
organisms in 
the product. 
This purpose 
has to be 
apparent from 
the presentation 
of the 
product. ⌫ 

(cid:206)10 1
4  

(cid:206)10 Hydroquinone41 
 

⌦ Hydroquinone ⌫ 

(cid:206)10 (a) 
Oxidising 
colouring 
agent for hair-
dying:  

(cid:206)10 0,3 %   ⌦ No use on 

(cid:206)10 (a) 

eyelashes or 
eyebrows ⌫  

1. 

- Do not use to 
dye eyelashes or 
eyebrows  

(cid:206)10- Rinse the 
eyes immediately 
if the product 
comes into contact 

39 
40 
41 

EN 

⌦ As a preservative, see Annex V, No. 5. ⌫ 
Only if the concentration exceeds 0,05 %. 
These substances may be used singly or in combination provided that the sum of the ratios of the levels of each of them in the cosmetic product expressed with reference to 
the maximum level authorized for each of them does not exceed 2. 

174 

EN 

 
  
 
 
 
                                                 
(cid:206)10 1. 
General use 

(cid:206)10 2. 
Professional 
use  

with them 

- Contains 
Hydroquinone 

(cid:206)10 - Rinse the 
eyes immediately 
if the product 
comes into contact 
with them 

Contains 
hydroquinone  

(cid:206)10 2. 

- For professional 
use only 

- Contains 
hydroquinone 

- Rinse the eyes 
immediately if the 
product comes 
into contact with 
them  

(cid:206)10 (b) 
Artificial nail 
systems  

(cid:206)10 0,02 % 
(after mixing 
for use)  

(cid:206)10 Profession
al use only  

(cid:206)10 (b) 

- For professional 
use only 

EN 

175 

EN 

 
  
 
 
 
 
(cid:206)11 1
5a  

(cid:206)11 Potassium or 
sodium hydroxide  

⌦ Potassium 
hydroxide, sodium 
hydroxide ⌫ 

(cid:206)11 (a) Nail 
cuticle 
solvent  

(cid:206)11 (a) 5 % 
by weight42  

(cid:206)11 (b) Hair 
straightener  

(cid:206)11 (b)  

(cid:206)11 1. 2 % by 
weight43  

(cid:206)11 1. General 
use  

- Avoid skin 
contact 

- Read directions 
for use 
carefully  

(cid:206)11 (a) Contains 
alkali. Avoid 
contact with eyes. 
Can cause 
blindness. Keep 
out of reach of 
children  

(cid:206)11 (b)  

(cid:206)11 1. Contains 
alkali. Avoid 
contact with eyes. 
Can cause 
blindness. Keep 
out of reach of 
children  

42 

43 

EN 

(cid:206)1 The quantity of sodium, potassium or lithium hydroxide is expressed as weight of sodium hydroxide. In cases of mixtures, the sum should not exceed the limits given in 
column d.  
(cid:206)1 The quantity of sodium, potassium or lithium hydroxide is expressed as weight of sodium hydroxide. In cases of mixtures, the sum should not exceed the limits given in 
column d.  

176 

EN 

 
  
 
 
 
 
 
                                                 
(cid:206)12 1
5b  

(cid:206)12 Lithium 
hydroxide  

⌦ Lithium 
hydroxide ⌫ 

depilatories  

(cid:206)11 (d) Other 
uses as pH 
adjuster  

(cid:206)12 (a) Hair 
straighteners 
 

(cid:206)11 2. 4,5 % 
by weight44  

(cid:206)11 2. 
Professional 
use  

(cid:206)11 (c) pH 
adjuster 

(cid:206)11 (c) Up to 
pH 12,7  

(cid:206)11 2. For 
professional use 
only. Avoid 
contact with eyes. 
Can cause 
blindness.  

(cid:206)11 (c) Keep out 
of reach of 
children. Avoid 
contact with 
eyes  

(cid:206)11 (d) Up to 
pH 11  

(cid:206)12 (a)  

(cid:206)12 (a)  

(cid:206)12 1. 
2 %45 by 
weight  

(cid:206)12 1. General 
use  

(cid:206)12 1. Contains 
alkali 

Avoid contact 
with eyes 

44 

45 

EN 

(cid:206)1 The quantity of sodium, potassium or lithium hydroxide is expressed as weight of sodium hydroxide. In cases of mixtures, the sum should not exceed the limits given in 
column d.  
(cid:206)3 The concentration of sodium, potassium or lithium hydroxide is expressed as weight of sodium hydroxide. In case of mixtures, the sum should not exceed the limits 
given in column d.  

177 

EN 

 
  
 
 
 
 
 
 
 
 
 
                                                 
Can cause 
blindness 

Keep out of reach 
of children  

(cid:206)12 2. 
4,5 %46 by 
weight  

(cid:206)12 2. 
Professional 
use  

(cid:206)12 2. For 
professional use 
only 

Avoid contact 
with eyes 

Can cause 
blindness  

(cid:206)12 (b) Contains 
alkali 

Keep out of reach 
of children 

Avoid contact 
with eyes  

(cid:206)12 (b) pH 
value ⌦ < ⌫ 
not to exceed 
pH 12,7  

(cid:206)12 (c) pH 
value ⌦ < ⌫ 
not to exceed 

(cid:206)12 (b) pH 
adjuster — for 
depilatories  

(cid:206)12 (c) Other 
uses — as pH 
adjuster (for 
rinse-off 

46 

EN 

(cid:206)3 The concentration of sodium, potassium or lithium hydroxide is expressed as weight of sodium hydroxide. In case of mixtures, the sum should not exceed the limits 
given in column d.  

178 

EN 

 
  
 
 
 
 
                                                 
(cid:206)12 1
5c  

(cid:206)12 Calcium 
hydroxide  

⌦ Calcium 
hydroxide ⌫ 

(cid:206)13 1
6  

(cid:206)13 1-Naphthol and its 
salts  

⌦ 1-Naphtol ⌫ 

products 
only)  

(cid:206)12 ⌦ (a) ⌫ 
Hair 
straighteners 
containing two 
components: 
calcium 
hydroxide and 
a guanidine 
salt  

(cid:206)12 (b) pH 
ajuster — for 
depilatories  

(cid:206)12 (c) Other 
uses (e.g. pH 
adjuster, 
processing 
aid)  

(cid:206)13 Oxidising 
colouring 
agents for hair 

pH 11  

(cid:206)12 (a) 7 % 
by weight of 
(as calcium 
hydroxide)  

(cid:206)12 (b) pH 
value not to 
exceed pH 
⌦ < ⌫ 
12,7  

(cid:206)12 (c) pH 
value not to 
exceed pH 
⌦ < ⌫ 11  

(cid:206)12 (a) Contains 
alkali 

Avoid contact 
with eyes 

Keep out of reach 
of children 

Can cause 
blindness  

(cid:206)12 (b) Contains 
alkali 

Keep out of reach 
of children 

Avoid contact 
with eyes  

(cid:206)13 2,0 %   (cid:206)13 In 

combination 
with hydrogen 

(cid:206)13 Can cause 
allergice 

EN 

179 

EN 

 
  
 
 
 
 
 
 
 
 
(cid:206)1 1
7  

(cid:206)1 1
8  

(cid:206)14 -
--  

(cid:206)1 2
1  

(cid:206)1 Sodium nitrite   ⌦ Sodium nitrite ⌫ 

(cid:206)1 Nitromethane  ⌦ Nitromethane ⌫ 

(cid:206)14 ---  

⌦ Cinchonan-9-ol, 6'-
methoxy-, (8.alpha., 
9R) and its salts ⌫  

(cid:206)1Quinine  

dyening  

(cid:206)1 Rust 
inhibitor  

reaction  

peroxide the 
maximum use 
concentration 
upon 
application is 
1,0 %  

(cid:206)1 0,2 %   (cid:206)1 Do not use 
with secondary 
and/or tertiary 
amines or other 
substances 
forming 
nitrosamines  

(cid:206)14 ---  

(cid:206)1 Rust 
inhibitor  

(cid:206)1 0,3 %  

(cid:206)14 ---  

(cid:206)14 ---  

(cid:206)1 (a) 
Shampoos  

(cid:206)1 (b) Hair 
lotions  

(cid:206)1 (a) 0,5 % 
calculated (as 
quinine 
base)  

(cid:206)1 (b) 0,2 % 
calculated (as 
quinine 
base)  

EN 

180 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
(cid:206)1 Resorcinol47   ⌦ Resorcinol ⌫ 

(cid:206)1 2
2  

(cid:206)1 (a) 5 %  

(cid:206)1 (a)  

(cid:206)1 (a) 
Oxidizing 
colouring 
agent for hair 
dyeing  

(cid:206)1 1. general 
use  

(cid:206)1 2. 
professional 
use  

(cid:206)1 1. Contains 
resorcinol. Rinse 
hair well after 
application. Do 
not use to dye 
eyelashes or 
eyebrows. 

Rinse eyes 
immediately if 
product comes 
into contact with 
them  

(cid:206)1 2. For 
professional use 
only. Contains 
resorcinol. 

Rinse eyes 
immediately if 
product comes 

47 

EN 

These substances may be used singly or in combination provided that the sum of the ratios of the levels of each of them in the cosmetic product expressed with reference to 
the maximum level authorized for each of them does not exceed 2. 

181 

EN 

 
  
 
 
 
 
 
 
 
 
                                                 
(cid:206)1 2
3  

(cid:206)1 (a) Alkali 
sulphides  

⌦ Barium sulfide ⌫ 

(cid:206)1 (b) Alkaline earth 
sulphides  

⌦ Barium sulfide ⌫ 

(cid:206)1 2
4  

(cid:206)1 Water-soluble zinc 
salts with the exception 
of zinc 4-hydroxy-
benzenesulphonate and 
zinc pyrithione  

⌦ Zinc acetate, zinc 
chloride, zinc 
glucomate, zinc 
glutamate ⌫ 

(cid:206)1 2
5  

(cid:206)1 Zinc 4-
hydroxybenzene 
sulphonate  

⌦ Zinc 
phenolsulfonate ⌫ 

(cid:206)1 (b) Hair 
lotions and 
shampoos  

(cid:206)1 (a) 
Depilatories 
 

(cid:206)1 (b) 
Depilatories 
 

(cid:206)1 (b) 
0,5 %  

(cid:206)1 (a) 2 % 
calculated (as 
sulphur) 
pH ≤ 12,7  

(cid:206)1 (b) 6 % 
calculated (as 
sulphur) 
pH ≤ 12,7  

(cid:206)1 1 % 
calculated (as 
zinc)  

(cid:206)1 Deodorant
s, 
antiperspirants 
and astringent 
lotions  

(cid:206)1 6 % 
calculated (as 
% of 
anhydrous 
substance)  

into contact with 
them  

(cid:206)1 (b) Contains 
resorcinol  

(cid:206)1 (a) Keep out 
of reach of 
children. Avoid 
contact with 
eyes  

(cid:206)1 (b) Keep out 
of reach of 
children. Avoid 
contact with 
eyes  

(cid:206)1 Avoid contact 
with eyes  

(cid:206)1 2 (cid:206)1 Sodium 

(cid:206)1 Oral 

(cid:206)1 0,15 % 

(cid:206)1 Contains 

EN 

182 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
6   Ammonium 

monofluorophosphate 
 

hygiene 
products  

calculated (as 
F). When 
mixed with 
other fluorine 
compounds 
permitted 
under this 
Annex, total F 
concentration 
must not 
exceed 
0,15 %  

ammonium 
monofluorophosp
hate  

(cid:206)31 For any 
toothpaste 
containing 0,1 to 
0,15 % fluoride 
unless it is already 
labelled as contra-
indicated for 
children (e.g. “for 
adult use only”) 
the following 
labelling is 
obligatory: 

“Children of 6 
years and 
younger: Use a 
pea sized amount 
for supervised 
brushing to 
minimize 
swallowing. In 
case of intake of 
fluoride from 
other sources 
consult a dentist or 
doctor.”   

(cid:206)1 2 ⌦ Disodium 

(cid:206)1 Sodium 

(cid:206)1 Ditto   (cid:206)1 0,15 % 

(cid:206)1 Contains 

EN 

183 

EN 

 
  
 
 
 
7  

fluorophosphate ⌫ 

monofluorophosphate
 

Ditto  

sodium 
monofluorophosp
hate  

(cid:206)31 For any 
toothpaste 
containing 0,1 to 
0,15 % fluoride 
unless it is already 
labelled as contra-
indicated for 
children (e.g. “for 
adult use only”) 
the following 
labelling is 
obligatory: 

“Children of 6 
years and 
younger: Use a 
pea sized amount 
for supervised 
brushing to 
minimize 
swallowing. In 
case of intake of 
fluoride from 
other sources 
consult a dentist or 
doctor.”   

(cid:206)1 2 ⌦ Dipotassium 

(cid:206)1 Potassium 

(cid:206)1 Ditto   (cid:206)1 0,15 % 

(cid:206)1 Contains 

EN 

184 

EN 

 
  
 
 
 
8  

fluorophosphate ⌫ 

monofluorophosphate
 

Ditto  

potassium 
monofluorophosp
hate 

(cid:206)31 For any 
toothpaste 
containing 0,1 to 
0,15 % fluoride 
unless it is already 
labelled as contra-
indicated for 
children (e.g. “for 
adult use only”) 
the following 
labelling is 
obligatory: 

“Children of 6 
years and 
younger: Use a 
pea sized amount 
for supervised 
brushing to 
minimize 
swallowing. In 
case of intake of 
fluoride from 
other sources 
consult a dentist or 
doctor.”   

(cid:206)1 2 ⌦ Calcium 

(cid:206)1 Calcium 

(cid:206)1 Ditto   (cid:206)1 0,15 % 

(cid:206)1 Contains 

EN 

185 

EN 

 
  
 
 
 
9  

fluorophosphate ⌫ 

monofluorophosphate 
 

Ditto  

calcium 
monofluorophosp
hate  

(cid:206)31 For any 
toothpaste 
containing 0,1 to 
0,15 % fluoride 
unless it is already 
labelled as contra-
indicated for 
children (e.g. “for 
adult use only”) 
the following 
labelling is 
obligatory: 

“Children of 6 
years and 
younger: Use a 
pea sized amount 
for supervised 
brushing to 
minimize 
swallowing. In 
case of intake of 
fluoride from 
other sources 
consult a dentist or 
doctor.”   

(cid:206)1 3 ⌦ Calcium 

(cid:206)1 Calcium 

(cid:206)1 Ditto   (cid:206)1 0,15 % 

(cid:206)1 Contains 

EN 

186 

EN 

 
  
 
 
 
0  

fluoride ⌫  

fluoride  

Ditto  

(cid:206)1 3
1  

⌦ Sodium 
fluoride ⌫  

(cid:206)1 Sodium 
fluoride  

(cid:206)1 Ditto   (cid:206)1 0,15 % 

calcium 
fluoride  

(cid:206)31 For any 
toothpaste 
containing 0,1 to 
0,15 % fluoride 
unless it is already 
labelled as contra-
indicated for 
children (e.g. “for 
adult use only”) 
the following 
labelling is 
obligatory: 

“Children of 6 
years and 
younger: Use a 
pea sized amount 
for supervised 
brushing to 
minimize 
swallowing. In 
case of intake of 
fluoride from 
other sources 
consult a dentist or 
doctor.”   

(cid:206)1 Contains 
sodium 

EN 

187 

EN 

 
  
 
 
 
Ditto  

(cid:206)1 3
2  

⌦ Potassium 
fluoride ⌫  

(cid:206)1 Potassium 
fluoride  

(cid:206)1 Ditto   (cid:206)1 0,15 % 

Ditto  

fluoride  

(cid:206)31 For any 
toothpaste 
containing 0,1 to 
0,15 % fluoride 
unless it is already 
labelled as contra-
indicated for 
children (e.g. “for 
adult use only”) 
the following 
labelling is 
obligatory: 

“Children of 6 
years and 
younger: Use a 
pea sized amount 
for supervised 
brushing to 
minimize 
swallowing. In 
case of intake of 
fluoride from 
other sources 
consult a dentist or 
doctor.”   

(cid:206)1 Contains 
potassium 
fluoride  

EN 

188 

EN 

 
  
 
 
 
(cid:206)1 3
3  

(cid:206)1 Ammonium 
fluoride  

⌦ Ammonium 
fluoride ⌫  

(cid:206)1 Ditto   (cid:206)1 0,15 % 

Ditto  

(cid:206)1 Contains 
ammonium 
fluoride  

(cid:206)31 For any 
toothpaste 
containing 0,1 to 
0,15 % fluoride 
unless it is already 
labelled as contra-
indicated for 
children (e.g. “for 
adult use only”) 
the following 
labelling is 
obligatory: 

“Children of 6 
years and 
younger: Use a 
pea sized amount 
for supervised 
brushing to 
minimize 
swallowing. In 
case of intake of 
fluoride from 
other sources 
consult a dentist or 
doctor.”   

EN 

189 

EN 

 
  
 
 
 
(cid:206)1 3
4  

(cid:206)1 Aluminium 
fluoride  

⌦ Aluminium 
fluoride ⌫  

(cid:206)1 Ditto   (cid:206)1 0,15 % 

Ditto  

(cid:206)1 Contains 
aluminium 
fluoride  

(cid:206)31 For any 
toothpaste 
containing 0,1 to 
0,15 % fluoride 
unless it is already 
labelled as contra-
indicated for 
children (e.g. “for 
adult use only”) 
the following 
labelling is 
obligatory: 

“Children of 6 
years and 
younger: Use a 
pea sized amount 
for supervised 
brushing to 
minimize 
swallowing. In 
case of intake of 
fluoride from 
other sources 
consult a dentist or 
doctor.”   

EN 

190 

EN 

 
  
 
 
 
(cid:206)1 3
5  

⌦ Tin difluoride ⌫  (cid:206)1 Stannous 

fluoride  

(cid:206)1 Ditto   (cid:206)1 0,15 % 

Ditto  

(cid:206)1 Contains 
stannous 
fluoride  

(cid:206)31 For any 
toothpaste 
containing 0,1 to 
0,15 % fluoride 
unless it is already 
labelled as contra-
indicated for 
children (e.g. “for 
adult use only”) 
the following 
labelling is 
obligatory: 

“Children of 6 
years and 
younger: Use a 
pea sized amount 
for supervised 
brushing to 
minimize 
swallowing. In 
case of intake of 
fluoride from 
other sources 
consult a dentist or 
doctor.”   

EN 

191 

EN 

 
  
 
 
 
(cid:206)1 3
6  

(cid:206)1 Hexadecyl 
ammonium fluoride  

⌦ Cetylamine 
hydrofluoride ⌫ 

(cid:206)1 Ditto   (cid:206)1 0,15 % 

Ditto  

(cid:206)1 Contains 
hexadecyl 
ammonium 
fluoride  
⌦ Cetylamine 
hydrofluoride ⌫  

(cid:206)31 For any 
toothpaste 
containing 0,1 to 
0,15 % fluoride 
unless it is already 
labelled as contra-
indicated for 
children (e.g. “for 
adult use only”) 
the following 
labelling is 
obligatory: 

“Children of 6 
years and 
younger: Use a 
pea sized amount 
for supervised 
brushing to 
minimize 
swallowing. In 
case of intake of 
fluoride from 
other sources 

EN 

192 

EN 

 
  
 
 
 
⌦ Olaflur ⌫ 

(cid:206)1 Ditto   (cid:206)1 0,15 % 

Ditto  

(cid:206)1 3
7  

(cid:206)1 3-(N-Hexadecyl-N-
2-
hydroxyethylammonio) 
propylbis (2-
hydroxyethyl) 
ammonium 
difluoride  

consult a dentist or 
doctor.”   

(cid:206)1 Contains 3-
(N-Hexadecyl-N-
2-
hydroxyethylamm
onio) propylbis (2-
hydroxyethyl) 
ammonium 
difluoride  
⌦ Olaflur ⌫  

(cid:206)31 For any 
toothpaste 
containing 0,1 to 
0,15 % fluoride 
unless it is already 
labelled as contra-
indicated for 
children (e.g. “for 
adult use only”) 
the following 
labelling is 
obligatory: 

“Children of 6 
years and 
younger: Use a 
pea sized amount 
for supervised 
brushing to 

EN 

193 

EN 

 
  
 
 
 
(cid:206)1 3
8  

(cid:206)1 N,N',N'-
Tris(polyoxyethylene)-
N-
hexadecylpropylenedia
mine 
dihydrofluoride  

⌦ Palprityl 
trihydroxyethyl 
propylenediamine 
dihydrofluorid ⌫ 

(cid:206)1 Ditto   (cid:206)1 0,15 % 

Ditto  

minimize 
swallowing. In 
case of intake of 
fluoride from 
other sources 
consult a dentist or 
doctor.”   

(cid:206)1 Contains 
NN'N'-
tris(polyoxyethyle
ne)-N-
hexadecylpropyle
nediamine 
dihydrofluoride  

⌦ Palprityl 
trihydroxyethyl 
propylenediamine 
dihydrofluorid⌫ 

(cid:206)31 For any 
toothpaste 
containing 0,1 to 
0,15 % fluoride 
unless it is already 
labelled as contra-
indicated for 
children (e.g. “for 
adult use only”) 
the following 
labelling is 

EN 

194 

EN 

 
  
 
 
 
(cid:206)1 3
9  

⌦ 9-Octadecenamine, 
hydrofluoride ⌫ 

(cid:206)1 Octadecenyl-
ammonium 
fluoride  

(cid:206)1 Ditto   (cid:206)1 0,15 % 

Ditto  

obligatory: 

“Children of 6 
years and 
younger: Use a 
pea sized amount 
for supervised 
brushing to 
minimize 
swallowing. In 
case of intake of 
fluoride from 
other sources 
consult a dentist or 
doctor.”   

(cid:206)1 Contains 
octadecenyl-
ammonium 
fluoride  

(cid:206)31 For any 
toothpaste 
containing 0,1 to 
0,15 % fluoride 
unless it is already 
labelled as contra-
indicated for 
children (e.g. “for 
adult use only”) 
the following 
labelling is 

EN 

195 

EN 

 
  
 
 
 
(cid:206)1 4
0  

⌦ Disodium 
hexafluorosilicate ⌫ 

(cid:206)1 Sodium 
fluorosilicate  

(cid:206)1 Ditto   (cid:206)1 0,15 % 

Ditto  

obligatory: 

“Children of 6 
years and 
younger: Use a 
pea sized amount 
for supervised 
brushing to 
minimize 
swallowing. In 
case of intake of 
fluoride from 
other sources 
consult a dentist or 
doctor.”   

(cid:206)1 Contains 
sodium 
fluorosilicate  

(cid:206)31 For any 
toothpaste 
containing 0,1 to 
0,15 % fluoride 
unless it is already 
labelled as contra-
indicated for 
children (e.g. “for 
adult use only”) 
the following 
labelling is 
obligatory: 

EN 

196 

EN 

 
  
 
 
 
(cid:206)1 4
1  

⌦ Dipotassium 
hexafluorosilicate ⌫ 

(cid:206)1 Potassium 
fluorosilicate  

(cid:206)1 Ditto   (cid:206)1 0,15 % 

Ditto  

“Children of 6 
years and 
younger: Use a 
pea sized amount 
for supervised 
brushing to 
minimize 
swallowing. In 
case of intake of 
fluoride from 
other sources 
consult a dentist or 
doctor.”   

(cid:206)1 Contains 
potassium 
fluorosilicate  

(cid:206)31 For any 
toothpaste 
containing 0,1 to 
0,15 % fluoride 
unless it is already 
labelled as contra-
indicated for 
children (e.g. “for 
adult use only”) 
the following 
labelling is 
obligatory: 

“Children of 6 

EN 

197 

EN 

 
  
 
 
 
(cid:206)1 4
2  

⌦ Ammonium 
hexafluorosilicate ⌫ 

(cid:206)1 Ammonium 
fluorosilicate  

(cid:206)1 Ditto   (cid:206)1 0,15 % 

Ditto  

years and 
younger: Use a 
pea sized amount 
for supervised 
brushing to 
minimize 
swallowing. In 
case of intake of 
fluoride from 
other sources 
consult a dentist or 
doctor.”   

(cid:206)1 Contains 
ammonium 
fluorosilicate  

(cid:206)31 For any 
toothpaste 
containing 0,1 to 
0,15 % fluoride 
unless it is already 
labelled as contra-
indicated for 
children (e.g. “for 
adult use only”) 
the following 
labelling is 
obligatory: 

“Children of 6 
years and 

EN 

198 

EN 

 
  
 
 
 
(cid:206)1 4
3  

⌦ Magnesium 
hexafluorosilicate ⌫ 

(cid:206)1 Magnesium 
fluorosilicate  

(cid:206)1 Ditto   (cid:206)1 0,15 % 

Ditto  

younger: Use a 
pea sized amount 
for supervised 
brushing to 
minimize 
swallowing. In 
case of intake of 
fluoride from 
other sources 
consult a dentist or 
doctor.”   

(cid:206)1 Containes 
(SIC! Contains) 
magnesium 
fluorosilicate  

(cid:206)31 For any 
toothpaste 
containing 0,1 to 
0,15 % fluoride 
unless it is already 
labelled as contra-
indicated for 
children (e.g. “for 
adult use only”) 
the following 
labelling is 
obligatory: 

“Children of 6 
years and 

EN 

199 

EN 

 
  
 
 
 
younger: Use a 
pea sized amount 
for supervised 
brushing to 
minimize 
swallowing. In 
case of intake of 
fluoride from 
other sources 
consult a dentist or 
doctor.”   

(cid:206)15 Contains 1,3-
bis 
(hydroxymethyl) 
immidazolidine-2-
thione  

⌦ Dimethylol 
ethylene 
thiourea ⌫  

(cid:206)15 (a) Up to 
2 % 

(b) Up to 
2 %  

(cid:206)15 (a) Hair- 
⌦ products 
⌫ care 
preparations 

(b) Nail- 
⌦ products 
⌫ care 
preparations 
 

(cid:206)15 (a) 
Prohibited 
⌦ No use ⌫ 
in aerosol 
dispensers 
(sprays) 

(b) The pH of 
the product as 
applied must be 
less ⌦ < ⌫ 
than 4  

(cid:206)1 Solvents, 
perfumes and 
flavourings  

⌦ For 
purposes other 
than inhibiting 
the 

(cid:206)15 4
4  

(cid:206)15 1,3-Bis 
(hydroxymethyl)imidaz
olidine-2-thione  

⌦ Dimethylol 
ethylene thiourea ⌫ 

(cid:206)1 Benzyl alcohol   ⌦ Benzyl 
alcohol ⌫  

⌦ 100-
51-6 ⌫ 

⌦ 202-
859-9 ⌫ 

(cid:206)1 4
5  
⌦ 48 
⌫ 

48 

⌦ As preservative, see Annex V, No. 34. ⌫ 

EN 

200 

EN 

 
  
 
 
 
 
                                                 
(cid:206)16 4
6  

(cid:206)16 6-
Methylcoumarin  

⌦ 6-
Methylcoumarin ⌫  

(cid:206)17 4
7  

⌦ 3-
Pyridinemethanol, 
hydrofluoride ⌫ 

(cid:206)17 Nicomethanol 
hydrofluoride  

(cid:206)16 Oral 
hygiene 
products  

(cid:206)17 Oral 
hygiene 
products  

EN 

201 

development 
of micro-
organisms in 
the product. 
This purpose 
has to be 
apparent from 
the 
presentation of 
the 
product. ⌫ 

(cid:206)16 0,003 % 
 

(cid:206)17 0,15 % 

calculated (as 
F) 

When mixed 
with other 
fluorine 
compounds 
permitted 
under this 
Annex, total F 
concentration 
must not 
exceed 
0,15 %  

(cid:206)17 Contains 
nicomethanol 
hydrofluoride  

(cid:206)31 For any 
toothpaste 
containing 0,1 to 
0,15 % fluoride 
unless it is already 
labelled as contra-
indicated for 
children (e.g. “for 
adult use only”) 
the following 
labelling is 
obligatory: 

EN 

 
  
 
 
 
 
 
 
 
(cid:206)17 4
8  

(cid:206)17 Silver nitrate   ⌦ Silver nitrate ⌫  

(cid:206)18 4
9  

⌦ Selenium 
sulfide ⌫ 

(cid:206)18 Selenium 
disulphide  

(cid:206)17 4 %  

(cid:206)17 Solely for 
products 
intended 
⌦ Only ⌫ 
for colouring 
eyelashes and 
eyebrows  

(cid:206)18 Antidandr
uff 
shampoos  

(cid:206)18 1 %  

“Children of 6 
years and 
younger: Use a 
pea sized amount 
for supervised 
brushing to 
minimize 
swallowing. In 
case of intake of 
fluoride from 
other sources 
consult a dentist or 
doctor.”   

(cid:206)17 Contains 
silver nitrate 

Rinse the eyes 
immediately if 
product comes 
into contact with 
them  

(cid:206)18 Contains 
selenium 
disulphide 

Avoid contact 
with eyes or 

EN 

202 

EN 

 
  
 
 
 
 
 
 
 
(cid:206)18 5
0  

(cid:206)18 Aluminium 
zirconium chloride 
hydroxyde complexes 

AlxZr(OH)yClz and the 
aluminium zirconium 
chloride sydroxide 
glycine complexes  

(cid:206)18 Antipersp
irants  

(cid:206)18 20 % (as 
anhydrous 
aluminium 
zirconium 
chloride 
hydroxide) 

5,4 % (as 
zirconium)  

damaged skin  

(cid:206)18 Do not apply 
to irritated or 
damaged skin  

(cid:206)18 1. The 
ratio of the 
number of 
aluminium 
atoms to that of 
zirconium 
atoms must be 
between two an 
10 

2. The ratio of 
the number of 
(Al + Zr) atoms 
to that of 
chlorine atoms 
must be 
between 0,9 and 
2,1 

3. Prohibited 
⌦ No use ⌫ 
in aerosol 
dispensers 
(sprays)  

(cid:206)4 5
1  

(cid:206)4 Quinolin-8-ol and 
bis (8-hydroxy-
quinolium) sulphate  

⌦ Oxyquinoline and 
oxyquinoline 
sulfate ⌫ 

(cid:206)4 Stabilizer 
for hydrogen 
peroxide in 
rinse-off hair- 
⌦ products 

(cid:206)4 0,3 % 
calculated (as 
base)  

EN 

203 

EN 

 
  
 
 
 
 
 
 
 
⌫ care 
preparations 
 

(cid:206)4 Stabilizer 
for hydrogen 
peroxide in 
⌦ leave-on 
hair 
products ⌫ 
non-rinse-off 
hair-care 
preparations 
 

(cid:206)9 Denaturant 
for ethanol and 
isopropyl 
alcohol  

(cid:206)4 (a) Hair- 
⌦ product ⌫ 
care  

(cid:206)4 (b) 
Soap  

(cid:206)4 0,03 % 
calculated (as 
base)  

(cid:206)9 5 % 
calculated (as 
a % ethanol 
and isopropyl 
alcohol)  

(cid:206)4 1,5 % 
expressed (as 
etidronic 
acid)  

(cid:206)4 0,2 % 
expressed as 
etidronic 
acid  

204 

EN 

(cid:206)9 Methanol  

⌦ Methyl alcohol ⌫  

(cid:206)4 (1-
Hhydroxyethylidene-
di-phosphonic acid and 
its salts)  

⌦ Etidronic acid ⌫ 

(cid:206)9 5
2  

(cid:206)4 5
3  

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
(cid:206)4 5
4  
⌦ 49 
⌫ 

(cid:206)19 -
--  

(cid:206)20 5
6  

(cid:206)4 1-Phenoxy-propan-
2-ol  

⌦ Phenoxyisopropan
ol ⌫ 

(cid:206)4 2 %  

(cid:206)4 — ⌦ Use 
only in ⌫ 
rinse-off 
products 
only  

(cid:206)4 — 
Prohibited 
⌦ No use ⌫ 
in oral hygiene 
products  

(cid:206)4 As a 
preservative, 
see AnnexVI, 
Part 1, No 
43  

⌦ For 
purposes other 
than inhibiting 
the 
development of 
micro-
organisms in 
the product. 
This purpose 
has to be 
apparent from 
the presentation 
of the 
product. ⌫ 

(cid:206)19 ---  

(cid:206)19 ---  

(cid:206)19 ---  

(cid:206)19 ---  

(cid:206)20 Magnesium 
fluoride  

⌦ Magnesium 
fluoride ⌫  

(cid:206)20 Dental 
⌦ Oral ⌫ 
hygiene 
products  

(cid:206)20 0,15 % 
calculated (as 
F). When 
mixed with 
other fluorine 
compounds 

(cid:206)20 Contains 
magnesium 
fluoride  

49 

⌦ As a preservative, see Annex V, No 43. ⌫ 

EN 

205 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
                                                 
(cid:206)21 5
7  

(cid:206)21 Strontium chloride 
hexahydrate  

⌦ Strontium 
chloride ⌫  

(cid:206)21 Contains 
strontium 
chloride. Frequent 
use by children is 
not advisable  

(cid:206)21 (a) 
Toothpaste  

⌦ Oral 
products ⌫ 

(cid:206)21 (b) 
Shampoo and 
face care 
products  

permitted 
under this 
Annex, total F 
concentration 
must not 
exceed 
0,15 %  

(cid:206)21 3,5 %, 
calculated (as 
strontium). 
When mixed 
with other 
permitted 
strontium 
products the 
total strontium 
content must 
not exceed 
3,5 %  

(cid:206)21 2,1 %, 
calculated (as 
strontium). 
When mixed 
with other 
permitted 
strontium 
products the 
total strontium 
content must 
not exceed 

EN 

206 

EN 

 
  
 
 
 
 
 
 
 
(cid:206)6 5
8  

(cid:206)6 Strontium acetate 
hemihydrate  

⌦ Strontium 
acetate ⌫ 

(cid:206)6 Toothpaste
  ⌦ Oral 
products ⌫ 

2,1 %  

(cid:206)6 3,5 %, 
calculated (as 
strontium). 
When mixed 
with other 
permitted 
strontium 
products the 
total strontium 
content must 
not exceed 
3,5 %  

(cid:206)6 Contains 
strontium acetate. 
Frequent use by 
children is not 
advisable  

(cid:206)31 For any 
toothpaste 
containing 0,1 to 
0,15 % fluoride 
unless it is already 
labelled as contra-
indicated for 
children (e.g. “for 
adult use only”) 
the following 
labelling is 
obligatory: 

“Children of 6 
years and 
younger: Use a 
pea sized amount 
for supervised 
brushing to 
minimize 
swallowing. In 
case of intake of 
fluoride from 
other sources 

EN 

207 

EN 

 
  
 
 
 
(cid:206)22 5
9  

(cid:206)22 Talc: Hydrated 
magnesium silicate  

⌦ Talc ⌫ 

(cid:206)24 6
0  

(cid:206)24 Fatty acid 
dialkylamides and 
dialkanolamides  

(cid:206)22 (a) 
Powdery 
products 
intended to be 
used for 
children under 
three years of 
age 

(b) other 
products  

consult a dentist or 
doctor.”   

(cid:206)23 (a) Keep 
powder away from 
children's nose 
and mouth  

(cid:206)24 Maximu
m secondary 
amine content: 
0,5 %  

(cid:206)24 - Do not 
use with 
nitrosating 
systems 

- Maximum 
secondary 
amine content: 
5 % (applies to 
raw materials) 

- Maximum 
nitrosamine 
content: 
50 µg/kg 

- Keep in 

EN 

208 

EN 

 
  
 
 
 
 
 
 
 
 
 
(cid:206)24 6
1  

(cid:206)24 Monoalkylamines, 
monoalkanolamines 
and their salts  

⌦ Ethanolamine, 
Isopropanolimine, 
Methyl thioglycolate, 
Methyethanolamine 
⌫ 

nitrite-free 
containers  

(cid:206)24 Maximu
m secondary 
amine content: 
0,5 %  

(cid:206)24 - Do not 
use with 
nitrosating 
systems 

–  Minimum 

purity: 99 % 

–  Maximum 
secondary 
amine 
content: 
0,5 % 
(applies 
raw 
materials) 

to 

–  Maximum 

nitrosamine 
content: 
50 µg/kg 

–  Keep 

in 

nitrite-free 
containers 
 

(cid:206)24 (a) (b) 

–  Do  not  use 

(cid:206)24 6
2  

(cid:206)24 Trialkylamines, 
trialkanolamines and 

⌦ Triethanolamine, 
Triisopropanolamine, 

(cid:206)24 (a) 
⌦ Leave-on 

(cid:206)24 (a) 
2,5 %  

EN 

209 

EN 

 
  
 
 
 
 
 
 
 
their salts  

Trilaurylamine ⌫ 

products ⌫ 
Non-rinse-off 
products 

(b) Other 
products  

⌦ Rinse-off 
products ⌫ 

with 
nitrosating 
systems 

–  Minimum 

purity: 99 % 

–  Maximum 
secondary 
amine 
content: 
0,5 % 
(applies 
raw 
materials) 

to 

–  Maximum 

nitrosamine 
content: 
50 µg/kg 

–  Keep 

in 

nitrite-free 
containers 
 

(cid:206)22 6
3  

(cid:206)22 Strontium 
hydroxide  

⌦ Strontium 
hydroxide ⌫ 

(cid:206)22 pH-
regulator in 
depilatory 
products  

(cid:206)22 3,5 % 
calculated (as 
strontium), 
max. pH of 
12,7  

(cid:206)22 - Keep out of 
reach of children 

- Avoid contact 
with the eyes  

EN 

210 

EN 

 
  
 
 
 
(cid:206)22 6
4  

(cid:206)22 Strontium 
peroxide  

⌦ Strontium 
peroxide ⌫ 

(cid:206)22 Rinse-off 
hair products 
care 
preparations  

professional 
use  

(cid:206)22 4,5 % 
calculated (as 
strontium) in 
the ready-for-
use 
preparation  

(cid:206)22 All 
products must 
meet the 
hydrogen 
peroxide release 
requirements  

⌦ professional 
use ⌫  

(cid:206)25 6
5  

(cid:206)25 Benzalkonium 
Chloride, bromide and 
saccharinate  
⌦ 50 ⌫ 

(cid:206)25 (a) Rinse-
off hair (head) 
care 
products  

(cid:206)25 (a) 3 % 
(as 
benzalkonium 
chloride)  

(cid:206)25 (a) In the 
final products 
the 
concentrations 
of 
benzalkonium 
chloride, 
bromide and 
saccharinate 
with an alkyl 
chain of C14, or 
less must not 
exceed 0,1 % 
(as 

(cid:206)22 - Avoid 
contact with eyes 

- Rinse eyes 
immediately if 
product comes 
into contact with 
them 

- For professional 
use only 

- Wear suitable 
gloves  

(cid:206)25 (a) Avoid 
contact with the 
eyes  

50 

⌦ As a preservative, see Annex V, No. 54. ⌫ 

EN 

211 

EN 

 
  
 
 
 
 
 
                                                 
benzalkonium 
chloride)  

⌦ For 
purposes other 
than inhibiting 
the 
development of 
micro-
organisms in 
the product. 
This purpose 
has to be 
apparent from 
the presentation 
of the 
product. ⌫ 

(cid:206)25 (b) Other 
products  

(cid:206)25 (b) 0,1 % 
(as 
benzalkonium 
chloride)  

(cid:206)25 (b) Avoid 
contact with the 
eyes  

(cid:206)26 (a) Body-
care leave-on 
products  

(cid:206)26 (b) Other 
cosmetic 

(cid:206)26 (a) 
Maximum 
residual 
acrylamide 
content 
0,1 mg/kg  

(cid:206)26 (b) 
Maximum 

(cid:206)26 6
6  

(cid:206)26 Polyacrylamides 
 

EN 

212 

EN 

 
  
 
 
 
 
 
 
 
 
products  

(cid:206)27 6
7  

⌦ 2-
Benzylideneheptanal 
⌫ 

(cid:206)27 Amyl 
cinnamal  

122-40-7 

residual 
acrylamide 
content 
0,5 mg/kg  

(cid:206)27 The 
presence of the 
substance must 
be indicated in 
the list of 
ingredients 
referred to in 
Article 
146(1)(g) when 
its 
concentration 
exceeds: 

in 

–  0,001 % 
leave-on 
products 

–  0,01 % 

in 

rinse-off 
products  

(cid:206)27 The 
presence of the 
substance must 
be indicated in 
the list of 
ingredients 

(cid:206)27 Benzyl alcohol  ⌦ Benzyl alcohol ⌫  100-51-6  

(cid:206)27 6
8  

EN 

213 

EN 

 
  
 
 
 
 
 
 
 
 
(cid:206)27 6
9  

⌦ Cinnamyl 
alcohol ⌫ 

(cid:206)27 Cinnamyl 
alcohol  

104-54-1 

referred to in 
Article 
146(1)(g) when 
its 
concentration 
exceeds: 

in 

–  0,001 % 
leave-on 
products 

–  0,01 % 

in 

rinse-off 
products  

(cid:206)27 The 
presence of the 
substance must 
be indicated in 
the list of 
ingredients 
referred to in 
Article 
146(1)(g) when 
its 
concentration 
exceeds: 

in 

–  0,001 % 
leave-on 
products 

EN 

214 

EN 

 
  
 
 
 
 
(cid:206)27 7
0  

(cid:206)27 Citral  

5392-40-
5 

(cid:206)27 7
1  

⌦ Phenol, 2-methoxy-
4-(2-propenyl) ⌫ 

(cid:206)27 Eugenol  

97-53-0 

–  0,01 % 

in 

rinse-off 
products  

(cid:206)27 The 
presence of the 
substance must 
be indicated in 
the list of 
ingredients 
referred to in 
Article 
146(1)(g) when 
its 
concentration 
exceeds: 

in 

–  0,001 % 
leave-on 
products 

–  0,01 % 

in 

rinse-off 
products  

(cid:206)27 The 
presence of the 
substance must 
be indicated in 
the list of 
ingredients 
referred to in 

EN 

215 

EN 

 
  
 
 
 
 
 
 
 
 
 
(cid:206)27 7
2  

⌦ 7-Hydroxy-
citronellal ⌫ 

(cid:206)27 Hydroxy-
citronellal  

107-75-5 

Article 
146(1)(g) when 
its 
concentration 
exceeds: 

in 

–  0,001 % 
leave-on 
products 

–  0,01 % 

in 

rinse-off 
products  

(cid:206)27 The 
presence of the 
substance must 
be indicated in 
the list of 
ingredients 
referred to in 
Article 
146(1)(g) when 
its 
concentration 
exceeds: 

in 

–  0,001 % 
leave-on 
products 

–  0,01 % 

in 

EN 

216 

EN 

 
  
 
 
 
 
(cid:206)27 7
3  

 ⌦ Phenol, 2-
methoxy-4-(1-
propenyl)- ⌫ 

(cid:206)27 Isoeugenol  

97-54-1 

(cid:206)27 7
4  

⌦ 2-Pentyl-3-
phenylprop-2-en-1-
ol ⌫ 

(cid:206)27 Amylcin namyl 
alcohol 

101-85-9 

rinse-off 
products  

(cid:206)27 The 
presence of the 
substance must 
be indicated in 
the list of 
ingredients 
referred to in 
Article 
146(1)(g) when 
its 
concentration 
exceeds: 

in 

–  0,001 % 
leave-on 
products 

–  0,01 % 

in 

rinse-off 
products  

(cid:206)27 The 
presence of the 
substance must 
be indicated in 
the list of 
ingredients 
referred to in 
Article 

EN 

217 

EN 

 
  
 
 
 
 
 
 
 
 
(cid:206)27 7
5  

 ⌦ Benzyl 
salicylate ⌫ 

(cid:206)27 Benzyl 
salicylate  

118-58-1 

146(1)(g) when 
its 
concentration 
exceeds: 

in 

–  0,001 % 
leave-on 
products 

–  0,01 % 

in 

rinse-off 
products  

(cid:206)27 The 
presence of the 
substance must 
be indicated in 
the list of 
ingredients 
referred to in 
Article 
146(1)(g) when 
its 
concentration 
exceeds: 

in 

–  0,001 % 
leave-on 
products 

–  0,01 % 

in 

rinse-off 

EN 

218 

EN 

 
  
 
 
 
 
(cid:206)27 7
6  

⌦ Cinnamaldehyde 
⌫ 

(cid:206)27 Cinnamal  

104-55-2 

(cid:206)27 7
7  

⌦ Coumarin ⌫ 

(cid:206)27 Coumarin  

91-64-5 

products  

(cid:206)27 The 
presence of the 
substance must 
be indicated in 
the list of 
ingredients 
referred to in 
Article 
146(1)(g) when 
its 
concentration 
exceeds: 

in 

–  0,001 % 
leave-on 
products 

–  0,01 % 

in 

rinse-off 
products  

(cid:206)27 The 
presence of the 
substance must 
be indicated in 
the list of 
ingredients 
referred to in 
Article 
146(1)(g) when 

EN 

219 

EN 

 
  
 
 
 
 
 
 
 
 
(cid:206)27 7
8  

⌦ 2,6-Octadien-1-ol, 
3,7-dimethyl-, (2E)- ⌫ 

(cid:206)27 Geraniol  

106-24-1 

its 
concentration 
exceeds: 

in 

–  0,001 % 
leave-on 
products 

–  0,01 % 

in 

rinse-off 
products  

(cid:206)27 The 
presence of the 
substance must 
be indicated in 
the list of 
ingredients 
referred to in 
Article 
146(1)(g) when 
its 
concentration 
exceeds: 

in 

–  0,001 % 
leave-on 
products 

–  0,01 % 

in 

rinse-off 
products  

EN 

220 

EN 

 
  
 
 
 
 
(cid:206)27 7
9  

(cid:206)27 Hydroxy-
methylpentylcyclohexe
necarboxaldehyde  

⌦ Hydroxy-isohexyl 
3-cyclohexene 
carboxaldehyde ⌫ 

31906-
04-4 ⌦ , 
51414-
25-6 ⌫ 

(cid:206)27 8
0  

(cid:206)27 Anisyl alcohol   ⌦ Anisyl alcohol, 

anise alcohol 
alcohol ⌫ 

⌦ 105-
13-5 ⌫ 

(cid:206)27 The 
presence of the 
substance must 
be indicated in 
the list of 
ingredients 
referred to in 
Article 
146(1)(g) when 
its 
concentration 
exceeds: 

in 

–  0,001 % 
leave-on 
products 

–  0,01 % 

in 

rinse-off 
products  

(cid:206)27 The 
presence of the 
substance must 
be indicated in 
the list of 
ingredients 
referred to in 
Article 
146(1)(g) when 
its 
concentration 

EN 

221 

EN 

 
  
 
 
 
 
 
 
 
 
(cid:206)27 8
1  

 ⌦ 2-Propenoic acid, 
3-phenyl, phenylmethyl 
ester ⌫ 

(cid:206)27 Benzyl 
cinnamate  

103-41-3 

(cid:206)27 8 ⌦ 2,6,10-Dodecatrien- (cid:206)27 Farnesol  

4602-84-

exceeds: 

in 

–  0,001 % 
leave-on 
products 

–  0,01 % 

in 

rinse-off 
products  

(cid:206)27 The 
presence of the 
substance must 
be indicated in 
the list of 
ingredients 
referred to in 
Article 
146(1)(g) when 
its 
concentration 
exceeds: 

in 

–  0,001 % 
leave-on 
products 

–  0,01 % 

in 

rinse-off 
products  

(cid:206)27 The 

EN 

222 

EN 

 
  
 
 
 
 
 
 
 
 
2  

1-ol, 3,7,11-trimethyl-
 ⌫ 

0 

(cid:206)27 8
3  

(cid:206)27 2-(4-tert-
bButylbenzyl)propional
dehyde 

⌦ Butylphenyl 
methylpropional ⌫ 

80-54-6 

presence of the 
substance must 
be indicated in 
the list of 
ingredients 
referred to in 
Article 
146(1)(g) when 
its 
concentration 
exceeds: 

in 

–  0,001 % 
leave-on 
products 

–  0,01 % 

in 

rinse-off 
products  

(cid:206)27 The 
presence of the 
substance must 
be indicated in 
the list of 
ingredients 
referred to in 
Article 
146(1)(g) when 
its 
concentration 
exceeds: 

EN 

223 

EN 

 
  
 
 
 
 
(cid:206)27 8
4  

⌦ 1,6-Octadien-3-ol, 
3,7-dimethyl- ⌫ 

(cid:206)27 Linalool  

78-70-6 

(cid:206)27 8
5  

⌦ Benzyl 
benzoate ⌫ 

(cid:206)27 Benzyl 
benzoate  

120-51-4 

in 

–  0,001 % 
leave-on 
products 

–  0,01 % 

in 

rinse-off 
products  

(cid:206)27 The 
presence of the 
substance must 
be indicated in 
the list of 
ingredients 
referred to in 
Article 
146(1)(g) when 
its 
concentration 
exceeds: 

in 

–  0,001 % 
leave-on 
products 

–  0,01 % 

in 

rinse-off 
products  

(cid:206)27 The 
presence of the 
substance must 

EN 

224 

EN 

 
  
 
 
 
 
 
 
 
 
(cid:206)27 8
6  

 ⌦ Citronellol ⌫ 

(cid:206)27 Citronellol  

106-22-9 

be indicated in 
the list of 
ingredients 
referred to in 
Article 
146(1)(g) when 
its 
concentration 
exceeds: 

in 

–  0,001 % 
leave-on 
products 

–  0,01 % 

in 

rinse-off 
products  

(cid:206)27 The 
presence of the 
substance must 
be indicated in 
the list of 
ingredients 
referred to in 
Article 
146(1)(g) when 
its 
concentration 
exceeds: 

–  0,001 % 

in 

EN 

225 

EN 

 
  
 
 
 
 
(cid:206)27 8
7  

(cid:206)27 Hexyl cinnam-
al  

101-86-0 

(cid:206)27 8
8  

(cid:206)27 d-Limonene  

5989-27-
5 

leave-on 
products 

–  0,01 % 

in 

rinse-off 
products  

(cid:206)27 The 
presence of the 
substance must 
be indicated in 
the list of 
ingredients 
referred to in 
Article 
146(1)(g) when 
its 
concentration 
exceeds: 

in 

–  0,001 % 
leave-on 
products 

–  0,01 % 

in 

rinse-off 
products  

(cid:206)27 The 
presence of the 
substance must 
be indicated in 

EN 

226 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
(cid:206)27 8
9  

(cid:206)27 Methyl heptin 
carbonate  

⌦ Methyl 2-
octynoate ⌫ 

111-12-6 

⌦ Methyl oct-2-
ynoate ⌫ 

the list of 
ingredients 
referred to in 
Article 
146(1)(g) when 
its 
concentration 
exceeds: 

in 

–  0,001 % 
leave-on 
products 

–  0,01 % 

in 

rinse-off 
products  

(cid:206)27 The 
presence of the 
substance must 
be indicated in 
the list of 
ingredients 
referred to in 
Article 
146(1)(g) when 
its 
concentration 
exceeds: 

–  0,001 % 
leave-on 

in 

EN 

227 

EN 

 
  
 
 
 
 
(cid:206)27 9
0  

(cid:206)27 3-Methyl-4-(2,6,6-
tri-methyl-2-
cyclohexen-1-yl)-3-
buten-2-one  

⌦ alpha-Isomethyl 
ionone ⌫ 

127-51-5 

(cid:206)27 9
1  

(cid:206)27 Oak moss 
extract  

⌦ Evernia prunastri 
extract ⌫ 

90028-
68-5 

products 

–  0,01 % 

in 

rinse-off 
products 

(cid:206)27 The 
presence of the 
substance must 
be indicated in 
the list of 
ingredients 
referred to in 
Article 
146(1)(g) when 
its 
concentration 
exceeds: 

in 

–  0,001 % 
leave-on 
products 

–  0,01 % 

in 

rinse-off 
products 

(cid:206)27 The 
presence of the 
substance must 
be indicated in 
the list of 

EN 

228 

EN 

 
  
 
 
 
 
 
 
 
 
(cid:206)27 9
2  

(cid:206)27 Treemoss 
extract  

⌦ Evernia furfuracea 
extract ⌫ 

90028-
67-4 

ingredients 
referred to in 
Article 
146(1)(g) when 
its 
concentration 
exceeds: 

in 

–  0,001 % 
leave-on 
products 

–  0,01 % 

in 

rinse-off 
products 

(cid:206)27 The 
presence of the 
substance must 
be indicated in 
the list of 
ingredients 
referred to in 
Article 
146(1)(g) when 
its 
concentration 
exceeds: 

in 

–  0,001 % 
leave-on 
products 

EN 

229 

EN 

 
  
 
 
 
 
(cid:206)28 9
3  

(cid:206)28 2,4-
Pyrimidinediamine, 3-
oxide   

⌦ Diaminopyrimidin
e oxide ⌫ 

74638-
76-9 

(cid:206)28 9
4  

⌦ Dibenzoyl 
peroxide ⌫ 

(cid:206)28 Benzoyl 
peroxide  

–  0,01 % 

in 

rinse-off 
products 

(cid:206)28 1,5 %  

(cid:206)28 Hair 
⌦ products 
⌫ care 
formulations 
 

(cid:206)28 Artificial 
nail 
systems  

(cid:206)28 0,7 % 
(after 
mixing)  

(cid:206)28 Profession
al use only  

(cid:206)28 9
5  

(cid:206)28 Hydroquinone 
methylether  

⌦ Mequinol ⌫ 

(cid:206)28 Artificial 
nail 
systems  

(cid:206)28 0,02 % 
(after mixing 
for use)  

(cid:206)28 Profession
al use only  

(cid:206)28 - For 
professional use 
only 

- Avoid skin 
contact 

- Read directions 
for use 
carefully  

(cid:206)28 - For 
professional use 
only 

- Avoid skin 
contact 

Read directions 
for use 
carefully  

EN 

230 

EN 

 
  
 
 
 
 
 
 
 
 
 
(cid:206)29 9
6  

⌦ 5-tert-Butyl-2,4,6-
trinitro-m-xylene ⌫ 

(cid:206)29 Musk xylene  

81-15-2 

(cid:206)29 9
7  

⌦ 4’-tert-Butyl-2’,6’-
dimethyl-3’,5’-
dinitroacetophenone 
⌫ 

(cid:206)29Musk ketone  

81-14-1 

(cid:206)29 All 
cosmetic 
products, with 
the exception 
of oral care 
products  

(cid:206)29 All 
cosmetic 
products, with 
the exception 
of oral care 
products  

(a) 

(cid:206)29 
1,0 % in fine 
fragrance 

(b) 

0,4 % in eau 
de toilette 

(c) 
0,03 % in 
other 
products  

(a) 

(cid:206)29 
1,4 % in fine 
fragrance 

(b) 

0,56 % in eau 
de toilette 

(c) 
0,042 % in 
other 
products  

(cid:206)30 9
8 51 

 ⌦ Salicylic acid ⌫   (cid:206)30Salicylic acid 

69-72-7 

(cid:206)30 a) Rinse-
off hair 
products 

(cid:206)30 a) 3,0 % 

b) 2,0 %  

(cid:206)30 Not to be 
used in 
preparations for 

(cid:206)30 Not to be 
used for children 
under three 

51 

As a preservative, see Annex VI, Part 1, No 3. 

EN 

231 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
                                                 
b) Other 
products  

(cid:206)30 9
9 53 

(cid:206)30 Inorganic sulfites 
and bisulfites  

⌦ Ammonium 
bisulfite, ammonium 
sulfite, potassium 
metabisulfite, 
potassium sulfite, 
sodium bisulfite, 
sodium hydrosulfite, 
sodium metabisulfite, 

(cid:206)30 a) 
Oxidative hair 
dye products 

(cid:206)30 a) 0,67 % 
expressed (as 
free SO2) 

b) Hair 
straightening 
products 

b) 6,7 % 
expressed (as 
free SO2) 

c) Self tanning 

c) 0,45 % 

52 
53 

Solely for products which might be used for children under three years of age and which remain in prolonged contact with the skin. 
As a preservative, see Annex VI, Part 1, No 9. 

⌦ 3 ⌫ years of 
age52  

(cid:206)30  

children under 
three ⌦ 3 ⌫ 
years of age, 
except for 
shampoos. 

For purposes 
other than 
inhibiting the 
development of 
micro-
organisms in 
the product. 
This purpose 
has to be 
apparent from 
the presentation 
of the 
product.  

(cid:206)30 For 
purposes other 
than inhibiting 
the 
development of 
micro-
organisms in 
the product. 

EN 

232 

EN 

 
  
 
 
                                                                                                                                                                                                                                                    
sodium sulfite ⌫ 

products for 
the face 

expressed (as 
free SO2) 

d) Other self 
tanning 
products  

d) 0,40 % 
expressed (as 
free SO2)  

This purpose 
has to be 
apparent from 
the presentation 
of the 
product.  

(cid:206)30 1
00 
54 

⌦ 1-(4-
Chlorophenyl)-3-(3,4-
dichlorophenyl)urea ⌫ 

(cid:206)30 Triclocarban  

101-20-2 

(cid:206)30 Rinse-off 
products  

(cid:206)30 1,5 %   (cid:206)30 Purity 

(cid:206)30  

criteria: 

3,3',4,4'-
Tetrachloroazo
benzene 
≤ 1 ppm 

3,3',4,4'-
Tetrachloroazo
xybenzene 
≤ 1 ppm 

For purposes 
other than 
inhibiting the 
development of 
micro-
organisms in 
the product. 
This purpose 
has to be 

54 

As a preservative, See Annex VI, Part 1, No 23. 

EN 

233 

EN 

 
  
 
                                                 
(cid:206)30 1
01 
55 

⌦ Pyrithione zinc ⌫  (cid:206)30 Zinc 

pyrithione  

13463-
41-7 

(cid:206)30 Leave-on 
hair 
products  

apparent from 
the presentation 
of the 
product.  

(cid:206)30 0,1 %   (cid:206)30 For 

(cid:206)30  

purposes other 
than inhibiting 
the 
development of 
micro-
organisms in 
the product. 
This purpose 
has to be 
apparent from 
the presentation 
of the 
product.  

102  ⌦ 1,2-Dimethoxy-4-
(2-propenyl)-
benzene ⌫ 

⌦ Methyl 
eugenol ⌫ 

⌦ 93-
15-2 ⌫ 

⌦ 202-
223-0 ⌫ 

⌦ fine 
fragrance ⌫ 

⌦ 0,01 % 

0,004 % 

0,002 % 

⌦ eau de 
toilette ⌫ 

⌦ fragrance 
cream ⌫ 

⌦ in other 

55 

As a preservative, see Annex VI, Part 1, No 8. 

EN 

234 

EN 

 
  
 
 
 
 
                                                 
leave-on 
products and 
oral ⌫ 
hygiene 
⌦ products 
⌫ 

⌦ rinse-off 
products ⌫ 

0,0002 %  

0,001 % ⌫ 

: 

except for 
normal content 
in the natural 
essences used 
and provided 
that the 
concentration 
does not 
exceed 

EN 

235 

EN 

 
  
 
 
 
 
 
 
 
(cid:208) 86/199/EEC (adapted) 
(cid:206)1 88/667/EEC 
(cid:206)2 2002/34/EC Art. 1 and Annex .3 
(cid:206)3 2007/67/EC Art. 1 
(cid:206)4 2002/34/EC Art. 1 and Annex .3 amended by Corrigendum, OJ L 151, 19.6.2003, p. 44 

(cid:174)1 PART 2 (cid:173) 

LIST OF SUBSTANCES PROVISIONALLY ALLOWED 

Refere
nce 
numbe
r 

Substance 

Field of 
application 
and/or use 

Restrictions 

Maximum 
authorized 
concentration in 
the finished 
cosmetic 
product 

Other limitations 
and requirements 

Allowed 
until 

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

(cid:206)2 10
53  

(cid:206)2 4-Amino-3-
nitrophenol and its 
salts  

610-
81-1 

⌦ 4-
Amino-
3-
nitrophe
nol ⌫ 

(cid:206)2 (a) 
3,0 %  

(cid:206)2 (a) 
Oxidising 
colouring 
agents for hair 
dyeing  

(cid:206)2 In 
combination with 
hydrogen 
peroxide the 
maximum use 

(cid:206)2 (a) (b) Can 
cause allergic 
reaction  

EN 

236 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
(cid:206)2 (b) 
3,0 %  

(cid:206)2 (b) Non-
oxidising 
colouring 
agents for hair 
dyeing  

concentration 
upon application 
is 1,5 %  

⌦ No use 
after ⌫ 
(cid:206)3 31.12.2009 
 

(cid:206)2 10
64  

(cid:206)2 2,7-Naphthalenediol 
and its salts  

582-
17-2 

⌦ Nap
hthalene
-2,7-diol 
(CI 
76645). 
⌫ 

(cid:206)2 Oxidising 
colouring 
agents for hair 
dyeing  

(cid:206)2 1,0 %   (cid:206)2 In 

combination with 
hydrogen 
peroxide the 
maximum use 
concentration 
upon application 
is 0,5 %  

⌦ No use 
after ⌫ 
(cid:206)3 31.12.2009 
 

(cid:206)2 10
75  

(cid:206)2 m-Aminophenol and 
its salts  

591-
27-5  

⌦ 3-
Aminop
henol 
(CI 
76545). 
⌫ 

(cid:206)2 Oxidising 
colouring 
agents for hair 
dyeing  

(cid:206)2 Can cause 
allergic 
reaction  

(cid:206)2 2,0 %   (cid:206)2 In 

combination with 
hydrogen 
peroxide the 
maximum use 
concentration 
upon application 
is 1,0 %  

EN 

237 

EN 

 
  
 
 
 
 
 
 
(cid:206)2 10
86  

(cid:206)2 2,6-Dihydroxy-3,4-
dimethylpyridine and its 
salts  

84540-
47-6 

⌦ 2,6-
Dihydro
xy-3,4-
dimethyl
pyridine 
⌫  

(cid:206)2 Oxidising 
colouring 
agents for hair 
dyeing  

(cid:206)2 10
97  

⌦ 1-hydroxy-3-nitro-4-
(3-
hydroxypropylamino)be
nzene and its salts ⌫ 

92952-
81-3 

(cid:206)2 4-
Hydroxy
propyla
mino-3-
nitrophe
nol  

(cid:206)2 (a) 
5,2 %  

(cid:206)2 (b) 
2,6 %  

(cid:206)2 (a) 
Oxidising 
colouring 
agents for hair 
dyeing  

(cid:206)2 (b) Non-
oxidising 
colouring 
agents for hair 
dyeing  

⌦ No use 
after ⌫ 
(cid:206)3 31.12.2009 
 

(cid:206)2 2,0 %   (cid:206)2 In 

combination with 
hydrogen 
peroxide the 
maximum use 
concentration 
upon application 
is 1,0 %  

⌦ No use 
after ⌫ 
(cid:206)3 31.12.2009 
 

(cid:206)2 In 
combination with 
hydrogen 
peroxide the 
maximum use 
concentration 
upon application 
is 2,6 %  

⌦ No use 
after ⌫ 
(cid:206)3 31.12.2009 

(cid:206)2 (a) (b) Can 
cause allergic 
reaction  

EN 

238 

EN 

 
  
 
 
 
 
 
 
(cid:206)2 11
19  

⌦ 1-[(2'-
methoxyethyl)amino]-2-
nitro-4-[di-(2'-
hydroxyethyl)amino]ben
zene and its salts ⌫ 

(cid:206)2 HC 
Blue No 
11 

23920-
15-2 

(cid:206)2 11
20  

⌦ 1-methyl-3-nitro-4-
(.beta.-
hydroxyethyl)aminobenz
ene and its salts ⌫ 

100418
-33-5 

(cid:206)2 Hyd
roxyethy
l-2-
nitro-p-
toluidine 
 

(cid:206)2 (a) 
3,0 %  

(cid:206)2 (b) 
2,0 %  

(cid:206)2 (a) 
2,0 %  

(cid:206)2 (b) 
1,0 %  

(cid:206)2 (a) 
Oxidising 
colouring 
agents for hair 
dyeing  

(cid:206)2 (b) Non-
oxidising 
colouring 
agents for hair 
dyeing  

(cid:206)2 (a) 
Oxidising 
colouring 
agents for hair 
dyeing  

(cid:206)2 (b) Non-
oxidising 
colouring 
agents for hair 
dyeing  

(cid:206)2 (a) (b) Can 
cause allergic 
reaction  

(cid:206)2 (a) (b) Can 
cause allergic 
reaction  

 

(cid:206)2 In 
combination with 
hydrogen 
peroxide the 
maximum use 
concentration 
upon application 
is 1,5 %  

⌦ No use 
after ⌫ 
(cid:206)3 31.12.2009 
 

(cid:206)2 In 
combination with 
hydrogen 
peroxide the 
maximum use 
concentration 
upon application 
is 1,0 %  

⌦ No use 
after ⌫ 
(cid:206)3 31.12.2009 
 

EN 

239 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
(cid:206)2 11
3  

⌦ 1-hydroxy-2-.beta.-
hydroxyethylamino-4,6-
dinitrobenzene and its 
salts ⌫ 

99610-
72-7 

(cid:206)2 2-
Hydroxy
ethylpicr
amic 
acid  

(cid:206)2 11
42  

⌦ 4-
methylaminophenol and 
its salts ⌫  

150-
75-4 

(cid:206)2 p-
Methyla
minophe
nol  

(cid:206)2 (a) (b) Can 
cause allergic 
reaction  

(cid:206)2 Can cause 
allergic 
reaction  

(cid:206)2 (a) 
Oxidising 
colouring 
agents for hair 
dyeing  

(cid:206)2 (b) Non-
oxidising 
colouring 
agents for hair 
dyeing  

(cid:206)2 Oxidising 
colouring 
agent for hair 
dyeing  

(cid:206)2 (a) 
3,0 %  

(cid:206)2 (b) 
2,0 %  

(cid:206)2 In 
combination with 
hydrogen 
peroxide the 
maximum use 
concentration 
upon application 
is 1,5 %  

⌦ No use 
after ⌫ 
(cid:206)3 31.12.2009 
 

(cid:206)2 3,0 %   (cid:206)2 In 

combination with 
hydrogen 
peroxide the 
maximum use 
concentration 
upon application 
is 1,5 %  

⌦ No use 
after ⌫ 
(cid:206)3 31.12.2009 
 

(cid:206)2 11 ⌦ 1-(3-

hydroxypropylamino)-2-

(cid:206)2 HC 
Violet 

104226

(cid:206)2 Non-
oxidising 

(cid:206)2 2,0 %   ⌦ No use 

after ⌫ 

EN 

240 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
64  

nitro-4-bis(2-
hydroxyethylamino)benz
ene and its salts ⌫ 

No 2  

-19-9 

colouring 
agent for hair 
dyeing  

(cid:206)2 11
86  

⌦ 1-(.beta.-
Hydroxyethyl)amino-2-
nitro-4-N-ethyl-N-
(.beta.-
hydroxyethyl)aminobenz
ene and its salts ⌫ 

(cid:206)2 HC 
Blue No 
12  

104516
-93-0 

(cid:206)2 11
98  

⌦ 4,4'-[1,3-
propanediylbis(oxy)]bis-
, benzene-1,3-diamine 
and its salts ⌫ 

81892-
72-0 

(cid:206)2 1,3-
Bis-(2,4-
diamino
phenoxy
)propane 
 

(cid:206)2 (a) 
Oxidising 
colouring 
agents for hair 
dyeing  

(cid:206)2 (b) Non-
oxidising 
colouring 
agents for hair 
dyeing  

(cid:206)2 Oxidising 
colouring 
agents for hair 
dyeing  

(cid:206)2 (a) 
1,5 %  

(cid:206)2 (b) 
1,5 %  

(cid:206)3 31.12.2009 
 

(cid:206)2 In 
combination with 
hydrogen 
peroxide the 
maximum use 
concentration 
upon application 
is 0,75 %  

⌦ No use 
after ⌫ 
(cid:206)3 31.12.2009 
 

(cid:206)2 2,0 %   (cid:206)2 In 

combination with 
hydrogen 
peroxide the 
maximum use 
concentration 
upon application 
is 1,0 %  

⌦ No use 
after ⌫ 
(cid:206)3 31.12.2009 

(cid:206)2 (a) (b) Can 
cause allergic 
reaction  

(cid:206)2 Can cause 
allergic 
reaction  

EN 

241 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
(cid:206)2 12
09  

(cid:206)4 3-Amino-2,4-
dichlorophenol and its 
salts  

61693-
43-4 

⌦ 3-
Amino-
2,4-
dichloro
phenol 
⌫  

(cid:206)2 Oxidising 
colouring 
agents for hair 
dyeing  

(cid:206)2 12
10  

⌦ 3-methyl-1-phenyl-
5-pyrazolone and its 
salts ⌫ 

89-25-
8 

(cid:206)2 Phe
nyl 
methyl 
pyrazolo
ne  

(cid:206)2 Oxidising 
colouring 
agents for hair 
dyeing  

(cid:206)2 Can cause 
allergic 
reaction  

 

(cid:206)2 2,0 %   (cid:206)2 In 

combination with 
hydrogen 
peroxide the 
maximum use 
concentration 
upon application 
is 1,0 %  

⌦ No use 
after ⌫ 
(cid:206)3 31.12.2009 
 

(cid:206)2 0,5 %   (cid:206)2 In 

combination with 
hydrogen 
peroxide the 
maximum use 
concentration 
upon application 
is 0,25 %  

⌦ No use 
after ⌫ 
(cid:206)3 31.12.2009 
 

(cid:206)2 12
21  

⌦ 5-[(2-
hydroxyethyl)amino]-o-

(cid:206)2 2-
Methyl-

55302-
96-0 

(cid:206)2 Oxidising 
colouring 

(cid:206)2 2,0 %   (cid:206)2 In 

combination with 

(cid:206)2 Can cause 
allergic 

EN 

242 

EN 

 
  
 
 
 
 
 
 
 
 
cresol. and its salts ⌫ 

5-
hydroxy
ethylami
nopheno
l  

agents for hair 
dyeing  

(cid:206)2 12
32  

⌦ 3,4-dihydro-2H-1,4-
benzoxazin-6-ol and its 
salts ⌫ 

26021-
57-8 

(cid:206)2 Hyd
roxyben
zomorph
oline  

(cid:206)2 Oxidising 
colouring 
agents for hair 
dyeing  

reaction  

hydrogen 
peroxide the 
maximum use 
concentration 
upon application 
is 1,0 %  

⌦ No use 
after ⌫ 
(cid:206)3 31.12.2009 
 

(cid:206)2 Can cause 
allergic 
reaction  

(cid:206)2 2,0 %   (cid:206)2 In 

combination with 
hydrogen 
peroxide the 
maximum use 
concentration 
upon application 
is 1,0 %  

⌦ No use 
after ⌫ 
(cid:206)3 31.12.2009 
 

(cid:206)2 12
4  

⌦ 1,5-bis(.beta.-
hydroxyethyl)amino-2-
nitro-4-chlorobenzene 
and its salts ⌫ 

(cid:206)2 HC 
Yellow 
No 10 
 

109023
-83-8 

(cid:206)2 Non-
oxidising 
colouring 
agents for hair 
dyeing  

(cid:206)2 0,2 %   ⌦ No use 

after ⌫ 
(cid:206)3 31.12.2009 
 

EN 

243 

EN 

 
  
 
 
 
 
 
 
 
(cid:206)2 12
5  

⌦ 3,5-diamino-2,6-
dimethoxypyridine 
dihydrochloride. and its 
salts ⌫ 

85679-
78-3 

(cid:206)2 2,6-
Dimetho
xy-3,5-
pyridine
diamine 
 

(cid:206)2 Oxidising 
colouring 
agents for hair 
dyeing  

(cid:206)2 12
6  

⌦ 1-(2-
aminoethyl)amino-4-(2-
hydroxyethyl)oxy-2-
nitrobenzene and its 
salts ⌫ 

(cid:206)2 HC 
Orange 
No 2  

85765-
48-6 

(cid:206)2 12
7  

⌦ Ethanol, 2-[(4-
amino-2-methyl-5-
nitrophenyl)amino]-and 
its salts ⌫ 

(cid:206)2 HC 
Violet 
No 1  

82576-
75-8 

EN 

(cid:206)2 Non-
oxidising 
colouring 
agents for hair 
dyeing  

(cid:206)2 (a) 
Oxidising 
colouring 
agents for hair 
dyeing  

(cid:206)2 (b) Non-
oxidising 
colouring 
agents for hair 
dyeing  

244 

(cid:206)2 Can cause 
allergic 
reaction  

(cid:206)2 0,5 %   (cid:206)2 In 

combination with 
hydrogen 
peroxide the 
maximum use 
concentration 
upon application 
is 0,25 %  

⌦ No use 
after ⌫ 
(cid:206)3 31.12.2009 
 

(cid:206)2 1,0 %   ⌦ No use 

(cid:206)2 (a) 
0,5 %  

(cid:206)2 (b) 
0,5 %  

after ⌫ 
(cid:206)3 31.12.2009 
 

(cid:206)2 In 
combination with 
hydrogen 
peroxide the 
maximum use 
concentration 
upon application 
is 0,25 %  

⌦ No use 
after ⌫ 
(cid:206)3 31.12.2009 

EN 

 
  
 
 
 
 
 
 
 
 
 
(cid:206)2 12
8  

⌦ 2-[3-(methylamino)-
4-nitrophenoxy]ethanol 
and its salts ⌫ 

(cid:206)2 12
9  

⌦ 2-[(2-methoxy-4-
nitrophenyl)amino]ethan
ol and its salts ⌫ . 

59820-
63-2 

66095-
81-6 

(cid:206)2 3-
Methyla
mino-4-
nitro-
phenoxy
ethanol 
 

(cid:206)2 2-
Hydroxy
-
ethylami
no-5-
nitro-
anisole 
 

(cid:206)2 13
1  

⌦ 2,2'-[(4-amino-3-
nitrophenyl)imino]biseth
anol hydrochlorideand 
its salts ⌫ 

(cid:206)4 HC 
Red No 
13  

94158-
13-1 

 

(cid:206)2 1,0 %   ⌦ No use 

after ⌫ 
(cid:206)3 31.12.2009 
 

(cid:206)2 1,0 %   ⌦ No use 

after ⌫ 
(cid:206)3 31.12.2009 
 

(cid:206)2 Non-
oxidising 
colouring 
agents for hair 
dyeing  

(cid:206)2 Non-
oxidising 
colouring 
agents for hair 
dyeing  

(cid:206)2 (a) 
Oxidising 
colouring 
agents for hair 
dyeing  

(cid:206)2 (b) Non-
oxidising 
colouring 

(cid:206)2 (a) 
2,5 %  

(cid:206)2 (b) 
2,5 %  

(cid:206)2 In 
combination with 
hydrogen 
peroxide the 
maximum use 
concentration 
upon application 
is 1,25 %  

EN 

245 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
(cid:206)2 13
2  

⌦ Naphthalene-1,5-diol 
(CI 76625). and its 
salts ⌫ 

83-56-
7 

(cid:206)2 1,5-
Naphtha
lenediol 
 

(cid:206)2 13
3  

(cid:206)2 Hydroxypropyl bis 
(N-hydroxyethyl-p-
phenylenediamine) and 
its salts  

128729
-30-6 

agents for hair 
dyeing  

(cid:206)2 Oxidising 
colouring 
agents for hair 
dyeing  

(cid:206)2 Oxidising 
colouring 
agents for hair 
dyeing  

(cid:206)2 13
4  

(cid:206)2 o-Aminophenol and 
its salts  

95-55-
6 

⌦ o-
Aminop
henol 
⌫ 

(cid:206)2 Oxidising 
colouring 
agents for hair 
dyeing  

(cid:206)2 Can cause 
allergic 
reaction  

⌦ No use 
after ⌫ 
(cid:206)3 31.12.2009 
 

(cid:206)2 1,0 %   ⌦ No use 

after ⌫ 
(cid:206)3 31.12.2009 
 

(cid:206)2 3,0 %   (cid:206)2 In 

combination with 
hydrogen 
peroxide the 
maximum use 
concentration 
upon application 
is 1,5 %  

⌦ No use 
after ⌫ 
(cid:206)3 31.12.2009 
 

(cid:206)2 2,0 %   (cid:206)2 In 

combination with 
hydrogen 
peroxide the 
maximum use 
concentration 
upon application 

EN 

246 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
(cid:206)2 13
5  

⌦ 5-amino-o-cresol and 
its salts ⌫  

2835-
95-2 

(cid:206)2 4-
Amino-
2-
hydroxy
toluene 
 

(cid:206)2 Oxidising 
colouring 
agents for hair 
dyeing  

(cid:206)2 13
6  

⌦ 2,4-
Diaminophenoxyethano 
and its salts ⌫  

66422-
95-5 

(cid:206)4 2,4-
Diamino
phenoxy
ethanol 
 

(cid:206)2 Oxidising 
colouring 
agents for hair 
dyeing  

is 1,0 %  

⌦ No use 
after ⌫ 
(cid:206)3 31.12.2009 
 

(cid:206)2 3,0 %   (cid:206)2 In 

combination with 
hydrogen 
peroxide the 
maximum use 
concentration 
upon application 
is 1,5 %  

⌦ No use 
after ⌫ 
(cid:206)3 31.12.2009 
 

(cid:206)2 4,0 %   (cid:206)2 In 

combination with 
hydrogen 
peroxide the 
maximum use 
concentration 
upon application 
is 2,0 %  

⌦ No use 
after ⌫ 

EN 

247 

EN 

 
  
 
 
 
 
 
 
(cid:206)2 13
7  

⌦ 1,3-Benzenediol, 2-
methyl and its salts ⌫ - 

608-
25-3 

(cid:206)2 2-
Methylr
esorcino
l  

(cid:206)2 Oxidising 
colouring 
agents for hair 
dyeing  

(cid:206)2 13
8  

⌦ 4-Amino-m-cresol 
and its salts ⌫  

2835-
99-6 

(cid:206)2 4-
Amino-
m-cresol 
 

(cid:206)2 Oxidising 
colouring 
agents for hair 
dyeing  

(cid:206)3 31.12.2009 
 

(cid:206)2 2,0 %   (cid:206)2 In 

combination with 
hydrogen 
peroxide the 
maximum use 
concentration 
upon application 
is 1,0 %  

⌦ No use 
after ⌫ 
(cid:206)3 31.12.2009 
 

(cid:206)2 3,0 %   (cid:206)2 In 

combination with 
hydrogen 
peroxide the 
maximum use 
concentration 
upon application 
is 1,5 %  

⌦ No use 
after ⌫ 
(cid:206)3 31.12.2009 
 

(cid:206)2 13 ⌦ 2-[(3-amino-4-

(cid:206)2 2-

83763-

(cid:206)2 Oxidising  (cid:206)2 3,0 %   (cid:206)2 In 

EN 

248 

EN 

 
  
 
 
 
 
 
 
 
 
 
9  

methoxyphenyl)amino]e
thanol and its salts ⌫ . 

47-7 

Amino-
4-
hydroxy
ethylami
noanisol
e  

colouring 
agents for hair 
dyeing  

(cid:206)2 14
24  

(cid:206)2 Hydroxyethyl-3,4-
methylenedioxyaniline 
and its salts  

⌦ HCI 
⌫ 

81329-
90-0 

(cid:206)2 Oxidising 
colouring 
agents for hair 
dyeing  

combination with 
hydrogen 
peroxide the 
maximum use 
concentration 
upon application 
is 1,5 %  

⌦ No use 
after ⌫ 
(cid:206)3 31.12.2009 
 

(cid:206)2 3,0 %   (cid:206)2 In 

combination with 
hydrogen 
peroxide the 
maximum use 
concentration 
upon application 
is 1,5 %  

⌦ No use 
after ⌫ 
(cid:206)3 31.12.2009 
 

EN 

249 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
(cid:206)2 2,8 %   ⌦ No use 

(cid:206)2 14
57  

⌦ 2,2'-[[4-[(2-
hydroxyethyl)amino]-3-
nitrophenyl]imino]biseth
anol. and its salts ⌫ 

(cid:206)2 HC 
Blue No 
2  

33229-
34-4 

(cid:206)2 14
68  

⌦ 4-[(2-
hydroxyethyl)amino]-3-
nitrophenol. and its 
salts ⌫ 

65235-
31-6 

(cid:206)2 3-
Nitro-p-
hydroxy
ethylami
nopheno
l  

(cid:206)2 Non-
oxidising 
colouring 
agents for hair 
dyeing  

(cid:206)2 (a) 
Oxidising 
colouring 
agents for hair 
dyeing  

(cid:206)2 (b) Non-
oxidising 
colouring 
agents for hair 
dyeing  

(cid:206)2 (a) 
6,0 %  

(cid:206)2 (b) 
6,0 %  

(cid:206)2 14
79  

⌦ 1-(.beta.-
ureidoethyl)amino-4-
nitrobenzene and its 
salts ⌫ 

27080-
42-8 

(cid:206)2 4-
Nitrophe
nyl 
aminoet
hylurea 
 

EN 

(cid:206)2 (a) 
0,5 %  

(cid:206)2 (a) 
Oxidising 
colouring 
agents for hair 
dyeing  

(cid:206)2 (b) Non-
oxidising 

(cid:206)2 (b) 

250 

after ⌫ 
(cid:206)3 31.12.2009 
 

(cid:206)2 In 
combination with 
hydrogen 
peroxide the 
maximum use 
concentration 
upon application 
is 3,0 %  

⌦ No use 
after ⌫ 
(cid:206)3 31.12.2009 
 

(cid:206)2 In 
combination with 
hydrogen 
peroxide the 
maximum use 
concentration 
upon application 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
(cid:206)2 14
850  

⌦ 1-amino-2-nitro-4-
(2',3'-
dihydroxypropyl)amino-
5-chlorobenzene and 
1,4-bis-(2',3'-
dihydroxypropyl)amino-
2-nitro-5-chlorobenzene 

(cid:206)2 HC 
Red No 
10 
and HC 
Red No 
11  

95576-
89-9 
and 
95576-
92-4 

And 

1,4-bis-(2',3'-
dihydroxypropyl)amino-
2-nitro-5-chlorobenzene 
and its salts ⌫ 

(cid:206)2 (a) 
2,0 %  

(cid:206)2 (b) 
1,0 %  

(cid:206)2 (a) 
Oxidising 
colouring 
agents for hair 
dyeing  

(cid:206)2 (b) Non-
oxidising 
colouring 
agents for hair 
dyeing  

colouring 
agents for hair 
dyeing  

0,5 %  

is 0,25 %  

⌦ No use 
after ⌫ 
(cid:206)3 31.12.2009 
 

(cid:206)2 In 
combination with 
hydrogen 
peroxide the 
maximum use 
concentration 
upon application 
is 1,0 %  

⌦ No use 
after ⌫ 
(cid:206)3 31.12.2009 
 

EN 

251 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
(cid:206)2 15
355  

⌦ Phenol, 2-chloro-6-
(ethylamino)-4-nitro-
 and its salts ⌫ 

(cid:206)2 15
456  

(cid:206)2 2-Amino-6-chloro-
4-nitrophenol and its 
salts  

131657
-78-8 

(cid:206)2 2-
Chloro-
6-
ethylami
no-4-
nitrophe
nol  

6358-
09-4)  

⌦ 2-
Amino-
6-
chloro-
4-
nitrophe
nol ⌫  

(cid:206)2 (a) 
3,0 %  

(cid:206)2 (b) 
3,0 %  

(cid:206)2 (a) 
2,0 %  

(cid:206)2 (b) 
2,0 %  

(cid:206)2 (a) 
Oxidising 
colouring 
agents for hair 
dyeing  

(cid:206)2 (b) Non-
oxidising 
colouring 
agents for hair 
dyeing  

(cid:206)2 (a) 
Oxidising 
colouring 
agents for hair 
dyeing  

(cid:206)2 (b) Non-
oxidising 
colouring 
agents for hair 
dyeing  

(cid:206)2 In 
combination with 
hydrogen 
peroxide the 
maximum use 
concentration 
upon application 
is 1,5 %  

⌦ No use 
after ⌫ 
(cid:206)3 31.12.2009 
 

(cid:206)2 In 
combination with 
hydrogen 
peroxide the 
maximum use 
concentration 
upon application 
is 1,0 %  

⌦ No use 
after ⌫ 
(cid:206)3 31.12.2009 
 

EN 

252 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
(cid:206)2 15
57  

⌦ [4-[[4-anilino-1-
naphthyl][4-
(dimethylamino)phenyl]
methylene]cyclohexa-
2,5-dien-1-
ylidene]dimethylammon
ium chloride (CI 44045). 
and its salts ⌫ 

2580-
56-5 

(cid:206)2 Basi
c Blue 
26 (CI 
44045) 
 

(cid:206)2 15
658  

(cid:206)2 15
759  

(cid:206)2 15
860  

⌦ Disodium 5-amino-
4-hydroxy-3-
(phenylazo)naphthalene-
2,7-disulphonate (CI 
17200). and its salts ⌫ 

⌦ Disodium 3-[(2,4-
dimethyl-5-
sulphonatophenyl)azo]-
4-hydroxynaphthalene-
1-sulphonate (14700). 
and its salts ⌫ 

⌦ (4-(4-
Aminophenyl)(4-
iminocyclohexa-2,5-
dienylidene)methyl)-2-
methylaniline 

3567-
66-6 

4548-
53-2 

(cid:206)2 Acid 
Red 33 
(CI 
17200) 
 

(cid:206)2 Pon
ceau SX 
(CI 
14700) 
 

632-
99-5 

(cid:206)2 Basi
c Violet 
14 (CI 
42510) 

(cid:206)2 (a) 
Oxidising 
colouring 
agents for hair 
dyeing  

(cid:206)2 (b) Non-
oxidising 
colouring 
agents for hair 
dyeing  

(cid:206)2 Non-
oxidising 
colouring 
agents for hair 
dyeing  

(cid:206)2 Non-
oxidising 
colouring 
agents for hair 
dyeing  

(cid:206)2 (a) 
0,5 %  

(cid:206)2 (b) 
0,5 %  

(cid:206)2 In 
combination with 
hydrogen 
peroxide the 
maximum use 
concentration 
upon application 
is 0,25 %  

⌦ No use 
after ⌫ 
(cid:206)3 31.12.2009 
 

(cid:206)2 2,0 %   ⌦ No use 

after ⌫ 
(cid:206)3 31.12.2009 
 

(cid:206)2 2,0 %   ⌦ No use 

after ⌫ 
(cid:206)3 31.12.2009 
 

(cid:206)2 (a) 
Oxidising 
colouring 
agents for hair 

(cid:206)2 (a) 
0,3 %  

(cid:206)2 In 
combination with 
hydrogen 
peroxide the 
maximum use 

EN 

253 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
hydrochloride (CI 
42510). and its salts ⌫ 

 

dyeing  

(cid:206)2 (b) Non-
oxidising 
colouring 
agents for hair 
dyeing  

(cid:206)2 (b) 
0,3 %  

concentration 
upon application 
is 0,15 %  

⌦ No use 
after ⌫ 
(cid:206)3 31.12.2009 
 

EN 

254 

EN 

 
  
 
(cid:208) 76/768/EEC 

ANNEX IV 

(cid:208) 86/179/EEC (adapted) 
(cid:206)1 88/667/EEC 
(cid:206)2 90/121/EEC 

(cid:174)1 PART 1 (cid:173) 

LIST OF ⌦ COLORANTS ⌫ COLOURING AGENTS ALLOWED FOR USE IN COSMETIC PRODUCTS56 

⌦ PREAMBLE ⌫ 

⌦ Without prejudice to other provisions in this Directive, a colorant expressed as salt shall include lakes and its other salts. ⌫ 

Column 1  = 

Colouring agents allowed in all cosmetic products. 

Column 2  = 

Colouring agents allowed in all cosmetic products except those intended to 
be applied in the vicinity of the eyes, in particular eye make-up and eye 
make-up remover. 

Column 3  = 

Colouring agents allowed exclusively in cosmetic products intended not to 
come into contact with the mucous membranes. 

Column 4  = 

Colouring agents allowed exclusively in cosmetic products intended to 
come into contact only briefly with the skin. 

56 

EN 

Lakes or salts of these colouring agents using substances not prohibited under Annex II or not excluded under Annex V from the scope of this Directive are equally allowed. 

255 

EN 

 
  
 
 
                                                 
⌦ 
Refe
renc
e 
num
ber 
°⌫ 

a 

⌦ 1
 ⌫ 

⌦ Substance identification ⌫ 

⌦ Conditions ⌫ Field of application 

⌦ CAS 
number ⌫

⌦ EINECS/
ELINCS 
number ⌫ 

Colour  ⌦ Product type, 
Body parts ⌫ 
Field of 
application 

⌦ Maximum 
concentration 
⌫ 

Other 
limitations and 
requirements57 

⌦ Wordin
g of 
conditions 
of use and 
warnings 
⌫ 

⌦ Chemical Name ⌫ 

Colour index 

Number 
⌦ as 
contained in 
glossary ⌫ 
or 
denomination

1 

2 

3 

4 

g 

X ⌦ Rinse-off 
products ⌫ 

f 

Green 

h 

i 

j 

b 

c 

d 

e 

⌦ Sodium tris(1,2-
naphthoquinone 1-oximato-
O,O')ferrate(1-) ⌫ 

10006 

57 

EN 

Colouring agents whose number is preceded by the letter ‘E’ in accordance whith the EEC Directive of 1962 concerning foodstuffs and colouring matters must fulfil the 
purity requirements laid down in those Directives. They continue to be subject to the general criteria set out in Annex III to the 1962 Directive concerning colouring matters 
where the letter ‘E’ has been deleted therefrom. 

256 

EN 

 
  
 
 
 
 
 
 
 
 
 
                                                 
⌦ 2
 ⌫ 

⌦ Trisodium tris[5,6-
dihydro-5-(hydroxyimino)-
6-oxonaphthalene-2-
sulphonato(2-)-
N5,O6]ferrate(3-) ⌫ 

10020 

Green 

X ⌦ No use in 
products applied 
on mucous 
membranes ⌫ 

1031658 

⌦ 3
 ⌫ 

⌦ Disodium 5,7-dinitro-8-
oxidonaphthalene-2-
sulphonate and its insoluble 
barium, strontium and 
zirconium lakes, salts and 
pigments ⌫ 

⌦ 4
 ⌫ 

⌦ 2-[(4-methyl-2-
nitrophenyl)azo]-3-oxo-N-
phenylbutyramide ⌫ 

11680 

⌦ 5
 ⌫ 

⌦ 2-[(4-chloro-2-
nitrophenyl)azo]-N-(2-
chlorophenyl)-3-
oxobutyramide ⌫ 

11710 

⌦ 6
 ⌫ 

⌦ 2-[(4-methoxy-2-
nitrophenyl)azo]-3-oxo-N-
(o-tolyl)butyramide ⌫ 

11725 

Yellow  X ⌦ No use in 
eye products ⌫ 

Yellow  X ⌦ No use in 
products applied 
on mucous 
membranes ⌫ 

Yellow  X ⌦ No use in 
products applied 
on mucous 
membranes ⌫ 

Orange  X ⌦ Rinse-off 

products ⌫ 

58 

EN 

The insoluble barium, strontium and zirconium lakes, salts and pigments of these colouring agents shall also be permitted. They must pass the test for insolubility which will 
be determined by the procedure laid down in Article 8. 

257 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
⌦ 7
 ⌫ 

⌦ 4-
(phenylazo)resorcinol ⌫ 

11920 

⌦ 8
 ⌫ 

⌦ 4-[(4-
ethoxyphenyl)azo]naphthol
 ⌫ 

12010 

Orange  X 

Red 

X ⌦ No use in 
products applied 
on mucous 
membranes ⌫ 

⌦ 9
 ⌫ 

⌦ 1-[(2-chloro-4-
nitrophenyl)azo]-2-
naphthol and its insoluble 
barium, strontium and 
zirconium lakes, salts and 
pigments ⌫ 

⌦ 
10 
⌫ 

⌦ 1-(4-methyl-2-
nitrophenylazo)-2-
naphthol ⌫ 

⌦ 1
1 ⌫ 

⌦ 3-hydroxy-N-(o-tolyl)-
4-[(2,4,5-
trichlorophenyl)azo]naphth
alene-2-carboxamide ⌫ 

⌦ 1
2 ⌫ 

⌦ N-(4-chloro-2-
methylphenyl)-4-[(4-
chloro-2-

1208559 

Red 

X 

3 % maximum 
concentration 
in the finished 
product 

12120 

12370 

12420 

Red 

Red 

X ⌦ Rinse-off 
products ⌫ 

X ⌦ Rinse-off 
products ⌫ 

Red 

X ⌦ Rinse-off 
products ⌫ 

59 

EN 

The insoluble barium, strontium and zirconium lakes, salts and pigments of these colouring agents shall also be permitted. They must pass the test for insolubility which will 
be determined by the procedure laid down in Article 8. 

258 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
⌦ 1
3 ⌫ 

⌦ 1
4 ⌫ 

methylphenyl)azo]-3-
hydroxynaphthalene-2-
carboxamide ⌫ 

⌦ 4-[(2,5-
dichlorophenyl)azo]-N-
(2,5-dimethoxyphenyl)-3-
hydroxynaphthalene-2-
carboxamide ⌫ 

⌦ N-(5-chloro-2,4-
dimethoxyphenyl)-4-[[5-
[(diethylamino)sulphonyl]-
2-methoxyphenyl]azo]-3-
hydroxynaphthalene-2-
carboxamide ⌫ 

12480 

Brown 

X ⌦ Rinse-off 
products ⌫ 

12490 

Red 

X 

⌦ 1
5 ⌫ 

⌦ 2,4-dihydro-5-methyl-
2-phenyl-4-(phenylazo)-
3H-pyrazol-3-one ⌫ 

⌦ 1
6 ⌫ 

⌦ Disodium 2-amino-5-
[(4-
sulphonatophenyl)azo]benz
enesulphonate ⌫ 

12700 

13015 

⌦ 1
7 ⌫ 

⌦ Sodium 
4-(2,4-
dihydroxyphenylazo)benze
nesulphonate ⌫  

14270 

⌦ 1
8 ⌫ 

⌦ Disodium 
dimethyl-5-

3-[(2,4-

14700 

EN 

Yellow  X ⌦ Rinse-off 

products ⌫ 

Yellow  X 

Orange  X 

Red 

X 

259 

E 105 

E 103 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
sulphonatophenyl)azo]-4-
hydroxynaphthalene-1-
sulphonate ⌫ 

⌦ 1
9 ⌫ 

⌦ Disodium 4-hydroxy-3-
[(4-
sulphonatonaphthyl)azo]na
phthalenesulphonate ⌫ 

14720 

Red 

X 

14815 

Red 

X 

1551060 

Orange  X ⌦ No use in 
eye products ⌫ 

⌦ 2
0 ⌫ 

⌦ 2
1 ⌫ 

6-[(2,4-

⌦ Disodium 
dimethyl-6-
sulphonatophenyl)azo]-5-
hydroxynaphthalene-1-
sulphonate ⌫  

⌦Sodium  4-[(2-hydroxy-
1-
naphthyl)azo]benzenesulph
insoluble 
onate  and 
and 
barium, 
zirconium  lakes,  salts  and 
pigments ⌫  

its 
strontium 

⌦ 2
2 ⌫ 

⌦ Calcium 
bis[2-chloro-5-[(2-

disodium 

15525 

Red 

X 

E 122 ⌦ Purity 
criteria as set 
out in 
Commission 
Directive 
95/45/EC (E 
122) ⌫ 

E 125 

60 

EN 

The insoluble barium, strontium and zirconium lakes, salts and pigments of these colouring agents shall also be permitted. They must pass the test for insolubility which will 
be determined by the procedure laid down in Article 8. 

260 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
15580 

Red 

X 

⌦ 2
3 ⌫ 

⌦ 2
4 ⌫ 

⌦ 2
5 ⌫ 

hydroxy-1-naphthyl)azo]-
4-sulphonatobenzoate] ⌫ 

bis[4-[(2-

⌦ Barium 
hydroxy-1-naphthyl)azo]-
2-
methylbenzenesulphonate].
⌫  

⌦ Sodium  4(-2-hydroxy-
1-
naphthylazo)naphthalenesu
lphonate ⌫ 

⌦ Sodium 
2-[(2-
hydroxynaphthyl)azo]napht
halenesulphonate  and 
its 
insoluble barium, strontium 
and  zirconium  lakes,  salts 
and pigments ⌫ 

15620 

1563061 

⌦ 2
6 ⌫ 

⌦ Calcium bis[3-hydroxy-
4-(phenylazo)-2-
naphthoate] ⌫ 

15800 

⌦ 2 ⌦ Disodium  3-hydroxy-4- 1585062 

Red 

X ⌦ Rinse-off 
products ⌫ 

Red 

X 

Red 

X ⌦ No use in 
products applied 
on mucous 
membranes ⌫ 

3 % maximum 
concentration 
in the finished 
product 

Red 

X 

⌦ Purity 

61 

EN 

The insoluble barium, strontium and zirconium lakes, salts and pigments of these colouring agents shall also be permitted. They must pass the test for insolubility which will 
be determined by the procedure laid down in Article 8. 

261 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
1586563 

Red 

X 

criteria as set 
out in 
Commission 
Directive 
95/45/EC (E 
180) ⌫ 

7 ⌫ 

⌦ 2
8 ⌫ 

[(4-methyl-2-
sulphonatophenyl)azo]-2-
naphthoate 
its 
insoluble barium, strontium 
and  zirconium  lakes,  salts 
and pigments ⌫ 

and 

⌦ Disodium 4-[(5-chloro-
4-methyl-2-
sulphonatophenyl)azo]-3-
hydroxy-2-naphthoate and 
its insoluble barium, 
strontium and zirconium 
lakes, salts and 
pigments ⌫ 

⌦ 2
9 ⌫ 

⌦ 3
0 ⌫ 

⌦ Calcium  3-hydroxy-4-
[(1-sulphonato-2-
naphthyl)azo]-2-naphthoate 
⌫ 

15880 

 ⌦ Disodium  6-hydroxy-
5-[(3-
sulphonatophenyl)azo]naph
thalene-2-sulphonate ⌫ 

15980 

Red 

X 

Orange  X 

E 111 

62 

63 

EN 

The insoluble barium, strontium and zirconium lakes, salts and pigments of these colouring agents shall also be permitted. They must pass the test for insolubility which will 
be determined by the procedure laid down in Article 8. 
The insoluble barium, strontium and zirconium lakes, salts and pigments of these colouring agents shall also be permitted. They must pass the test for insolubility which will 
be determined by the procedure laid down in Article 8. 

262 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                                                                                                                                                                                                                    
1598564 

Yellow  X 

16035 

Red 

X 

16185 

Red 

X 

⌦ 3
1 ⌫ 

⌦ 3
2 ⌫ 

⌦ 3
3 ⌫ 

⌦Disodium  6-hydroxy-5-
[(4-
sulphonatophenyl)azo]naph
and 
thalene-2-sulphonate 
its 
barium, 
insoluble 
strontium  and  zirconium 
lakes,  salts  and  pigments 
⌫ 

⌦Disodium  6-hydroxy-5-
[(2-methoxy-4-sulphonato-
m-tolyl)azo]  naphthalene-
2-sulphonate ⌫ 

⌦ Trisodium  3-hydroxy-
4-(4'-
sulphonatonaphthylazo)nap
hthalene-2,7-disulphonate 
⌫ 

⌦ 3
4 ⌫  ⌦Disodium  7-hydroxy-8-
phenylazonaphthalene-1,3-

16230 

Orange  X ⌦ No use in 
products applied 
on mucous 

E 110 ⌦ Purity 
criteria as set 
out in 
Commission 
Directive 
95/45/EC (E 
110) ⌫ 

⌦ Purity 
criteria as set 
out in 
Commission 
Directive 
95/45/EC (E 
129) ⌫ 

E 123 ⌦ Purity 
criteria as set 
out in 
Commission 
Directive 
95/45/EC (E 
123) ⌫ 

64 

EN 

The insoluble barium, strontium and zirconium lakes, salts and pigments of these colouring agents shall also be permitted. They must pass the test for insolubility which will 
be determined by the procedure laid down in Article 8. 

263 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
disulphonate⌫ 

membranes ⌫ 

⌦ 3
5 ⌫ 

⌦ 3
6 ⌫ 

⌦ 3
7 ⌫ 

1625565 

Red 

X 

1-(1-

⌦ Trisodium 
naphthylazo)-2-
hydroxynaphthalene-4',6,8-
insoluble 
trisulphonate its 
barium, 
and 
zirconium  lakes,  salts  and 
pigments ⌫ 

strontium 

16290 

Red 

X 

17200(cid:206)2 66 
 

Red 

X 

⌦ Tetrasodium 
7-
hydroxy-8-[(4-sulphonato-
1-
naphthyl)azo]naphthalene-
1,3,6-trisulphonate ⌫ 

⌦ Disodium 5-amino-4-
hydroxy-3-
(phenylazo)naphthalene-
2,7-disulphonate and its 
insoluble barium, strontium 
and zirconium lakes, salts 
and pigments ⌫ 

E 124 ⌦ Purity 
criteria as set 
out in 
Commission 
Directive 
95/45/EC (E 
124) ⌫ 

E 126 

⌦ 3
8 ⌫ 

⌦ Disodium 5-
acetylamino-4-hydroxy-3-
(phenylazo)naphthalene-

18050 

Red 

X ⌦ No use in 
products applied 
on mucous 

⌦ Purity 
criteria as set 
out in 

65 

66 

EN 

The insoluble barium, strontium and zirconium lakes, salts and pigments of these colouring agents shall also be permitted. They must pass the test for insolubility which will 
be determined by the procedure laid down in Article 8. 
The insoluble barium, strontium and zirconium lakes, salts and pigments of these colouring agents shall also be permitted. They must pass the test for insolubility which will 
be determined by the procedure laid down in Article 8. 

264 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
2,7-disulphonate ⌫ 

membranes ⌫ 

Commission 
Directive 
95/45/EC 
(E128) ⌫ 

18130 

18690 

18736 

⌦ 3
9 ⌫ 

⌦ 4
0 ⌫ 

⌦ 4
1 ⌫ 

⌦ 2,7-
naphthalenedisulfonic acid, 
3-((4-cyclohexyl-2-
methylphenyl)azo)-4-
hydroxy-5-(((4-
methylphenyl)sulfonyl)ami
no)-, disodium salt ⌫ 

⌦ Hydrogen bis[2-[(4,5-
dihydro-3-methyl-5-oxo-1-
phenyl-1H-pyrazol-4-
yl)azo]benzoato(2-
)]chromate(1-) ⌫ 

⌦ Disodium hydrogen 
bis[5-chloro-3-[(4,5-
dihydro-3-methyl-5-oxo-1-
phenyl-1H-pyrazol-4-
yl)azo]-2-
hydroxybenzenesulphonato
(3-)]chromate(3-) ⌫ 

⌦ 4
2 ⌫ 

⌦ Sodium 4-(3-hydroxy-
5-methyl-4-
phenylazopyrazol-2-
yl)benzenesulphonate ⌫ 

18820 

Red 

X ⌦ Rinse-off 
products ⌫ 

Yellow  X ⌦ Rinse-off 

products ⌫ 

Red 

X ⌦ Rinse-off 
products ⌫ 

Yellow  X ⌦ Rinse-off 

products ⌫ 

EN 

265 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
⌦ 4
3 ⌫ 

⌦ 4
4 ⌫ 

⌦ Disodium 2,5-dichloro-
4-(5-hydroxy-3-methyl-4-
(sulphophenylazo)pyrazol-
1-yl)benzenesulphonate ⌫ 

18965 

Yellow  X 

1914067 

Yellow  X 

⌦ Trisodium 5-hydroxy-
1-(4-sulphophenyl)-4-(4-
sulphophenylazo)pyrazole-
3-carboxylate and its 
insoluble barium, strontium 
and zirconium lakes, salts 
and pigments ⌫ 

⌦ 4
5 ⌫ 

⌦ N,N'-(3,3'-
dimethyl[1,1'-biphenyl]-
4,4'-diyl)bis[2-[(2,4-
dichlorophenyl)azo]-3-
oxobutyramide] ⌫ 

⌦ 4
6 ⌫ 

⌦ Sodium 4-amino-5-
hydroxy-3-(4-
nitrophenylazo)-6-
(phenylazo)naphthalene-
2,7-disulphonate ⌫ 

20040 

20470 

Yellow  X ⌦ Rinse-off 

products ⌫ 

Black 

X ⌦ Rinse-off 
products ⌫ 

E 102 ⌦ Purity 
criteria as set 
out in 
Commission 
Directive 
95/45/EC (E 
102) ⌫ 

Mmaximum 
3,3'-
dimethylbenzidi
ne 
concentration in 
the colouring 
agent: 5 ppm 

⌦ 4 ⌦ 2,2'-[(3,3'-dichloro[1,1'- 21100 

Yellow  X ⌦ Rinse-off 

mMaximum 

67 

EN 

The insoluble barium, strontium and zirconium lakes, salts and pigments of these colouring agents shall also be permitted. They must pass the test for insolubility which will 
be determined by the procedure laid down in Article 8. 

266 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
7 ⌫  biphenyl]-4,4'-

diyl)bis(azo)]bis[N-(2,4-
dimethylphenyl)-3-
oxobutyramide] ⌫ 

products ⌫ 

⌦ 4
8 ⌫  ⌦ 2,2'-[(3,3'-dichloro[1,1'-

21108 

Yellow  X ⌦ Rinse-off 

Ditto 

products ⌫ 

⌦ 4
9 ⌫ 

⌦ 5
0 ⌫ 

biphenyl]-4,4'-
diyl)bis(azo)]bis[N-(4-
chloro-2,5-
dimethoxyphenyl)-3-
oxobutyramide] ⌫ 

⌦ 2,2'-
[cyclohexylidenebis[(2-
methyl-4,1-
phenylene)azo]]bis[4-
cyclohexylphenol] ⌫ 

4,6-

⌦ Disodium 
dihydroxy-3-[[4-[1-[4-[[1-
hydroxy-7-
[(phenylsulphonyl)oxy]-3-
sulphonato-2-
naphthyl]azo]phenyl]cyclo
hexyl]phenyl]azo]naphthal
ene-2-sulphonate ⌫ 

21230 

24790 

Yellow  X ⌦ No use in 
products applied 
on mucous 
membranes ⌫ 

Red 

X ⌦ Rinse-off 
products ⌫ 

3,3'-
dimethylbenzidi
ne 
concentration in 
the colouring 
agent: 5 ppm 

mMaximum 
3,3'-
dimethylbenzidi
ne 
concentration in 
the colouring 
agent: 5 ppm 

EN 

267 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
⌦ 5
1 ⌫ 

⌦ 1-(4-
(phenylazo)phenylazo)-2-
naphthol ⌫ 

(cid:206)1 26100  

(cid:208) 76/768/EEC (adapted) 
(cid:206)1 92/86/EEC 
(cid:206)2 86/179/EEC 
(cid:206)3 90/121/EEC 
(cid:206)4 87/137/EEC 
(cid:206)5 88/233/EEC 

(cid:206)1 Red 
 

(cid:206)1 X  ⌦ No 
use in products 
applied on 
mucous 
membranes ⌫ 

⌦ 5
2 ⌫ 

⌦ Tetrasodium 6-amino-
4-hydroxy-3-[[7-
sulphonato-4-[(4-
sulphonatophenyl)azo]-1-
naphthyl]azo]naphthalene-
2,7-disulphonate ⌫ 

(cid:206)2 27755  

(cid:206)2 Blac
k  

(cid:206)2 X  

(cid:206)1 Purity 
criteria: 
aniline ≤ 0,2 % 
2-naphtol 
≤ 0,2 % 
4-
aminoazobenze
ne ≤ 0,1 % 
1-(phenylazo)-
2-naphtol ≤ 3 % 
1-[2-
(phenylazo)phe
nylazo]-2-
napthalenol 
≤ 2 %  

(cid:206)2 E 152  

⌦ 5 ⌦ Tetrasodium 1-

(cid:206)2 28440  

acetamido-2-hydroxy-3-(4-

(cid:206)2 Blac (cid:206)2 X  

(cid:206)2 E 151  
⌦ Purity 

EN 

268 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
k  

(cid:206)2 40215  

(cid:206)2 Ora
nge  

(cid:206)2 X  
⌦ Rinse-off 
products ⌫ 

3 ⌫ 

((4-sulphonatophenylazo)-
7-sulphonato-1-
naphthylazo))naphthalene-
4,6-disulphonate ⌫ 

⌦ 5
4 ⌫ 

⌦ Benzenesulfonic acid, 
2,2'-(1,2-ethenediyl)bis[5-
nitro-, disodium salt, 
reaction products with 4-
[(4-
aminophenyl)azo]benzenes
ulfonic acid, sodium 
salts ⌫ 

⌦ 5
5 ⌫ 

⌦ .beta.,.beta.-
carotene ⌫ 

(cid:206)2 40800  

(cid:206)2 Ora
nge  

(cid:206)2 X  

⌦ 5
6 ⌫ 

⌦ 8'-apo-.beta.-caroten-8'-
al ⌫ 

(cid:206)2 40820  

(cid:206)2 Ora
nge  

(cid:206)2 X  

criteria as set 
out in 
Commission 
Directive 
95/45/EC (E 
151) ⌫ 

⌦ Purity 
criteria as set 
out in 
Commission 
Directive 
95/45/EC (E 
160a) ⌫ 

(cid:206)2 E 160 e  
⌦ Purity 
criteria as set 
out in 
Commission 
Directive 
95/45/EC (E 

EN 

269 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
⌦ 5
7 ⌫ 

⌦ Ethyl 8'-apo-.beta.-
caroten-8'-oate ⌫ 

(cid:206)2 40825  

(cid:206)2 Ora
nge  

(cid:206)2 X  

⌦ 5
8 ⌫ 

⌦ 5
9 ⌫ 

⌦ Canthaxanthin ⌫ 

(cid:206)2 40850  

(cid:206)2 Ora
nge  

(cid:206)2 X  

(cid:206)2 42045  

⌦ Ammonium, (4-(alpha-
(p-(diethylamino)phenyl)-
2,4-disulfobenzylidene)-
2,5-cyclohexadien-1-
ylidene)diethyl-, 
hydroxide, monosodium 
salt ⌫ 

(cid:206)2 Blue
  

(cid:206)3 X  ⌦ No 
use in products 
applied on 
mucous 
membranes ⌫ 

160c) ⌫ 

(cid:206)2 E 160 f  
⌦ Purity 
criteria as set 
out in 
Commission 
Directive 
95/45/EC (E 
160f) ⌫ 

(cid:206)2 E 161 
g ⌦ Purity 
criteria as set 
out in 
Commission 
Directive 
95/45/EC (E 
161g) ⌫ 

EN 

270 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
(cid:206)2 4205168 
 

(cid:206)2 Blue
  

(cid:206)2 X  

(cid:206)2 E 131  
⌦ Purity 
criteria as set 
out in 
Commission 
Directive 
95/45/EC (E 
131) ⌫ 

(cid:206)2 42053  

(cid:206)2 Gree
n  

(cid:206)2 X  

⌦ 6
0 ⌫ 

⌦ 6
1 ⌫ 

⌦ Ethanaminium, N-(4-
((4-
(diethylamino)phenyl)(5-
hydroxy-2,4-
disulfophenyl)methylene)-
2,5-cyclohexadien-1-
ylidene)-N-ethyl-, 
hydroxide, inner salt, 
calcium salt (2:1) and its 
insoluble barium, strontium 
and zirconium lakes, salts 
and pigments ⌫ 

⌦ Benzenemethanaminiu
m, N-ethyl-N-(4-((4-
(ethyl((3-
sulfophenyl)methyl)amino)
phenyl)(4-hydroxy-2-
sulfophenyl)methylene)-
2,5-cyclohexadien-1-
ylidene)-3-sulfo-, 
hydroxide, inner salt, 
disodium salt ⌫ 

⌦ 6
2 ⌫ 

⌦ Hydrogen (benzyl)[4-
[[4-
[benzylethylamino]phenyl]
(2,4-

(cid:206)2 42080  

(cid:206)2 Blue
  

(cid:206)2 X  
⌦ Rinse-off 
products ⌫ 

68 

EN 

The insoluble barium, strontium and zirconium lakes, salts and pigments of these colouring agents shall also be permitted. They must pass the test for insolubility which will 
be determined by the procedure laid down in Article 8. 

271 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
⌦ 6
3 ⌫ 

⌦ 6
4 ⌫ 

⌦ 6
5 ⌫ 

disulphonatophenyl)methyl
ene]cyclohexa-2,5-dien-1-
ylidene](ethyl)ammonium, 
sodium salt ⌫ 

⌦ Benzenemethanaminiu
m, N-ethyl-N-(4-((4-
(ethyl((3-
sulfophenyl)methyl)amino)
phenyl)(2-
sulfophenyl)methylene)-
2,5-cyclohexadien-1-
ylidene)-3-sulfo-, 
hydroxide, inner salt, 
disodium salt ⌫ 

⌦ Hydrogen [4-[(2-
chlorophenyl)[4-[ethyl(3-
sulphonatobenzyl)amino]p
henyl]methylene]cyclohex
a-2,5-dien-1-
ylidene](ethyl)(3-
sulphonatobenzyl)ammoni
um, sodium salt ⌫ 

⌦ Hydrogen [4-[(2-
chlorophenyl)[4-[ethyl(3-
sulphonatobenzyl)amino]-
o-tolyl]methylene]-3-
methylcyclohexa-2,5-dien-
1-ylidene](ethyl)(3-
sulphonatobenzyl)ammoni

EN 

(cid:206)2 42090  

(cid:206)2 Blue
  

(cid:206)2 X  

⌦ Purity 
criteria as set 
out in 
Commission 
Directive 
95/45/EC (E 
133) ⌫ 

(cid:206)2 42100  

(cid:206)2 42170  

(cid:206)2 Gree
n  

(cid:206)2 X  
⌦ Rinse-off 
products ⌫ 

(cid:206)2 Gree
n  

(cid:206)2 X  
⌦ Rinse-off 
products ⌫ 

272 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
(cid:206)2 42510  

(cid:206)2 42520  

(cid:206)2 42735  

⌦ 6
6 ⌫ 

⌦ 6
7 ⌫ 

⌦ 6
8 ⌫ 

um, sodium salt ⌫ 

⌦ (4-(4-aminophenyl)(4-
iminocyclohexa-2,5-
dienylidene)methyl)-2-
methylaniline 
hydrochloride ⌫ 

⌦ 4-[(4-amino-m-
tolyl)(4-imino-3-
methylcyclohexa-2,5-dien-
1-ylidene)methyl]-o-
toluidine 
monohydrochloride ⌫ 

⌦ Hydrogen [4-[[4-
(diethylamino)phenyl][4-
[ethyl[(3-
sulphonatobenzyl)amino]-
o-tolyl]methylene]-3-
methylcyclohexa-2,5-dien-
1-ylidene](ethyl)(3-
sulphonatobenzyl)ammoni
um, sodium salt ⌫ 

(cid:206)2 44045  

⌦ 6
9 ⌫ 

⌦ [4-[[4-anilino-1-
naphthyl][4-
(dimethylamino)phenyl]me
thylene]cyclohexa-2,5-
dien-1-
ylidene]dimethylammoniu

(cid:206)2 5 ppm 
maximum 
concentration in 
the finished 
product  

(cid:206)2 Viol
et  

(cid:206)2 X  ⌦ No 
use in products 
applied on 
mucous 
membranes ⌫ 

(cid:206)2 Viol
et  

(cid:206)2 X  
⌦ Rinse-off 
products ⌫ 

(cid:206)2 Blue
  

(cid:206)2 X  ⌦ No 
use in products 
applied on 
mucous 
membranes ⌫ 

(cid:206)2 Blue
  

(cid:206)3 X  ⌦ No 
use in products 
applied on 
mucous 
membranes ⌫ 

EN 

273 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
(cid:206)2 E 142  
⌦ Purity 
criteria as set 
out in 
Commission 
Directive 
95/45/EC (E 
142) ⌫ 

⌦ 7
0 ⌫ 

⌦ 7
1 ⌫ 

⌦ 7
2 ⌫ 

m chloride ⌫ 

⌦ Hydrogen [4-[4-
(dimethylamino)-.alpha.-
(2-hydroxy-3,6-
disulphonato-1-
naphthyl)benzylidene]cycl
ohexa-2,5-dien-1-
ylidene]dimethylammoniu
m, monosodium salt ⌫ 

⌦ Hydrogen 3,6-
bis(diethylamino)-9-(2,4-
disulphonatophenyl)xanthy
lium, sodium salt ⌫ 

⌦ Hydrogen 9-(2-
carboxylatophenyl)-3-(2-
methylanilino)-6-(2-
methyl-4-
sulphoanilino)xanthylium, 
monosodium salt ⌫ 

⌦ 7
3 ⌫ 

⌦ Hydrogen 9-(2,4-
disulphonatophenyl)-3,6-
bis(ethylamino)-2,7-
dimethylxanthylium, 
monosodium salt ⌫ 

(cid:206)2 44090  

(cid:206)2 Gree
n  

(cid:206)2 X  

(cid:206)2 45100  

(cid:206)2 45190  

(cid:206)2 45220  

(cid:206)2 Red 
 

(cid:206)2 X  
⌦ Rinse-off 
products ⌫ 

(cid:206)2 Viol
et  

(cid:206)2 X  
⌦ Rinse-off 
products ⌫ 

(cid:206)2 Red 
 

(cid:206)2 X  
⌦ Rinse-off 
products ⌫ 

⌦ 7
4 ⌫ 

⌦ Disodium 2-(3-oxo-6-
oxidoxanthen-9-

(cid:206)2 45350  

(cid:206)2 Yell
ow  

(cid:206)2 X  

(cid:206)2 6 % 
maximum 

EN 

274 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
yl)benzoate ⌫ 

⌦ 7
5 ⌫ 

⌦ 4',5'-dibromo-3',6'-
dihydroxyspiro[isobenzofu
ran-1(3H),9'-
[9H]xanthene]-3-one and 
its insoluble barium, 
strontium and zirconium 
lakes, salts and 
pigments ⌫ 

⌦ 7
6 ⌫ 

⌦ Disodium 2-(2,4,5,7-
tetrabromo-6-oxido-3-
oxoxanthen-9-yl)benzoate 
and its insoluble barium, 
strontium and zirconium 
lakes, salts and pigments 
⌫ 

(cid:206)2 4537069 
 

(cid:206)2 Ora
nge  

(cid:206)2 X  

(cid:206)2 4538070 
 

(cid:206)2 Red 
 

(cid:206)2 X  

concentration 
in the finished 
product  

(cid:206)2 nNot more 
than 1 % 2-(6-
hydroxy-3-oxo-
3H-xanthen-9-
y1) benzoic 
acid and 2 % 2-
(bromo-6-
hydroxy-3-oxo-
3H-xanthen-9-
yl) benzoic 
acid  

(cid:206)2 ditto   (cid:206)2 nNot more 
than 1 % 2-(6-
hydroxy-3-oxo-
3H-xanthen-9-
y1) benzoic 
acid and 2 % 2-
(bromo-6-
hydroxy-3-oxo-
3H-xanthen-9-
yl) benzoic 
acid  

69 

EN 

The insoluble barium, strontium and zirconium lakes, salts and pigments of these colouring agents shall also be permitted. They must pass the test for insolubility which will 
be determined by the procedure laid down in Article 8. 

275 

EN 

 
  
 
 
 
 
 
 
 
                                                 
⌦ 7
7 ⌫ 

⌦ 3',6'-dihydroxy-4',5'-
dinitrospiro[isobenzofuran-
1(3H),9'-[9H]xanthene]-3-
one ⌫ 

(cid:206)2 45396  

(cid:206)2 Ora
nge  

(cid:206)2 X  

⌦ 7
8 ⌫ 

⌦ Dipotassium 3,6-
dichloro-2-(2,4,5,7-
tetrabromo-6-oxido-3-
oxoxanthen-9-
yl)benzoate ⌫ 

(cid:206)2 45405  

(cid:206)2 Red 
 

(cid:206)2 X  ⌦ No 
use in eye 
products ⌫ 

(cid:206)2 ⌦ 1%, 
when used in 
lip 
products ⌫ 
when used in 
lipstick, the 
colouring 
agent is 
allowed only 
in free acid 
form and in a 
maximum 
concentration 
of 1 %  

⌦ Only in free 
acid form, when 
used in lip 
products ⌫ 

(cid:206)2 nNot more 
than 1 % 2-(6-
hydroxy-3-oxo-
3Η xanthen-9-
yl) benzoic acid 
and 2 % 2-
(bromo-6-
hydroxy-3-oxo-
3H-xanthen-9-
yl) benzoic 
acid  

70 

EN 

The insoluble barium, strontium and zirconium lakes, salts and pigments of these colouring agents shall also be permitted. They must pass the test for insolubility which will 
be determined by the procedure laid down in Article 8. 

276 

EN 

 
  
 
 
 
 
 
 
 
                                                                                                                                                                                                                                                    
(cid:206)2 4541071 
 

(cid:206)2 Red 
 

(cid:206)2 X  

(cid:206)2 4543072 
 

(cid:206)2 Red 
 

(cid:206)2 X  

⌦ 7
9 ⌫ 

⌦ 3,4,5,6-tetrachloro-2-
(1,4,5,8-tetrabromo-6-
hydroxy-3-oxoxanthen-9-
yl)benzoic acid and its 
insoluble barium, strontium 
and zirconium lakes, salts 
and pigments ⌫ 

⌦ 8
0 ⌫ 

⌦ Disodium 2-(2,4,5,7-
tetraiodo-6-oxido-3-
oxoxanthen-9-yl)benzoate 
and its insoluble barium, 
strontium and zirconium 
lakes, salts and 
pigments ⌫ 

(cid:206)2 ditto   (cid:206)2 nNot more 
than 1 % 2-(6-
hydroxy-3-oxo-
3Η xanthen-9-
yl) benzoic acid 
and 2 % 2-
(bromo-6-
hydroxy-3-oxo-
3H-xanthen-9-
yl) benzoic 
acid  

(cid:206)2 E 127 
ditto  

⌦ Purity 
criteria as set 
out in 
Commission 
Directive 
95/45/EC (E 
127) ⌫ 

⌦ Not more 
than 1 % 2-(6-
hydroxy-3-oxo-

71 

72 

EN 

The insoluble barium, strontium and zirconium lakes, salts and pigments of these colouring agents shall also be permitted. They must pass the test for insolubility which will 
be determined by the procedure laid down in Article 8. 
The insoluble barium, strontium and zirconium lakes, salts and pigments of these colouring agents shall also be permitted. They must pass the test for insolubility which will 
be determined by the procedure laid down in Article 8. 

277 

EN 

 
  
 
 
 
 
 
 
 
                                                 
3H-xanthen-9-
yl) benzoic acid 
and 3% 2-(iodo-
6-hydroxy-3-
oro-3H-
xanthen-9-yl) 
benzoic 
acid. ⌫ 

(cid:206)2 E 104  
⌦ Purity 
criteria as set 
out in 
Commission 
Directive 
95/45/EC (E 
104) ⌫ 

⌦ 8
1 ⌫ 

⌦ 1,3-
Isobenzofurandione, 
reaction products with 
methylquinoline and 
quinoline ⌫ 

⌦ 8
2 ⌫ 

⌦ 1H-Indene-1,3(2H)-
dione, 2-(2-quinolinyl)-, 
sulfonated, sodium 
salts ⌫ 

(cid:206)2 47000  

(cid:206)2 47005  

(cid:206)2 50325  

⌦ 8
3 ⌫ 

⌦ Hydrogen 9-[(3-
methoxyphenyl)amino]-7-
phenyl-5-(phenylamino)-
4,10-
disulphonatobenzo[a]phena
zinium, sodium salt ⌫ 

(cid:206)2 Yell
ow  

(cid:206)2 X  ⌦ No 
use in products 
applied on 
mucous 
membranes ⌫ 

(cid:206)2 Yell
ow  

(cid:206)2 X  

(cid:206)2 Viol
et  

(cid:206)2 X  
⌦ Rinse-off 
products ⌫ 

EN 

278 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
⌦ 8
4 ⌫ 

⌦ Sulfonated nigrosine 
color ⌫ 

(cid:206)2 50420  

⌦ 8
5 ⌫ 

⌦ 8,18-dichloro-5,15-
diethyl-5,15-
dihydrodiindolo[3,2-b:3',2'-
m]triphenodioxazine ⌫ 

(cid:206)2 51319  

⌦ 8
6 ⌫ 

⌦ 1,2-
dihydroxyanthraquinone 
⌫ 

(cid:206)2 58000  

⌦ 8
7 ⌫ 

⌦ Trisodium 8-
hydroxypyrene-1,3,6-
trisulphonate ⌫ 

(cid:206)2 59040  

⌦ 8
8 ⌫ 

⌦ 1-anilino-4-
hydroxyanthraquinone ⌫  

(cid:206)2 60724  

⌦ 8
9 ⌫ 

⌦ 1-hydroxy-4-(p-
toluidino)anthraquinone 
⌫ 

(cid:206)2 60725  

(cid:206)2 Blac
k  

(cid:206)2 X  ⌦ No 
use in products 
applied on 
mucous 
membranes ⌫ 

(cid:206)2 Viol
et  

(cid:206)2 X  
⌦ Rinse-off 
products ⌫ 

(cid:206)2 Red 
 

(cid:206)2 X  

(cid:206)2 Gree
n  

(cid:206)2 X  ⌦ No 
use in products 
applied on 
mucous 
membranes ⌫ 

(cid:206)2 Viol
et  

(cid:206)2 X  
⌦ Rinse-off 
products ⌫ 

(cid:206)2 Viol
et  

(cid:206)2 X  

EN 

279 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
⌦ 9
0 ⌫ 

⌦ Sodium 4-[(9,10-
dihydro-4-hydroxy-9,10-
dioxo-1-
anthryl)amino]toluene-3-
sulphonate ⌫ 

(cid:206)2 60730  

⌦ 9
1 ⌫ 

⌦ 1,4-bis(p-
tolylamino)anthraquinone 
⌫ 

(cid:206)2 61565  

⌦ 9
2 ⌫ 

⌦ 9
3 ⌫ 

⌦ 9
4 ⌫ 

⌦ Disodium 2,2'-(9,10-
dioxoanthracene-1,4-
diyldiimino)bis(5-
methylsulphonate) ⌫ 

⌦ Sodium 3,3'-(9,10-
dioxoanthracene-1,4-
diyldiimino)bis(2,4,6-
trimethylbenzenesulphonat
e) ⌫ 

⌦ Sodium 1-amino-4-
(cyclohexylamino)-9,10-
dihydro-9,10-
dioxoanthracene-2-
sulphonate ⌫ 

⌦ 9
5 ⌫ 

⌦ 6,15-
dihydroanthrazine-
5,9,14,18-tetrone ⌫ 

(cid:206)2 61570  

(cid:206)2 61585  

(cid:206)2 62045  

(cid:206)2 69800  

(cid:206)2 Viol
et  

(cid:206)2 X  ⌦ No 
use in products 
applied on 
mucous 
membranes ⌫ 

(cid:206)2 Gree
n  

(cid:206)2 X  

(cid:206)2 Gree
n  

(cid:206)2 X  

(cid:206)2 Blue
  

(cid:206)2 X  
⌦ Rinse-off 
products ⌫ 

(cid:206)2 Blue
  

(cid:206)2 X  
⌦ Rinse-off 
products ⌫ 

(cid:206)2 Blue
  

(cid:206)2 X  

(cid:206)2 E 130  

EN 

280 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
⌦ 9
6 ⌫ 

⌦ 7,16-dichloro-6,15-
dihydroanthrazine-
5,9,14,18-tetrone ⌫ 

⌦ 9
7 ⌫ 

⌦ Bisbenzimidazo[2,1-
b:2',1'-
i]benzo[lmn][3,8]phenanth
roline-8,17-dione ⌫ 

(cid:206)2 69825  

(cid:206)2 71105  

⌦ 9
8 ⌫ 

⌦ 9
9 ⌫ 

⌦ 2-(1,3-dihydro-3-oxo-
2H-indazol-2-ylidene)-1,2-
dihydro-3H-indol-3-
one ⌫ 

⌦ Disodium 5,5'-(2-(1,3-
dihydro-3-oxo-2H-indazol-
2-ylidene)-1,2-dihydro-3H-
indol-3-
one)disulphonate ⌫ 

(cid:206)2 73000  

(cid:206)2 73015  

(cid:206)2 Blue
  

(cid:206)2 X  

(cid:206)2 Ora
nge  

(cid:206)2 X  ⌦ No 
use in products 
applied on 
mucous 
membranes ⌫ 

(cid:206)2 Blue
  

(cid:206)2 X  

(cid:206)2 Blue
  

(cid:206)2 X  

⌦ 1
00 
⌫ 

⌦ 6-chloro-2-(6-chloro-4-
methyl-3-
oxobenzo[b]thien-2(3H)-
ylidene)-4-
methylbenzo[b]thiophene-
3(2H)-one ⌫ 

(cid:206)2 73360  

(cid:206)2 Red 
 

(cid:206)2 X  

(cid:206)2 E 132  
⌦ Purity 
criteria as set 
out in 
Commission 
Directive 
95/45/EC (E 
132) ⌫ 

EN 

281 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
(cid:206)2 73385  

(cid:206)2 Viol
et  

(cid:206)2 X  

⌦ 5-chloro-2-(5-chloro-7-
methyl-3-
oxobenzo[b]thien-2(3H)-
ylidene)-7-
methylbenzo[b]thiophene-
3(2H)-one ⌫ 

⌦ 1
01 
⌫ 

⌦ 1
02 
⌫ 

⌦ 1
03 
⌫ 

⌦ 1
04 
⌫ 

⌦ 1
05 
⌫ 

⌦ 1
06 
⌫ 

⌦ 1
07 

EN 

⌦ 5,12-dihydroquino[2,3-
b]acridine-7,14-dione ⌫ 

(cid:206)2 73900  

⌦ 5,12-dihydro-2,9-
dimethylquino[2,3-
b]acridine-7,14-dione ⌫ 

(cid:206)2 73915  

⌦ 29H,31H-
phthalocyanine ⌫ 

(cid:206)2 74100  

(cid:206)2 74160  

(cid:206)2 74180  

⌦ 29H,31H-
phthalocyaninato(2-)-
N29,N30,N31,N32 
copper ⌫ 

⌦ Disodium [29H,31H-
phthalocyaninedisulphonat
o(4-)-
N29,N30,N31,N32]cuprate
(2-) ⌫ 

⌦ Polychloro copper 

(cid:206)2 74260  

(cid:206)2 Viol
et  

(cid:206)2 Red 
 

(cid:206)2 Blue
  

(cid:206)2 X  
⌦ Rinse-off 
products ⌫ 

(cid:206)2 X  
⌦ Rinse-off 
products ⌫ 

(cid:206)2 X  
⌦ Rinse-off 
products ⌫ 

(cid:206)2 Blue
  

(cid:206)2 X  

(cid:206)2 Blue
  

(cid:206)2 X  
⌦ Rinse-off 
products ⌫ 

(cid:206)2 Gree (cid:206)2 X  ⌦ No 

use in eye 

282 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
⌫ 

phthalocyanine ⌫ 

⌦ 8,8'-diapo-.psi.,.psi.-
carotenedioic acid ⌫ 

(cid:206)2 75100  

⌦ Annatto ⌫ 

(cid:206)2 75120  

n  

products ⌫ 

(cid:206)2 Yell
ow  

(cid:206)2 X  

(cid:206)2 Ora
nge  

(cid:206)2 X  

⌦ Psi,psi-carotene ⌫ 

(cid:206)2 75125  

(cid:206)2 Yell
ow  

(cid:206)2 X  

⌦ β-β-carotene ⌫ 

(cid:206)2 75130  

(cid:206)2 Ora
nge  

(cid:206)2 X  

⌦ 1
08 
⌫ 

⌦ 1
09 
⌫ 

⌦ 1
10 
⌫ 

⌦ 1
11 
⌫ 

(cid:206)2 E 160 b  
⌦ Purity 
criteria as set 
out in 
Commission 
Directive 
95/45/EC (E 
160b) ⌫ 

(cid:206)2 E 160 d  
⌦ Purity 
criteria as set 
out in 
Commission 
Directive 
95/45/EC (E 
160d) ⌫ 

(cid:206)2 E 160 a  
⌦ Purity 
criteria as set 
out in 
Commission 
Directive 
95/45/EC (E 
160e) ⌫ 

EN 

283 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
⌦ (3R)-beta-4-caroten-3-
ol ⌫ 

(cid:206)2 75135  

⌦ 2-Amino-1,7-dihydro-
6H-purin-6-one ⌫ 

(cid:206)2 75170  

⌦ 1,7-bis(4-hydroxy-3-
methoxyphenyl)hepta-1,6-
diene-3,5-dione ⌫ 

(cid:206)2 75300  

(cid:206)2 Yell
ow  

(cid:206)2 X  

(cid:206)2 Whi
te  

(cid:206)2 X  

(cid:206)2 Yell
ow  

(cid:206)2 X  

⌦ Carmine ⌫ 

(cid:206)2 75470  

(cid:206)2 Red 
 

(cid:206)2 X  

⌦ 1
12 
⌫ 

⌦ 1
13 
⌫ 

⌦ 1
14 
⌫ 

⌦ 1
15 
⌫ 

⌦1
16 
⌫ 

⌦ Trisodium (2S-trans)-
[18-carboxy-20-
(carboxymethyl)-13-ethyl-
2,3-dihydro-3,7,12,17-
tetramethyl-8-vinyl-

(cid:206)2 75810  

(cid:206)2 Gree
n  

(cid:206)2 X  

(cid:206)2 E 161 d  

(cid:206)2 E 100  
⌦ Purity 
criteria as set 
out in 
Commission 
Directive 
95/45/EC (E 
100) ⌫ 

(cid:206)2 E 120  
⌦ Purity 
criteria as set 
out in 
Commission 
Directive 
95/45/EC (E 
120) ⌫ 

(cid:206)2 E 140 and E 
141  
⌦ Purity 
criteria as set 
out in 

EN 

284 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Commission 
Directive 
95/45/EC (E 
140, E 141) ⌫ 

(cid:206)2 E 173  
⌦ Purity 
criteria as set 
out in 
Commission 
Directive 
95/45/EC (E 
173) ⌫ 

21H,23H-porphine-2-
propionato(5-)-
N21,N22,N23,N24]cuprate
(3-) ⌫ 

⌦ Aluminium ⌫ 

(cid:206)2 77000  

(cid:206)2 Whi
te  

(cid:206)2 X  

⌦ Aluminium hydroxide 
sulphate ⌫ 

(cid:206)2 77002  

(cid:206)2 77004  

⌦ Natural hydrated 
aluminium silicate, 
Al2O3.2SiO2.2H2O, 
containing calcium, 
magnesium or iron 
carbonates, ferric 
hydroxide, quartz-sand, 
mica, etc. as impurities ⌫ 

(cid:206)2 Whi
te  

(cid:206)2 X  

(cid:206)2 Whi
te  

(cid:206)2 X  

⌦ Lazurite ⌫ 

(cid:206)2 77007  

(cid:206)2 Blue
  

(cid:206)2 X  

⌦ 1
17 
⌫ 

⌦ 1
18 
⌫ 

⌦ 1
19 
⌫ 

⌦ 1
20 
⌫ 

⌦ 1 ⌦ Aluminum silicate 

(cid:206)2 77015  

(cid:206)2 Red  (cid:206)2 X  

EN 

285 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
21 
⌫ 

coloured with ferric 
oxide ⌫ 

⌦ Barium sulfate ⌫ 

(cid:206)2 77120  

⌦ Bismuth chloride 
oxide ⌫ 

(cid:206)2 77163  

⌦ Calcium carbonate ⌫  (cid:206)2 77220  

⌦ Calcium sulfate ⌫ 

(cid:206)2 77231  

⌦ Carbon black ⌫ 

(cid:206)2 77266  

⌦ 1
22 
⌫ 

⌦ 1
23 
⌫ 

⌦ 1
24 
⌫ 

⌦ 1
25 
⌫ 

⌦ 1
26 
⌫ 

 

(cid:206)2 Whi
te  

(cid:206)2 X  

(cid:206)2 Whi
te  

(cid:206)2 X  

(cid:206)2 Whi
te  

(cid:206)2 X  

(cid:206)2 Whi
te  

(cid:206)2 X  

(cid:206)2 Blac
k  

(cid:206)2 X  

(cid:206)2 E 170  
⌦ Purity 
criteria as set 
out in 
Commission 
Directive 
95/45/EC (E 
170) ⌫ 

⌦ Purity 
criteria as set 
out in 
Commission 
Directive 
95/45/EC (E 
153) ⌫ 

EN 

286 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
⌦ Charcoal, bone. A fine 
black powder obtained by 
burning animal bones in a 
closed container. It consists 
primarily of calcium 
phosphate and carbon ⌫ 

⌦ Coke black ⌫ 

(cid:206)2 77267  

(cid:206)2 Blac
k  

(cid:206)2 X  

(cid:206)2 77268:1 
 

(cid:206)2 Blac
k  

(cid:206)2 X  

⌦ Chromium (III) 
oxide ⌫ 

(cid:206)4 77288  

⌦ Chromium (III) 
hydroxide ⌫ 

(cid:206)4 77289  

⌦ Cobalt Aluminum 
Oxide ⌫ 

(cid:206)2 77346  

⌦ Copper ⌫ 

(cid:206)2 77400  

(cid:206)4 Gree
n  

(cid:206)4 X  

(cid:206)4 Gree
n  

(cid:206)4 X  

(cid:206)2 Gree
n  

(cid:206)2 X  

(cid:206)2 Bro
wn  

(cid:206)2 X  

⌦ 1
27 
⌫ 

⌦ 1
28 
⌫ 

⌦ 1
29 
⌫ 

⌦ 1
30 
⌫ 

⌦ 1
31 
⌫ 

⌦ 1
32 
⌫ 

(cid:206)2 E 153  
⌦ Purity 
criteria as set 
out in 
Commission 
Directive 
95/45/EC ⌫ 

(cid:206)4 free from 
chromate ion 

(cid:206)4 free from 
chromate ion 

EN 

287 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
⌦ Gold ⌫ 

(cid:206)2 77480  

(cid:206)2 Bro
wn  

(cid:206)2 X  

⌦ Iron oxide ⌫ 

(cid:206)2 77489  

(cid:206)2 Ora
nge  

(cid:206)2 X  

⌦ Diiron trioxide ⌫ 

(cid:206)2 77491  

(cid:206)2 Red 
 

(cid:206)2 X  

⌦ Iron hydroxide oxide 
yellow⌫ 

(cid:206)2 77492   ⌦ 51274-

00-1 ⌫ 

⌦ 257-098-
5 ⌫ 

(cid:206)2 Yell
ow  

(cid:206)2 X  

⌦ 1
33 
⌫ 

⌦ 1
34 
⌫ 

⌦ 1
35 
⌫ 

⌦ 1
36 
⌫ 

⌦ Purity 
criteria as set 
out in 
Commission 
Directive 
95/45/EC ⌫ 

(cid:206)2 E 172  
⌦ Purity 
criteria as set 
out in 
Commission 
Directive 
95/45/EC (E 
172) ⌫ 

(cid:206)2 E 172  
⌦ Purity 
criteria as set 
out in 
Commission 
Directive 
95/42/EC (E 
172) ⌫ 

(cid:206)2 E 172  
⌦ Purity 
criteria as set 
out in 
Commission 
Directive 

EN 

288 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
⌦ Triiron tetraoxide ⌫  (cid:206)2 77499  

(cid:206)2 Blac
k  

(cid:206)2 X  

⌦ Ferric Ammonium 
Ferrocyanide ⌫ 

(cid:206)2 77510  

⌦ Magnesium 
carbonate ⌫ 

⌦ Ammonium 
manganese(3+) 
diphosphate ⌫ 

(cid:206)2 77713  

(cid:206)2 77742  

⌦ Trimanganese 
bis(orthophosphate) ⌫ 

(cid:206)2 77745  

⌦ Silver ⌫ 

(cid:206)2 77820  

(cid:206)2 Blue
  

(cid:206)2 X  

(cid:206)2 Whi
te  

(cid:206)2 X  

(cid:206)2 Viol
et  

(cid:206)2 X  

(cid:206)2 Red 
 

(cid:206)2 X  

(cid:206)2 Whi
te  

(cid:206)2 X  

⌦ 1
37 
⌫ 

⌦ 1
38 
⌫ 

⌦ 1
39 
⌫ 

⌦ 1
40 
⌫ 

⌦ 1
41 
⌫ 

⌦ 1
42 
⌫ 

95/45/EC (E 
173) ⌫ 

(cid:206)2 E 172  
⌦ Purity 
criteria as set 
out in 
Commission 
Directive 
95/45/EC (E 
172) ⌫ 

(cid:206)2 free from 
cyanide ions  

(cid:206)2 E 174  
⌦ Purity 
criteria as set 
out in 

EN 

289 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
⌦ Titanium dioxide ⌫  (cid:206)2 77891  

(cid:206)2 Whi
te  

(cid:206)2 X  

⌦ Zinc oxide ⌫ 

(cid:206)2 77947  

⌦ Riboflavin ⌫ 

(cid:206)2 Lactoflav
in  

(cid:206)2 Whi
te  

(cid:206)2 X  

(cid:206)2 Yell
ow  

(cid:206)2 X  

⌦ 1
43 
73 
⌫ 

⌦ 1
44 
⌫ 

⌦ 1
45 
⌫ 

⌦ Caramel ⌫  

⌦ 1
46 

(cid:206)2 Caramel 
 

(cid:206)2 Bro
wn  

(cid:206)2 X  

73 

⌦ As UV-Filter, see Annex VI, No. 27. ⌫ 

Commission 
Directive 
95/45/EC (E 
174) ⌫ 

(cid:206)2 E 171  
⌦ Purity 
criteria as set 
out in 
Commission 
Directive 
95/45/EC (E 
171) ⌫ 

(cid:206)2 E 101  
⌦ Purity 
criteria as set 
out in 
Commission 
Directive 
95/45/EC (E 
101) ⌫ 

(cid:206)2 E 150  
⌦ Purity 

EN 

290 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
⌫ 

⌦ 1
47 
⌫ 

⌦ (3R,3'S,5'R)-3,3'-
dihydroxy-.beta.,.kappa.-
caroten-6'-one ⌫ 

(cid:206)2 Capsanth
in, 
capsorubin 
 

(cid:206)2 Ora
nge  

(cid:206)2 X  

⌦ Beta vulgaris 
extract ⌫ 

(cid:206)2 Beetroot 
red  

(cid:206)2 Red 
 

(cid:206)2 X  

⌦ Anthocyanins ⌫ 

(cid:206)2 Anthocya
nins  

(cid:206)2 Red 
 

(cid:206)2 X  

⌦ 1
48 
⌫ 

⌦ 1
49 
⌫ 

criteria as set 
out in 
Commission 
Directive 
95/45/EC (E 
150) ⌫ 

(cid:206)2 E 160 c  
⌦ Purity 
criteria as set 
out in 
Commission 
Directive 
95/45/EC (E 
160c) ⌫ 

(cid:206)2 E 162  
⌦ Purity 
criteria as set 
out in 
Commission 
Directive 
95/45/EC (E 
162) ⌫ 

(cid:206)2 E 163  
⌦ Obtained by 
the physical 
processing of 
edible fruits or 
vegetables, 
purity criteria as 

EN 

291 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
set out in 
Commission 
Directive 
95/45/EC (E 
163) ⌫ 

⌦ 1
50 
⌫ 

⌦ Aluminium, zinc, 
magnesium and calcium 
stearates ⌫ 

⌦ 1
51 
⌫ 

⌦ 1
52 
⌫ 

⌦ 1
53 
⌫ 

⌦ Phenol, 4,4'-(3H-2,1-
benzoxathiol-3-
ylidene)bis[2-bromo-3-
methyl-6-(1-methylethyl)-, 
S,S-dioxide ⌫ 

⌦ Phenol, 4,4'-(3H-2,1-
benzoxathiol-3-
ylidene)bis[2,6-dibromo-3-
methyl-,S,S-dioxide ⌫ 

⌦ Sodium 4-[(4,5-
dihydro-3-methyl-5-oxo-1-
phenyl-1H-pyrazol-4-
yl)azo]-3-
hydroxynaphthalene-1-
sulphonate ⌫ 

(cid:206)2 aluminu
m stearate; 
zinc stearate; 
magnesium 
stearate and 
calcium 
stearate  

(cid:206)2 Bromoth
ymol blue  

(cid:206)2 Bromocr
esol green  

(cid:206)5 Acid red 
195  

(cid:206)2 Whi
te  

(cid:206)2 X  

(cid:206)2 Blue
  

(cid:206)2 X  
⌦ Rinse-off 
products ⌫ 

(cid:206)2 Gree
n  

(cid:206)2 X  
⌦ Rinse-off 
products ⌫ 

(cid:206)5 Red 
 

(cid:206)5 X  ⌦ No 
use in products 
applied on 
mucous 
membranes ⌫ 

EN 

292 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
(cid:208) 86/179/EEC (adapted) 

PART 2 

LIST OF COLOURING AGENTS PROVISIONALLY ALLOWED FOR USE IN 
COSMETIC PRODUCTS74 

Field of application 

Colour index 
number or 
denomination 

Colour 

Field of application 

1 

2 

3 

4 

Authorization 
valid until 

Other 
limitations 
and 
requirements
75 

74 
75 

EN 

Lakes or salts of these colouring agents using substances not prohibited under Annex II or not excluded under Annex V from the scope of this Directive are equally allowed. 
Colouring agents whose number is preceded by the letter ‘E’ in accordance with the EEC Directive of 1962 concerning foodstuffs and colouring matters must fulfil the 
purity requirements laid down in those Directives. They continue to be subject to the general criteria set out in Annex III to the 1962 Directive concerning colouring matters 
where the letter ‘E’ has been deleted therefrom. 

293 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
Column 1  = 

Colouring agents allowed in all cosmetic products. 

Column 2  = 

Colouring agents allowed in all cosmetic products except those intended to 
be applied in the vicinity of the eyes, in particular eye make-up and eye 
make-up remover 

Column 3  = 

Colouring agents allowed exclusively in cosmetic products intended not to 
come into contact with the mucous membranes. 

Column 4  = 

Colouring agents allowed exclusively in cosmetic products intended to 
come into contact only briefly with the skin. 

EN 

294 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
(cid:208) 76/768/EEC 

ANNEX V 

LIST OF SUBSTANCES EXCLUDED FROM THE SCOPE OF THE DIRECTIVE 

5. Strontium and its compounds, with the exception of strontium lactate, strontium nitrate and strontium polycarboxylate listed in Annex II, 
strontium sulphide, strontium chloride, strontium acetate, strontium hydroxide, strontium peroxide, under the conditions laid down in Annex 
III,  Part  1  and  of  strontium  lakes,  pigments  and  salts  of  the  colouring  agents  listed  with  the  reference  (3)  in  Annex  IV,  Part  1.

(cid:208) 94/32/EC 

EN 

295 

EN 

 
  
 
 
 
(cid:208) 86/199/EEC (adapted) 
(cid:206)1 2007/17/EC Art. 1 and Annex pt. 2(b) 
(cid:206)2 2007/17/EC Art. 1 and Annex pt. 2(c) 
(cid:206)3 2007/17/EC Art. 1 and Annex pt. 2(d) 

ANNEX VVI 

LIST OF PRESERVATIVES ⌦ ALLOWED IN ⌫ WHICH COSMETIC PRODUCTS MAY CONTAIN 

PREAMBLE 

1.  Preservatives are substances which may be added to cosmetic products for the primary purpose of inhibiting the development of  micro-
organisms in such products. 

2. The substances marked with the symbol (*) may also be added to cosmetic products in concentration other than those laid down in this 
Annex  for  other  specific  purposes  apparent  from  the  presentation  of  the  products,  e.g.  as  deodorants  in  soaps  or  as  anti-dandruff  agents  in 
shampoos. 

3. Other substances used in the formulation of cosmetic products may also have anti-microbial properties and thus help in the preservation of 
the products, as, for instance, many essential oils and some alcohols. These substances are not included in this Annex. 

14. For the purposes of this list: 

– 

‘Salts’ is taken to mean: salts of the cations sodium, potassium, calcium, magnesium, ammonium and ethanolamines; salts of the anions 
chloride, bromide, sulphate, acetate. 

– 

‘Esters’ is taken to mean: esters of methyl, ethyl, propyl, isopropyl, butyl, isobutyl, phenyl. 

25.  All  finished  products  containing  formaldehyde  or  substances  in  this  Annex  and  which  release  formaldehyde  must  be  labelled  with  the 
warning ‘contains formaldehyde’ where the concentration of formaldehyde in the finished product exceeds 0,05 %. 

EN 

296 

EN 

 
  
 
 
 
 
 
 
PART 1 

LIST OF PRESERVATIVES ALLOWED 

Refere
nce 

numbe
r 

⌦ Chemical 
name/INN 
⌫ 

Substance ⌦ identification ⌫ 

⌦ Conditions ⌫ 

⌦ Name of Common 
Ingredients Glossary ⌫ 

⌦ CAS 
number ⌫ 

⌦ EINECS
/ELINCS 
number ⌫ 

⌦ Product type, 
Body parts ⌫ 

Maximum 
authorized 
concentration 

⌦ Other ⌫ 
Limitations 
and 
requirements 

⌦ Wording 
of ⌫ 
Cconditions 
of use and 
warnings 
which must 
be printed 
on the label 

a 

b 

c 

d 

e 

f 

cg 

dh 

ei 

(cid:206)2 1 
 

(cid:206)2 Benzoic 
acid and its 
sodium salt 
 

 ⌦ Benzoic acid 

65-85-0 

Sodium Benzoate ⌫  

532-32-1 

 ⌦ 200-
618-2  

208-534-8 

(cid:206)2 Rinse-off 
products, except 
oral care 
products:  

(cid:206)2 2,5 % 
(acid) 

 

(cid:206)2  

(cid:206)2  

⌫ 

297 

Oral care 
products:  

(cid:206)2 1,7 % 
(acid)  

EN 

EN 

 
  
 
(cid:206)2 1a 
 

(cid:206)2 Salts of 
benzoic acid 
other than 
that listed 
under 
reference 
number 1 and 
esters of 
benzoic 
acid  

⌦ Ammonium 
benzoate, calcium 
benzoate, potassium 
benzoate, magnesium 
benzoate, MEA-
benzoate, methyl 
benzoate, ethyl 
benzoate, propyl 
benzoate, butyl 
benzoate, isobutyl 
benzoate, isopropyl 
benzoate, phenyl 
benzoate ⌫ 

⌦ 1863-63-4, 
2090-05-3, 582-
25-2, 553-70-8, 
4337-66-0, 93-
58-3, 93-89-0, 
2315-68-6, 136-
60-7, 120-50-3, 
939-48-0, 93-
99-2 ⌫ 

2 

Propionic 
acid and its 
salts 

⌦ Propionic acid, 
ammonium propionate, 
calcium propionate, 
magnesium propionate, 
potassium propionate, 
sodium propionate ⌫ 

⌦ 79-09-4, 
17496-08-1, 
4075-81-4, 557-
27-7, 327-62-8, 
137-40-6 ⌫ 

EN 

⌦ 217-
468-9, 218-
235-4, 209-
481-3, 209-
045-2, 224-
387-2, 202-
259-7, 202-
284-3, 219-
020-8, 205-
252-7, 204-
401-3, 213-
361-6, 202-
293-2 ⌫ 

⌦ 201-
176-3, 241-
503-7, 223-
795-8, 209-
166-0, 206-
323-5, 205-
290-4⌫ 

298 

Leave-on 
products:  

 

(cid:206)2 0,5 % 
(acid) 

(cid:206)2 0,5 % 
(acid)  

(cid:206)2  

(cid:206)2  

2 % (acid) 

EN 

 
  
 
 
 
 
3 
⌦ 76 
⌫ 

Salicylic acid 
and its salts 
(*) 

⌦ Salicylic acid, 
calcium salicylate, 
magnesium salicylate, 
MEA-salicylate, sodium 
salicylate, potassium 
salicylate, TEA-
salicylate ⌫  

⌦ 69-72-7, 
824-35-1, 
18917-89-0, 
59866-70-5, 54-
21-7, 578-36-9, 
2174-16-5 ⌫ 

4 

hHexa-2,4-
dienoic acid 
and its salts 

Sorbic acid ⌦ calcium 
sorbate, sodium sorbate, 
potassium sorbate ⌫ 

⌦ 110-44-1, 
7492-55-9, 
7757-81-5, 
24634-61-5 ⌫ 

⌦ Formaldehyde ⌫  ⌦ 50-00-0, 

30525-89-4 ⌫ 

5 
⌦ 78 
⌫ 

Formaldehyd
e, 
paraformalde
hyde 
(cid:206)1 (*)  

⌦ 200-
712-3, 212-
525-4, 242-
669-3, 261-
963-2, 200-
198-0, 209-
421-6, 218-
531-3 ⌫ 

⌦ 203-
768-7, 231-
321-6, 231-
819-3, 246-
376-1 ⌫ 

⌦ 200-
001-8 ⌫ 

0,5 % (acid) 

0,6 % (acid) 

Not to be used 
in preparations 
⌦ products 
⌫ for 
children under 
3 three years 
of age, except 
for shampoos  

Not to be 
used for 
children 
under 3 
three years 
of age77 

⌦Oral products 
⌫for oral 
hygiene) 

0,1 % 
(expressed as 
free 
formaldehyde) 

⌦No use 
⌫Prohibited 
in aerosol 
dispensers 
(sprays)  

⌦Other 
products 
⌫(except for 
products for oral 
hygiene) 

0,2 % 
(expressed as 
free 
formaldehyde) 

76 
77 
78 

⌦ For other uses than preservative, see Annex III, no. 98. ⌫ 
Solely for products which might be used for children under 3 years of age and which remain in prolonged contact with the skin. 
⌦ For other uses than preservative, see Annex III, No. 13. ⌫ 

EN 

299 

EN 

 
  
 
 
 
 
 
                                                 
⌦ Biphenyl-
2-ol, ⌫ 

Biphenyl-2-
ol (o-
phenylphenol
) and its salts  

⌦ o-Phenylphenol, 
sodium o-
phenylphenate, 
potassium o-
phenylphenate, MEA o-
phenylphenate ⌫ 

⌦ 90-43-7, 
132-27-4, 
13707-65-8, 
84145-04-0 ⌫ 

⌦ 201-
993-5, 205-
055-6, 237-
243-9, 282-
227-7 ⌫ 

0,2 % 
expressed as 
the (as phenol) 

⌦ Pyrithion
e zinc ⌫ 

(cid:206)3 Zinc 
pyrithione (*)  

(cid:206)3 13463-41-
7  

⌦ 236-
671-3 ⌫ 

(cid:206)3 Hair 
products  

(cid:206)3 1,0 %  

7 

(cid:206)3 8 
 
⌦ 79 
⌫ 

Other products 
 

(cid:206)3 0,5 % 

0,2 % 
expressed as 
(as free SO2) 

9 
⌦ 80 
⌫ 

Inorganic 
sulphites and 
hydrogen- 
sulphites (*) 

⌦ Sodium sulfite, 
ammonium bisulfite, 
ammonium sulfite, 
potassium sulfite, 
potassium hydrogen 
sulfite, sodium bisulfite, 
sodium metabisulfite, 
potassium 
metabisulfite ⌫ 

⌦ 7757-83-7, 
10192-30-0, 
10196-04-0, 
10117-38-1, 
7773-03-7, 
7631-90-5, 
7681-57-4, 
16731-55-8 ⌫ 

⌦ 231-
821-4, 233-
469-7, 233-
484-9, 233-
321-1, 231-
870-1, 231-
548-0, 231-
673-0, 240-
795-3 ⌫ 

79 
80 

⌦ For other uses than preservative, see Annex III. No. 101. ⌫ 
⌦ For other uses than preservative, see Annex III, No. 99. ⌫ 

(cid:206)3  

(cid:206)3 ⌦ Only 
in ⌫ rRinse-
off products 
only. 

No use in 
⌦ oral ⌫ 
products for 
oral 
hygiene.  

EN 

300 

EN 

 
  
 
 
 
 
 
 
                                                 
11 

⌦ Chlorobut
anol ⌫ 

12 

4-
Hydroxybenz
oic acid and 
its salts and 
esters 

EN 

Chlorobutanol (INN)  ⌦ 57-15-8 ⌫  ⌦ 200-

0,5 % 

0,4 % (as acid) 
for 1 ester, 

0,8 % (as acid) 
for mixtures of 
esters 

⌦ 4-Hydroxybenzoic 
acid, methylparaben, 
butylparaben, potassium 
ethylparaben, potassium 
paraben, propylparaben, 
isobutylparaben, sodium 
methylparaben, sodium 
ethylparaben, sodium 
propylparaben, sodium 
butylparaben, sodium 
isobutylparaben, 
ethylparaben, sodium 
paraben, 
isopropylparaben, 
passiummethylparaben, 
potassium butylparaben, 
potassium 
propylparaben, sodium 
propylparaben, calcium 
paraben, 
phenylparaben ⌫ 

⌦ 99-96-7, 99-
76-3, 94-26-8, 
36457-19-
9,16782-08-4, 
94-13-3, 4247-
02-3, 5026-62-
0, 35285-68-8, 
35285-69-9, 
36457-20-2, 
84930-15-4, 
120-47-8, 114-
63-6, 4191-73-
5, 2611-07-2, 
38566-94-8, 
84930-17-4, 
35285-69-9, 
69959-44-0, 
17696-62-7 ⌫ 

317-6 ⌫ 

⌦ 202-
804-9, 202-
785-7, 202-
318-7, 253-
048-1, 240-
830-2, 202-
307-7, 224-
208-8, 225-
714-1, 252-
487-6, 252-
488-1, 253-
049-7, 284-
595-4, 204-
399-4, 204-
051-1, 224-
069-3, 247-
464-2, 254-
009-1, 284-
597-5, 252-
488-1, 274-
235-4241-
698-9 ⌫ 

301 

Prohibited 
⌦ No use ⌫ 
in aerosol 
dispensers 
(sprays) 

Contains 
chlorobutan
ol 

EN 

 
  
 
 
 
 
 
13 

3-Acetyl-6-
methylpyran-
2,4 (3H)-
dione and its 
salts 

Dehydroacetic acid ⌦ , 
sodium 
dehydroacetate ⌫ 

⌦ 520-45-6, 
4418-26-2, 
16807-48-0 ⌫ 

⌦ 208-
293-9, 224-
580-1 ⌫ 

0,6 % (as acid)  Prohibited 

⌦ No use ⌫ 
in aerosol 
dispensers 
(sprays) 

(cid:208) 76/768/EEC (adapted) 
(cid:206)1 94/32/EC 
(cid:206)2 86/199/EEC 
(cid:206)3 89/174/EEC 
(cid:206)4 87/137/EEC 
(cid:206)5 88/233/EEC 
(cid:206)6 2007/17/EC Art. 1 and Annex pt. 2(b) 
(cid:206)7 91/184/EEC 
(cid:206)8 92/86/EEC 
(cid:206)9 96/41/EC 
(cid:206)10 2005/42/EC Art. 1 and Annex .3(a) 
(cid:206)11 98/62/EC 
(cid:206)12 2000/6/EC Art. 1 and Annex .3(I) 
(cid:206)13 2007/22/EC Art. 1 and Annex pt. 2(b) 
(cid:206)14 2005/42/EC Art. 1 and Annex .3(b) 

(cid:206)1 14 
 

(cid:206)2 15 
 

(cid:206)1 Formic 
acid and its 
sodium 
salt  

(cid:206)2 3,3‘-
Dibromo-
4,4‘-
hexamethyle

⌦ Formic acid, sodium 
formate ⌫ 

⌦ 64-18-6, 
141-53-7 ⌫ 

⌦ 200-
579-1, 205-
488-0 ⌫ 

Dibromohexamidine 
⌦ Isethionate ⌫ 

⌦ 93856-83-
8 ⌫ 

⌦ 299-
116-4 ⌫ 

(cid:206)1 0,5 % 
(expressed as 
acid)  

(cid:206)2 0,1 %  

EN 

302 

EN 

 
  
 
 
 
 
 
 
 
 
 
nedioxydi-
benzamidine 
and its salts 
(including 
isethionate) 
 

(cid:206)2 16 
 

(cid:206)2 Thiomers
al (INN)  

⌦ Thimerosal ⌫ 

⌦ 54-64-8 ⌫  ⌦ 200-

210-4 ⌫ 

⌦ Eye 
products ⌫ 

(cid:206)2 0,007 % 
(of Hg) 

If mixed with 
other 
mercurial 
compounds 
authorized by 
this Directive, 
the maximum 
concentration 
of Hg remains 
fixed at 
0,007 %  

(cid:206)2 For eye 
make-up and 
eye make-up 
remover 
only  

(cid:206)2 Contain
s 
thiomersal 
 

(cid:206)2 17 
 

(cid:206)2 Phenylm
ercuric salts 
(including 
borate)  

⌦ Phenyl Mercuric 
Acetate, Phenyl 
Mercuric Benzoate ⌫ 

⌦ 62-38-4, 94-
43-9 ⌫ 

⌦ 200-
532-5, 202-
331-8 ⌫ 

⌦ Eye 
products ⌫ 

(cid:206)2 Ditto  

(cid:206)2 Ditto   (cid:206)2 Contain

s 
phenylmerc
uric 
compounds 
 

⌦ 0,007 % 
(of Hg) 

If mixed with 
other 
mercurial 
compounds 
authorized by 

EN 

303 

EN 

 
  
(cid:206)2 18 
 

(cid:206)2 19 
 

(cid:206)2 Undec-
10-enoic acid 
and 
⌦ its ⌫ 
salts  

⌦ Undecylenic acid, 
potassium undecylenate, 
sodium undecylenate, 
calcium undecylenate, 
TEA-undecylenate, 
MEA-undecylenate ⌫ 

⌦ 112-38-9, 
6159-41-7, 
3398-33-2, 
1322-14-1, 
84471-25-0, 
56532-40-2 ⌫ 

⌦ 203-
965-8, 222-
264-8, 215-
331-8, 282-
908-9, 260-
247-7 ⌫ 

this Directive, 
the maximum 
concentration 
of Hg remains 
fixed at 
0,007 ⌫ %  

(cid:206)2 0,2 % (as 
acid)  

(cid:206)2 See Annex 
VI, Part 2, No 
8  

⌦ Hexetidine ⌫ 

⌦ 141-94-
6 ⌫ 

⌦ 205-
513-5 ⌫ 

(cid:206)2 0,1 %  

(cid:206)2 Hexetidin
e (INN)  5- 
⌦ Pyrimidin
amine, 1,3-
bis(2-
ethylhexyl)he
xahydro-5-
methyl- ⌫ 

(cid:206)2 20 
 

(cid:206)2 5-Bromo-
5-nitro-1,3-
dioxane  

⌦ 5-Bromo-5-nitro-1,3-
dioxane ⌫ 

⌦ 30007-47-
7 ⌫ 

⌦ 250-
001-7 ⌫ 

⌦ Rinse-off 
products ⌫ 

(cid:206)2 0,1 %   (cid:206)2 Rinse-off 
products only 

Avoid 
formation of 
nitrosamines 

(cid:206)3 ---   

EN 

304 

EN 

 
  
 
 
 
 
 
 
(cid:206)2 21 
 

(cid:206)2 Bronopol 
(INN)   

⌦ 2-Bromo-2-
nitropropane-1,3-diol ⌫

⌦ 52-51-7 ⌫  ⌦ 200-

143-0 ⌫ 

⌦ Dichlorobenzyl 
Alcohol ⌫ 

⌦ 1777-82-
8 ⌫ 

⌦ 217-
210-5 ⌫ 

(cid:206)2 0,1 %   (cid:206)2 Avoid 

formation of 
nitrosamines 
 

(cid:206)2 0,15 %  

(cid:206)2 Triclocarban (INN) 
(*)  

⌦ 101-20-
2 ⌫ 

⌦ 202-
924-1 ⌫ 

(cid:206)2 0,2 %   (cid:206)2 Purity 

criteria: 

(cid:206)2 22 
 

(cid:206)2 23 
 
⌦ 81 
⌫ 

(cid:206)2 2,4-
Dichlorobenz
yl alcohol  

⌦1-(4-
Chlorophenyl
)-3-(3,4-
dichlorophen
yl)urea ⌫ 

(cid:206)2 24 
 

(cid:206)2 4-Chloro-
m-cresol  

⌦ p-Chloro-m-
Cresol ⌫ 

⌦ 59-50-7 ⌫  ⌦ 200-

431-6 ⌫ 

3,3',4,4'-
Tetrachloroazo
benzene 
<1 ppm 

3,3',4,4'-
Tetrachloroazo
xybenzene 
<1 ppm  

(cid:206)2 Prohibited 
No use in 
products 
⌦ applied on 
mucuous 
membranes ⌫ 
the products 

(cid:206)2 0,2 %   (cid:206)2 Prohibited 
in the products 
intended to 
come into 
contact with 
mucous 
membranes  

81 

⌦ For other uses than preservative, see Annex III, No. 100. ⌫ 

EN 

305 

EN 

 
  
 
 
 
 
 
 
 
 
                                                 
intended to come 
into contact with 
mucous 
membranes   

⌦ Triclosan ⌫ 

⌦ 3380-34-
5 ⌫ 

⌦ 222-
182-2 ⌫ 

(cid:206)2 0,3 %  

⌦ Chloroxylenol ⌫  ⌦ 88-04-0 ⌫  ⌦ 201-

(cid:206)2 0,5 %  

793-8 ⌫ 

(cid:206)2 Imidazolidinyl 
urea  

⌦ 39236-46-
9 ⌫ 

⌦ 254-
372-6 ⌫ 

(cid:206)2 0,6 %  

(cid:206)2 25 
 

(cid:206)2 26 
 

(cid:206)2 27 
 

(cid:206)2 Tricolosa
n (INN)  
⌦ 5-Chloro-
2-(2,4-
dichlorophen
oxy)phenol 
⌫ 

(cid:206)2 4-Chloro-
3,5-
xylenol  

(cid:206)2 3,3'-Bis 
(1-
hydroxymeth
yl-2,5-
dioxoimidazo
lidin-4-yl)-
1,1'-
methylenediu
rea  
⌦ N,N''-
methylenebis
[N'-[3-
(hydroxymet
hyl)-2,5-
dioxoimidazo

EN 

306 

EN 

 
  
 
 
 
 
 
 
 
 
 
(cid:206)2 28 
 

(cid:206)2 29 
 

(cid:206)2 30 
 

lidin-4-
yl]urea] ⌫  

(cid:206)2 Poly (1-
hexamethyle
nebiguanide 
hydrochlorid
e  

⌦ Poly(met
hylene), 
.alpha.,.omeg
a.-
bis[[[(aminoi
minomethyl)
amino]imino
methyl]amin
o]-, 
dihydrochlori
de ⌫ 

(cid:206)2 2-
Phenoxyetha
nol  

(cid:206)2 ⌦ Meth
enamine ⌫ 
Hexamethyle
netetramine ) 
(INN)  

⌦ Polyaminopropyl 
biguanide ⌫ 

⌦ 70170-61-5, 
28757-47-3, 
133029-32-
0 ⌫ 

(cid:206)2 0,3 %  

⌦ Phenoxyethanol ⌫  ⌦ 122-99-

6 ⌫ 

⌦ Methenamine ⌫  ⌦ 100-97-

0 ⌫ 

⌦ 204-
589-7 ⌫ 

⌦ 202-
905-8 ⌫ 

(cid:206)2 1,0 %  

(cid:206)2 0,15 %  

(cid:206)2 31  (cid:206)2 Methena ⌦ Quaternium-15 ⌫  ⌦ 4080-31- ⌦ 223-

(cid:206)2 0,2 %  

EN 

307 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 

(cid:206)2 32 
 

(cid:206)2 33 
 

(cid:206)2 34 
 
⌦ 82 
⌫  

mine 3-
chloroallyloc
hloride 
(INN)  

(cid:206)2 1-(4-
Chloropheno
xy)-1-
(imidazol-1-
yl)-3,3-
dimethylbuta
n-2-one  

(cid:206)2 1,3-Bis 
(hydroxymet
hyl)-5,5-
dimethylimid
azolidine-2,4-
dione  

(cid:206)2 Benzyl 
alcohol 
(*)  

3 ⌫ 

805-0 ⌫ 

⌦ Climbazole ⌫ 

⌦ 38083-17-
9 ⌫ 

⌦ 253-
775-4 ⌫ 

(cid:206)2 0,5 %  

⌦ DMDM 
Hydantoin ⌫ 

⌦ 6440-58-
0 ⌫ 

⌦ 229-
222-8 ⌫ 

(cid:206)2 0,6 %  

⌦ Benzyl alcohol ⌫  ⌦ 100-51-

6 ⌫ 

⌦ 202-
859-9 ⌫ 

(cid:206)2 1,0 %  

(cid:206)2 35 
 

(cid:206)2 1-
Hydroxy-4-

⌦ 1-Hydroxy-4-
methyl-6-(2,4,4-

⌦ 50650-76-5, 
68890-66-4 ⌫ 

⌦ 272-
574-2 ⌫ 

⌦ Rinse-off 
products ⌫ 

(cid:206)2 1,0 % 

Products 
rinsed off 

82 

⌦ For other uses than preservative, cf. Annex III, No. 45, 68. ⌫ 

EN 

308 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
                                                 
(cid:206)2 37 
 

(cid:206)2 38 
 

(cid:206)2 39 
 

methyl-6-
(2,4,4-
trimethylpent
yl) 2-pyridon 
and its 
monoethanol
amine salt  

(cid:206)2 6,6-
Dibromo-4,4-
dichloro2,2‘-
methylene-
diphenol  
⌦ 2,2'-
methylenebis
(6-bromo-4-
chlorophenol
) ⌫ 

(cid:206)2 4-
Isopropyl-m-
cresol  

(cid:206)2 Mixture 
of 5-Chloro-
2-methyl-
isothiazol-
3(2H)-one 
and 2-
methylisothia
zol-3(2H)-
one with 

trimethylpentyl) 2-
pyridon, Piroctone 
Olamine ⌫ 

⌦ Other 
products ⌫ 

0,5 %  

For other 
products 

(cid:206)2 Bromochlorophene 
 

⌦ 15435-29-
7 ⌫ 

⌦ 239-
446-8 ⌫ 

(cid:206)2 0,1 %  

⌦ Isopropyl Cresols ⌫ ⌦ 3228-02-

2 ⌫ 

⌦ 221-
761-7 ⌫ 

⌦ Methylchloroisothiaz
olinone and 
Methylisothiazolinone 
⌫ 

⌦ 26172-55-4, 
2682-20-4, 
55965-84-9 ⌫ 

⌦ 247-
500-7, 220-
239-6 ⌫ 

(cid:206)2 0,1 %  

(cid:206)2 (cid:206)3 0,0015 
% (of a 
mixture in the 
ratio 3:1 of 5-
chloro-2-
methylisothiaz
ol 3(2H)-one 
and 2-
methylisothiaz

EN 

309 

EN 

 
  
 
 
 
 
 
 
 
 
 
Chlorophene 

⌦ 120-32-
1 ⌫ 

⌦ 204-
385-8 ⌫ 

ol-3 (2H)-
one  

(cid:206)4 0.,2 %  

⌦ Chloroacetamide ⌫  ⌦ 79-07-2 ⌫  ⌦ 201-

(cid:206)5 0,3 %  

174-2 ⌫ 

(cid:206)5 Contain
s 
chloroaceta
mide  

⌦ Chlorhexidine, 
Chlorhexidine Diacetate, 
Chlorhexidine 
Digluconate, 
Chlorhexidine 
Dihydrochloride ⌫ 

⌦ 55-56-1, 56-
95-1, 18472-51-
0, 3697-42-
5 ⌫ 

⌦ 200-
238-7, 200-
302-4, 242-
354-0, 223-
026-6 ⌫ 

(cid:206)5 0,3 % 
expressed (as 
chlorhexidine)
 

magnesium 
chloride and 
magnesium 
nitrate  

(cid:206)4 2-
Benzyl-4-
chlorophenol 
 

(cid:206)4 40 
 

(cid:206)5 41 
 

(cid:206)5 2-
Chloroaceta
mide  

(cid:206)5 42 
 

⌦ N,N"-
bis(4-
chlorophenyl
)-3,12-
diimino-
2,4,11,13-
tetraazatetrad
ecanediamidi
ne ⌫ 
(cid:206)5 Chlorhex
idine (INN) 
and its 
digluconate, 
diacetate and 
dihydrochlori
de  

EN 

310 

EN 

 
  
 
 
 
 
 
 
 
 
⌦ Phenoxyisopropanol 
⌫ 

⌦ 770-35-
4 ⌫ 

⌦ 212-
222-7 ⌫ 

⌦ Behentrimonium 
chloride, cetrimonium 
bromide, cetrimonium 
chloride, laurtrimonium 
bromide, laurtrimonium 
chloride, steartrimonium 
bromide, steartrimonium 
chloride ⌫ 

⌦ 17301-53-0, 
57-09-0, 112-
02-7, 1119-94-
4, 112-00-5, 
1120-02-1, 112-
03-8 ⌫ 

⌦ 241-
327-0, 200-
311-3, 203-
928-6, 214-
290-3, 203-
927-0, 214-
294-5, 203-
929-1 ⌫ 

⌦ Dimethyl 
Oxazolidine ⌫ 

⌦ 51200-87-
4 ⌫ 

⌦ 257-
048-2 ⌫ 

(cid:206)5 1,0 %   (cid:206)5 Only for 

rinse-off 
products  

(cid:206)7 0,1 %  

(cid:206)7 0,1 %   (cid:206)7 pH of the 

finished 
product > 6  

⌦ Diazolidinyl 
Urea ⌫ 

⌦ 78491-02-
8 ⌫ 

⌦ 278-
928-2 ⌫ 

(cid:206)7 0,5 %  

(cid:206)5 43 
 
⌦ 83 
⌫ 

(cid:206)7 44 
 

(cid:206)7 45 
 

(cid:206)7 46 
 

(cid:206)5 1-
Phenoxyprop
an-2-ol  
(cid:206)6 (*)  

(cid:206)7 Alkyl 
(C12-C22) 
trimethyl 
ammonium 
bromide and 
chloride 
(*)  

(cid:206)7 4,4-
dimethyl-1,3-
oxazolidine 
 

(cid:206)7 N-
(Hydroxymet
hyl)-N-
(dihydroxym
ethyl-1,3-
dioxo-2,5-
imidazolidiny
l-4)-N'-
(hydroxymet

83 

⌦ For other uses than preservative, see Annex III, No. 54. ⌫ 

EN 

311 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
                                                 
(cid:206)8 47 
 

(cid:206)1 48 
 

hyl) urea  

(cid:206)8 1,6-Di 
(4-
amidinophen
oxy)-n-
hexane  

⌦ Benzenec
arboximidam
ide, 4,4'-(1,6-
hexanediylbis
(oxy))bis- ⌫ 

and its salts 
(including 
isethionate 
and p-
hydroxybenz
oate)  

(cid:206)1 Glutarald
ehyde 
(Pentane-1,5-
dial)  

Hexamidine, 
⌦ Hexamidine 
diisethionate, 
Hexamidine paraben ⌫ 

⌦ 3811-75-4, 
659-40-5, 
93841-83-9 ⌫ 

⌦ 211-
533-5, 299-
055-3 ⌫ 

(cid:206)8 0,1 % 

⌦ Glutaral ⌫ 

⌦ 111-30-
8 ⌫ 

⌦ 203-
856-5 ⌫ 

(cid:206)1 0,1 %   (cid:206)1 ⌦ No 

use ⌫ 
Prohibited in 
aerosols 
(sprays)  

EN 

312 

(cid:206)1 Contain
s 
glutaraldehy
de 
⌦ glutaral 
⌫ (where 
glutaraldehy
de 
concentratio
n in the 
finished 

EN 

 
  
 
 
 
 
 
(cid:206)1 49 
 

(cid:206)1 5-Ethyl-
3,7-dioxa-1-
azabicyclo 
[3.3.0] 
octane  

⌦ 7- 
ethylbicyclooxazolidine 
⌫ 

⌦ 7747-35-
5 ⌫ 

⌦ 231-
810-4 ⌫ 

(cid:206)9 50 
 

(cid:206)9 51 
 

(cid:206)9 52 
 

(cid:206)9 3-(p-
chlorophenox
y)-propane-
1,2 diol  

(cid:206)9 Sodium 
hydroxymeth
ylamino 
acetate  

(cid:206)9 Silver 
chloride 
deposited on 
titanium 
dioxide  

(cid:206)9 Chlorphenesin   ⌦ 104-29-

0 ⌫ 

⌦ 203-
192-6 ⌫ 

(cid:206)9 Sodium 
Hydroxymethylglycinate
  

⌦ 70161-44-
3 ⌫ 

⌦ 274-
357-8 ⌫ 

⌦ Silver chloride ⌫  ⌦ 7783-90-

6 ⌫ 

⌦ 232-
033-3 ⌫ 

product 
exceeds 
0,05 %)  

(cid:206)1 0,3 %  (cid:206)1 Prohibited 
⌦ No use ⌫ 
in oral hygiene 
products and 
in products 
intended to 
come into 
contact with 
⌦ applied 
on ⌫ mucous 
membranes  

(cid:206)9 0,3 %  

(cid:206)9 0,5 %  

(cid:206)9 0,004 % 
calculated as 
(as AgCl)  

(cid:206)9 20 % 
AgCl (w/w) on 
TiO2. 
Prohibited 
⌦ No use ⌫ 
in products for 

EN 

313 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
children under 
3 three years 
of age, in oral 
hygiene 
products and 
in ⌦ eye and 
lip ⌫ 
productsintend
ed for 
application 
around the 
eyes and on 
the lips  

(cid:206)10 0,1 %   (cid:206)10 (a) Rinse-

off products, 

(b) Leave-on 
products other 
than for oral 
⌦ products 
⌫ care use 

(cid:206)10 Benzethonium 
Chloride  

⌦ 121-54-
0 ⌫ 

⌦ 204-
479-9 ⌫ 

(cid:206)10 53
  

(cid:206)10 Benzeth
onium 
Chloride 
(INCI)  
⌦ Benzene
methanamini
um, N,N-
dimethyl-N-
[2-[2-[4-
(1,1,3,3,-
tetramethylbu
tyl)phenoxy]
ethoxy]ethyl]
-, 
chloride ⌫ 

EN 

314 

EN 

 
  
 
 
(cid:206)11 54
  
⌦ 84 
⌫ 

(cid:206)11 Benzalk
onium 
chloride, 
bromide and 
saccharinate 
(+)  

Benzalkonium  chloride, 
benzalkonium  bromide, 
benzalkonium 
saccharinate 

⌦ 8001-54-5, 
63449-41-2, 
91080-29-4, 
68989-01-5, 
68424-85-1, 
68391-01-5, 
61789-71-7, 
85409-22-9 ⌫ 

⌦ 264-
151-6,  293-
522-5,  273-
545-7,  270-
325-2,  269-
919-4,  263-
080-8,  287-
089-1 ⌫ 

(cid:206)12 55
  

⌦ Methanol, 
(phenylmetho
xy-) ⌫ 

(cid:206)12 Benzylhemiformal 
 

⌦ 14548-60-
8 ⌫ 

⌦ 238-
588-8 ⌫ 

(cid:206)13 56
  

(cid:206)13 (IPBC) 
3-iodo-2-
propynylbuty
lcarbamate 
 

(cid:206)13 iIodopropynyl 
butylcarbamate  

55406-53-6  

259-627-5 

(cid:206)11 0,1% 
calculated (as 
benzalkonium 
chloride)  

(cid:206)11 Avoid 
contact with 
eyes  

(cid:206)12 0,15 % 
 

(cid:206)12 Only for 
⌦ Rinse off ⌫ 
products to be 
removed by 
rinsing  

(cid:206)13 (a) rinse-
off products: 
0,02 % 

(b) leave-on 
products: 
0,01 %, except 
in 
deodorants/ant
iperspirants: 
0,0075 %  

(cid:206)13 Not to be 
used in oral 
hygiene and 
lip care 
products 

(a) Not to be 
used in 
preparations
⌦ products 
⌫ for 
children under 

(cid:206)13 (a)“Not 
to be used 
for children 
under 3 
three years 
of age”86 

(b)“Not to 
be used for 
children 
under 3 
three years 

84 
85 
86 

⌦ For other uses than preservative, cf. Annex III, No. 65. ⌫ 
Concerns any products aimed to be applied on a large part of the body. 
Solely for products, other than bath products/shower gels and shampoo, which might be used for children under 3 years of age. 

EN 

315 

EN 

 
  
 
 
 
 
 
                                                 
of 
age””87  

3 three years 
of age, except 
in bath 
products/show
er gels and 
shampoo 

(b) 

- Not to be 
used in body 
lotion and 
body cream85 

- Not to be 
used in 
⌦ products 
⌫ 
preparations 
for children 
under 3 three 
years of 
age  

(cid:206)14 57
  

(cid:206)14 (INCI) 
 ⌦ 2-
methyl-2H-
isothiazol-3-
one ⌫ 

(cid:206)14 Methylisothiazolino
ne  

⌦ 2682-20-
4 ⌫ 

⌦ 220-
239-6 ⌫ 

(cid:206)14 0,01 % 
 

87 

Solely for products which might be used for children under 3 years of age. 

EN 

316 

EN 

 
  
 
 
 
                                                                                                                                                                                                                                                    
(cid:208) 86/199/EEC (adapted) 

PART 2 

LIST OF PRESERVATIVES PROVISIONALLY ALLOWED 

Reference 
number 

Substance 

Maximum 
authorized 
concentration 

Limitations 
and 
requirements 

Allowed 
until 

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

EN 

317 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
EN 

318 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
(cid:208) 83/574/EEC (adapted) 

ANNEX VIVII 

LIST OF UV FILTERS ⌦ ALLOWED IN ⌫ WHICH COSMETIC PRODUCTS MAY CONTAIN 

For the purposes of this Directive, UV filters are substances which, contained in cosmetic sun-screen products, are specifically intended to filter certain 
UV rays in order to protect the skin from certain harmful effects of these rays. 

These UV filters may be added to other cosmetic products within the limits and under the conditions laid down in this Annex. 

Other UV filters used in cosmetic products solely for the purpose of protecting the product against UV rays are not included in this list. 

PART 1 

List of permitted UV filters which cosmetic products may contain 

Ref
ere
nce
⌦ 
nu
mb
er
⌫ 
No 

EN 

Substances ⌦ identification ⌫ 

⌦ Conditions ⌫ 

⌦ Chemical 
name/INN ⌫ 

⌦ Name of 
Common 
Ingredients 
glossary ⌫ 

⌦ CAS 
number ⌫ 

⌦ EINECS/EL
INCS number 
⌫ 

⌦ Product 
type, body 
parts ⌫ 

Maximum 
authorized 
concentration 

Otherlimitatio
ns and 
requirements 

⌦ Wording 
of ⌫ 
Cconditions 
of use and 
warnings 
which must 
be printed 
on the label 

319 

EN 

 
  
 
a 

b 

c 

d 

e 

f 

cg 

dh 

ei 

1 

2 

4-
Aminobenzoic 
acid 

N,N,N-
Trimethyl-4-(2-
oxoborn-3-
ylidenemethyl) 
anilinium 
methyl 
sulfphate 

3  ⌦ Benzoic 
acid, 2-
hydroxy-, 3,3,5-
trimethylcycloh
exyl 
ester/Homosalat
e ⌫ 
Homosaolate 
(INN)  

4  ⌦ 2-Hydroxy-

4-
methoxybenzop

EN 

⌦ PABA ⌫ 

⌦ 150-13-0 ⌫  ⌦ 205-753-

0 ⌫ 

⌦ Camphor 
Benzalkonium 
Methosulfate ⌫ 

⌦ 52793-97-2 ⌫  ⌦ 258-190-

8 ⌫ 

5 % 

6 % 

Homosalate 

⌦ 118-56-9 ⌫  ⌦ 204-260-

10 % 

8 ⌫ 

⌦ Benzophenone
-3 ⌫ 

⌦ 131-57-7 ⌫  ⌦ 205-031-

10 % 

5 ⌫ 

320 

Contains 
⌦ Benzoph
enone-3 ⌫ 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
⌦ Phenylbenzimi
dazole 
Sulfonic 
Acid ⌫ 

⌦ 27503-81-7 ⌫  ⌦ 248-502-

8 % 

0 ⌫ 

(expressed as 
acid) 

oxybenzone
88 

6 

henone/Oxyben
zone ⌫ 
Oxybenzone 
(INN) 

2-
Pphenylbenzimi
dazole-5-
sulfphonic acid 
and its 
potassium, 
sodium and 
triethanolamine 
salts 
⌦ /Ensulizole 
⌫ 

88 

Not requiered if concentration is 0,5 % or less and when it is used only for product protection purposes. 

EN 

321 

EN 

 
  
 
 
 
                                                 
(cid:208) 76/768/EEC (adapted) 
(cid:206)1 94/32/EC 
(cid:206)2 93/47/EEC 
(cid:206)3 95/34/EC 
(cid:206)4 96/41/EC 
(cid:206)5 97/45/EC 
(cid:206)6 98/62/EC 
(cid:206)7 2000/6/EC Art. 1 and Annex .4(I) 
(cid:206)8 2002/34/EC Art. 1 and Annex .4 
(cid:206)9 2005/9/EC Art. 1 and Annex  

⌦ Terephthalylid
ene Dicamphor 
Sulfonic Acid ⌫ 

⌦ 92761-26-7, 
90457-82-2 ⌫ 

⌦ 410-960-
6 ⌫ 

(cid:206)1 10 % 

(expressed as 
acid)  

⌦ Butyl 
Methoxydibenzoyl
methane ⌫ 

⌦ 70356-09-1 ⌫  ⌦ 274-581-

(cid:206)2 5 %  

6 ⌫ 

(cid:206)1 7 
 

(cid:206)2 8 
 

(cid:206)1 3,3'-(1,4-
Phenylenedi
methylene) 
bis (7, 7-
dimethyl-2-
oxobicyclo-
[2,.2,.1]hept-
1-yl-
methanesulfo
nic acid) and 
its salts  

⌦ /Ecamsule 
⌫ 

(cid:206)2 1-(4-tert-
butylphenyl)-
3-(4-
methoxyphen
yl)propane-

EN 

322 

EN 

 
  
 
 
 
 
 
 
 
(cid:206)1 9 
 

(cid:206)3 1
0  

(cid:206)4 1
1  

1,3-dione  

(cid:206)1 alpha-(2-
Oxoborn-3-
ylidene)-
toluene-4-
sulphonic 
acid and its 
salts  
⌦ /Avobenz
one ⌫ 

(cid:206)3 2-cyano-
3,3-diphenyl 
acrylic acid, 
2-ethylhexyl 
ester  
⌦ /Octocrile
ne ⌫ 

(cid:206)4 Polymer 
of N-{(2 and 
4)-[(2-
oxoborn-3-
ylidene)meth
yl]benzyl}acr
ylamide  

⌦ Benzylidene 
Camphor Sulfonic 
Acid ⌫ 

⌦ 56039-58-8 ⌫ 

⌦ Octocrylene 
⌫ 

⌦ 6197-30-4 ⌫  ⌦ 228-250-

8 ⌫ 

⌦ Polyacrylamid
omethyl 
Benzylidene 
Camphor ⌫ 

⌦ 113783-61-
2 ⌫ 

(cid:206)1 6 % 

(expressed as 
acid)  

(cid:206)3 10 % 

(expressed as 
acid)  

(cid:206)4 6 %  

(cid:206)5 1
2  

⌦ 2-
Ethylhexyl 4-
methoxycinna
mate ⌫ 

(cid:206)5 Ethylhexyl 
Mmethoxycinnam
ate  

EN 

⌦ 5466-77-3 ⌫  ⌦ 226-775-

(cid:206)5 10 %  

7 ⌫ 

323 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
(cid:206)6 PEG-25 
PABA  

⌦ 116242-27-
4 ⌫ 

(cid:206)6 10 %  

(cid:206)6 Isoamyl p-
mMethoxycinnam
ate  

⌦ Ethylhexyl 
Triazone ⌫ 

⌦ 71617-10-2 ⌫  ⌦ 275-702-

(cid:206)6 10 %  

5 ⌫ 

⌦ 88122-99-0 ⌫  ⌦ 402-070-

(cid:206)6 5 %  

1 ⌫ 

⌦ Drometrizole 
Trisiloxane ⌫ 

⌦ 155633-54-
8 ⌫ 

(cid:206)6 15 %  

(cid:206)6 1
3  

(cid:206)6 1
4  

(cid:206)6 1
5  

(cid:206)6 1
6  

(cid:206)6 Ethoxylat
ed Eethyl-4-
aAminobenzo
ate  

(cid:206)6 Isopentyl
-4-
methoxycinna
mate  

(cid:206)6 2,4,6-
Trianilino-(p-
Ccarbo-2‘-
Eethylhexyl-
1‘-oxy)-1,3,5-
Triazine 
(Octyl 
Triazone)  

(cid:206)6 Phenol,2-
(2H-
Bbenzotriazol
-2-yl)-4-
mMethyl-6-
(2-mMethyl-
3-(1,3,3,3-
Tetramethyl-
I1-
(tTrimethylsil
yl)oOxy)-
Ddisiloxanyl)

EN 

324 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
(cid:206)6 1
7  

(cid:206)6 1
8  

(cid:206)6 1
9  

(cid:206)6 2
0  

Ppropyl) 

(cid:206)6 Benzoic 
acid, 4,4-((6-
((((1,1-
dimethylethyl
)amino)carbo
nyl)phenyl)a
mino) 1,3,5-
triazine-2,4-
diyl)diimino)
bis-,bis-(2-
ethylhexyl) 
ester)   

(cid:206)6 3-(4‘-
Methylbenzx
ylidene)-d-1 
camphor 
⌦ /Enzac
amene ⌫ 

(cid:206)6 3-
Benzylidene 
camphor  

(cid:206)6 2-
Ethylhexyl 
salicylate 
(Octyl-
salicylate)  

⌦ Diethylhexyl 
Butamido 
Triazone ⌫ 

⌦ 154702-15-
5 ⌫ 

(cid:206)6 10 %  

(cid:206)6 4-
Methylbenzyliden
e Camphor  

⌦ 38102-62-4, 
36861-47-9 ⌫ 

⌦ 253-242-
6 ⌫ 

(cid:206)6 4 %  

(cid:206)6 3-Benzylidene 
Camphor  

⌦ Ethylhexyl 
Salicylate ⌫ 

⌦ 15087-24-8 ⌫  ⌦ 239-139-

(cid:206)6 2 %  

9 ⌫ 

⌦ 118-60-5 ⌫  ⌦ 204-263-

(cid:206)6 5 %  

4 ⌫ 

EN 

325 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
⌦ Ethylhexyl 
dDimethyl 
PABA ⌫ 

⌦ 21245-02-3 ⌫  ⌦ 244-289-

(cid:206)7 8 %  

3 ⌫ 

⌦ Benzophenone
-4, Benzophen 
one-5 ⌫ 

⌦ 4065-45-6, 
6628-37-1 ⌫ 

⌦ 223-772-
2 ⌫ 

(cid:206)7 5 % (of as 
acid)  

(cid:206)7 2
1  

(cid:206)7 2
2  

(cid:206)7 4-
Dimethyl-
amino-
benzoate of 
ethyl-2-hexyl 
(octyl 
dimethyl 
PABA)  
⌦ 2-
Ethylhexyl 4-
(dimethylami
no)benzoate 
⌫ 

(cid:206)7 2-
Hydroxy-4-
methoxybenz
ophenone-5-
sulfonic acid 
and its 
sodium 
salt  
⌦ /Sulisobe
nzone, 
Sulisobenzon
e sodium ⌫ 

(cid:206)7 2
3  

(cid:206)7 2,2'-
Methylene-
bis(-6-(2H-
benzotriazol-

⌦ Methylene 
Bis-Benzotriazolyl 
Tetramethylbutylp
henol ⌫ 

⌦ 103597-45-
1 ⌫ 

⌦ 604-052-00-
0, 403-800-
1 ⌫ 

(cid:206)7 10 %  

EN 

326 

EN 

 
  
 
 
 
 
 
 
 
 
 
(cid:206)7 2
4  

(cid:206)7 2
5  

2-yl)-4-
(tetramethyl-
butyl)-
1,1,3,3-
phenol  
⌦ /Bisoctriz
ole ⌫ 

(cid:206)7 Monosod
ium 
⌦ Sodium 
⌫ salt of 2,-
2'-bis-(1,4-
phenylene)-
1H-
benzimidazol
e-4,6-
disulphfonic 
acid)  
⌦ /Bisdisuli
zole 
disodium ⌫ 

(cid:206)7 (1,3,5)-
Triazine-2,4-
bis((4-(2-
ethyl-
hexyloxy)-2-
hydroxy)-
phenyl)-6-(4-
methoxyphen
yl)-1,3,5-

⌦ Disodium 
Phenyl 
Dibenzimidazole 
Tetrasulfonate ⌫ 

⌦ 180898-37-
7 ⌫ 

⌦ 429-750-
0 ⌫ 

(cid:206)7 10 % (of as 
acid)  

⌦ 187393-00-
6 ⌫ 

⌦ Bis-
Ethylhexyloxyphe
nol 
Methoxyphenyl 
tTriazine ⌫ 

(cid:206)7 10 %  

EN 

327 

EN 

 
  
 
 
 
 
 
 
 
(cid:206)8 2
6  

(cid:206)8 2
7  
⌦ 89 
⌫  

(cid:206)9 2
8  

⌦ Polysilicone-
15 ⌫ 

⌦ 207574-74-
1 ⌫ 

Triazine  

(cid:206)8 Dimethic
odiethylbenza
lmalonate 
(CAS No 
207574-74-
1)  

(cid:206)8 Titanium 
dioxide  

⌦ Titanium 
Dioxide ⌫ 

⌦ 13463-67-7, 
1317-70-0, 1317-
80-2 ⌫ 

⌦ 236-675-
5205-280-1, 
215-282-2 ⌫ 

(cid:206)9 302776-68-
7  

⌦ 443-860-
6 ⌫ 

(cid:206)9 Diethylamino 
Hydroxybenzoyl 
Hexyl 
Benzoate  

(cid:206)9 Benzoic 
acid, 2-[-4-
(diethylamino
)-2-
hydroxybenz
oyl]-, 
hexylester  

(cid:206)8 10 %  

(cid:206)8 25 %  

(cid:206)9 10 % in 
sunscreen 
products  

89 

⌦ For use as colorants, see Annex IV, No. 143. ⌫ 

EN 

328 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
                                                 
(cid:208) 89/174/EEC (adapted) 

PART 2 

LIST OF UV FILTERS WHICH COSMETIC PRODUCTS MAY PROVISIONALLY CONTAIN 

Reference 
number 

Substances 

Maximum 
authorized 
concentration 

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

Allowed 
until 

Other 
limitations 
and 
requirement
s 

EN 

329 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ANNEX VIII VII 
 ⌦ Symbols used on packaging/container ⌫ 

(cid:208) 93/35/EEC (adapted) 

⌦ 1.  Reference to enclosed or attached information ⌫ 

(cid:208) 2003/15/EC Art. 1.11 (adapted) 

ANNEX VIIIa 

⌦ 2.  Period-after-opening ⌫ 

.

EN 

330 

   EN 

 
 
 
 
 
 
3. 

Date of minimum durability 

(cid:216) new 

(cid:208) 2003/15/EC Art. 1.11 

EN 

331 

   EN 

 
 
 
 
(cid:208) 2004/94/EC Art. 1 and 
Annex(adapted) 

ANNEX IX VIII 

LIST OF VALIDATED ALTERNATIVE METHODS TO ANIMAL TESTING 

This Annex lists the alternative methods validated by the European Centre on Validation of 
Alternative  Methods  (ECVAM)  of  the  Joint  Research  Centre  available  to  meet  the 
requirements  of  this  ⌦ Regulation ⌫  Directive  and  which  are  not  listed  in  Annex  V  to 
Council Directive 67/548/EEC on the approximation of laws, regulations and administrative 
provisions relating to the classification, packaging and labelling of dangerous substances. As 
animal  testing  may  not  be  replaced  completely  by  an  alternative  method,  it  should  be 
mentioned in Annex IXVIII whether the alternative method fully or partially replaces animal 
testing. 

Reference number  Validated alternative methods  Nature of replacement full or partial 

A 

B 

C 

EN 

332 

   EN 

 
 
 
(cid:207) 

ANNEX IX 

Part A 

Repealed Directive with its successive amendments 
(referred to in Article 33) 

Council  Directive  76/768/EEC  of  27  July 
1976 

(OJ L 262, 27.9.1976, p. 169) 

Council Directive 79/661/EEC of 24 July 1979 

(OJ L 192, 31.7.1979, p. 35) 

Commission  Directive  82/147/EEC  of  11  February 
1982 

(OJ L 063, 6.3.1982, p. 26) 

Council Directive 82/368/EEC of 17 May 1982 

(OJ L 167, 15.6.1982, p. 1) 

Commission  Directive  83/191/EEC  of  30  March 
1983 

(OJ L 109, 26.4.1983, p. 25) 

Commission Directive 83/341/EEC of 29 June 1983 

(OJ L 188, 13.7.1983, p. 15) 

Commission  Directive  83/496/EEC  of  22  September 
1983 

(OJ L 275, 08.10.1983, p. 20) 

Council Directive 83/574/EEC of 26 October 1983 

(OJ L 332, 28.11.1983, p. 38) 

Commission Directive 84/415/EEC 18 July 1984 

(OJ L 228 of 25.08.1984, p. 31) 

Commission Directive 85/391/EEC 16 July 1985 

(OJ L 224 of 22.08. 1985, p. 40) 

Commission  Directive  86/179/EEC  of  28  February 
1986 

(OJ L 138 of 24.05.1986, p. 40) 

Commission  Directive  86/199/EEC  of  26  March 
1986 

(OJ L 149 of 3.06.1986, p. 38) 

Commission  Directive  87/137/EEC  of  2  February 
1987 

(OJ L 56 of 26.02.1987, p. 20) 

Commission Directive 88/233/EEC of 2 March 1988 

(OJ L 105 of 26.04.1988, p. 11) 

Council Directive 88/667/EEC of 21 December 1988 

(OJ L 382 of 31.12.1988, p. 46) 

Commission  Directive  89/174/EEC  of  21  February 
1989 

(OJ L 64 of 8.03.1989, p. 10) 

Council Directive 89/679/EEC of 21 December 1989 

(OJ L 398, 30.12.1989, p. 25) 

EN 

333 

   EN 

 
 
Commission  Directive  90/121/EEC  of  20  February 
1990  

(OJ L 71 of 17.03.1990, p. 40) 

Commission  Directive  91/184/EEC  of  12  March 
1991 

(OJ L 91 of 12.04.1991, p. 59) 

Commission  Directive  92/8/EEC  of  18  February 
1992 

(OJ L 70 of 17.03.1992, p. 23) 

Commission  Directive  92/86/EEC  of  21  October 
1992 

(OJ L 325 of 11.11.1992, p. 18) 

Council Directive 93/35/EEC of 14 June 1993 

(OJ L 151, 23.06.1993, p. 32) 

Commission Directive 93/47/EC of 22 June 1993 

(OJ L 203 of 13. 08. 1993, p. 24) 

Commission Directive 94/32/EC of 29 June 1994 

(OJ L 181 of 15.07.1994, p. 31) 

Commission Directive 95/34/EC of 10 July 1995 

(OJ L 167 of 18.07.1995, p. 19) 

Commission Directive 96/41/EC of 25 June 1996 

(OJ L 198 of 08.08.1996, p. 36) 

Commission Directive 97/1/EC of 10 January 1997 

(OJ L 16 of 18.01.1997, p. 85) 

Commission Directive 97/18/EC of 17 April 1997 

(OJ L 114, 1.5.1997, p. 43) 

Commission Directive 97/45/EC of 14 July 1997 

(OJ L 196 of 24.07.1997, p. 77) 

Commission Directive 98/16/EC of 5 March 1998 

(OJ L 77 of 14.03.1998, p. 44) 

Commission  Directive  98/62/EC  of  3  September 
1998 

(OJ L 253 of 15.09.1998, p. 20) 

Commission  Directive  2000/6/EC  of  29  February 
2000 

(OJ L 56 of 01.03.2000, p. 42) 

Commission Directive 2000/11/EC of 10 March 2000 (OJ L 65 of 14.03.2000, p. 22) 

Commission Directive 2000/41/EC of 19 June 2000 

(OJ L 145, 20.6.2000, p. 25) 

Commission Directive 2002/34/EC of 15 April 2002 

(OJ L 102 of 18.04.2002, p. 19) 

Commission Directive 2003/1/EC of 6 January 2003 

(OJ L 5 of 10.01.2003, p. 14) 

Commission  Directive  2003/16/EC  of  19  February 
2003 

(OJ L 46 of 20.02.2003, p. 24) 

Directive  2003/15/EC  of  the  European  Parliament 
and of the Council of 27 February 2003 

(OJ L 66, 11.03.2003, p. 26) 

Commission  Directive  2003/80/EC  of  5  September  (OJ L 224 of 06.09.2003, p. 27) 

EN 

334 

   EN 

 
2003 

Commission  Directive  2003/83/EC  of  24  September 
2003 

(OJ L 238 of 25.09.2003, p. 23) 

Commission  Directive  2004/87/EC  of  7  September 
2004 

(OJ L 287, 08.09.2004, p. 4) 

Commission  Directive  2004/88/EC  of  7  September 
2004 

(OJ L 287 of 08.09.2004, p. 5) 

Commission  Directive  2004/94/EC  of  15  September 
2004 

(OJ L 294 of 17.09.2004, p. 28) 

Commission  Directive  2004/93/EC  of  21  September 
2004 

(OJ L 300 of 25.09.2004, p. 13) 

Commission Directive 2005/9/EC of 28 January 2005 (OJ L 27 of 29.01.2005, p. 46) 

Commission Directive 2005/42/EEC of 20 June 2005 

(OJ L 158 of 21.06.2005, p. 17) 

Commission  Directive  2005/52/EC  of  9  September 
2005 

(OJ L 234, 10.09.2005, p. 9) 

Commission  Directive  2005/80/EC  of  21  November 
2005 

(OJ L 303, 22.11.2005, p. 32) 

Commission Directive 2006/65/EC of 19 July 2006 

(OJ L 198 of 20.07.2006, p. 11) 

Commission  Directive  2006/78/EC  of  29  September 
2006 

(OJ L 271 of 30.09.2006, p. 56) 

Commission Directive 2007/1/EC of 29 January 2007 (OJ L 25, 01.02.2007, p. 9) 

Commission Directive 2007/17/EC of 22 March 2007 (OJ L 82, 23.03.2007, p. 27) 

Commission Directive 2007/22/EC of 17 April 2007 

(OJ L 101, 18.04.2007, p. 11) 

Commission  Directive  2007/53/EC  of  29  August 
2007  

(OJ L 226, 30.08. 2007, p. 19) 

Commission  Directive  2007/54/EC  of  29  August 
2007 

(OJ L 226, 30.08. 2007, p. 21) 

Commission  Directive  2007/67/EC  of  22  November 
2007 

(OJ L 305, 23.11.2007, p. 22) 

Commission Directive 95/17/EC of 19 June 1995 

(OJ L 140, 23.06.1995, p. 26) 

EN 

Part B 

335 

   EN 

 
List of time-limits for transposition into national law and application 
(referred to in Article 33) 

Directive 

Time-limit for transposition 

Council Directive 76/768/EEC of 27 July 1976 

Council Directive 79/661/EEC of 24 July 1979 

30.01.1978 

30.07.1979 

Commission Directive 82/147/EEC of 11 February 1982 

31.12.1982 

Council Directive 82/368/EEC of 17 May 1982 

31.12.1983 

Commission Directive 83/191/EEC of 30 March 1983 

31.12.1984 

Commission Directive 83/341/EEC of 29 June 1983 

31.12.1984 

Commission Directive 83/496/EEC of 22 September 1983 

31.12.1984 

Council Directive 83/574/EEC of 26 October 1983 

Commission Directive 84/415/EEC 18 July 1984 

Commission Directive 85/391/EEC 16 July 1985 

31.12.1984 

31.12.1985 

31.12.1986 

Commission Directive 86/179/EEC of 28 February 1986 

31.12.1986 

Commission Directive 86/199/EEC of 26 March 1986 

31.12.1986 

Commission Directive 87/137/EEC of 2 February 1987 

31.12.1987 

Commission Directive 88/233/EEC of 2 March 1988 

30.09.1988 

Council Directive 88/667/EEC of 21 December 1988 

31.12.1993 

Commission Directive 89/174/EEC of 21 February 1989 

31.12.1989 

Council Directive 89/679/EEC of 21 December 1989 

03.01.1990 

Commission Directive 90/121/EEC of 20 February 1990 

31.12.1990 

Commission Directive 91/184/EEC of 12 March 1991 

31.12.1991 

Commission Directive 92/8/EEC of 18 February 1992 

31.12.1992 

Commission Directive 92/86/EEC of 21 October 1992 

30.06.1993 

Council Directive 93/35/EEC of 14 June 1993 

Commission Directive 93/47/EC of 22 June 1993 

Commission Directive 94/32/EC of 29 June 1994 

14.06.1995 

30.06.1994 

30.06.1995 

EN 

336 

   EN 

 
Commission Directive 95/34/EC of 10 July 1995 

Commission Directive 96/41/EC of 25 June 1996 

Commission Directive 97/1/EC of 10 January 1997 

Commission Directive 97/18/EC of 17 April 1997 

Commission Directive 97/45/EC of 14 July 1997 

Commission Directive 98/16/EC of 5 March 1998 

30.06.1996 

30.06.1997 

30.06.1997 

31.12.1997 

30.06.1998 

01.04.1998 

Commission Directive 98/62/EC of 3 September 1998 

30.06.1999 

Commission Directive 2000/6/EC of 29 February 2000 

01.07.2000 

Commission Directive 2000/11/EC of 10 March 2000 

01.06.2000 

Commission Directive 2000/41/EC of 19 June 2000 

29.06.2000 

Commission Directive 2002/34/EC of 15 April 2002 

15.04.2003 

Commission Directive 2003/1/EC of 6 January 2003 

15.04.2003 

Commission Directive 2003/16/EC of 19 February 2003 

28.02.2003 

Directive  2003/15/EC  of  the  European  Parliament  and  of  the 
Council of 27 February 2003 

10.09.2004 

Commission Directive 2003/80/EC of 5 September 2003 

11.09.2004 

Commission Directive 2003/83/EC of 24 September 2003 

23.09.2004 

Commission Directive 2004/87/EC of 7 September 2004 

01.10.2004 

Commission Directive 2004/88/EC of 7 September 2004 

1.10.2004 

Commission Directive 2004/94/EC of 15 September 2004 

21.09.2004 

Commission Directive 2004/93/EC of 21 September 2004 

30.09.2004 

Commission Directive 2005/9/EC of 28 January 2005 

16.02.2006 

Commission Directive 2005/42/EEC of 20 June 2005 

31.12.2005 

Commission Directive 2005/52/EC of 9 September 2005 

01.01.2006 

Commission Directive 2005/80/EC of 21 November 2005 

22.05.2006 

Commission Directive 2006/65/EC of 19 July 2006 

01.09.2006 

Commission Directive 2006/78/EC of 29 September 2006 

30.03.2007 

EN 

337 

   EN 

 
Commission Directive 2007/1/EC of 29 January 2007 

21.08.2007 

Commission Directive 2007/17/EC of 22 March 2007 

23.09.2007 

Commission Directive 2007/22/EC of 17 April 2007 

18.01.2008 

Commission Directive 2007/53/EC of 29 August 2007  

19.04.2008 

Commission Directive 2007/54/EC of 29 August 2007 

18.03.2008 

Commission Directive 2007/67/EC of 22 November 2007 

31.12.2007 

Commission Directive 95/17/EC of 19 June 1995 

30.11.1995 

____ 

EN 

338 

   EN 

 
ANNEX X 

CORRELATION TABLE 

Directive 76/768/EEC 

This Regulation 

Article 1 

Article 2 

Article 3 

Article 4(1) 

Article 4(2) 

Article 4a 

Article 4b 

Article 5 

Article 5a 

Article 2(1)(a) 

Article 3 

- 

Article 11(1) 

Article 13 

Article 14 

Article 12(1) 

- 

Article 28 

Article 6(1),(2) 

Article 15(1),(2),(3),(4) 

Article 6(3) 

Article 7(1) 

Article 7(2) 

Article 7(3) 

Article 7a (1) (h) 

Article 7a(1),(2),(3) 

Article 7a(4) 

Article 7a(5) 

Article 8(1) 

Article 8(2) 

Article 8a 

Article 9 

Article 10 

EN 

Article 16 

Article 6 

Article 15(5), (7) 

Article 10 

Article 17 

Article 7, 8, Annex I 

Article 10 

Article 24, 29 

Article 9 

Article 26 

- 

Article 30 

Article 27 

339 

   EN 

 
Article 11 

Article 12 

Article 13 

Article 14 

Article 15 

Annex I 

Annex II 

Annex III 

Annex IV 

Annex V 

Annex VI 

Annex VII 

Annex VIII 

Annex VIIIa 

Annex IX 

- 

- 

- 

Article 22 

Article 23 

- 

- 

Preamble, No. 10 

Annex II 

Annex III 

Annex IV 

- 

Annex V 

Annex VI 

Annex VII 

Annex VII 

Annex VIII 

Annex IX 

Annex X 

EN 

340 

   EN 

 
 
LEGISLATIVE FINANCIAL STATEMENT 

1. 

NAME OF THE PROPOSAL: 

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

2. 

ABM / ABB FRAMEWORK 

Policy  Area(s)  concerned  and  associated  Activity/Activities:  Enterprise  -  Internal 
market, product safety 

3. 

BUDGET LINES 

3.1. 

Budget  lines  (operational  lines  and  related  technical  and  administrative 
assistance lines (ex- B..A lines)) including headings: 

02.010401 (internal market) 

3.2. 

Duration of the action and of the financial impact: 

The  action  will  start  in  2009.  While  the  budget  is  successively  decreasing  (see 
below), the action is going to run continuously unless subsequent amendments to this 
Regulation provide differently. 

3.3. 

Budgetary characteristics: 

Budget 
line 

Type of expenditure 

New 

EFTA 
contribution 

Contributions 
from applicant 
countries 

Heading in 
financial 
perspective 

02.01040
1 

Non-comp 

Non-
diff90 

NO 

YES 

NO 

No 1a 

90 

Non-differentiated appropriations hereafter referred to as NDA 

EN 

341 

   EN 

 
                                                 
4. 

SUMMARY OF RESOURCES 

4.1. 

Financial Resources 

4.1.1. 

Summary of commitment appropriations (CA) and payment appropriations (PA) 

Expenditure type 

Section 
no. 

n + 1 

n + 2 

n + 3 

n + 4 

Year 
n 

n + 5 
and 
later 

Total 

EUR million (to 3 decimal places) 

Operational expenditure91 

Commitment Appropriations 
(CA) 

8.1. 

Payment 
(PA) 

Appropriations 

a 

b 

Administrative expenditure within reference amount92 

Technical  &  administrative 
assistance (NDA) 

8.2.4. 

c 

TOTAL REFERENCE AMOUNT 

0.11 

0.05 

0.015 

0.01 

0.01 

0.01 

0.205 

Commitment 
Appropriations 

0.11 

0.05 

0.015 

0.01 

0.01 

0.01 

0.205 

a+c 

Payment Appropriations 

b+c  0.11 

0.05 

0.015 

0.01 

0.01 

0.01 

0.205 

Administrative expenditure not included in reference amount93 

0.02 

0.005 

0.005 

0.005 

0.005 

0.005 

0.045 

Human 
associated 
(NDA) 

resources 

and 
expenditure 

8.2.5. 

d 

Administrative  costs,  other 
than  human  resources  and 
not 
associated 
included 
reference 
in 
amount (NDA) 

costs, 

8.2.6. 

e 

Total indicative financial cost of intervention 

TOTAL CA including cost 
of Human Resources 

TOTAL  PA  including  cost 
of Human Resources 

a+c
+d+
e 

b+c
+d+
e 

0.13 

0.055 

0.002 

0.015 

0.015 

0.015 

0.25 

0.13 

0.055 

0.002 

0.015 

0.015 

0.015 

0.25 

91 
92 
93 

Expenditure that does not fall under Chapter xx 01 of the Title xx concerned. 
Expenditure within article xx 01 04 of Title xx. 
Expenditure within chapter xx 01 other than articles xx 01 04 or xx 01 05. 

EN 

342 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
Co-financing details 

n.a. 

4.1.2.  Compatibility with Financial Programming 

(cid:56) 

Proposal is compatible with existing financial programming. 

4.1.3.  Financial impact on Revenue 

(cid:56) 

Proposal has no financial implications on revenue 

4.2. 

Human Resources FTE (including officials, temporary and external staff) – see 
detail under point 8.2.1. 

Annual requirements 

Year n 

n + 1 

n + 2 

n + 3 

n + 4 

n + 5 
and 
later 

Total  number  of  human 
resources 

0.2 

0.05 

0.05 

0.05 

0.05 

0.05 

5. 

CHARACTERISTICS AND OBJECTIVES 

5.1. 

Need to be met in the short or long term 

The proposed Regulation aims at facilitating the application of the rules for placing 
cosmetic  products  on  the  EU  market.  Up  until  now,  prior  to  placing  a  cosmetic 
product  on  the  market,  several  notifications  had  to  be  made  to  different  competent 
national authorities. This lead to a multiple submission of identical information. 

In  order  to  reduce  administrative  burden,  the  proposed  Regulation  provides  for  a 
centralised submission of this data to all relevant competent authorities concerned in 
a “on-stop-shop”. 

This would be done by an informatics portal: notifying companies would submit the 
relevant  information  once  through  this  portal.  The  portal  would  “forward”  that 
information to the competent authorities concerned. 

In  order  to  set  up  this  portal,  the  Commission  would  make  use  of  a  (framework) 
Community 
contract for the technical IT-work.5.2.  Value-added 
involvement and coherence of the proposal with other financial instruments and 
possible synergy 

of 

The  value-added  of  this  measure  has  been  assessed  thoroughly  in  the  impact 
assessment  accompanying 
the 
administrative burden would be reduced considerably by this measure: It would save 
EU-businesses  approx.  EUR  45  Mil.  per  annum.  As  such,  this  measure  is  an 
important contribution to the Commission’s policy to reduce administrative costs for 
EU-businesses to better reap the benefits from the internal market. 

the  Commission  proposal. 

reveals 

that 

It 

EN 

343 

   EN 

 
 
 
 
 
 
 
This impact assessment has been approved by the impact assessment board.  

5.3. 

Objectives, expected results and related indicators of the proposal in the context 
of the ABM framework 

To create and maintain an electronic portal which would allow for single submission 
of information on cosmetic products placed on the EU market. 

5.4.  Method of Implementation (indicative) 

Show below the method(s)94 chosen for the implementation of the action. 

(cid:56) 

Centralised Management 

(cid:56) 

directly by the Commission 

(cid:133) 

indirectly by delegation to: 

(cid:133) 

executive Agencies 

(cid:133) 

bodies set up by the Communities as referred to in art. 185 of the 
Financial Regulation 

(cid:133) 

national public-sector bodies/bodies with public-service mission 

(cid:133) 

Shared or decentralised management 

(cid:133)  with Member states 

(cid:133)  with Third countries 

(cid:133) 

Joint management with international organisations (please specify) 

Relevant comments: 

94 

If  more  than  one  method  is  indicated  please  provide  additional  details  in  the  "Relevant  comments" 
section of this point 

EN 

344 

   EN 

 
                                                 
6. 

MONITORING AND EVALUATION 

6.1.  Monitoring system 

The effectiveness of the electronic portal can be monitored by assessing its usability. 
Important  fora  to  exchange  information  in  this  respect  are  the  working  group 
“Cosmetic products” (a regulators and stakeholders meeting held approx. 4-5 times 
per year) and the “Platform of market surveillance authorities for cosmetic products” 
(PEMSAC, a forum for enforcing authorities of the Member States). 

6.2. 

Evaluation 

6.2.1.  Ex-ante evaluation 

An ex-ante evaluation, assessing impacts of this measures and possible alternatives is 
contained  in  the  impact  assessment  submitted  together  with  the  Commission 
proposal  in  Inter-Service  Consultation.  The  impact  assessment  concludes  that  a 
centralised  notification  greatly  contributes  to  efficient  in-market  surveillance  by 
competent  authorities  in  the  Member  States.  Moreover,  compared  to  the  present 
system  of  multiple  national  notifications  it  reduces  administrative  costs  for 
companies by approx. 50% (approx. 45 million EUR). In fact, the introduction of a 
centralised notification procedure is a useful example for the benefits of a re-cast in 
terms  of  reducing  costs  for  regulatory  compliance  (here:  administrative  costs) 
without compromising product safety. 

The impact assessment board supported the impact assessment. The final opinion is 
available here: http://ec.europa.eu/governance/impact/cia_2007_en.htm. 

6.2.2.  Measures taken  following  an intermediate/ex-post evaluation (lessons  learned from 

similar experiences in the past) 

6.2.3.  Terms and frequency of future evaluation 

Ongoing  in  view  of  the  continuous  use  of  the  electronic  portal  by  the  economic 
actors. 

7. 

ANTI-FRAUD MEASURES  

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8. 

DETAILS OF RESOURCES 

8.1. 

Objectives of the proposal in terms of their financial cost 

Commitment appropriations in EUR million (to 3 decimal places) 

Year n 

Year n+1 

Year n+2 

Year n+3 

Year n+4 

Year n+5 and 
later 

TOTAL 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

Type of output 

Av. 
cost 

of 

(Headings 
Objectives, 
and 
actions 
outputs should be 
provided) 

OPERATIONAL 
OBJECTIVE  No.1 
95……… 

N.A. 

Action 
1………………. 

- Output 1 

- Output 2 

Action 
2………………. 

- Output 1 

Sub-total 
Objective 1 

OPERATIONAL 
OBJECTIVE  No.2 
1……… 

Action 

95 

As described under Section 5.3 

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346 

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1………………. 

- Output 1 

Sub-total 
Objective 2 

OPERATIONAL 
OBJECTIVE  No.n 
1 

Sub-total 
Objective n 

TOTAL COST 

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8.2. 

Administrative Expenditure 

8.2.1.  Number and type of human resources 

Types of post 

Staff to be assigned to management of the action using existing and/or 
additional resources (number of posts/FTEs) 

Year n 

Year n+1  Year n+2  Year n+3  Year n+4  Year n+5 

A*/AD 

0.2 

0.05 

0.05 

0.05 

0.05 

0.05 

B*, 
C*/AST 

Officials or 
temporary 
staff96 (XX 01 
01) 

Staff  financed97  by  art. 
XX 01 02 

Other  staff98  financed by 
art. XX 01 04/05 

TOTAL 

0.2 

0.05 

0.05 

0.05 

005 

0.05 

8.2.2.  Description of tasks deriving from the action 

Initiating work on an electronic portal/interface within a framework contract initiated 
by DIGIT or, if necessary, through a call for tender launched by this DG. 

8.2.3. 

Sources of human resources (statutory) 

(cid:56) 

Posts  to  be  redeployed  using  existing  resources  within  the  managing  service 
(internal redeployment) 

96 
97 
98 

Cost of which is NOT covered by the reference amount 
Cost of which is NOT covered by the reference amount 
Cost of which is included within the reference amount 

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8.2.4.  Other  Administrative  expenditure  included  in  reference  amount  (XX  01  04/05  – 

Expenditure on administrative management) 

Budget line 

(number and heading) 

EUR million (to 3 decimal places) 

Year 
n 

Year 
n+1 

Year 
n+2 

Year 
n+3 

Year 
n+4 

Year 
n+5  

and 
later 

TOTAL 

Technical 

1 
and 
assistance (including related staff costs) 

administrative 

Executive agencies99 

Other 

technical 

and 

administrative 

assistance 

- intra muros  

- extra muros 

0.11 

0.05 

0.015 

0.01 

0.01 

0.01 

0.205 

Total  Technical  and  administrative 
assistance 

0.11 

0.05 

0.015 

0.01 

0.01 

0.01 

0.205 

8.2.5.  Financial cost of human resources and associated costs not included in the reference 

amount 

Type of human resources 

Year n 

Year n+1  Year n+2  Year n+3  Year n+4 

Year n+5 

and later 

EUR million (to 3 decimal places) 

0.02 

0.005 

0.005 

0.005 

0.005 

0.005 

Officials  and  temporary  staff 
(XX 01 01) 

Staff  financed  by  Art  XX  01 
02  (auxiliary,  END,  contract 
staff, etc.) 

(specify budget line) 

cost 

Total 
of  Human 
Resources  and  associated 
in  reference 
costs 
amount) 

(NOT 

0.02 

0.005 

0.005 

0.005 

0.005 

0.005 

Calculation– Officials and Temporary agents 

99 

Reference should be made to the specific legislative financial statement for the Executive Agency(ies) 
concerned. 

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349 

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Reference should be made to Point 8.2.1, if applicable 

[…] 

Calculation– Staff financed under art. XX 01 02 

Reference should be made to Point 8.2.1, if applicable 

[…] 

8.2.6. Other administrative expenditure not included in reference amount  

n.a. 

EUR million (to 3 decimal places)

Year 
n 

Year 
n+1 

Year 
n+2 

Year 
n+3 

Year 
n+4 

Year 
n+5 

and 
later 

TOTAL 

XX 01 02 11 01 – Missions 

XX 01 02 11 02 – Meetings & Conferences 

XX 01 02 11 03 – Committees100  

XX 01 02 11 04 – Studies & consultations 

XX 01 02 11 05 - Information systems 

2 

Total 

Other  Management 

Expenditure (XX 01 02 11) 

3  Other 

expenditure 

administrative 
including reference to budget line) 

nature 

of 

an 
(specify 

expenditure, 
than  human  resources  and 
in 

Total  Administrative 
other 
associated  costs  (NOT 
reference amount) 

included 

Calculation - Other administrative expenditure not included in reference amount 

[…] 

100 

Specify the type of committee and the group to which it belongs. 

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350 

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