EN    EN EN  
EN    EN  COMMISSION OF THE E UROPEAN COMMUNITIES 
Brussels, 5.2.2008 
COM(2008)49 final 
2008/0025 (COD) 
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)  
EN 2   EN EXPLANATORY MEMORANDUM  
1. BACKGROUND TO THE PROPOSAL  
Simplification of Council Directiv e 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 progr amme: 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 uncerta inties and inconsistencies. These 
inconsistencies can be explained by the hi gh 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 instea d add to the regulatory burden and 
administrative costs; 
– Objective 3: To ensure that cosmetic pr oducts placed on the EU market are safe in 
the light of innovation in this sector. 
2. PUBLIC CONSULTATION  
A stakeholder consultation was held fr om 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 a nd 1 from an animal welfare organisation. 
In terms of regions, 7 contri butions 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 Fi nland, Malta, Hungary, the Netherlands, 
Slovenia, Greece, Slovakia, Latvia and Sw itzerland and 7 from non-European Third 
Countries. 
Generally speaking, the consultation confirmed that the Cosmetics Directive needed 
to be recast and that many provisions re quired clarification. The stakeholder 
consultation also stressed that in order to ensure a high level of protection of human 
                                                
 
1 OJ L 262, 27.9.1976, p. 169, as amended. 
2 COM(2005) 535 of 25.10.2005. 
3 COM(2006) 122 of 14.3.2006. 
4 Including retailers, manufacturers of machinery/equipment, chemists, the hairdressing industry and 
branding companies.  
EN 3   EN health throughout the EU and to ensure an  internal market for cosmetic product, a 
recast Cosmetics Directive s hould take the form of a Re gulation. In terms of product 
safety, responses in the stakeholder consu ltation stressed the need to sharpen the 
focus on the manufacturer’s responsibility fo r 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 va rious 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 Commission
6 assessed a 
draft version of this imp act 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 effectiv e means of achieving this aim thereby 
reducing the regulatory burdens considerab ly. For example, the impact assessment 
shows a potential to reduce administrative  costs associated with notification to 
poison control centres by approx. 80%. The cl arification and streamlining of various 
provisions – including those on label ling – facilitates compliance without 
compromising product safety. 
With regard to objective 2, the impact asse ssment 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 (appr oximately three to five times a year in 
recent years). Albeit minor, the differences in the 27 national transposing laws create 
additional costs for industry wit hout contributing to product safety. 
With regard to objective 3, the impact a ssessment supports striking a better balance 
between “manufacturer responsibility” a nd “prescriptive regul ation of individual 
ingredients”: This is a crucial element, as the Cosmetics Directive is still shaped by the original concept – developed 30 years a go – of regulation of all substances used 
in cosmetic products “ingredient by ingredie nt”. Today it is acknow ledged that this 
approach alone is not sufficient to ensu re that cosmetic products placed on the 
market are safe. Instead, manufacturer res ponsibility and in-market control aspects 
need to be strengthened to make sure th at 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; 
                                                
 
5 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. 
6 http://ec.europa.eu/governance/impact/iab_en.htm  
EN 4   EN – a system of administrative cooperation of  competent authoritie s: 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 re port serious undesi rable 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 im pact 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 th e contents of a cosmetics 
safety assessment. This has contribut ed to a relatively high degree of non-
compliance. Clear minimum requirements incr ease 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 ex ample, the increased costs can be largely 
outbalanced by the considerable decrease in administrative co sts. Any residual 
increase can be justified on th e strength of the benefits to  the consumer in terms of 
solid safety assessments brought about by this option. 
4. L
EGAL 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 act ion 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 accordi ng to the Member State for which the 
products are intended. Consequently, the di fferent 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 res pond to this, it was necessary to determine 
at Community level, the rules which must  be observed as rega rds the composition, 
labelling and packaging of cosmetic produc ts. This objective could only be achieved 
with a very limited efficiency at national level.  
This rationale is still valid today: Co mmunity 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 ha rmonises 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 es tablished in Article 5 of the EC Treaty.  
EN 5   EN 5. CODIFICATION OF THE 55 AMENDMENTS OF THE COSMETICS DIRECTIVE AND 
ADOPTION OF TEXT AS REGULATION  
The Cosmetics Directive has been amende d 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 trans position of the highly detailed provisions 
of the Cosmetics Directive. 
6. SUBSTANTIVE AMENDMENTS  
According to the interinstitutional ag reement of 28 November 2001 on a more 
structured use of the recas ting 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 coheren ce 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 facilita ted system to update a glossary of 
ingredient names. This glossary takes up e ssentially the function of the “inventory of 
ingredient names”, which was already pr ovided for in the Cosmetics Directive.9 It 
contains the names of all relevant cosm etic 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 en sure 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. 
                                                 
7 OJ C 77, 28.03.2002, p. 1. 
8 COM (2007)53. 
9 Article 5a, 6 (1) (g), 7 (2) Cosmetics Directive.  
EN 6   EN 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 recas t is clarification as to wh at information has to be 
contained in the cosmetic product safety a ssessment to provide ev idence 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 e ffective. The proposal streng thens 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 respons ible 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 simpli fied, 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 Cosmetic s Directive contains two notification 
requirements: one to competent authori ties 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 possi bility for competent authority to 
investigate on a broader basis the exte nt of the use of certain substances. 
– Articles 21, 23, 24 and 25  of the proposal introduce a nd strengthen the rules that 
apply to non-compliant products, incl uding more detailed provisions on 
administrative cooperation in market su rveillance. 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 thei r 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.  
EN 7   EN dangerous for humans) but a li on 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 carcinogen ic, 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 Scie ntific 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 wa s considered for classification as CMR 1 
substance in 2006. The dossier  is pending. A classificat ion 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 substa nce 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, subjec t 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 clarif ies 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 ha s 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. 
                                                 
11 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 3: “Substances which cause concern for man owing to possible carcinogenic/mutagenic/reprotoxic effects but in respect of which the available information is not 
adequate for making a satisfactory assessment.” 
12 Article 4b Cosmetics Directive.  
EN 8   EN • Article 11(1)(d), (f)  of the proposal clarif ies that the restrictions for substances 
contained in Annex IV (colorants) and V (preservatives) also apply if the 
substance is added to the product for anot her than a colorant/p reservative 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 po ssibility to highlight on the label 
the relevant address for competent author ities 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 mini mum 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 pr ocedure for the application of the 
safeguard clause (cf. Article 12 of the Cosmetics Directive). 
• Article 26  of the proposal introduces and cl arifies the rules applying to the 
amendment of the A nnexes of the text. 
• Article 27(3),(4)  of the proposal introduces th e Comitology procedure with 
scrutiny. 
• Article 31  of the proposal allows for the formal objection against harmonised 
standards. 
• Article 32  of the proposal introduces the oblig ation 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 fo rce and application of the Regulation. 
• Article 8a as well as Annex V of the Cosm etics 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 cen tral electronic inte rface for the product 
notification to the competent authori ties of the Member States. Budgetary 
implications are discussed in the legislative financial statement annexed to this proposal.  
EN 9   EN 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 exte nd to the European 
Economic Area.  
EN 10   EN 2008/0025 (COD) 
Proposal for a 
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 
on cosmetic products 
(recast) 
(Text with EEA relevance) 
 
Ð 76/768/EEC (adapted) 
THE EUROPEAN PARLIAMENT AND THE CO UNCIL OF THE EUROPEAN UNION, 
Having regard to the Treaty esta blishing the European Communit y, and in particular Article 
⌦ 95 ⌫ thereof, 
Having regard to the proposal from the Commission13, 
Having regard to the opinion of the Eu ropean 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: 
 
Ø 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 OJ C […], […], p. […].  
14 OJ C […], […], p. […].  
15 OJ C […], […], p. […].  
16 OJ C […], […], p. […].  
17 OJ L262, 27.9.1976, p. 169. Directive as last amended by […].  
EN 11   EN (2) The recast aims at simplifying procedur es and streamlining terminology thereby 
reducing administrative burden and ambiguiti es. Moreover, the recast strengthens 
certain elements of the regulatory framework for cosmetics, such as in-market control, 
with a view to ensuring a high leve l of protection of  human health. 
(3) A recast as a Regulation is the appropriate legal instrument as it imposes clear and 
detailed rules which do not give room fo r diverging transposition by Member States. 
Moreover, a Regulation ensures that legal requirements are implemented at the same 
time throughout the Community. 
 
Ð 76/768/EEC Recital 1 
(4) The provisions laid down by law, regulation or administrative action in force in the 
Member States define the composition characteristics to whic h cosmetic products must 
conform and prescribe rules for their la belling and for their packaging. These 
provisions differ from one Member State to another.  
 
Ð 76/768/EEC Recital 2 
(5) The differences between these laws oblige Community cosmetic p roducers to vary 
their production according to the Member St ate for which the products are intended. 
Consequently, they hinder trade in these produc ts and, as a result, have a direct effect 
on the establishment and func tioning of the common market.  
 
Ð 76/768/EEC Recital 3 
(6) The main objective of these laws is the safeguarding of public health and, as a result, 
the pursuit of the same objective must insp ire Community legislation in this sector. 
However, this objective must be attained by means wh ich also take account of 
economic and technological requirements.  
 
Ð 76/768/EEC Recital 4 
(7) It is necessary to determine at Commun ity level the regulations which must be 
observed as regards the composition, labe lling and packaging of cosmetic p roducts.  
 
Ð 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 an d has as its main objective the protection of 
⌦ human ⌫ public health. To this e nd, it continues to be indi spensable 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).   
EN 12   EN  
Ð 76/768/EEC Recital 5 (adapted) 
(9) This Directive  ⌦ Regulation ⌫ relates only to cosme tic products and not to 
⌦ medicinal products, medical de vices or biocidal products ⌫ pharmaceutical 
specialities and medicinal products . For this purpose it is nece ssary 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 pr oducts 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 int ended to be ingested, inhaled, injected or 
implanted in the human body do not come under the field of cosmetics.  
 
Ð 76/768/EEC Annex I (adapted) 
Ö new 
(10) Ö The assessment whether a product is a co smetic 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 Õ 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, po wders), 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, deodor ants and anti-perspiran ts, 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 pr oducts and anti-wrinkle products. 
 
Ð 76/768/EEC Recital 6 (new) 
(11) In the present state of research, it is advi sable to exclude cosme tic products containing 
one of the substances listed in Anne x V from the scope of this Directive.  
 
Ð 76/768/EEC Recital 7 (adapted) 
Ö 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 dange r to zones of the body that ar e contiguous to the area of 
application.   
EN 13   EN (13) ⌦ In order to establish clea r responsibilities, each cosmetic product should be linked 
to a responsible person who is established within the Community. ⌫ Ö It is in 
particular necessary to determine who is the responsible person for cosmetic products 
which are sold directly to the consum er without recurring to an importer. Õ 
(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 surve illance, a product information file should 
be made readily accessible at one singl e 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 qua lity, the results of the non-clinical safety 
studies carried out for the purposes of assessing the sa fety of a cosmetic product 
should comply with the rele vant Community legislation. ⌫ 
 
Ð 93/35/EEC Recital 4 (adapted) 
Ö new 
(17) Whereas, with regard to th e finished cosmetic product,  Iit should be made clear which 
information is to be made available to the monitoring  ⌦ competent ⌫ authorities.  of 
the place of m anufacture or of initial importa tion into the Community market ; whereas  
Tthat information should include  all the necessary particul ars relating to identity, 
quality, safety for human health and the effects claimed for th e 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 cont rol of the restricti ons for substances, 
sampling and analysis should be carried out in a reproducible  and standardised 
manner. ⌫ 
 
Ð 93/35/EEC Recital 5 (adapted) 
Ö new 
(19) Whereas, however,  Ffor reasons of monitoring  ⌦ effective market surveillance ⌫ , 
the competent authorities should be ⌦ notified ⌫ apprised  Ö of certain information 
about the cosmetic product placed on the market. Õ the place of manufacture and of 
the infor mation needed for rapid and appropriate  medical treatment in the event of 
difficultires . 
(20) ⌦ In order to allow for rapid and appropr iate medical treatment in the event of 
difficulties, the necessary information about the product formula should be submitted to poison control centres and assimilated en tities if such centres are established by 
Member States to that effect. ⌫  
(21) Ö In order to keep administrative burdens to a minimum, both notifications should be 
submitted centrally for the Community by way of an electronic interface. Õ  
EN 14   EN  
Ð 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 clar ified that the list of allowed colorants 
contained in Annex IV only includes substa nces which colour through absorption and 
reflection and not substancess which col our through photoluminescence, interference, 
or chemical reaction. ⌫ 
 
Ø new 
(25) To address safety concerns raised, Annex IV , which is currently restricted to skin 
colorants, should also include hair colo rants once the risk assessment of these 
substances by the Scientific Committee for Consumer Products (SCCP) has been 
finalised. To this end, the Commission shoul d have the possibility to include hair 
colorants in the scope of this Annex by Comitology procedure. 
 
Ð 03/15/EC Recital 13 (adapted) 
Ö new 
(26) Given the Ö hazardous properties of Õ 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 pr ovisions relating to the classification, 
packaging and labelling of dangerous substances19 ⌫ Directive 67/548/EEC  may 
entail for human health , their use in cosmetic pr oducts 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 exposur e and concentration, th ey have been found 
safe for use in cosmetic products by the S CCP and are regulated by the Commission in 
the Annexes to this Regulation. ⌫ Ö 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 alternativ e substances exist, 
to use such substances in cosmetic products  if such use has b een found safe by the 
SCCP. Such substances should be continuously reviewed by the SCCP. Õ 
                                                 
19 OJ 196, 16.8.1967, p. 1. Directive as last amended by […].  
EN 15   EN  
Ð 82/368/EEC Recital 11 
(adapted) 
(27) Whereas the presence of traces of subs tances  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 manufact uring processes ⌦ and provided that 
the product is safe. ⌫ ; whereas therefore certain prov isions should be made in this 
connection;  
 
Ð 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 Stat es 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. 
 
Ð 03/15/EC Recital 3 (adapted) 
(29) Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, 
regulations and administrati ve provisions of the Member States regarding the 
protection of animals used for experi mental and other scientific purposes20 has 
established common rules for the use of anim als 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 sc ientifically satisf actory. In order to  facilitate the 
develo pment 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 th e 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 ex periments 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 cosmet ic products in the Community, 
these provisions should be amended in orde r to provide for the systematic use of 
alternative methods, which reduce the nu mber of animals used or reduce the 
suffering caused, in those cases where full replacement alternatives a re not yet 
available, as provided by Article 7(2) a nd (3) of Directive 86/609/EEC, when these 
methods offer consumers a level of protecti on equivalent to that  of the conventional 
methods which they are intended to replace.  
                                                 
20 OJ L 358, 18.12.1986, p. 1. 
21 OJ L 151, 23.6.1993, p. 32.   
EN 16   EN  
Ð 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 (O ECD) and applicable to the whole 
chemical sector are systematically adopted at Community level. However,  Tthe safety 
of cosmetic products and th eir ingredients may be en sured through the use of 
alternative methods which are not necessarily  applicable to all uses of chemical 
ingredients. Therefore, the use of such me thods by the whole cosmetic industry should 
be promoted and their adopti on at Community level ensured,  when such methods offer 
an equivalent level of protection to consumers. 
 
Ð 03/15/EC Recital 6 (adapted) 
Ö new 
(31) The safety of finished cosmetic products  can already be ensu red on the basis of 
knowledge of the safety of the ingredients that they contain. Pr ovisions prohibiting 
animal testing of finished cosmetic products can  Ö should Õ therefore ⌦ be 
provided. ⌫ be incorporated in to 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 ⌫ . 
 
Ð 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 me thods 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 Scienti fic 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. 
 
Ð 03/15/EC Recital 8 (adapted) 
(33) The Commission should  establish  ⌦ has established ⌫ timetables of deadlines for 
the prohibition of the marketing of co smetic products, the final formulation, 
ingredients or combinations of ingredients which have been tested on animals, and for 
the prohibition of each te st currently carried out using animals, up to ⌦ 11 March 
2009 ⌫ a maximum of six years from the date of entry in to force of this Directive . In 
view, however, of the fact that there are no alternatives yet under consideration for  
tests concerning repeated-dose toxicity, repr oductive toxicity and toxicokinetics, it is 
appropriate for the maximum deadline for the prohibition of the marketing of cosmetic  
EN 17   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 adap t the timetables within the respective 
abovementioned maximum time limits. 
 
Ð 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 promoti on 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. 
 
Ð 03/15/EC Recital 10 (adapted) 
(35) The recognition by ⌦ third ⌫ non -member  countries of alternative methods 
developed in the Community should be encour aged. 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 car ried 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 hinde red and to prevent or avoid ⌦ third ⌫ non
-member  
countries requiring the repetition of such tests using animals. 
 
Ð 93/35/EEC Recital 3 (adapted) 
(36) Whereas greater  Ttransparency is needed regardi ng 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 fi nished product is to be available 
solely at the place of manufacture or of in itial importation into the Community and if 
better information is to be provided to the consumer; whereas  Ssuch transparency 
should be achieved by indi cation of a product's functi on and of  the ingredients used in 
a cosmetic product on its packaging.;  whereas  Ww here 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.;   
 
Ð 93/35/EEC Recital 2 (adapted) 
(37) Whereas it has become apparent that  it is desirable that data on th e 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 nomenc lature of ingredients used in co smetic 
products; whereas the gathering of that data can be faci litated if the Commission 
                                                 
22 OJ L 232, 29.8.2002, p. 1.   
EN 18   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 subs tances used in cosmetic products; 
 
Ð 03/15/EC Recital 14 (adapted) 
(38) In order to ⌦ inform ⌫ improve the information provided to  consumers, cosmetic 
products should bear more  precise ⌦ and easily understandable ⌫ indications 
concerning their durability for use. 
 
Ð 03/15/EC Recital 15 (adapted) 
Ö 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 su ch consumers are adequately informed, it is therefore necessary to 
amend the provisions of Direc tive 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. ⌫ Ö In order to address specific claims 
concerning the characteristics of cosmetic products, the po ssibility to make use of 
harmonised standards should be provided. Õ 
 
Ð 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 understandi ng of the claims is 
reached, and in particular that such claims  do not mislead the consumer. In developing 
such guidelines, the Commission ⌦ has ⌫ must  also ⌦ taken ⌫ take  into account 
the views of the many small and medium -sized enterprises which make up the 
majority of the "non-animal testing"  producers, relevant non-governmental 
organisations, and the need of consumers to be able to make pr actical distinctions 
between products on the basis of animal testing criteria. 
(42) ⌦ In addition to the labelled information, consumers should be given the possibility 
to request certain product-rel ated information from the responsible person in order to 
make informed product choices. ⌫  
EN 19   EN  
Ð 76/768/EEC Recital 8 
(43) In particul ar, 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 t echnical research, are implemen ting measures of a technical 
nature. It is ad visable to entrust their adoption to  the Commission, s ubject to certain 
conditions specified in this Directive, fo r the purpose of simplifying and accelerating 
the procedure.  
 
Ø new 
(44) An effective market surveillance is necessary in order to ensure th at the provisions of 
this Regulation are respected. To this end, serious undesirable effects should be 
notified and competent authorities should ha ve 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 Regula tion, 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. 
 
Ð 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 procedur e intended to remove this danger.  
 
Ø new 
(47) In order to comply with pr inciples of good administrative  practices, any decision by a 
competent authority in the framework of  market surveillance should be duly 
substantiated. 
(48) In order to ensure an efficient in-marke t control, a high degr ee 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. 
 
Ð 76/768/EEC Recital 10 
(49) It is necessary, on the basis of scientific and technical research, to draw up proposals 
for lists of authorized substances whic h could include antioxidants, hair dye s, 
preservatives and ultraviolet filters, taking into account in particular the problem of 
sensitization.   
EN 20   EN  
Ð 76/768/EEC Recital 9 (adapted) 
(50) Technical progress necessitates rapid adaptati on of the technical pr ovisions defined in 
this Directive  and in subsequent Directives in this field. It is advisable, in order to 
facilitate implementation of the measures n ecessary for this purpose, to provide for a 
procedure establishing close cooperati on between the Member States and the 
Commission within th e Committee for adaptation to tec hnical progress of Directives 
aimed at the removal of tec hnical obstacles to trade in the cosmetic products sector.  
 
Ø 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 impl ementing 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 w ith 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 Re gulation and ensure that th ey are implemented. Those 
penalites should be effective,  proportionate and dissuasive. 
(55) Economic operators as well as Member St ates 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 w ithout prejudice to the obligat ions of the Member States 
relating to the time-limits for transposition into  national law of the Di rectives 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 21   EN  
Ð 76/768/EEC (adapted) 
HAVE ADOPTED THIS DIRECTIVE  ⌦ REGULATION ⌫ : 
 
Ð 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 th e 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 m ean 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 th e 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 correcti ng body odours and/or  
protecting them,  or keeping them in good condition ⌦ or correcting body 
odours ⌫. 
 
Ð 76/768/EEC (adapted) 
2. The products to be considered as cosmetic products within the meaning of this definition 
are listed in Annex I.   
EN 22   EN  
Ð 88/667/EEC 
3. Cosmetic products containing one of the substances list ed in Annex V shall be excluded 
from the scope of this Directive. Member St ates may take such measures as they deem 
necessary with regard  to those products.  
 
Ø new  
(b) ‘manufacturer’ means any natural or le gal person who designs or manufactures 
a cosmetic product or who has such a product designed or manufactured, under 
his name or trademark; 
(c) ‘making available on the market’ m eans any supply by any means, including 
electronic means, of a product for di stribution, consumption or use on the 
Community market in the course of a commercial activity, whether in return 
for payment or free of charge; 
(d) ‘placing on the market’ means the firs t making available of a product on the 
market; 
(e) ‘importer’ means any natural or legal person established within the 
Community, who places a product from a third country on the market; 
(f) ‘harmonised standard’ means a sta ndard 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 st andards and regulations and of rules on 
information society services24 in accordance with Article  6 of that Directive; 
(g) ‘traces’ means the non-intended presen ce of a substance stemming from 
impurities of natural or synthetic ingredients, the manufacturing process, 
storage, migration from transport facilities or packaging; 
(h) ‘preservatives’ means substances which are exclusively or mainly intended to 
inhibit the development of micro-or ganisms in the cosmetic product; 
(i) ‘colorants’ means substances which ar e exclusively or mainly intended to 
colour the cosmetic produc t, 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 23   EN (k) ‘undesirable effect’ means a harmful re action for human health attributable to 
the normal or reasonably foreseeable use of a cosmetic product; 
(l) ’serious undesirable effect’ means an undesirable effect  which results in 
temporary or permanent functional in capacity, disability, hospitalisation, 
congenital anomalies or an immediate vital risk or death; 
(m) ‘withdrawal’ means any measure aime d 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. 
 
Ð 76/768/EEC, recital 5 (adapted) 
⌦ 2. For the purposes of point (a) of paragra ph 1, a substance or mi xture intended to be 
ingested, inhaled, injected or implanted in to the human body shall not be considered 
to be a cosmetic product. ⌫ 
 
Ð 93/35/EEC (adapted) 
⌦ Chapter II 
Safety, responsible pe rson, free movement ⌫ 
Article 2 3 
⌦ 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 w ell as  any other indication or informa tion provided by the manufacturer or 
his authorized agen t or by any other person resp onsible for placing the product 
on the Community market.  ⌦ the person define d in Article 4. ⌫ 
The provision of such warnings shall no t, in any event, exempt any person  from compliance 
with the other requirements laid down in this Directive  ⌦ Regulation ⌫.  
EN 24   EN  
Ø new 
Article 4 
Responsible person 
1. For each cosmetic product placed on the market, a legal or natural person shall 
ensure compliance with the relevant obligations set out in this Regulation 
(hereinafter ‘responsible person’). 
2. For a cosmetic product manufactured w ithin the Community, and not subsequently 
exported and imported back into the Co mmunity, 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. 
3. Where, for a cosmetic product manuf actured within the Community, and not 
subsequently exported and imported back into the Community the manufacturer is 
established outside the Comm unity, 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, design ate a person established within the 
Community as the responsible person. 
5. For a cosmetic product made available on th e 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 Comm unity as the responsible person. 
 
Ð 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 Direc tive and its Annexes may be put on the mar ket. 
 
Ð 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 th e objectives of Article 1. ⌫  
EN 25   EN  
Ø new 
2. Compliance with good manufacturing pr actice 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 . 
 
Ð 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 Direc tive and the Annexes thereto  ⌦ Regulation ⌫ . 
 
Ð 93/35/EEC (adapted) 
Ö new 
⌦ Chapter III 
Safety assessment, product in formation 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 cosme tic product safety report in accordance with 
Annex I is set up. ⌫ 
Ö The responsible person shall ensure that the cosmetic pr oduct safety report is kept 
up-to-date in view of additional relevant in formation generated subsequent to placing 
the product on the market. Õ 
⌦ 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 completi on of a university course of study, or a 
course recognised as equivalent by a Memb er State, extending over a period of at 
least three years of theoretical and practi cal study in pharmacy, toxicology, medicine 
or a similar discipline. ⌫  
EN 26   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 purpo se of assessing the safety 
of a cosmetic product shall comply with th e Community legislation on the principles 
of good laboratory practice, as  applicable at the time of performance of the study, or 
with other international sta ndards recognised as being e quivalent 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 Ar ticle 6 (1) (a):  
⌦ 2. The product information file shall cont ain the following information and data: ⌫ 
⌦ (a) a description of the cosmetic product wh ich allows for a clear  attribution of the 
product information file to the cosmetic product; ⌫ 
⌦ (b) the cosmetic product safety re port referred to in Article 7(1); ⌫ 
⌦ (c) a description of the method of manuf acturing and a statemen t on compliance with 
good manufacturing practice refe rred to in Article 5; ⌫ 
(a) the qualitative and quantitative composition of the product; in th e 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 specifi cations of the raw materials and 
the finished product and the purity and microbiological control criteria of the 
cosmetic product;  
 (c) the method of ma nufacture 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 manufact ure or first importation into the 
Community must possess an appropr iate level of profe ssional qualification or 
experience in accordance with the legisl ation and practice of the Member State 
which is the place of manuf acture or first importation ; 
 
Ð 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 considerati on the general toxicol ogical profile of the 
ingredients, their chemical structure and their level of exposur e. It shall take  
EN 27   EN particular account of the specifi c 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 cosm etic products intende d for use on children 
under the age of three and for co smetic 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 si ngle place of manufacture where that 
information will be avai lable. In this connection, and when so requested for 
monitoring purposes, it shal l be obliged to indicate th e place so chosen to the 
monitoring authority or author ities concerned. In this cas e this information shall be 
easily accessible;   
 
Ð 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 mu st hold a diploma as defined in Article 1 
of Directive 89/48/EEC in the fiel d of pharmacy, toxicology, dermato logy, medicine 
or a similar discipline;   
 (f) existing data on undesirab le effects on human health resulting from use of the 
cosmetic product;  
(dg)⌦ where justified by the nature or th e effect of the cosmetic product, ⌫ proof 
of the effect claimed for the cosmetic pr oduct, where justified by the nature of the 
effect or product ; 
 
Ð 2003/15/EC Art. 1.7 (new) 
 (eh ) data on any animal testing performe d by the manufacturer, his agents or 
suppliers, relating to the deve lopment or safety evaluation ⌦ assessment ⌫ of the 
⌦ cosmetic ⌫ product or its ingredient s, 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 sh all ensure that the information required 
under (a) and (f) shall be made easily acce ssible to the public by any appropriate 
means, including electronic means. The qua ntitative 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 saf ety for human health referred to  in paragraph 1 (d) shall be 
carried out in accordance with the principl e of good laboratory practice laid down in 
Council Directive 87/18/EEC of 18 Decem ber 1986 on the harmonization of laws, 
regulations and administrative provisions relating to the appl ication of the principles  
EN 28   EN of good laboratory practice a nd the verification of their application for tests on 
chemical substances (25). 
3. ⌦ The responsible person shall make the produ ct information file readily accessible 
in electronic or other format at his addre ss 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 ag ent, or the person to whose order a cosmetic product is 
manufactured, or the person responsible fo r placing imported cosmetic products on 
the Community market, sh all notify the competent author ity of the Member State of 
the place of manufacture or of the initial importation of the addr ess of the place of 
manufacture or of initial importation into the Community of the cosmetic products 
before the latter are placed o n the Community market.  
5. Member States shall designate  the competent authorities referred to in paragraphs 1 and 4 
and shall send details thereof to the Commission, which shall publish that 
information  in the Official Journal of  the European Communities.  
 The Member States shall ensure that th e abovementioned author ities continue to 
cooperate in areas wh ere such cooperation is necessary  to the smooth application of 
this Directive.  
 
Ð 82/368/EEC (adapted) 
⌦ Article 9 
Sampling and analysis ⌫ 
⌦ 1. Sampling and analysis of cosmetic produc ts shall be performed in a reliable and 
reproducible manner. ⌫ 
 
Ø new 
2. In absence of any applicable Community  legislation, complianc e with paragraph 1 
shall be presumed if the method used is in accordance with the relevant harmonised 
standards, the references of wh ich have been published in the Official Journal of the 
European Union . 
                                                 
25 OJ No L 15, 17.1.1987, p. 29.   
EN 29   EN  
Ð 76/768/EEC (adapted) 
Article 7 10 
 ⌦ Notification ⌫ 
 
Ð 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. Furthe rmore, 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 us ed only for the purposes of such treatment.  
Each Member State shall designate a competen t authority and send details thereof to the 
Commission, which shall publish that information in the Official Journal of the Euro pean 
Communitites . 
 
Ø new 
1. The responsible person shall submit, pr ior to placing the cosm etic product on the 
market, the following information to the Commission: 
(a) the category of cosmetic product and its complete commercial name; 
(b) the name and address of the responsible person where the product information file is 
made readily accessible; 
(c) the Member State where the cosm etic product is placed on the market; 
(d) the contact details of a physical pe rson to contact in th e case of necessity; 
(e) the presence of substances in the form of  micronised particles ot her than substances 
listed in Annexe III to VI to this Regulation; 
(f) the presence of substances classified  as carcinogenic, mutagenic or toxic for 
reproduction, of category 1 or 2, unde r Annex I to Directive 67/548/EEC;  
EN 30   EN (g) the frame formulation allowing for prompt  and appropriate medical treatment in the 
event of difficulties; 
2. 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 fr ame formulation, relevant quantitative and 
qualitative information shall be provided. 
3. 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. 
4. 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 t hose bodies for the purposes of medical 
treatment. 
5. Where any of the information set out in pa ragraph 1 changes, the responsible person 
shall provide an update without delay. 
 
Ð 93/35/EEC (new) 
Each Member State shall designate a competen t authority and send details thereof to the 
Commission, which shall p ublish that information in the  Official Journal of the European 
Communities . 
 
Ð 82/368/EEC (adapted) 
Ö new 
⌦ Chapter IV 
Restrictions for certain substances ⌫ 
Article 4 11 
 ⌦ 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 Ö shall not 
contain Õ containing  ⌦ any of the following ⌫ : 
(a) substances listed in Annex II;  
EN 31   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 ⌫ ; 
 
Ð 88/667/EEC (new) 
Ö new 
(c) ⌦ except for hair colouring products re ferred to in paragraph 2, colorants ⌫ 
colouring agents  other than those listed  in Annex IV, Part 1,  with the exception of 
cosmetic products containing colouring ag ents 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 co smetic products containing colouring agents intended 
solely to colour hair;  
Ö (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. Õ 
 
Ð 82/368/EEC (adapted) 
(e) preservatives other than thos e listed in Annex VI, Part 1,  V ⌦ and preservatives 
which are not used in accordance with th e conditions laid down in that Annex ⌫; 
 
Ø new 
(f) Without prejudice to points (b) (c) and (g ), substances listed in Annex V but which 
are not intended to be used as preservati ves, and which are not used in accordance 
with the conditions laid  down in that Annex. 
 
Ð 82/368/EEC (new) 
(f) preservatives listed in Annex VI, Part 1, beyond the limits  and outside the conditions laid 
down, unless other concentrati ons are used for specific purposes apparent from the 
presentation of the product;   
 
Ð 83/574/EEC (adapted) 
(g) UV- filters other than those listed in Part 1 of  Annex VII VI ⌦ and UV-filters which 
are not used in accordance with th e conditions set out in that Annex ⌫;  
EN 32   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.  
 
Ø new 
2. Subject to a Commission Decisi on to extend the scope of Annex IV to hair colouring 
products, these products shall no t 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 condi tions laid down in that Annex. 
The Commission Decision referred to in th e first subparagraph, designed to amend 
non-essential elements of this Regulation, shall be adopted in accordance with the 
regulatory procedure with scruti ny referred to in Article 27(3). 
 
Ð 2003/15/EC Art. 1.2 (adapted) 
Ö new 
Article 4b 12 
 ⌦ Substances classified as carcinogenic , mutagenic or toxic for reproduction ⌫ 
(1) The use in cosmetic products of substan ces classified as carci nogenic, mutagenic or 
toxic for reproduction, of category 1, 2 and 3, under Annex I to  Directive 67/548/EEC 
shall be prohibited. To that end the Comm ission shall adopt the necessary measures 
in acco rdance with the procedure referred to in Article 10(2).  ⌦ However, a ⌫ A 
substance classified in cat egory 3 may be used in ⌦ cosmetic products ⌫ 
cosmetics  if the substance has been evaluated by the ⌦ SCCP ⌫ SCCNFP  and 
found acceptable  Ö safe Õ 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) ⌫ . 
 
Ø new 
(2) The use in cosmetic products of substan ces classified as carci nogenic, mutagenic or 
toxic for reproduction, of cat egory 1 or 2, under Annex I to Directive 67/548/EEC 
shall be prohibited. 
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 33   EN – they are complying with the food safety  requirements as defined in Regulation 
(EC) No 178/2002 of the European Parlia ment and of the Council of 28 January 
2002 laying down the general principl es and requirements of food law, 
establishing the European Food Safety Au thority and laying down procedures in 
matters of food safety26; 
– there are no suitable alternative substa nces available, as documented in an 
analysis of alternatives. 
Specific labelling in order to  avoid misuse of the cosme tic product shall be provided 
in accordance with Article 3, taking into acc ount 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 Co mmission may use the urgency procedure 
referred to in Article 27(4). 
The Commission shall mandate the SCCP to re-evaluate those subs tances as soon as 
safety concerns arise and at the latest ev ery 5 years after their inclusion in Annexes 
III to VI. 
 
Ð 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 a nd that it conforms with Article 2 . 
                                                 
26 OJ L 31, 1.2.2002, p. 1. Regul ation as last amended by […].  
EN 34   EN  
Ð 2003/15/EC Art. 1.2 (adapted) 
Ö new 
⌦ Chapter V 
Animal testing ⌫ 
Article 4a  14 
⌦ Animal testing ⌫ 
1. Without prejudice to the general ob ligations deriving from Article 2 3, ⌦ the 
following shall not be allowed ⌫ Member States shall prohibit : 
(a) the marketing  ⌦ placing on the market ⌫ of cosmetic products where the final 
formulation, in order to m eet the requirements of this ⌦ Regulation ⌫ Directive , 
has been the subject of animal testing using a method other th an an alternative 
method after such alternative method has b een validated and adopted at Community 
level with due regard to the development of validation within the OECD; 
(b) the ⌦ placing on the market ⌫ marketing  of cosmetic products containing 
ingredients or combinations of ingredient s which, in order to meet the requirements 
of this ⌦ Regulation ⌫ Directive , have been the subject of animal testing using a 
method other than an altern ative method after such alternative method has been 
validated and adopted at Community level with due regard to the development of 
validation within the OECD; 
(c) the performance ⌦ within the Community ⌫ on their territory  of animal testing of 
finished cosmetic products in order to meet the requirements of this 
⌦ Regulation ⌫ Directive ; 
(d) the performance ⌦ within the Community ⌫ on their terr itory  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 wh ich such tests are required 
to be replaced by one or more validated alternative methods li sted 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 Comm ission shall, in accordance with the 
procedure referred to in Article 10(2) a nd after consultation of the Scientific 
Committee on Cosmetic Product s 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 35   EN 2. The Commission, after cons ultation of the SC CNF P ⌦ SCCP ⌫ and of the 
European Centre for the Validation of A lternative 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 th e entry into force of Directive 
2003/15/EC 28 in relation to paragraph 1(a), (b) and (d). 
2.1. In relation to the tests concerning repe ated-dose toxicity, re productive 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 maxi mum of 10 years after the entry in to force of Directive 2003/15/EC . 
2.2. The Commission shall study possible technica l difficulties in complying with the 
ban in relation to tests, in particular  those concerning repe ated-dose toxicity, 
reproductive toxicity and toxico kinetics, for which there are no alternatives yet under 
consideration. Information about the provisi onal and final result s of these studies 
should form part of the yearly repor ts presented pursuant to Article 9 30. 
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 di fficulties in complying with the ban. Information about 
the provisional and final re sults of the Commission studie s should form part of the 
yearly reports presented pursuant to Article 9 30. 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 fo rward a legislative pr oposal 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 Me mber State may request the Commission to 
grant a derogation from paragraph 1. The re quest shall contain an evaluation of the 
situation and indicate the measures necessa ry. On this basis, the Commission may, 
after consultation of the ⌦ SCCP ⌫ SCC NFP and by means of a reasoned 
decision, authorise the derogation in accordan ce 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 36   EN Ö 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 scruti ny referred to in Article 27(3). Õ 
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 condi tions associated w ith it and the final 
result achieved shall be part of the annual report to be presen ted by the Commission 
in accordance with Article 9 30. 
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 desi gn that has not been produced in batches, 
and from which the finished cosmetic pr oduct is copied or finally developed.  
 
Ð 88/667/EEC (adapted) 
Article  5 
Member States shall all ow 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, with in the limits and under the 
conditions laid down, until the admi ssion 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. Howe ver, 
some of these substances may be used in  other concentrations for specific purposes 
apparent from the pres entation 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 37   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.  
 
Ð 93/35/EEC 
Article  5a 
1. No later than 14 December 1994 the Comm ission shall, under the procedure laid dow n 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 ingr edient’ shall mean any chemical substance or 
preparation of synthetic or natu ral origin, except for perfume a nd aromatic compositions, used 
in the composition of cosmetic products.  
The inventory shall be divided into two sec tions: one concerning perfume and aromatic raw 
materials and the second concer ning other substances.  
2. The inventory shall contain informtion on:  
– the identity of each ingredient, in particul ar its chemical name, the CTFA name, the 
European Pharmacopoeia name, the international non -proprietary names 
recommended by the World Health O rganization, the Einecs, Iupac, CAS and colour 
index numbers, and the common name  referred to in Article 7 (2),  
– the usual function(s) of the in gredient in the final product,  
– where appropriate, restrictions and conditi ons of use and warnings which must be 
printed on the label by re ference to the Annexes.  
3. The Commission shall publish the inventory and shall update it periodically under the 
procedure provided for in Article 10. The invent ory shall be indicative and shall not constitute 
a list of the substan ces authorized for use in cosmetic products   
EN 38   EN  
Ð 88/667/EEC (adapted) 
⌦ Chapter VI 
Consumer information ⌫ 
Article 6 15 
⌦ Labelling ⌫ 
 
Ð 93/35/EEC (adapted) 
1. Member States sh all 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 legibl e and visible lettering; the information 
mentioned in point (g) may, however, be indicated on the packaging alone:  
 
Ð 88/667/EEC (adapted) 
Ö new 
(a) the name or style and the address or registered office  of the manufacturer or  the 
⌦ responsible ⌫ person responsible for  marketing the cosmetic product who is 
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 ⌫. Ö If several addresses are indica ted, the one where the responsible 
person makes readily available the pr oduct information file shall be 
highlighted; ÕMember States may require that the country of origin be specified for 
goods manufactured outside the Community;  
(b) the nominal content at th e 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 pr e-packages normally sold as a number of 
items, for which details of weight or volum e 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 num ber of items is easy to see from the outside or if the 
product is normally only sold individually;  
EN 39   EN  
Ð 2003/15/EC Art. 1.3 (adapted) 
Ö new 
(c) the date of minimum durability  Ö date until which the co smetic product, stored 
under appropriate conditions, continues to fulf il its initial functi on and, in particular, 
remains in conformity with Article 3 (h ereinafter: “date of minimum durability”); Õ 
⌦ The date itself or details of where it appears on the packaging ⌫ shall be 
⌦ preceded by ⌫  
– Ö the symbol given in point 3 of Annex VII to this Regulation Õ ⌦ 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 guarant ee the stated durability. 
Indication of the date of ⌦ minimum ⌫ durability shall not be mandatory for 
cosmetic products with a minimum durabili ty 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); 
 
Ð 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’ in Annexes 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 us e.., in particular in hairdressing . Where this is 
impossible for practical reasons, an enclosed le aflet, 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;  
 
Ð 88/667/EEC (adapted) 
(e) the batch number of manufacture or the reference for identifying the ⌦ cosmetic 
product ⌫ goods . Where this is impossible for practical reasons because the  
EN 40   EN cosmetic products are too small, such information need appear only on the 
packaging; 
 
Ð 93/35/EEC (adapted) 
(f) the function of the ⌦ cosmetic ⌫ product, unless it is clear from ⌦ its ⌫ the 
presentation of the product ; 
 
Ð 2003/15/EC Art. 1.4 (adapted) 
Ö 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 th at is impossible for 
practical reasons, an enclosed leaflet, la bel, tape or card must contain the i ngredients 
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 th eir raw materials shall be referred to by 
the ⌦ terms ‘parfum’ ⌫ word ‘perfume’  or ‘aroma’. However, the presence of 
substances, the mention of which is require d 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 establis hed in descending orde r of weight of the 
ingredients at the time they ar e added to the cosmetic product. ⌫ Ingredients in 
concentrations of less than 1 % may be listed in any or der after those in 
concentrations of more than 1 %. 
 Colo uring 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 severa l 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 41   EN  In accordance with the pro cedure 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 th e 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 trad e secrecy, apply not to include one or more ingredients on the abovementioned 
list. 
 
Ð 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 informa tion referred in point (d) of paragraph 1 
and on packaging for the information re ferred 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 encl osed leaflet, those particulars shall appear 
on a label, tape or card which is enclosed or attached to the cosm etic 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, thos e particulars sh all 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-pack aged, are packaged at the point of sale 
at the purchaser’s request, or are pre-pack aged 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 th e end user is responsible for the respect 
of paragraphs 3 to 5. ⌫ 
                                                
 
29 OJ L 140, 23.6.1995, p. 26.   
EN 42   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 te rm as contained in a generally accepted 
nomenclature shall be used. ⌫
 
 
Ð 88/667/EEC (adapted) 
Î1 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 pr oducts have characteristics 
which they do not have. Î1 --- Í 
 
Ø new 
Compliance with the first subparagraph shall be presumed if the cosmetic products 
are in accordance with the relevant harmoni sed standards, the references of which 
have been published in the Official Journal of the European Union . 
 
Ð 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, no tice, 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 s uppliers have not carried out 
or commissioned any animal tests on the finished ⌦ cosmetic ⌫ product, or its 
prototype, or any of the ingr edients contained in it, or us ed any ingredients that have 
been tested on animals by others for the purpose of developing new cosmetic 
products. Guidelines shall be adopted in ac cordance with the pro cedure referred to in 
Article 10(2) and published in the  Official Journal of the European Union . The 
European Parliament sha ll receive copies of the draft measures submitted to the 
Committee.   
EN 43   EN  
Ð 2003/15/EC Art. 1.7 (adapted) 
⌦ Article 17 
Access to information for the public ⌫ 
Without prejudice to the protection, in particular, of comm ercial secrecy and of intellectual 
property rights, Member States  ⌦ the responsible person ⌫ shall ensure that the 
⌦ qualitative and quantitativ e 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 req uired 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 acces sible shall be limited to dange rous substances covered by 
Directive 67/548/EEC30. 
 
Ø new  
Chapter VII 
Market surveillance 
Article 18 
In-market control 
Member States shall survey compliance with th is Regulation via in-mar ket controls of the 
cosmetic products made available on the market. 
Article 19 
Communication of serious undesirable effects 
1. The responsible person shall without de lay notify the following to the competent 
authority where the product information file is readily accessible: 
(a) all serious undesirable effects which are known to him or which should 
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 44   EN 2. The competent authority concerned shall transmit the information referred to in 
paragraph 1 to the competent author ities of the other Member States. 
3. Competent authorities may use the information referred to in this Article only for the 
purposes of in-market surveillance. 
Article 20 
Information on concentr ation of substances 
In case of serious doubt regarding the safety of any substa nce contained in cosmetic products, 
the competent authority of a Member State wher e 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 whic h 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 re sponsible person to take all appropriate 
measures, including corrective actions bri nging 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 inform ation file referred to in Article 8; 
(b) the notification requirement s 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 pr oduct claims set out in Article 16; 
(g) the animal testing requireme nts referred to in Article 14.  
EN 45   EN 2. The responsible person shall en sure that the measures refe rred to in paragraph 1 are 
taken in respect of all th e products concerned which ar e made available on the 
market throughout the Community. 
3. In the case of serious risks for huma n health, where the competent authority 
considers that the non-complian ce is not limited to the terr itory of the Member State 
where the product is made available on the market, it shall info rm the Commission 
and the competent authorities of the other Member States of the measures which it 
has required the responsible person to take. 
4. The competent authority shall take all appropriate measures to prohibit or restrict the 
making available on the market of the cosm etic product or to withdraw the product 
from the market or to reca ll 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 th e time limit referred to in paragraph 1, 
does not take all appropriate measures. 
In the case of serious risks for human hea lth, 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. 
 
Ð 76/768/EEC (new) 
Article  12 
1. If a Member State not es, on the basis of a substantiate d justification, th at a cosmetic 
product, although complying with the requirements of the Directive, represents a hazard to 
health, it may p rovisionally 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 46   EN  
Ð 88/667/EEC (new) 
2. The Commission shall as soon as possible consult the Member  States concerned, following 
which it shall deliver its opinion without delay and ta ke the appropriate steps.  
 
Ð 76/768/EEC (new) 
3. If the Commission is of the opinion that tech nical adaptations to the Directive are 
necessary, such adaptations shall be adopted by either the Commissi on or the Council in 
accordance with the procedure laid down in Articl e 10. In that event, the Member State which 
has adopted safeguard measures may m aintain them until entry into force of the adaptations.  
 
Ø new 
Article 22 
Safeguard clause 
1. Where Article 21 does not apply, and a competent authority ascertains that a 
cosmetic product placed on the market is liable to presen t a serious risk for human 
health, it shall take all appropriate provision al measures in order to ensure that a 
cosmetic product is withdrawn, recalled or its availability otherwise restricted. 
2. The competent authority shall immediat ely 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 subparagr aph, the information exchange system 
provided for in Article 12(1) of Di rective 2001/95/EC shall be used. 
Article 12 (2), (3) and (4) of Directive 2001/95/EC shall apply. 
3. 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. 
4. If the provisional measures are ju stified, Article 26(1) shall apply. 
5. If the provisional measures are not justified the Commission shall inform the 
Member States thereof and the competen t authority concerned shall repeal the 
provisional measures in question.  
EN 47   EN  
Ð 76/768/EEC (new) 
Article  13 
Precise reasons shall be stated for any individual measures pl acing a restriction or ban on the 
marketing of cosmetic products taken pursu ant to this Directive. It shall be no tified to the 
party concerned together with pa rticulars 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.  
 
Ø new 
Article 23 
Good administrative practices 
1. Any decision taken pursuant to Articles  21 and 22 shall state the exact grounds on 
which it is based. It shall be notified 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 tim e limits to which remedies are subject. 
2. Except in case where immediate action is ne cessary for reasons of serious risk for 
human health, the responsible person sha ll have the opportunity to put forward his 
viewpoint before a ny decision is taken. 
Chapter IX 
Administrative cooperation 
Article 24 
Cooperation between competent authorities  
1. The competent authorities of the Member St ates shall cooperate with each other and 
with the Commission and transmit to each othe r all information necessary in view of 
applying this Regulation uniformly. 
2. The Commission shall provide for the organi sation of an excha nge of experience 
between the competent authorities in order to coordinate the uniform application of 
this Regulation. 
3. Cooperation may be part of initiatives  developed at international level.  
EN 48   EN Article 25 
Cooperation regarding verification of product information file 
The competent authority of any Member State wh ere the cosmetic product is made available 
may request the competent authority of the Me mber State where the product information file 
is made readily accessible to verify whether the product information file satisfies the 
requirements referred to in Ar ticle 8(2) and whethe r the information set out therein provide 
evidence of the safety of the cosmetic product. 
The requesting competent authority sha ll provide a motivation for the request. 
Upon that request, the co mpetent authority request ed shall, without undue  delay, carry out the 
verification and shall inform the reques ting competent authority of its finding. 
 
Ð 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 microbiol ogical and chemical purity for cosmetic products and 
methods for checking compliance with those criteria.  
 
Ð 93/35/EEC (new) 
Î1 2003/15/EC Art. 1.8 
2. The common nomenclature of in gredients used in cosmetic products and, afte r consultation 
of the  Î1 Scientific Committee for Cosmetic Products and Non -Food Products intended for 
Consumers  Í, the amendments necessary for the adaptation to technical progress o f the 
Annexes shall be adopted in accordance with  the same procedure, as appropriate.   
EN 49   EN  
Ø new  
Chapter X 
Implementing measures, final provisions 
Article 26 
Amendment of the Annexes 
1. Where there is a potential risk to human h ealth, 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-esse ntial 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 Co mmission 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-esse ntial 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 ensu re the safety of cosm etic products placed 
on the market, the Commission may, after c onsultation of the SCCP, amend Annex I. 
Those measures, designed to amend non-esse ntial elements of this Regulation, shall 
be adopted in accordance with the regulatory procedure with scrutiny referred to in 
Article 27(3). 
 
Ð 2003/15/EC Art. 1.9 (adapted) 
Article 10 27 
⌦ Committee ⌫ 
1. The Commission shall be assisted by th e Standing Committee on Cosmetic Products.  
EN 50   EN 2. Where reference is made to this pa ragraph, 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 sh all be set at three months. 
 
Ø new 
3. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of 
Decision 1999/468/EC shall apply, having re gard to the provisions of Article 8 
thereof. 
4. Where reference is made to this paragraph, Article 5a(1), (2), (4 ) and (6) and Article 
7 of Decision 1999/468/EC shall apply having regard to the provisions of Article 8 
thereof. 
 
Ð 2003/15/EC Art. 1.9 (new) 
3. The Committee shall  adopt its rules of procedure  
 
Ø new 
Article 28 
Glossary of common ingredient names 
The Commission shall compile and update a glo ssary 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 mont hs after publication of the glossary in the 
Official Journal of the European Union . 
Article 29 
Competent authorities, poison contro l centres or assimilated entities 
1. Member States shall designate their national competent authorities. 
2. Member States shall communicate the details of authorities referre d 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. 
3. The Commission shall compile and update a li st of the authorities and bodies referred 
to in paragraph 2 and make  it available to the public.  
EN 51   EN  
Ð 82/368/EEC 
Î1 2003/15/EC Art. 1.8 
Article  8a 
1. Notwithstanding Article 4 and without prejud ice to Article 8 (2), a Member State may 
authorize the use within its territory of othe r substances not contai ned in the lists of 
substances allowed, for certain cosmetic products sp ecified in its nati onal 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 cosmet ic products 
manufactured from the substance or prep aration use of whic h it has authorized;  
 (c) cosmetic products thus manufactured mu st bear a distinc tive indication which 
will be defined in the authorization.  
2. The Member Stats shall forward to the Comm ission and to the other Member States the 
next of any authorization deci sion 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 m ay 
submit to the Commission a request for the inclusion in a list of permitted substances of the 
substance given national authorization in accord ance 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 th e substance or preparation is intended. Within 
18 months of submission of the request, a decisi on shall be taken on the basis of the latest 
scientific and tec hnical knowledge, after consultation, at the initia tive of the Commission or 
of a Member State, of the  Î1 Scientific Committee for Cosmetic Products and Non -Food 
Products intended for Consumers  Í and in accordance with the procedure laid down in 
Articl e 10 as to whether the substance in question may be included in a list of permitted 
substances or whether the national auth orization should be revoked. Notwithstanding 
paragraph 1 (a), the national authorization shall remain in force until a decision is ta ken on the 
request for inclusion in the list.   
EN 52   EN  
Ð 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 pr ovisions of the Member States regarding 
the prote ction of animals used for experime ntal and other sc ientific 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 effo rts 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 safe ty tests carried out  in the Community 
using alternative methods, in particular  within the framework of cooperation 
agreements between the Comm unity and these countries; 
(c3) the manner in which the specific needs of  small and medium-sized enterprises have 
been taken into account. 
 
Ð 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 scien tific and technical research, submit to the 
Council appropriate proposals establishing lists of permitted substances.  
                                                 
32 OJ L 358, 18.12.1986, p. 1.   
EN 53   EN Article  14 
1. Member States shall bring into force the prov isions needed in order to comply with this 
Directive within 18 months of its no tification 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 
requirem ents 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.  
 
Ø new 
Article 31 
Formal objection against harmonised standards 
1. When a Member State or the Commission considers that a harmonised standard does 
not entirely satisfy the requirements set out in the relevant provisions of this 
Regulation, the Commission or the Member  State concerned shall bring the matter 
before the Committee set up by Article 5 of Directive 98/34/EC, giving its 
arguments. The Committee shall deliver its opinion without delay. 
2. In the light of the Committee’s opinion, the Commission shall deci de to publish, not 
to publish, to publish with restriction, to main tain, to maintain with restriction or to 
withdraw the references to the harmonised st andard concerned in the Official Journal 
of the European Union. 
3. The Commission shall inform the Member St ates 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 pe nalties applicable for infringement of the 
provisions of this Regulation and shall take all measures necessa ry 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 th e Official Journal of the European Union] at 
the latest and shall notify it without delay of  any subsequent amendment affecting them.  
EN 54   EN Article 33 
Repeal 
Directive 76/768/EEC is repealed with effect  from [date to be added: 36 months after 
publication of this Regulati on 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 nationa l law of the Directives set out in Part B of 
Annex IX. 
Article 34 
Entry into force 
1. This Regulation shall enter into force on the [twentieth day after its publication in the 
Official Journal of the European Union ] 
2. It shall apply from [date to be added: 36 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. 
 
Ð 76/768/EEC 
Article  15 
This Directive is addressed to the Member States.  
 
Ø new 
Done at Brussels, […] 
For the European Parliament For the Council 
The President The President 
[…] […]  
EN 55   EN  
Ð 76/768/EEC (adapted) 
ANNEX I  
ILLUSTRATIVE LIST BY C ATEGORY 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 powde rs, etc.  
– Toilet soaps, deodorant soaps, etc.  
– Perfumes, toilet waters and eau de Cologne.  
– Bath and shower preparations (s alts, foams, oils, gels, etc.).  
– Depilatories.  
– Deodorants and anti -perspirants.  
– Hair care products:  
– hair tints and bleaches,  
– products for  waving, straight ening and fixing,  
– setting products,  
– cleansing products (lotions, powders, shampoos),  
– conditioning products (lotions, creams, oils),  
– hairdressing products (loti ons, 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 ap plication 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 prod ucts.  
EN 56   EN – Products for tanning without sun.  
– Skin-whitening products.  
– Anti-wrinkle products.  
 
Ø new 
ANNEX I  
Cosmetic product safety report  
The cosmetic product safety report shall, as a minimum, contain the following: 
PART A – Cosmetic pro duct safety information 
1. Quantitative and qualitative composition of the product 
Description of the qualitative a nd quantitative composition of th e product, including chemical 
identity of the substances (incl. chemical  name, INCI, CAS, EINE CS/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 ch emical characteristics of the s ubstances, the raw-material as 
well as the cosmetic product. 
Description of the stability of the cosmetics product under r easonably foreseeable storage 
conditions. 
3. Microbiological quality 
Description of the microbiological specificati ons 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 dama ged skin, on children under thre e years of age, on elderly 
people and persons showing compromised immune responses. 
Results of preservation challenge test.  
EN 57   EN 4. Impurities, traces, information about th e 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 ch aracteristics of packaging materi al, in particular purity and 
stability. 
5. Normal and reasonably foreseeable use 
Description of the normal and reasonably forese eable use of the product.  The reasoning shall 
be justified in particular in  the light of warnings and ot her 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 expos ure shall also take into consider ation 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 ot her than those resulting from 
direct application should also be consid ered (e.g. non-intended inhalation of sprays, non-
intended ingestion of lip products, etc.). 
Particular consideration shall be given to a ny possible impacts on exposure due to particle 
sizes.  
EN 58   EN 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 absorptio n, 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 to xicological 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 sh all be clearly identified. 
9.Undesirable effects and se rious undesirable effects 
Description of the undesirable e ffects and serious undesirable e ffects to the cosmetic product 
or, where relevant, other cosmetic pr oducts. This includes statistical data. 
10. Information on the cosmetic product 
Other relevant information, e.g. description of existing studies fr om human volunteers.  
EN 59   EN PART B – Cosmetic product safety assessment 
1. Assessment conclusion 
Statement on the safety of the cosme tic product in relation to Article 3. 
2. Labelled warnings and instructions of use 
Statement on the need to label any particular wa rnings and instructions  of use in accordance 
with Article 15(1)(d). 
3. Reasoning 
Explanation of the scientific reasoning lead ing to the assessment conclusion set out under 
Section 1 and the statement set out under Secti on 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 inte nded exclusively for use in 
external intimate hygiene. 
Possible interactions of the substances containe d in the cosmetic product shall be assessed. If 
such interaction is not expecte d, this shall be duly justified. 
The consideration and non-consideration of the different toxicological profiles shall be duly 
justified. 
Impacts of the stability on th e 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 60   EN  
EN 61   EN Preamble to Annexes II to VI  
(1) For the purposes of the Annexes II to VI: 
(a) ‘Rinse-off product’ means a cosmetic product which is intended not to stay in 
prolonged contact with the skin, the hair or the mucous membranes; 
(b) ‘Leave-on product’ means a cosmetic product which is intended to stay in 
prolonged contact with the skin, the hair or the mucous membranes; 
(c) ‘Hair product’ means a cosmetic product which is intended to be applied on the 
hair of head or face, except eye lashes; 
(d) ‘Skin product’ means a cosmetic product which is intended to be applied on the 
skin; 
(e) ‘Lip product’ means a cosmetic produc t which is intended to be applied on the 
lips; 
(f) ‘Face product’ means a cosmetic product which is intended to be applied on 
the skin of the face; 
(g) ‘Nail product’ means a cosmetic produc t which is intended to be applied on 
nails; 
(h) ‘Oral product’ means a cosmetic produc t which is intended to be applied on 
teeth or the mucous membranes of the oral cavity; 
(i) ‘Product applied on mucous membrane s’ 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) ‘Eye product’ means a cosmetic product which is intended to be applied in the 
vicinity of the eyes; 
(k) ‘Professional use’ means the appli cation and use of cosmetic products by 
persons in the exercise of  their professional activity. 
(2) In order to facilitate substance iden tification, the following descriptors are used: 
– The Non-proprietary Names (INN) for pharmaceutical products, WHO, Geneva, 
August 1975. 
– The Chemical Abstracts Service numbers (CAS).  
EN 62   EN – The European Inventory of Existing Comm ercial chemical Substances (EINECS) 
numbers and the European List of Notified Chemical Substances (ELINCS) 
numbers. 
 
Ð 76/768/EEC 
ANNEX II  
 
Ð 82/368/EEC (adapted) 
LIST OF SUBSTANCES ⌦ PROHIBITED IN  ⌫ WHICH MUST NOT FORM PART 
OF THE COMPOSITION OF  COSMETIC PRODUCTS 
 
Ð 76/768/EEC (adapted) 
Î1 82/368/EEC 
Î2 90/121/EEC 
  
⌦ Substance identification ⌫ ⌦ 
Refe
renc
e 
num
ber 
⌫ ⌦ Chemical name/INN ⌫ ⌦ CAS 
number ⌫ ⌦ EINECS/ELI
NCS number ⌫ 
⌫ ⌦ b ⌫ ⌦ c ⌫ ⌦ d ⌫ 
1. N-5-Chlorobenzoxazol-2-ylacetamide ⌦ 35783-57-
4 ⌫  
2. Î1 (2-
Acetoxyethyl) trimethylammonium 
hydroxide (acetylcholine)  and its salts Í ⌦51-84-3 ⌫ ⌦ 200-128-9 ⌫ 
3. Deanol aceglumate ⌦ (INN) ⌫ (33) ⌦ 3342-61-
8 ⌫  ⌦ 222-085-5 ⌫ 
4. Spironolactone ⌦ (INN) ⌫ * ⌦ 52-01-7 ⌫ ⌦ 200-133-6 ⌫ 
5. Î1 [4-(4-Hydroxy-3-iodophenoxy)-3,5-
diiodophenyl]acetic acid and its salts Í ⌦ 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 (IN N) for pharmaceutical products, Lists 1 -33 of p roposed INN’, 
WHO, Geneva, August 1975.   
EN 63   EN 7. Aminocaproic acid ⌦ (INN) ⌫ * and 
its salts ⌦ 60-32-2 ⌫ ⌦ 200-469-3 ⌫ 
8. Cinchophen ⌦ (INN) ⌫ *, its salts, 
derivatives and salts of these derivatives ⌦ 132-60-
5 ⌫ ⌦ 205-067-1 ⌫ 
9. Thyropropic acid ⌦ (INN) ⌫ * and its 
salts ⌦ 51-26-3 ⌫  
10. Trichloroacetic acid ⌦ 76-03-9 ⌫ ⌦ 200-927-2 ⌫ 
11. Aconitum napellus L.  (leaves, roots and 
galenical preparations)  ⌦ 84603-50-
9 ⌫ ⌦ 283-252-6 ⌫ 
12. Aconitine (principal alkaloid of 
Aconitum napellus L. )and its salts  ⌦ 302-27-
2 ⌫ ⌦ 206-121-7 ⌫ 
13. Adonis vernalis L. and its preparations ⌦ 84649-73-
0 ⌫ ⌦ 283-458-6 ⌫ 
14. Epinephrine ⌦ (INN) ⌫ * ⌦ 51-43-4 ⌫ ⌦ 200-098-7 ⌫ 
15. Rauwolfia serpentina  alkaloids and their 
salts ⌦ 90106-13-
1 ⌫ ⌦ 290-234-1 ⌫ 
16. Alkyne alcohols, thei r esters, ethers and 
salts   
17. Isoprenaline ⌦ (INN) ⌫ * ⌦ 7683-59-
2 ⌫ ⌦ 231-687-7 ⌫ 
18. Allyl isothiocyanate ⌦ 57-06-7 ⌫ ⌦ 200-309-2 ⌫ 
19. Alloclamide ⌦ (INN) ⌫ * and its salts ⌦ 5486-77-
1 ⌫  
20. Nalorphine ⌦ (INN) ⌫ *, its salts and 
ethers ⌦ 62-67-9 ⌫ ⌦ 200-546-1 ⌫ 
21. Sympathicomimetic amines acting on the 
central nervous system: any substance contained in the firs t list of medicaments 
which are subject to medical prescription and are referred to in resolution AP (69) 2 of the Council of Europe ⌦ 300-62-
9 ⌫ ⌦ 206-096-2 ⌫ 
22. Aniline, its salts and its halogenated and 
sulphonated derivatives ⌦ 62-53-3 ⌫ ⌦ 200-539-3 ⌫ 
23. Betoxycaine ⌦ (INN) ⌫ * and its salts ⌦ 3818-62-
0 ⌫   
EN 64   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) ⌫ *, its 
isomers and salts ⌦ 123-82-
0 ⌫ ⌦ 204-655-5 ⌫ 
28. Octodrine ⌦ (INN) ⌫ * and its salts ⌦ 543-82-
8 ⌫ ⌦ 208-851-1 ⌫ 
29. Î1 2-Amino-1,2-bis(4-
methoxyphenyl)ethanol and its salts Í ⌦ 530-34-
7 ⌫  
30. 1,3-dimethylpentylamine and its salts ⌦ 105-41-
9 ⌫ ⌦ 203-296-1 ⌫ 
31. 4-Aminosalicylic acid and its salts ⌦ 65-49-6 ⌫ ⌦ 200-613-5 ⌫ 
32. Toluidines, their isomers, salts and 
halogenated and sul phonated derivatives ⌦ 26915-12-
8 ⌫ ⌦ 248-105-2 ⌫ 
33. Xylidines, their isomers, salts and 
halogenated and sul phonated derivatives ⌦ 1300-73-
8 ⌫ ⌦ 215-091-4 ⌫ 
34. Î1 Imperatorin (9-(3-methoxylbut-2-
enyloxy)furo[3,2-g]chromen-7-one) Í ⌦ 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 ⌦ 120-12-
7 ⌫ ⌦ 204-371-1 ⌫ 
39. Antibiotics Î2 --- Í   
40. Antimony and its compounds ⌦ 7440-36-
0 ⌫ ⌦ 231-146-5 ⌫ 
41. Apocynum cannabinum L. and its 
preparations ⌦ 84603-51-
0 ⌫ ⌦ 283-253-1 ⌫ 
42. Î1 Apomorphine (R 5,6,6a, 7-
tetrahydro-6-methyl-4 H-dibenzo ⌦ 58-00-4 ⌫ ⌦ 200-360-0 ⌫  
EN 65   EN [de,g]quinoline-10,11-diol) and its 
salts Í 
43. Arsenic and its compounds ⌦ 7440-38-
2 ⌫ ⌦ 231-148-6 ⌫ 
44. Atropa belladonna L. and its 
preparations ⌦ 8007-93-
0 ⌫ ⌦ 232-365-9 ⌫ 
45. Atropine, its salts and derivatives ⌦ 51-55-8 ⌫ ⌦ 200-104-8 ⌫ 
 
Ð 83/191/EEC (adapted) 
  
46. Barium salts, with the exception of 
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    
 
Ð 76/768/EEC (adapted) 
Î1 82/368/EEC 
Î2 85/391/EEC 
  
47. Benzene ⌦ 71-43-2 ⌫ ⌦ 200-753-7 ⌫ 
48. Î1 Benzimidazol-2(3 H)-one Í ⌦ 615-16-
7 ⌫ ⌦ 210-412-4 ⌫ 
49. Î1 Benzazepines and 
benzodiazepines Í ⌦ 12794-10-
4 ⌫  
50. Î1 1-Dimethylaminomethyl-1-
methylpropyl benzoate (amylocaine) and its salts Í ⌦ 644-26-
8 ⌫ ⌦ 211-411-1 ⌫ 
51. Î1 2,2,6-Trimethyl-4-piperidyl benzoate 
(benzamine) and its salts Í ⌦ 500-34-
5 ⌫  
52. Î1 Isocarboxazid ⌦ (INN) ⌫ * Í ⌦ 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 66   EN 7 ⌫ 
55. Bromine, elemental ⌦ 7726-95-
6 ⌫ ⌦ 231-778-1 ⌫ 
56. Bretylium tosilate ⌦ (INN) ⌫ * ⌦ 61-75-6 ⌫ ⌦ 200-516-8 ⌫ 
57. Carbromal ⌦ (INN) ⌫ * ⌦ 77-65-6 ⌫ ⌦ 201-046-6 ⌫ 
58. Bromisoval ⌦ (INN) ⌫ * ⌦ 496-67-
3 ⌫ ⌦ 207-825-7 ⌫ 
59. Brompheniramine ⌦ (INN) ⌫ * and its 
salts ⌦ 86-22-6 ⌫ ⌦ 201-657-8 ⌫ 
60. Benzilonium bromide ⌦ (INN) ⌫ * ⌦ 1050-48-
2 ⌫ ⌦ 213-885-5 ⌫ 
61. Tetrylammonium bromide ⌦ (INN) ⌫ 
* ⌦ 71-91-0 ⌫ ⌦ 200-769-4 ⌫ 
62. Brucine ⌦ 357-57-
3 ⌫ ⌦ 206-614-7 ⌫ 
63. Tetracaine ⌦ (INN) ⌫ * and its salts ⌦ 94-24-6 ⌫ ⌦ 202-316-6 ⌫ 
64. Mofebutazone ⌦ (INN) ⌫ * ⌦ 2210-63-
1 ⌫ ⌦ 218-641-1 ⌫ 
65. Tolbutamide ⌦ (INN) ⌫ * ⌦ 64-77-7 ⌫ ⌦ 200-594-3 ⌫ 
66. Carbutamide ⌦ (INN) ⌫ * ⌦ 339-43-
5 ⌫ ⌦ 206-424-4 ⌫ 
67. Phenylbutazone ⌦ (INN) ⌫ * ⌦ 50-33-9 ⌫ ⌦ 200-029-0 ⌫ 
68. Cadmium and its compounds ⌦ 7440-43-
9 ⌫ ⌦ 231-152-8 ⌫ 
69. Cantharides, Cantharis vesicatoria  ⌦ 92457-17-
5 ⌫ ⌦ 296-298-7 ⌫ 
70. (1R,2S)-Hexahydro-1,2-dimethyl-3,6-
epoxyphthalic anhydride (cantharidin) ⌦ 56-25-7 ⌫ ⌦ 200-263-3 ⌫ 
71. Phenprobamate ⌦ (INN) ⌫ * ⌦ 673-31-
4 ⌫ ⌦ 211-606-1 ⌫ 
72. Î1 Nitroderivatives of carbazole Í ⌦ 31438-22-
9 ⌫   
EN 67   EN 73. Carbon disulphide ⌦ 75-15-0 ⌫ ⌦ 200-843-6 ⌫ 
74. Catalase ⌦ 9001-05-
2 ⌫ ⌦ 232-577-1 ⌫ 
75. Cephaeline and its salts ⌦ 483-17-
0 ⌫ ⌦ 207-591-6 ⌫ 
76. Chenopodium ambrosioides ⌦ L. ⌫ 
(essential oil) ⌦ 8006-99-
3 ⌫  
77. 2,2,2-Trichloroethane-1,1-diol ⌦ 302-17-
0 ⌫ ⌦ 206-117-5 ⌫ 
78. Chlorine ⌦ 7782-50-
5 ⌫ ⌦ 231-959-5 ⌫ 
79. Chlorpropamide ⌦ (INN) ⌫ * ⌦ 94-20-2 ⌫ ⌦ 202-314-5 ⌫ 
80. Î1 Diphenoxylate ⌦ (INN) ⌫ *  
hydrochloride Í ⌦ 3810-80-
8 ⌫ ⌦ 223-287-6 ⌫ 
81. 4-Phenylazophenylene-1,3-diamine 
citrate hydrochloride (chrysoidine citrate 
hydrochloride) ⌦ 5909-04-
6 ⌫  
82. Chlorzoxazone ⌦ (INN) ⌫ * ⌦ 95-25-0 ⌫ ⌦ 202-403-9 ⌫ 
83. 2-Chloro-6-methylpyrimidin-4-
yldimethylamine (crimidine-ISO) ⌦ 535-89-
7 ⌫ ⌦ 208-622-6 ⌫ 
84. Chlorprothixene ⌦ (INN) ⌫ * and its 
salts ⌦ 113-59-
7 ⌫ ⌦ 204-032-8 ⌫ 
85. Clofenamide ⌦ (INN) ⌫ * ⌦ 671-95-
4 ⌫ ⌦ 211-588-5 ⌫ 
86. Î1 N,N-bis(2-chloroethyl)methylamine 
N-oxide and its salts Í ⌦ 126-85-
2 ⌫  
87. Chlormethine ⌦ (INN) ⌫ * and its 
salts ⌦ 51-75-2 ⌫ ⌦ 200-120-5 ⌫ 
88. Cyclophosphamide ⌦ (INN) ⌫ * and 
its salts ⌦ 50-18-0 ⌫ ⌦ 200-015-4 ⌫ 
89. Mannomustine ⌦ (INN) ⌫ * and its 
salts ⌦ 576-68-
1 ⌫ ⌦ 209-404-3 ⌫ 
90. Butanilicaine ⌦ (INN) ⌫ * and its salts ⌦ 3785-21-
5 ⌫   
EN 68   EN 91. Î1 Chlormezanone ⌦ (INN) ⌫ * Í ⌦ 80-77-3 ⌫ ⌦ 201-307-4 ⌫ 
92. Triparanol ⌦ (INN) ⌫ * ⌦ 78-41-1 ⌫ ⌦ 201-115-0 ⌫ 
93. 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. Î1 2-[2-(4-Chlorophenyl) -2-
phenylacetyl]indan 1,3 -dione 
(chlorophacinone - ISO)  Í 
⌦ Phenaglycodol (INN) ⌫ * ⌦ 79-93-6 ⌫ ⌦ 201-235-3 ⌫ 
96. Chloroethane ⌦ 75-00-3 ⌫ ⌦ 200-830-5 ⌫ 
97. Chromium; chromic acid and its salts ⌦ 7440-47-
3 ⌫ ⌦ 231-157-5 ⌫ 
98. Claviceps purpurea Tul.,  its alkaloids and 
galenical preparations  ⌦ 84775-56-
4 ⌫ ⌦ 283-885-8 ⌫ 
99. Conium maculatum L  (fruit, powder, 
galenical preparations)  ⌦ 85116-75-
2 ⌫ ⌦ 285-527-6 ⌫ 
100. Glycyclamide ⌦ (INN) ⌫ * ⌦ 664-95-
9 ⌫ ⌦ 211-557-6 ⌫ 
101. Cobalt benzenesulphonate ⌦ 23384-69-
2 ⌫  
102. Colchicine, its salts and derivatives ⌦ 64-86-8 ⌫ ⌦ 200-598-5 ⌫ 
103. Colchicoside and its derivatives ⌦ 477-29-
2 ⌫ ⌦ 207-513-0 ⌫ 
104. GColchicum autumnale L  and its 
galenical preparations ⌦ 84696-03-
7 ⌫ ⌦ 283-623-2 ⌫ 
105. Convallatoxin ⌦ 508-75-
8 ⌫ ⌦ 208-086-3 ⌫ 
106. Anamirta cocculus L.  (fruit)   
107. Croton tiglium  (oil) ⌦ 8001-28-
3 ⌫  
108. 1-Butyl-3-( N-crotonoylsulphanilyl)urea ⌦ 52964-42-
8 ⌫   
EN 69   EN 109. Curare and curarine ⌦ 8063-06-7; 
22260-42-0 ⌫ ⌦ 232-511-1; 
244-880-6 ⌫ 
110. Synthetic curarizants   
111. Hydrogen cyanide and its salts ⌦ 74-90-8 ⌫ ⌦ 200-821-6 ⌫ 
112. Î1 2-α-Cyclohexylbenzyl( N,N,N',N', -
tetraethyl)trimethylenediamine (phenetamine) Í   
113. Cyclomenol ⌦ (INN) ⌫ * and its salts ⌦ 5591-47-
9 ⌫ ⌦ 227-002-6 ⌫ 
114. Sodium hexacyclonate ⌦ (INN) ⌫ * ⌦ 7009-49-
6 ⌫  
115. Hexapropymate ⌦ (INN) ⌫ * ⌦ 358-52-
1 ⌫ ⌦ 206-618-9 ⌫ 
116. Dextropropoxyphene ⌦ (INN) ⌫ * ⌦ 469-62-
5 ⌫ ⌦ 207-420-5 ⌫ 
117. Î1 O,O' -Diacetyl- N-allyl- N-
normorphine Í ⌦ 2748-74-
5 ⌫  
118. Pipazetate ⌦ (INN) ⌫ * and its salts ⌦ 2167-85-
3 ⌫ ⌦ 218-508-8 ⌫ 
119. Î1 5-(αβ-Dibromophenethyl)-5-
methylhydantoin Í ⌦ 511-75-
1 ⌫ ⌦ 208-133-8 ⌫ 
120. Î1 N,N'-Pentamethylenebis 
(trimethylammonium salts), e. g. pentamethonium bromide ⌦ (INN) ⌫ 
*
 Í ⌦ 541-20-
8 ⌫  ⌦ 208-771-7 ⌫ 
121. Î1 N,N'-
[(Methylimino)diethylene]bis(ethyldimethylammonium) salts, e. g. azamethonium bromide ⌦ (INN) ⌫ *
 Í ⌦ 306-53-
6 ⌫ ⌦ 206-186-1 ⌫ 
122. Cyclarbamate ⌦ (INN) ⌫ * ⌦ 5779-54-
4 ⌫ ⌦ 227-302-7 ⌫ 
123. Clofenotane ⌦ (INN) ⌫ *; DDT (ISO) ⌦ 50-29-3 ⌫ ⌦ 200-024-3 ⌫ 
124. Î1 N,N'-
Hexamethylenebis(trimethylammonium) salts, e. g. hexamethonium bromide ⌦ (INN) ⌫ *
 Í ⌦ 55-97-0 ⌫ ⌦ 200-249-7 ⌫  
EN 70   EN 125. Dichloroethanes (ethylene chlorides)   
126. Dichloroethylenes (acetylene chlorides)   
127. Lysergide ⌦ (INN) ⌫ * and its salts ⌦ 50-37-3 ⌫ ⌦ 200-033-2 ⌫ 
128. Î1 2-Diethylaminoethyl-3-hydroxy-4-
phenylbenzoate and its salts Í   
129. Cinchocaine ⌦ (INN) ⌫ * and its salts ⌦ 85-79-0 ⌫ ⌦ 201-632-1 ⌫ 
130. 3-Diethylaminopropyl cinnamate ⌦ 538-66-
9 ⌫  
131. Î1 O,O' -Diethyl O-4-nitrophenyl 
phosphorothioate (p Parathion-lSO) Í ⌦ 56-38-2 ⌫ ⌦ 200-271-7 ⌫ 
132. Î1 [Oxalylbisiminoethylene)]bis[( o-
chlorobenzyl)diethylammonium salts], e. g. ambenonm
ium chloride ⌦ (INN) ⌫ 
* Í ⌦ 115-79-
7 ⌫ ⌦ 204-107-5 ⌫ 
133. Methyprylon ⌦ (INN) ⌫ * and its salts ⌦ 125-64-
4 ⌫ ⌦ 204-745-4 ⌫ 
134. Digitaline and a ll heterosides of Digitalis 
purpurea L.  ⌦ 752-61-
4 ⌫ ⌦ 212-036-6 ⌫ 
135. 7-[2-Hydroxy-3-(2-hydroxyethyl- N-
methylamino)propyl]theophylline (xanthinol) ⌦ 2530-97-
4 ⌫  
136. Dioxethedrin ⌦ (INN) ⌫ * and its salts ⌦ 497-75-
6 ⌫ ⌦ 207-849-8 ⌫ 
137. Piprocurarium iodide ⌦ (INN) ⌫ * ⌦ 3562-55-
8 ⌫ ⌦ 222-627-0 ⌫ 
138. Propyphenazone ⌦ (INN) ⌫ * ⌦ 479-92-
5 ⌫ ⌦ 207-539-2 ⌫ 
139. Tetrabenazine ⌦ (INN) ⌫ * and its 
salts ⌦ 58-46-8 ⌫ ⌦ 200-383-6 ⌫ 
140. Captodiame ⌦ (INN) ⌫ * ⌦ 486-17-
9 ⌫ ⌦ 207-629-1 ⌫ 
141. Mefeclorazine ⌦ (INN) ⌫ * and its 
salts ⌦ 1243-33-
0 ⌫  
142. Dimethylamine ⌦ 124-40- ⌦ 204-697-4 ⌫  
EN 71   EN 3 ⌫ 
143. Î1 1,1-Bis(dimethylaminomethyl)propyl 
benzoate (amydricaine, alypine) and its salts Í ⌦ 963-07-
5 ⌫ ⌦ 213-512-6 ⌫ 
144. Methapyrilene ⌦ (INN) ⌫ * and its 
salts ⌦ 91-80-5 ⌫ ⌦ 202-099-8 ⌫ 
145. Metamfepramone ⌦ (INN) ⌫ * and its 
salts ⌦ 15351-09-
4 ⌫ ⌦ 239-384-1 ⌫ 
146. Amitriptyline ⌦ (INN) ⌫ * and its salts ⌦ 50-48-6 ⌫ ⌦ 200-041-6 ⌫ 
147. Metformin ⌦ (INN) ⌫ * and its salts ⌦ 657-24-
9 ⌫ ⌦ 211-517-8 ⌫ 
148. Isosorbide dinitrate ⌦ (INN) ⌫ * ⌦ 87-33-2 ⌫ ⌦ 201-740-9 ⌫ 
149. Malononitrile ⌦ 109-77-
3 ⌫ ⌦ 203-703-2 ⌫ 
150. Succinonitrile ⌦ 110-61-
2 ⌫ ⌦ 203-783-9 ⌫ 
151. Dinitrophenol isomers   
152. Inproquone ⌦ (INN) ⌫ ⌦ 436-40-
8 ⌫  
153. Dimevamide ⌦ (INN) ⌫ * and its salts ⌦ 60-46-8 ⌫ ⌦ 200-479-8 ⌫ 
154. Diphenylpyraline ⌦ (INN) ⌫ * and its 
salts ⌦ 147-20-
6 ⌫ ⌦ 205-686-7 ⌫ 
155. Sulfinpyrazone ⌦ (INN) ⌫ * ⌦ 57-96-5 ⌫ ⌦ 200-357-4 ⌫ 
156. Î1 N-(3-Carbamoyl-3,3-
diphenylpropyl)- N,N-diisopropylmethyl-
ammonium salts, e. g. isopropamide iodide Í⌦  (INN) ⌫ *
  ⌦ 71-81-8 ⌫ ⌦ 200-766-8 ⌫ 
157. Benactyzine ⌦ (INN) ⌫ * ⌦ 302-40-
9 ⌫ ⌦ 206-123-8 ⌫ 
158. Benzatropine ⌦ (INN) ⌫ * and its salts ⌦ 86-13-5 ⌫  
159. Cyclizine ⌦ (INN) ⌫ * and its salts ⌦ 82-92-8 ⌫ ⌦ 201-445-5 ⌫ 
160. Î1 5,5-Diphenyl-4-imidazolidone Í ⌦ 3254-93-
1 ⌫ ⌦ 221-851-6 ⌫  
EN 72   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 ⌦ 483-18-
1 ⌫ ⌦ 207-592-1 ⌫ 
164. Ephedrine and its salts ⌦ 299-42-
3 ⌫ ⌦ 206-080-5 ⌫ 
165. Oxanamide ⌦ (INN) ⌫ * and its 
derivatives ⌦ 126-93-
2 ⌫  
166. Eserine or physostigmine and its salts ⌦ 57-47-6 ⌫ ⌦ 200-332-8 ⌫ 
167. Esters of 4-aminobenzoic acid, with the 
free amino group, with  the exception of 
that given in Î2 Annex VI VII, Part 2  Í   
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 ⌦ 311-45-
5 ⌫ ⌦ 206-221-0 ⌫ 
171. Metethoheptazine ⌦ (INN) ⌫ * and its 
salts ⌦ 509-84-
2 ⌫  
172. Oxpheneridine ⌦ (INN) ⌫ * and its 
salts ⌦ 546-32-
7 ⌫  
173. Ethoheptazine ⌦ (INN) ⌫ * and its 
salts ⌦ 77-15-6 ⌫ ⌦ 201-007-3 ⌫ 
174. Metheptazine ⌦ (INN) ⌫ * and its salts ⌦ 469-78-
3 ⌫  
175. Methylphenidate ⌦ (INN) ⌫ * and its 
salts ⌦ 113-45-
1 ⌫ ⌦ 204-028-6 ⌫ 
176. Doxylamine ⌦ (INN) ⌫ * and its salts ⌦ 469-21-
6 ⌫ ⌦ 207-414-2 ⌫ 
177. Tolboxane ⌦ (INN) ⌫ * ⌦ 2430-46-
8 ⌫   
EN 73   EN  
Ð 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 ⌫ 
 
Ð 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) ⌫ * ⌦ 1480-19-
9 ⌫ ⌦ 216-038-8 ⌫ 
188. Trifluperidol ⌦ (INN) ⌫ * ⌦ 749-13-
3 ⌫  
189. Fluoresone ⌦ (INN) ⌫ * ⌦ 2924-67-
6 ⌫ ⌦ 220-889-0 ⌫ 
190. Fluorouracil ⌦ (INN) ⌫ * ⌦ 51-21-8 ⌫ ⌦ 200-085-6 ⌫ 
 
 
Ð 82/368/EEC (adapted) 
  
191.  Hydrofluoric acid, its normal salts, its ⌦ 7664-39- ⌦ 231-634-8 ⌫  
EN 74   EN complexes and hydrofluorides with the 
exception of those given in Annex III,  
Part 1  3 ⌫ 
 
 
Ð 76/768/EEC (adapted) 
Î1 82/368/EEC 
  
192. Furfuryltrimethylammo nium 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. Î1 (1R,4S,5R,8S)-1,2,3,4,10,10-
Hexachloro-6,7-epoxy-1,4,4a,5,6,7,8,8a-
octahydro-1,4: 5,8-dimethano-
naphthalene (endrin-ISO) Í ⌦ 72-20-8 ⌫ ⌦ 200-775-7 ⌫ 
197. Hexachloroethane ⌦ 67-72-1 ⌫ ⌦ 200-666-4 ⌫ 
198. (1 R,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 deriva tives and their salts ⌦ 302-01-
2 ⌫ ⌦ 206-114-9 ⌫ 
202. Octamoxin ⌦ (INN) ⌫ * and its salts ⌦ 4684-87-
1 ⌫  
203. Warfarin ⌦ (INN) ⌫ * and its salts ⌦ 81-81-2 ⌫ ⌦ 201-377-6 ⌫ 
204. Î1 Ethyl bis(4-hydroxy-2-oxo-1-
benzopyran-3-yl) acetate and salts of the acid Í ⌦ 548-00-
5 ⌫ ⌦ 208-940-5 ⌫ 
205. Methocarbamol ⌦ (INN) ⌫ * ⌦ 532-03- ⌦ 208-524-3 ⌫  
EN 75   EN 6 ⌫ 
206. Propatylnitrate ⌦ (INN) ⌫ * ⌦ 2921-92-
8 ⌫ ⌦ 220-866-5 ⌫ 
207. Î1 4,4'-Dihydroxy-3,3'-(3-
methylthiopropylidene) dicoumarin Í   
208. Fenadiazole ⌦ (INN) ⌫ * ⌦ 1008-65-
7 ⌫  
209. Nitroxoline ⌦ (INN) ⌫ * and its salts ⌦ 4008-48-
4 ⌫ ⌦ 223-662-4 ⌫ 
210. Hyoscyamine, its salts and derivatives ⌦ 101-31-
5 ⌫ ⌦ 202-933-0 ⌫ 
211. Hyoscyamus niger L.  (leaves, seeds, 
powder and galenical preparations)  ⌦ 84603-65-
6 ⌫ ⌦ 283-265-7 ⌫ 
212. Pemoline ⌦ (INN) ⌫ * and its salts ⌦ 2152-34-
3 ⌫ ⌦ 218-438-8 ⌫ 
213. Iodine ⌦ 7553-56-
2 ⌫ ⌦ 231-442-4 ⌫ 
214. Î1 Decamethylenebis(trimethylammoniu
m) salts, e. g. decamethonium bromide Í ⌦ 541-22-
0 ⌫ ⌦ 208-772-2 ⌫ 
215. Ipecacuanha (Cephaelis ipecacuanha 
Brot and related species) (roots, powder 
and galenical preparations)  ⌦ 8012-96-
2 ⌫ ⌦ 232-385-8 ⌫ 
216. (2-Isopropylpent4-enoyl)urea 
(apronalide) ⌦ 528-92-
7 ⌫ ⌦ 208-443-3 ⌫ 
217. Î1 α-Santonin [(3S,5a R,9bS)-
3,3a,4,5,5a,9b-hexahydro-3,5a,9-trimethylnaphto [1,2-b] furan-2,8-dione] Í ⌦ 481-06-
1 ⌫ ⌦ 207-560-7 ⌫ 
218. Lobelia inflata L.  and its galenical 
preparations ⌦ 84696-23-
1 ⌫ ⌦ 283-642-6 ⌫ 
219. Lobeline ⌦ (INN) ⌫ * and its salts ⌦ 90-69-7 ⌫ ⌦ 202-012-3 ⌫ 
220. Barbiturates    
EN 76   EN  
Ð 86/199/EEC (adapted) 
Î1 91/184/EEC 
  
221. Mercury and its compounds, except those 
special cases included Î1 in Annex V VI, 
Part 1  Í ⌦ 7439-97-
6 ⌫ ⌦ 231-106-7 ⌫ 
 
 
Ð 76/768/EEC (adapted) 
Î1 82/368/EEC 
Î2 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) ⌫ *, its 
derivatives and salts ⌦ 134-49-
6 ⌫ ⌦ 205-143-4 ⌫ 
233. Thiamazole ⌦ (INN) ⌫ * ⌦ 60-56-0 ⌫ ⌦ 200-482-4 ⌫ 
234. Î1 3,4-Dihydro-2-methoxy-2-methyl-4-
phenyl-2H,5 H-pyrano [3,2-c]-[1] ⌦ 518-20- ⌦ 208-248-3 ⌫  
EN 77   EN benzopyran-5-one (cyclocoumarol) Í 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; 
91-59-8 ⌫ ⌦ 205-138-7; 202-
080-4 ⌫ 
243. Î1 3-(1-Naphthyl)-4-
hydroxycoumarin Í ⌦ 39923-41-
6 ⌫  
244. Naphazoline ⌦ (INN) ⌫ * and its salts ⌦ 835-31-
4 ⌫ ⌦ 212-641-5 ⌫ 
245. Neostigmine and its salts (e. g. 
neostigmine bromide ⌦ (INN) ⌫ *) ⌦ 114-80-
7 ⌫ ⌦ 204-054-8 ⌫ 
246. Nicotine and its salts ⌦ 54-11-5 ⌫ ⌦ 200-193-3 ⌫ 
247. Amyl nitrites ⌦ 110-46-
3 ⌫ ⌦ 203-770-8 ⌫ 
248. Inorganic nitrites, wi th 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 78   EN 255. Alkali pentacyanonitrosylferrate (2-)   
256. Nitrostilbenes, th eir homologues and 
their derivatives   
257. Noradrenaline and its salts ⌦ 51-41-2 ⌫ ⌦ 200-096-6 ⌫ 
258. Noscapine ⌦ (INN) ⌫ * and its salts ⌦ 128-62-
1 ⌫ ⌦ 204-899-2 ⌫ 
259. Guanethidine ⌦ (INN) ⌫ * and its salts ⌦ 55-65-2 ⌫ ⌦ 200-241-3 ⌫ 
260. Oestrogens Î2 --- Í   
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. Pentaerithrity l 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 ⌫ 
 
 
Ð 82/368/EEC (adapted) 
  
268. Picric acid ⌦ 88-89-1 ⌫ ⌦ 201-865-9 ⌫ 
 
 
Ð 76/768/EEC (adapted) 
Î1 82/368/EEC 
  
269. Phenacemide ⌦ (INN) ⌫ * ⌦ 63-98-9 ⌫ ⌦ 200-570-2 ⌫ 
270. Difencld oxazine ⌦ (INN) ⌫ * ⌦ 5617-26-
5 ⌫   
EN 79   EN 271. Î1 2-Phenylindan-1,3-dione 
(phenindione) Í ⌦ (INN) ⌫ ⌦ 83-12-5 ⌫ ⌦ 201-454-4 ⌫ 
272. Ethylphenacemide ⌦ (pheneturide) 
(INN) ⌫ * ⌦ 90-49-3 ⌫ ⌦ 201-998-2 ⌫ 
273. Phenprocoumon ⌦ (INN) ⌫ * ⌦ 435-97-
2 ⌫ ⌦ 207-108-9 ⌫ 
274. Fenyramidol ⌦ (INN) ⌫ * ⌦ 553-69-
5 ⌫ ⌦ 209-044-7 ⌫ 
275. Triamterene ⌦ (INN) ⌫ * and its salts ⌦ 396-01-
0 ⌫ ⌦ 206-904-3 ⌫ 
276. Î1 Tetraethyl pyr ophosphate; TEPP 
(ISO) Í ⌦ 107-49-
3 ⌫ ⌦ 203-495-3 ⌫ 
277. Tritolyl phosphate ⌦ 1330-78-
5 ⌫ ⌦ 215-548-8 ⌫ 
278. Psilocybine ⌦ (INN) ⌫ * ⌦ 520-52-
5 ⌫ ⌦ 208-294-4 ⌫ 
279. Phosphorus and metal phosphides ⌦ 7723-14-
0 ⌫ ⌦ 231-768-7 ⌫ 
280. Thalidomide ⌦ (INN) ⌫ * and its salts ⌦ 50-35-1 ⌫ ⌦ 200-031-1 ⌫ 
281. Physostigma venenosum Balf. ⌦ 89958-15-
6 ⌫ ⌦ 289-638-0 ⌫ 
282. Picrotoxin ⌦ 124-87-
8 ⌫ ⌦ 204-716-6 ⌫ 
283. Pilocarpine and its salts ⌦ 92-13-7 ⌫ ⌦ 202-128-4 ⌫ 
284. Î1 α-Piperidin-2-ylbenzyl acette (SIC!  
acetate)  , laevorotatory threoform 
(levofph acetoperane) ⌦ (INN) ⌫ and 
its salts Í ⌦ 24558-01-
8 ⌫  
285. Pipradrol ⌦ (INN) ⌫ * and its salts ⌦ 467-60-
7 ⌫ ⌦ 207-394-5 ⌫ 
286. Azacyclonol ⌦ (INN) ⌫ * and its salts ⌦ 115-46-
8 ⌫ ⌦ 204-092-5 ⌫ 
287. Bietamiverine ⌦ (INN) ⌫ * ⌦ 479-81-
2 ⌫ ⌦ 207-538-7 ⌫  
EN 80   EN 288. Butopiprine ⌦ (INN) ⌫ * and its salts ⌦ 55837-15-
5 ⌫ ⌦ 259-848-7 ⌫ 
 
 
Ð 2004/93/EC Art. 1 and Annex .1 
(adapted) 
  
289. Lead and its compounds ⌦ 7439-92-
1 ⌫ ⌦ 231-100-4 ⌫ 
 
 
Ð 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 ⌫ 
 
 
Ð 2002/34/EC Art. 1 and Annex 
.1(i) 
  
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   
 
 
Ð 76/768/EEC (adapted) 
  
                                                 
34 OJ L 159, 29.6.1996, p. 1.  
EN 81   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   
 
Ð 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 ⌫ 
 
 
Ð 76/768/EEC (adapted) 
Î1 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. Datura stramonium L.  and its galenical 
preparations  ⌦ 84696-08-
2 ⌫ ⌦ 283-627-4 ⌫ 
302. Strophantines, their aglucones and their 
respective derivatives ⌦ 11005-63-
3 ⌫ ⌦ 234-239-9 ⌫ 
303. Strophantus  species and their galenical 
preparations   
304. Strychnine and its salts ⌦ 57-24-9 ⌫ ⌦ 200-319-7 ⌫ 
305. Strychnos  species and their galenical 
preparations   
306. Narcotics, natural and synthetic: All 
substances listed in Tables I and II of the single Convention on narcotic drugs signed in New York on 30 March 1961   
307. Î1 Sulphonamides (sulphanilamide and 
its derivatives…) and their salts obtained    
EN 82   EN by substitution of one or more H-atoms 
of the -NH 2 groups) and their salts Í 
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 ⌦ 13494-80-
9 ⌫ ⌦ 236-813-4 ⌫ 
313. Î1 Xylometazoline ⌦ (INN) ⌫ * and 
its salts Í ⌦ 526-36-
3 ⌫ ⌦ 208-390-6 ⌫ 
314. Tetrachloroethylene ⌦ 127-18-
4 ⌫ ⌦ 204-825-9 ⌫ 
315. Carbon tetrachloride ⌦ 56-23-5 ⌫ ⌦ 200-262-8 ⌫ 
316. Hexaethyl tetraphosphate ⌦ 757-58-
4 ⌫ ⌦ 212-057-0 ⌫ 
317. Thallium and its compounds ⌦ 7440-28-
0 ⌫ ⌦ 231-138-1 ⌫ 
318. Thevetia neriifolia Juss. , glycoside 
extract  ⌦ 90147-54-
9 ⌫ ⌦ 290-446-4 ⌫ 
319. Ethionamide ⌦ (INN) ⌫ * ⌦ 536-33-
4 ⌫ ⌦ 208-628-9 ⌫ 
320. Phenothiazine ⌦ (INN) ⌫ * and its 
compounds ⌦ 92-84-2 ⌫ ⌦ 202-196-5 ⌫ 
 
 
Ð 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 83   EN  
Ð 76/768/EEC (adapted) 
Ö 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 
laid down by law, regulation or 
administrative action relating to 
proprietary medicina l products (OJ No L 
147, 9. 6. 1975, p. 13)     
324. Tranylcypromine ⌦ (INN) ⌫ * and its 
salts ⌦ 155-09-
9 ⌫ ⌦ 205-841-9 ⌫ 
325. Trichloronitromethane (chloropicrine) ⌦ 76-06-2 ⌫ ⌦ 200-930-9 ⌫ 
326. 2,2,2-Tribromoethanol (tribromoethyl 
alcohol) ⌦ 75-80-9 ⌫ ⌦ 200-903-1 ⌫ 
327. 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. Urginea scilla Steinhrn . and its galenical 
preparations  ⌦ 84650-62-
4 ⌫ ⌦ 283-520-2 ⌫ 
331. Veratrine, its sa lts and galenical 
preparations ⌦ 8051-02-
3 ⌫ ⌦ 613-062-00-
4 ⌫ 
332. Schoenocaulon o  ⌦ f ⌫ lficinale Lind  
(seeds and galenical preparations)  ⌦ 84604-18-
2 ⌫ ⌦ 283-296-6 ⌫ 
 
 
Ð 84/415/EEC (adapted) 
  
333. Veratrum Spp  and their preparations ⌦ 90131-91-
2 ⌫ ⌦ 290-407-1 ⌫  
EN 84   EN  
 
Ð 76/768/EEC (adapted) 
Î1 82/368/EEC 
  
334. Vinyl chloride monomer ⌦ 75-01-4 ⌫ ⌦ 200-831-
0 ⌫ 
335. Ergocalciferol ⌦ (INN) ⌫ * and 
cholecalciferol (vitamins D 2 and D 3) ⌦ 50-14-6; 67-
97-0 ⌫ ⌦ 200-014-9: 
200-673-2 ⌫ 
336. Salts of O-alkyldithiocarbonic acids   
337. Yohb imbine and its salts ⌦ 146-48-5 ⌫ ⌦ 205-672-
0 ⌫ 
338. Dimethyl sulfoxide ⌦ (INN) ⌫ * ⌦ 67-68-5 ⌫ ⌦ 200-664-
3 ⌫ 
339. Diphenhydramine ⌦ (INN) ⌫ * and its 
salts ⌦ 58-73-1 ⌫ ⌦ 200-396-
7 ⌫ 
340. 4-tert-Butylphenol ⌦ 98-54-4 ⌫ ⌦ 202-679-
0 ⌫ 
341. 4-tert-Butylpyrocatechol ⌦ 98-29-3 ⌫ ⌦ 202-653-
9 ⌫ 
342. Dihydrotachysterol ⌦ (INN) ⌫ ⌦ 67-96-9 ⌫ ⌦ 200-672-
7 ⌫ 
343. Dioxane ⌦ 123-91-1 ⌫ ⌦ 204-661-
8 ⌫ 
344. Morpholine and its salts ⌦ 110-91-8 ⌫ ⌦ 203-815-
1 ⌫ 
345. Pyretb hrum album L.  and its galenical 
preparations    
346. Î1 2-[4-Methoxybenzyl- N-(2-
pyridyl)amino]ethyldimethylamine maleate Í ⌦ 59-33-6 ⌫ ⌦ 200-422-
7 ⌫ 
347. Tripelennamine ⌦ (INN) ⌫ * ⌦ 91-81-6 ⌫ ⌦ 202-100-
1 ⌫ 
348. Tetrachlorosalicylanilides ⌦ 7426-07-5 ⌫   
EN 85   EN 349. Dichlorosalicylanilides ⌦ 1147-98-4 ⌫  
 
Ð 82/368/EEC (adapted) 
  
350. Tetrabromosalicylanilides   
351. Dibromosalicylanilides ⌦ 24556-64-
7 ⌫ ⌦ 246-310-1 ⌫ 
 
Ð 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 4-hydroxy-3-
methoxycinnamyl alcohol except for normal content in natural essences used   
 
Ð 95/34/EC (adapted) 
  
358. Furocoumarines (e. g. trioxyy salea n 
⌦ (INN) ⌫ *, 8-methoxypsoralen, 5-
methoxypsoralen) except for normal content in natural essences used. 
In sun protection and in bronzing 
products, furocoumarines shall be below 1 mg/kg ⌦ 3902-71-4; 
298-81-7; 484-20-8 ⌫ ⌦ 223-459-0; 
206-066-9; 207-604-5 ⌫ 
 
Ð 76/768/EEC (adapted) 
  
359. Oil from the seeds of Laurus nobilis L.  ⌦ 84603-73-
6 ⌫ ⌦ 283-272-5 ⌫  
EN 86   EN  
Ð 82/368/EEC (adapted) 
  
360. Safrole except for normal content in the 
natural essences used and provided the concentration does not exceed: 
100 ppm in the finish ed product, 50 ppm 
in products for dental  and oral hygiene, 
and provided that Safrol e is not present in 
toothpastes intende d specifically for 
children ⌦ 94-59-7⌫ ⌦ 202-345-4 ⌫ 
 
 
Ð 76/768/EEC (adapted) 
  
361. 5,5'-Di-isopropyl-2,2'-dimethylbiphenyl-
4,4'-diyl dihypoiodite ⌦ 552-22-7 ⌫ ⌦ 209-007-5 ⌫ 
 
 
Ð 2000/11/EC Art. 1 and Annex 
.II (adapted) 
  
362. 3'-Ethyl-5',6',7',8'-tetrahydro-5',5',8',8'-
tetramethyl-2'-acetonaphthone or 7-acetyl-6-ethyl-1,1,4,4-tetramethyl-1,2,3,4-tetrahydronaphtalen ⌦ 88-29-9 ⌫ ⌦ 201-817-7 ⌫ 
 
 
Ð 83/341/EEC (adapted) 
  
363. Oo-phenylenediamine and its salts ⌦ 95-54-5 ⌫ ⌦ 202-430-6 ⌫ 
364. 4-methyl- m-phenylenediamine and its 
salts ⌦ 95-80-7 ⌫ ⌦ 202-453-1 ⌫ 
  
EN 87   EN  
Ð 2000/11/EC Art. 1 and Annex 
.II (adapted) 
  
365. Aristolochic acid and its salts; 
Aristolochia  spp. and their preparations ⌦ 475-80-9; 
313-67-7; 15918-62-4 ⌫ ⌦ 202-499-6; 
206-238-3; - ⌫  
 
 
Ð 86/179/EEC (adapted) 
  
366. Chloroform ⌦ 67-66-3 ⌫ ⌦ 200-663-8 ⌫ 
 
 
Ð 2000/11/EC Art. 1 and Annex 
.II (adapted) 
  
367. 2,3,7,8-Tetra chlorodibenzo-p-dioxin ⌦ 1746-01-6 ⌫ ⌦ 217-122-7 ⌫ 
 
Ð 86/179/EEC (adapted) 
  
368. 2,6-Dimethyl-1,3-di oxan-4-yl acetate 
(Dimethoxane) ⌦ 828-00-2 ⌫ ⌦ 212-579-9 ⌫ 
369. Pyrithione sodium (INNM) ⌦ 3811-73-2 ⌫ ⌦ 223-296-5 ⌫ 
 
Ð 87/137/EEC (adapted) 
  
370. N-(Trichloromethylthio)-4-cyclohexene-
1,2-dicarboximide (captan) ⌦ 133-06-2 ⌫ ⌦ 205-087-0 ⌫ 
371. 2,2'-Dihydroxy-3,3',5,5',6,6'-
hexachlorodiphenylmethane (hexachlorophene) ⌦ (INN) ⌫ ⌦ 70-30-4 ⌫ ⌦ 200-733-8 ⌫  
EN 88   EN  
Ð 2000/11/EC Art. 1 and Annex 
.II (adapted) 
  
372. 6-(Piperidinyl)-2,4-pyrimidinediamine 3-
oxide (minoxidil) ⌦ (INN) ⌫ and its 
salts ⌦ 38304-91-
5 ⌫ ⌦ 253-874-2 ⌫ 
373. 3,4',5-Tribromosalicylanilide 
⌦ tribromsalan) (INN) ⌫ ⌦ 87-10-5 ⌫ ⌦ 201-723-6 ⌫ 
374. Phytolacca  spp and their preparations ⌦ 65497-07-6; 
60820-94-2 ⌫  
 
Ð 88/233/EEC (adapted) 
Î1 90/121/EEC 
  
375. Tretinoin ⌦ (INN) ⌫ (retinoic acid and 
its salts) ⌦ 302-79-4 ⌫ ⌦ 206-129-0 ⌫ 
376. 1-Methoxy-2,4-diaminobenzene (2,4-
diaminoanisole - CI 76050) Î1 and their 
salts Í ⌦ 615-05-4 ⌫ ⌦ 210-406-1 ⌫ 
377. 1-Methoxy-2,5-diaminobenzene (2,5-
diaminoanisole) Î1 and their salts Í ⌦ 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 
Colouring agent CI 42555:1 Colouring agent CI 42555:2 ⌦ 548-62-9 
467-63-0 ⌫ ⌦ 208-953-6 
207-396-6 ⌫ 
  
 
Ð 89/174/EEC (adapted) 
  
381. Amyl 4-dimethylaminobenzoate, mixed 
isomers (Padimate A (INN)) ⌦ 14779-78-
3 ⌫ ⌦ 238-849-6 ⌫  
EN 89   EN  
Ð 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 ⌫ 
 
Ð 90/121/EEC (adapted) 
  
385. 11- α-Hydroxypregn-4-ene-3,20-dione 
and its esters ⌦ 80-75-1 ⌫ ⌦ 201-306-9 ⌫ 
 
 
Ð 2000/11/EC Art. 1 and Annex 
.II (adapted) 
 385. 11 α-Hydroxypregn -4-ene-3, 20 -dione) and its esters  
 
Ð 2000/11/EC Art. 1 and Annex 
.II (adapted) 
  
386. Colouring agent CI 42640 ⌦ 1694-09-3 ⌫ ⌦ 216-901-9 ⌫ 
 
Ð 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 ⌫ 
 
Ð 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 90   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 ⌦ Tetryzoline 
(INN) ⌫ and its salts ⌦ 84-22-0 ⌫ ⌦ 201-522-3 ⌫ 
 
Ð 91/184/EEC (adapted) 
  
395. 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 ⌫ 
396. Dithio-2,2-bispyr idine-dioxide 1,1' 
(additive with trihydrated magnesium sulphate) - (pyrithione disulphide + magnesium sulphate) ⌦ 43143-11-9 ⌫ ⌦ 256-115-3 ⌫ 
397. Colouring agent CI 12075 and its lakes, 
pigments and salts ⌦ 3468-63-1 ⌫ ⌦ 222-429-4 ⌫ 
398. Colouring agent CI 45170 and CI 
45170:1 ⌦ 81-88-9; 509-
34-2 ⌫ ⌦ 201-383-9; 
208-096-8 ⌫ 
399. Lidocaine ⌦ (INN) ⌫ ⌦ 137-58-6 ⌫ ⌦ 205-302-8 ⌫ 
 
 
Ð 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 91   EN salts 
407. 2,4-diaminophenylethanol and its salts ⌦ 14572-93-1 ⌫  
408. Catechol ⌦ 120-80-9 ⌫ ⌦ 204-427-5 ⌫ 
409. Pyrogallol ⌦ 87-66-1 ⌫ ⌦ 201-762-9 ⌫ 
410. Nitrosamines   
 
Ð 2003/83/EC Art. 1 and Annex 
.1(c) 
  
411. Secondary alkyl- and alkanolamines and 
their salts   
 
Ð 93/47/EEC (adapted) 
  
412. 4-Amino-2-nitrophenol ⌦ 119-34-6 ⌫ ⌦ 204-316-1 ⌫ 
 
 
Ð 94/32/EC (adapted) 
  
413. 2-Methyl-m-phenylenediamine ⌦ 823-40-5 ⌫ ⌦ 212-513-9 ⌫ 
 
Ð 95/34/EC (adapted) 
  
414. 4-tert-Butyl-3-methoxy-2,6-
dinitrotoluene (Musk Ambrette) ⌦ 83-66-9 ⌫ ⌦ 201-493-7 ⌫ 
 
 
Ð 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 92   EN  
Ð 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 ⌫ 
 
  
 
Ð 2006/78/EC Art. 1 
  
419. Category 1 material and Category 2 
material as defined in Articles 4 and 5 respectively of Re gulation (EC) No 
1774/2002 of the European Parliament and of the Council
35, and ingredients derived 
therefrom   
 
Ð 97/45/EC (adapted) 
  
420. Crude and refined coal tars ⌦ 8007-45-2 ⌫ ⌦ 232-361-7 ⌫ 
 
 
Ð 98/62/EC (adapted) 
  
421. 1,1,3,3,5,-Pentamethyl-4,6-dinitroindane 
(moskene) ⌦ 116-66-5 ⌫ ⌦ 204-149-4 ⌫ 
422. 5- tert-Butyl-1,2,3-trimethyl-4,6-
dinitrobenzene (musk tibetene) ⌦ 145-39-1 ⌫ ⌦ 205-651-6 ⌫ 
 
 
Ð 2002/34/EC Art. 1 and Annex 
.1(ii) (adapted) 
Î1 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 93   EN 423. Alanroot oil ( Inula helenium ) (CAS No 
97676 -35-2), when used as a fragrance 
ingredient ⌦ 97676-35-
2 ⌫  
424. Benzyl cyanide (CAS No 140 -29-4), when 
used as a fragrance ingredient ⌦ 140-29-4 ⌫ ⌦ 205-410-5 ⌫ 
425. Cyclamen alcohol (CAS No 4756 -19-8), 
when used as a fragrance ingredient ⌦ 4756-19-8 ⌫ ⌦ 225-289-2 ⌫ 
426. Diethyl maleate (CAS No 141 -05-9), when 
used as a fragrance ingredient ⌦ 141-05-9 ⌫ ⌦ 205-451-9 ⌫ 
427. Dihydrocoumarine (CAS No 119 -84-6), 
when used as a fragrance ingredient ⌦ 119-84-6 ⌫ ⌦ 204-354-9 ⌫ 
428. 2,4-Dihydroxy-3-methylbenzaldehyde 
(CAS No 6248 -20-0), when used as a 
fragrance ingredient ⌦ 6248-20-0 ⌫ ⌦ 228-369-5 ⌫ 
429.  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 ⌫ 
430. 4,6-Dimethyl-8- tert-butylcoumarin (CAS 
No 17874 -34-9), when used as a fragrance 
ingredient ⌦ 17874-34-
9 ⌫ ⌦ 241-827-9 ⌫ 
431. Dimethyl citraconate (CAS No 617 -54-9), 
when used as a fragrance ingredient ⌦ 617-54-9 ⌫  
432. 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 ⌫ 
433. 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 ⌫ 
434. Diphenylamine (CAS No 122 -39-4), when 
used as a fragrance ingredient ⌦ 122-39-4 ⌫ ⌦ 204-539-4 ⌫ 
435. Ethyl acrylate (CAS No 140 -88-5), when 
used as a fragrance ingredient ⌦ 140-88-5 ⌫ ⌦ 205-438-8 ⌫ 
436. 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 94   EN 438. trans -2-Hexenal diethyl acetal (CAS No 
67746 -30-9), when used as a fragrance 
ingredient ⌦ 67746-30-
9 ⌫ ⌦ 266-989-8 ⌫ 
439. trans -2-Hexenal dimethyl acetal (CAS No 
18318 -83-7), when used as a fragrance 
ingredient ⌦ 18318-83-
7 ⌫ ⌦ 242-204-4 ⌫ 
440. Hydroabietyl alc ohol (CAS No 13393 -93-
6), when used as a fragrance ingredient ⌦ 13393-93-
6 ⌫ ⌦ 236-476-3 ⌫ 
441. 6-Isopropyl-2-decahydronaphthalenol 
(CAS No 34131 -99-2), when used as a 
fragrance ingredient ⌦ 34131-99-
2 ⌫ ⌦ 251-841-7 ⌫ 
442. 7-Methoxycoumarin (CAS No 531 -59-9), 
when used as a fragrance ingredient ⌦ 531-59-9 ⌫ ⌦ 208-513-3 ⌫ 
443. 4-(4-Methoxyphenyl )-3-butene-2-one 
(CAS No 943 -88-4), when used as a 
fragrance ingredient ⌦ 943-88-4 ⌫ ⌦ 213-404-9 ⌫ 
444. 1-(4-Methoxyphenyl)-1-penten-3-one 
(CAS No 104 -27-8), when used as a 
fragrance ingredient ⌦ 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. 7-Methylcoumarin (CAS No 2445 -83-2), 
when used as a fragrance ingredient ⌦ 2445-83-2 ⌫ ⌦ 219-499-3 ⌫ 
447. 5-Methyl-2,3-hexanedione (CAS No 
13706 -86-0), when used as a fragrance 
ingredient ⌦ 13706-86-
0 ⌫ ⌦ 237-241-8 ⌫ 
448. 2-Pentylidenecyclohexanone (CAS No 
25677 -40-1), when used as a fragrance 
ingredient ⌦ 25677-40-
1 ⌫ ⌦ 247-178-8 ⌫ 
449. 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 ⌫ 
450. Verbena oil ( Lippia citriodora  Kunth.) 
(CAS No 8024 -12-2), when used as a 
fragrance ingredient ⌦ 8024-12-2 ⌫  
451. Î1Methyleugenol  (CAS No 93 -15-2) Í 
except for normal content in the natural 
essences used and provided that the    
EN 95   EN concentration does not exceed:  
(a) 0,01  % in fine fragrance  
(b) 0,004  % in eau de toilette  
(c) 0,002  % in fragrance cr eam 
(d) 0,001  % in rinse -off products  
(e) 0,0002  % in other leave -on products 
and oral hygiene products  
. 
 
Ð 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-
2 ⌫ ⌦ 234-829-6 ⌫ 
459. Tetracarbonylnickel (Cas No 13463 -39-3) ⌦ 13463-39-
3 ⌫ ⌦ 236-669-2 ⌫ 
460. Nickel sulphide (Cas No 16812 -54-7) ⌦ 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 96   EN ≥ 0,1 % w/w Butadiene 
465. Butane (Cas No 106 -97-8), if it contains 
≥ 0,1 % w/w Butadiene ⌦ 106-97-8 ⌫ ⌦ 203-448-7 ⌫ 
466. Gases (petroleum), C 3-4 (Cas No 68131 -
75-9), if they contain > 0,1 % w/w 
Butadiene ⌦ 68131-75-
9 ⌫ ⌦ 268-629-5 ⌫ 
467. Tail gas (petroleum),  catalytic cracked 
distillate and catalyt ic cracked naphtha 
fractionation absorber (Cas No 68307 -98-
2), if it contains > 0,1 % w/w Butadiene ⌦ 68307-98-
2 ⌫ ⌦ 269-617-2 ⌫ 
468. Tail gas (petroleum), catalytic polymn. 
naphtha fractionation stabiliser (Cas No 
68307 -99-3), if it contains > 0,1 % w/w 
Butadiene ⌦ 68307-99-
3 ⌫ ⌦ 269-618-8 ⌫ 
469. Tail gas (petroleum), catalytic reformed 
naphtha fractionation stabiliser, hydrogen 
sulfide-free (Cas No 68308 -00-9), if it 
contains > 0,1 % w/w Butadiene ⌦ 68308-00-
9 ⌫ ⌦ 269-619-3 ⌫ 
470. Tail gas (petroleum), cracked distillate 
hydrotreater stripper (Cas No 68308 -01-
0), if it contains > 0,1 % w/w Butadiene ⌦ 68308-01-
0 ⌫ ⌦ 269-620-9 ⌫ 
471. Tail gas (petroleum),  gas oil catalytic 
cracking absorber (Cas No 68308 -03-2), if 
it contains > 0,1 % w/w Butadiene ⌦ 68308-03-
2 ⌫ ⌦ 269-623-5 ⌫ 
472. Tail gas (petroleum),  gas recovery plant 
(Cas No 68308 -04-3), if it contains 
> 0,1 % w/w Butadiene ⌦ 68308-04-
3 ⌫ ⌦ 269-624-0 ⌫ 
473. Tail gas (petroleum),  gas recovery plant 
deethaniser (Cas No 68308 -05-4), if it 
contains > 0,1 % w/w Butadiene ⌦ 68308-05-
4 ⌫ ⌦ 269-625-6 ⌫ 
474. Tail gas (petroleum), hydrodesulfurised 
distillate and hydrodesulfurised naphtha fractionator, acid-free (Cas No 68308
-06-
5), if it contains > 0,1 % w/w Butadiene ⌦ 68308-06-
5 ⌫ ⌦ 269-626-1 ⌫ 
475. Tail gas (petroleum), hydrodesulfurised 
vacuum gas oil stripper, hydrogen sulfide-free (Cas No 68308
-07-6), if it contains 
> 0,1 % w/w Butadiene ⌦ 68308-07-
6 ⌫ ⌦ 269-627-7 ⌫ 
476.  Tail gas (petroleum), isomerised naphtha ⌦ 68308-08- ⌦ 269-628-2 ⌫  
EN 97   EN fractionation stabiliser (Cas No 68308 -08-
7), if it contains > 0,1 % w/w Butadiene 7 ⌫ 
477. Tail gas (petroleum), light straight-run 
naphtha stabiliser, hydrogen sulfide-free (Cas No 68308
-09-8), if it contains 
> 0,1 % w/w Butadiene ⌦ 68308-09-
8 ⌫ ⌦ 269-629-8 ⌫ 
478. Tail gas (petroleum), straight-run distillate 
hydrodesulferised, hydrogen sulfide-free (Cas No 68308
-10-1), if it contains 
> 0,1 % w/w Butadiene ⌦ 68308-10-
1 ⌫ ⌦ 269-630-3 ⌫ 
479. Tail gas (petroleum ), propane-propylene 
alkylation feed prep deethaniser (Cas No 
68308 -11-2), if it contains > 0,1 % w/w 
Butadiene ⌦ 68308-11-
2 ⌫ ⌦ 269-631-9 ⌫ 
480. Tail gas (petroleum), vacuum gas oil 
hydrodesulferised, hydrogen sulfide-free (Cas No 68308
-12-3), if it contains 
> 0,1 % w/w Butadiene ⌦ 68308-12-
3 ⌫ ⌦ 269-632-4 ⌫ 
481. Gases (petroleum),  catalytic cracked 
overheads (Cas No 68409 -99-4), if they 
contain > 0,1 % w/w Butadiene ⌦ 68409-99-
4 ⌫ ⌦ 270-071-2 ⌫ 
482. Alkanes, C 1-2 (Cas No 68475 -57-0), if 
they contain > 0,1 % w/w Butadiene ⌦ 68475-57-
0 ⌫ ⌦ 270-651-5 ⌫ 
483. Alkanes, C 2-3 (Cas No 68475 -58-1), if 
they contain > 0,1 % w/w Butadiene ⌦ 68475-58-
1 ⌫ ⌦ 270-652-0 ⌫ 
484. Alkanes, C 3-4 (Cas No 68475 -59-2), if 
they contain > 0,1 % w/w Butadiene ⌦ 68475-59-
2 ⌫ ⌦ 270-653-6 ⌫ 
485. Alkanes, C 4-5 (Cas No 68475 -60-5), if 
they contain > 0,1 % w/w Butadiene ⌦ 68475-60-
5 ⌫ ⌦ 270-654-1 ⌫ 
486. Fuel-gases (Cas No 68476 -26-6), if they 
contain > 0,1 % w/w Butadiene ⌦ 68476-26-
6 ⌫ ⌦ 270-667-2 ⌫ 
487. Fuel gases, crude oi l distillates (Cas No 
68476 -29-9), if they contain > 0,1 % w/w 
Butadiene ⌦ 68476-29-
9 ⌫ ⌦ 270-670-9 ⌫ 
488. Hydrocarbons, C 3-4 (Cas No 68476 -40-4), 
if they contain > 0,1 % w/w Butadiene ⌦ 68476-40-
4 ⌫ ⌦ 270-681-9 ⌫ 
489. Hydrocarbons, C 4-5 (Cas No 68476 -42-6), 
if they contain > 0,1 % w/w Butadiene ⌦ 68476-42-
6 ⌫ ⌦ 270-682-4 ⌫  
EN 98   EN 490. Hydrocarbons, C 2-4, C 3-rich (Cas No 
68476 -49-3), if they contain > 0,1 % w/w 
Butadiene ⌦ 68476-49-
3 ⌫ ⌦ 270-689-2 ⌫ 
491. Petroleum gases, liquefied (Cas No 
68476 -85-7), if they contain > 0,1 % w/w 
Butadiene ⌦ 68476-85-
7 ⌫ ⌦ 270-704-2 ⌫ 
492. Petroleum gases, liquefied, sweetened 
(Cas No 68476 -86-8), if they contain 
> 0,1 % w/w Butadiene ⌦ 68476-86-
8 ⌫ ⌦ 270-705-8 ⌫ 
493. Gases (petroleum), C 3-4, isobutane-rich 
(Cas No 68477 -33-8), if they contain 
> 0,1 % w/w Butadiene ⌦ 68477-33-
8 ⌫ ⌦ 270-724-1 ⌫ 
494. Distillates (petroleum), C 3-6, piperylene-
rich (Cas No 68477 -35-0), if they contain 
> 0,1 % w/w Butadiene ⌦ 68477-35-
0 ⌫ ⌦ 270-726-2 ⌫ 
495. Gases (petroleum), amine system feed 
(Cas No 68477 -65-6), if they contain 
> 0,1 % w/w Butadiene ⌦ 68477-65-
6 ⌫ ⌦ 270-746-1 ⌫ 
496. Gases (petroleum), benzene unit 
hydrodesulferised off (Cas No 68477 -66-
7), if they contain > 0,1 % w/w Butadiene ⌦ 68477-66-
7 ⌫ ⌦ 270-747-7 ⌫ 
497. Gases (petroleum), benzene unit recycle, 
hydrogen-rich (Cas No 68477 -67-8), if 
they contain > 0,1 % w/w Butadiene ⌦ 68477-67-
8 ⌫ ⌦ 270-748-2 ⌫ 
498. Gases (petroleum), blend oil, hydrogen-
nitrogen-rich (Cas No 68477 -68-9), ,if 
they contain > 0,1 % w/w Butadiene ⌦ 68477-68-
9 ⌫ ⌦ 270-749-8 ⌫ 
499. Gases (petroleum), butane splitter 
overheads (Cas No 6 8477 -69-0), if they 
contain > 0,1 % w/w Butadiene ⌦ 68477-69-
0 ⌫ ⌦ 270-750-3 ⌫ 
500. Gases (petroleum), C 2-3 (Cas No 68477 -
70-3), if they contain > 0,1 % w/w 
Butadiene ⌦ 68477-70-
3 ⌫ ⌦ 270-751-9 ⌫ 
501. Gases (petroleum), catalytic-cracked gas 
oil depropaniser bottoms, C 4-rich acid-free 
(Cas No 68477 -71-4), if they contain 
> 0,1 % w/w Butadiene ⌦ 68477-71-
4 ⌫ ⌦ 270-752-4 ⌫ 
502. Gases (petroleum),  catalytic-cracked 
naphtha debutaniser bottoms, C 3-5-rich ⌦ 68477-72- ⌦ 270-754-5 ⌫  
EN 99   EN (Cas No 68477 -72-5), if they contain 
> 0,1 % w/w Butadiene 5 ⌫ 
503. Gases (petroleum),  catalytic cracked 
naphtha depropaniser overhead, C 3-rich 
acid-free (Cas No 68477 -73-6), if they 
contain > 0,1 % w/w Butadiene ⌦ 68477-73-
6 ⌫ ⌦ 270-755-0 ⌫ 
504. Gases (petroleum), catalytic cracker (Cas 
No 68477 -74-7), if they contain > 0,1 % 
w/w Butadiene ⌦ 68477-74-
7 ⌫ ⌦ 270-756-6 ⌫ 
505. Gases (petroleum), catalytic cracker, C 1-5-
rich (Cas No 68477 -75-8), if they contain 
> 0,1 % w/w Butadiene ⌦ 68477-75-
8 ⌫ ⌦ 270-757-1 ⌫ 
506. Gases (petroleum), catalytic polymd. 
naphtha stabiliser overhead, C 2-4-rich (Cas 
No 68477 -76-9), if they contain > 0,1 % 
w/w Butadiene ⌦ 68477-76-
9 ⌫ ⌦ 270-758-7 ⌫ 
507. Gases (petroleum), catalytic reformed 
naphtha stripper overheads (Cas No 
68477 -77-0), if they contain > 0,1 % w/w 
Butadiene ⌦ 68477-77-
0 ⌫ ⌦ 270-759-2 ⌫ 
508. Gases (petroleum), catalytic reformer, C 1-
4-rich (Cas No 68477 -79-2), if they 
contain > 0,1 % w/w Butadiene ⌦ 68477-79-
2 ⌫ ⌦ 270-760-8 ⌫ 
509. Gases (petroleum), C 6-8 catalytic reformer 
recycle (Cas No 68477 -80-5), if they 
contain > 0,1 % w/w Butadiene ⌦ 68477-80-
5 ⌫ ⌦ 270-761-3 ⌫ 
510. Gases (petroleum), C 6-8 catalytic reformer 
(Cas No 68477 -81-6), if they contain 
> 0,1 % w/w Butadiene ⌦ 68477-81-
6 ⌫ ⌦ 270-762-9 ⌫ 
511. Gases (petroleum), C 6-8 catalytic reformer 
recycle, hydrogen-rich (Cas No 68477 -82-
7), if they contain > 0,1 % w/w Butadiene ⌦ 68477-82-
7 ⌫ ⌦ 270-763-4 ⌫ 
512. Gases (petroleum), C 3-5 olefinic-paraffinic 
alkylation feed, (Cas No 68477 -83-8), if 
they contain > 0,1 % w/w Butadiene ⌦ 68477-83-
8 ⌫ ⌦ 270-765-5 ⌫ 
513. Gases (petroleum), C 2-return stream (Cas 
No 68477 -84-9), if they contain > 0,1 % 
w/w Butadiene ⌦ 68477-84-
9 ⌫ ⌦ 270-766-0 ⌫ 
514. Gases (petroleum), C 4-rich ( Cas No ⌦ 68477-85- ⌦ 270-767-6 ⌫  
EN 100   EN 68477 -85-0), if they contain > 0,1 % w/w 
Butadiene 0 ⌫ 
515. Gases (petroleum), deethaniser overheads 
(Cas No 68477 -86-1), if they contain 
> 0,1 % w/w Butadiene ⌦ 68477-86-
1 ⌫ ⌦ 270-768-1 ⌫ 
516. Gases (petroleum), deisobutaniser tower 
overheads (Cas No 68477 -87-2), if they 
contain > 0,1 % w/w Butadiene ⌦ 68477-87-
2 ⌫ ⌦ 270-769-7 ⌫ 
517. Gases (petroleum), depropaniser dry, 
propene-rich (Cas No 68477 -90-7), if they 
contain > 0,1 % w/w Butadiene ⌦ 68477-90-
7 ⌫ ⌦ 270-772-3 ⌫ 
518. Gases (petroleum), depropaniser 
overheads (Cas No 68477 -91-8), if they 
contain > 0,1 % w/w Butadiene ⌦ 68477-91-
8 ⌫ ⌦ 270-773-9 ⌫ 
519. Gases (petroleum), dry sour, gas-concn. -
unit-off (Cas No 68477 -92-9), if they 
contain > 0,1 % w/w Butadiene ⌦ 68477-92-
9 ⌫ ⌦ 270-774-4 ⌫ 
520. Gases (petroleum), gas concn. reabsorber 
distn. (Cas No 68477 -93-0), if they 
contain > 0,1 % w/w Butadiene ⌦ 68477-93-
0 ⌫ ⌦ 270-776-5 ⌫ 
521. Gases (petroleum), gas recovery plant 
depropaniser overheads (Cas No 68477 -
94-1), if they contain > 0,1 % w/w 
Butadiene ⌦ 68477-94-
1 ⌫ ⌦ 270-777-0 ⌫ 
522. Gases (petroleum), Girbatol unit feed (Cas 
No 68477 -95-2), if they contain > 0,1 % 
w/w Butadiene ⌦ 68477-95-
2 ⌫ ⌦ 270-778-6 ⌫ 
523. Gases (petroleum), hydrogen absorber off 
(Cas No 68477 -96-3), if they contain 
> 0,1 % w/w Butadiene ⌦ 68477-96-
3 ⌫ ⌦ 270-779-1 ⌫ 
524. Gases (petroleum), hydrogen-rich (Cas No 
68477 -97-4), if they contain > 0,1 % w/w 
Butadiene ⌦ 68477-97-
4 ⌫ ⌦ 270-780-7 ⌫ 
525. Gases (petroleum), hydrotreater blend oil 
recycle, hydrogen-nitr ogen-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, C 4-rich, hydrogen sulfide-⌦ 68477-99-
6 ⌫ ⌦ 270-782-8 ⌫  
EN 101   EN free (Cas No 68477 -99-6), if they contain 
> 0,1 % w/w Butadiene 
527. Gases (petroleum), recycle, hydrogen-rich 
(Cas No 68478 -00-2), if they contain 
> 0,1 % w/w Butadiene ⌦ 68478-00-
2 ⌫ ⌦ 270-783-3 ⌫ 
528. Gases (petroleum), reformer make-up, 
hydrogen-rich, (Cas No 6847 8-01-3), if 
they contain > 0,1 % w/w Butadiene ⌦ 68478-01-
3 ⌫ ⌦ 270-784-9 ⌫ 
529. Gases (petroleum), reforming hydrotreater 
(Cas No 68478 -02-4), if they contain 
> 0,1 % w/w Butadiene ⌦ 68478-02-
4 ⌫ ⌦ 270-785-4 ⌫ 
530. Gases (petroleum), reforming 
hydrotreater, hydrogen-methane-rich (Cas 
No 68478 -03-5), if they contain > 0,1 % 
w/w Butadiene ⌦ 68478-03-
5 ⌫ ⌦ 270-787-5 ⌫ 
531. Gases (petroleum), reforming hydrotreater 
make-up, hydrogen-rich (Cas No 68478 -
04-6), if they contain > 0,1 % w/w 
Butadiene ⌦ 68478-04-
6 ⌫ ⌦ 270-788-0 ⌫ 
532. Gases (petroleum), thermal cracking 
distn., (Cas No 68478 -05-7), if they 
contain > 0,1 % w/w Butadiene ⌦ 68478-05-
7 ⌫ ⌦ 270-789-6 ⌫ 
533. Tail gas (petroleum),  catalytic cracked 
clarified oil and thermal cracked vacuum residue fractionation re flux drum (Cas No 
68478 -21-7), if it contains > 0,1 % w/w 
Butadiene ⌦ 68478-21-
7 ⌫ ⌦ 270-802-5 ⌫ 
534. Tail gas (petroleum),  catalytic cracked 
naphtha stabilisation absorber (Cas No 
68478 -22-8), if it contains > 0,1 % w/w 
Butadiene ⌦ 68478-22-
8 ⌫ ⌦ 270-803-0 ⌫ 
535. Tail gas (petroleum), catalytic cracker, 
catalytic reformer and hydrodesulferised combined fractionater (Cas No 68478
-24-
0), if it contains > 0,1 % w/w Butadiene ⌦ 68478-24-
0 ⌫ ⌦ 270-804-6 ⌫ 
536. Tail gas (petroleum), catalytic cracker 
refractionation absorber (Cas No 68478 -
25-1), if it contains > 0,1 % w/w 
Butadiene ⌦ 68478-25-
1 ⌫ ⌦ 270-805-1 ⌫ 
537.  Tail gas (petroleum),  catalytic reformed ⌦ 68478-26- ⌦ 270-806-7 ⌫  
EN 102   EN naphtha fractionation stabiliser (Cas No 
68478 -26-2), if it contains > 0,1 % w/w 
Butadiene 2 ⌫ 
538. Tail gas (petroleum), catalytic reformed 
naphtha separator (Cas No 68478 -27-3), if 
it contains > 0,1 % w/w Butadiene ⌦ 68478-27-
3 ⌫ ⌦ 270-807-2 ⌫ 
539. Tail gas (petroleum), catalytic reformed 
naphtha stabiliser, (Cas No 68478 -28-4), 
if it contains > 0,1 % w/w Butadiene ⌦ 68478-28-
4 ⌫ ⌦ 270-808-8 ⌫ 
540.  Tail gas (petroleum), cracked distillate 
hydrotreater separator (Cas No 68478 -29-
5), if it contains > 0,1 % w/w Butadiene ⌦ 68478-29-
5 ⌫ ⌦ 270-809-3 ⌫ 
541. 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 ⌫ 
542. Tail gas (petroleum), saturate gas plant 
mixed stream, C 4-rich (Cas No 68478 -32-
0), if it contains > 0,1 % w/w Butadiene ⌦ 68478-32-
0 ⌫ ⌦ 270-813-5 ⌫ 
543. Tail gas (petroleum), saturate gas recovery 
plant, C 1-2-rich (Cas No 68478 -33-1), if it 
contains > 0,1 % w/w Butadiene ⌦ 68478-33-
1 ⌫ ⌦ 270-814-0 ⌫ 
544. Tail gas (petroleum), vacuum residues 
thermal cracker, (Cas No 68478 -34-2), if 
it contains > 0,1 % w/w Butadiene ⌦ 68478-34-
2 ⌫ ⌦ 270-815-6 ⌫ 
545. Hydrocarbons, C 3-4-rich, petroleum 
distillate (Cas No 68512 -91-4), if they 
contain > 0,1 % w/w Butadiene ⌦ 68512-91-
4 ⌫ ⌦ 270-990-9 ⌫ 
546. Gases (petroleum), catalytic reformed 
straight-run naphtha st abiliser overheads, 
(Cas No 68513 -14-4), if they contain 
> 0,1 % w/w Butadiene ⌦ 68513-14-
4 ⌫ ⌦ 270-999-8 ⌫ 
547. Gases (petroleum), full-range straight-run 
naphtha dehexaniser off (Cas No 68513 -
15-5), if they contain > 0,1 % w/w 
Butadiene ⌦ 68513-15-
5 ⌫ ⌦ 271-000-8 ⌫ 
548. Gases (petroleum), hydrocracking 
depropaniser off, hydrocarbon-rich (Cas 
No 68513 -16-6), if they contain > 0,1 % 
w/w Butadiene ⌦ 68513-16-
6 ⌫ ⌦ 271-001-3 ⌫  
EN 103   EN 549. Gases (petroleum), light straight-run 
naphtha stabiliser off (Cas No 68513 -17-
7), if they contain > 0,1 % w/w Butadiene ⌦ 68513-17-
7 ⌫ ⌦ 271-002-9 ⌫ 
550. Gases (petroleum), reformer effluent high-
pressure flash drum off (Cas No 68513 -
18-8), if they contain > 0,1 % w/w 
Butadiene ⌦ 68513-18-
8 ⌫ ⌦ 271-003-4 ⌫ 
551. Gases (petroleum), reformer effluent low-
pressure flash drum off (Cas No 68513 -
19-9), if they contain > 0,1 % w/w 
Butadiene ⌦ 68513-19-
9 ⌫ ⌦ 271-005-5 ⌫ 
552. 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 ⌫ 
553. Hydrocarbons, C 1-4 (Cas No 68514 -31-8), 
if they contain > 0,1 % w/w Butadiene ⌦ 68514-31-
8 ⌫ ⌦ 271-032-2 ⌫ 
554. Hydrocarbons, C 1-4, sweetened (Cas No 
68514 -36-3) , if they contain > 0,1 % w/w 
Butadiene ⌦ 68514-36-
3 ⌫ ⌦ 271-038-5 ⌫ 
555. Gases (petroleum), oil refinery gas distn. 
off (Cas No 68527 -15-1), if they contain 
> 0,1 % w/w Butadiene ⌦ 68527-15-
1 ⌫ ⌦ 271-258-1 ⌫ 
556. Hydrocarbons, C 1-3 (Cas No 68 527-16-2), 
if they contain > 0,1 % w/w Butadiene ⌦ 68527-16-
2 ⌫ ⌦ 271-259-7 ⌫ 
557. Hydrocarbons, C 1-4, debutanizer fraction 
(Cas No 68527 -19-5), if they contain 
> 0,1 % w/w Butadiene ⌦ 68527-19-
5 ⌫ ⌦ 271-261-8 ⌫ 
558. Gases (petroleum), benzene unit 
hydrotreater depentaniser overheads (Cas 
No 68602 -82-4), if they contain > 0,1 % 
w/w Butadiene ⌦ 68602-82-
4 ⌫ ⌦ 271-623-5 ⌫ 
559. Gases (petroleum), C 1-5, wet (Cas No 
68602 -83-5), if they contain > 0,1 % w/w 
Butadiene ⌦ 68602-83-
5 ⌫ ⌦ 271-624-0 ⌫ 
560. Gases (petroleum), secondary absorber 
off, fluidised catalytic cracker overheads fractionator (Cas No 68602
-84-6), if they 
contain > 0,1 % w/w Butadiene ⌦ 68602-84-
6 ⌫ ⌦ 271-625-6 ⌫  
EN 104   EN 561. Hydrocarbons, C 2-4 (Cas No 68606 -25-7), 
if they contain > 0,1 % w/w Butadiene ⌦ 68606-25-
7 ⌫ ⌦ 271-734-9 ⌫ 
562. Hydrocarbons, C 3 (Cas No 68606 -26-8), if 
they contain > 0,1 % w/w Butadiene ⌦ 68606-26-
8 ⌫ ⌦ 271-735-4 ⌫ 
563. Gases (petroleum), alkylation feed (Cas 
No 68606 -27-9), if they contain > 0,1 % 
w/w Butadiene ⌦ 68606-27-
9 ⌫ ⌦ 271-737-5 ⌫ 
564. Gases (petroleum), depropaniser bottoms 
fractionation off (Cas No 68606 -34-8), if 
they contain > 0,1 % w/w Butadiene ⌦ 68606-34-
8 ⌫ ⌦ 271-742-2 ⌫ 
565. Petroleum products, re finery gases (Cas 
No 68607 -11-4), if they contain > 0,1 % 
w/w Butadiene ⌦ 68607-11-
4 ⌫ ⌦ 271-750-6 ⌫ 
566. Gases (petroleum), hydrocracking low-
pressure separator (Cas No 68783 -06-2), if 
they contain > 0,1 % w/w Butadiene ⌦ 68783-06-
2 ⌫ ⌦ 272-182-1 ⌫ 
567. Gases (petroleum), refinery blend (Cas No 
68783 -07-3), if they contain > 0,1 % w/w 
Butadiene ⌦ 68783-07-
3 ⌫ ⌦ 272-183-7 ⌫ 
568. Gases (petroleum), cat alytic cracking (Cas 
No 68783 -64-2), if they contain > 0,1 % 
w/w Butadiene ⌦ 68783-64-
2 ⌫ ⌦ 272-203-4 ⌫ 
569. Gases (petroleum), C 2-4, sweetened (Cas 
No 68783 -65-3), if they contain > 0,1 % 
w/w Butadiene ⌦ 68783-65-
3 ⌫ ⌦ 272-205-5 ⌫ 
570. Gases (petroleum), refinery (Cas No 
68814 -67-5), if they contain > 0,1 % w/w 
Butadiene ⌦ 68814-67-
5 ⌫ ⌦ 272-338-9 ⌫ 
571. Gases (petroleum), platformer products 
separator off (Cas No 68814 -90-4), if they 
contain > 0,1 % w/w Butadiene ⌦ 68814-90-
4 ⌫ ⌦ 272-343-6 ⌫ 
572. 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 ⌫ 
573. 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 105   EN 574. Gases (petroleum), crude oil fractionation 
off (Cas No 68918 -99-0), if they contain 
> 0,1 % w/w Butadiene ⌦ 68918-99-
0 ⌫ ⌦ 272-871-7 ⌫ 
575. Gases (petroleum), dehexaniser off (Cas 
No 68919 -00-6), if they contain > 0,1 % 
w/w Butadiene ⌦ 68919-00-
6 ⌫ ⌦ 272-872-2 ⌫ 
576. Gases (petroleum), distillate unifiner 
desulfurisation tripper off (Cas No 68919 -
01-7), if they contain > 0,1 % w/w 
Butadiene ⌦ 68919-01-
7 ⌫ ⌦ 272-873-8 ⌫ 
577. Gases (petroleum), fluidised catalytic 
cracker fractionation off (Cas No 68919 -
02-8) if they contain > 0,1 % w/w 
Butadiene ⌦ 68919-02-
8 ⌫ ⌦ 272-874-3 ⌫ 
578. Gases (petroleum), fluidised catalytic 
cracker scrubbing secondary absorber off (Cas No 68919
-03-9), if they contain 
> 0,1 % w/w Butadiene ⌦ 68919-03-
9 ⌫ ⌦ 272-875-9 ⌫ 
579. Gases (petroleum), heavy distillate 
hydrotreater desulfuris ation stripper off 
(Cas No 68919 -04-0), if they contain 
> 0,1 % w/w Butadiene ⌦ 68919-04-
0 ⌫ ⌦ 272-876-4 ⌫ 
580. Gases (petroleum), light straight run 
gasoline fractionation stabiliser off (Cas 
No 68919 -05-1), if they contain > 0,1 % 
w/w Butadiene ⌦ 68919-05-
1 ⌫ ⌦ 272-878-5 ⌫ 
581. Gases (petroleum), naphtha unifiner 
desulfurisation stripper off (Cas No 
68919 -06-2), if they contain > 0,1 % w/w 
Butadiene ⌦ 68919-06-
2 ⌫ ⌦ 272-879-0 ⌫ 
582. Gases (petroleum), platformer stabiliser 
off, light ends fractionation (Cas No 
68919 -07-3), if they contain > 0,1 % w/w 
Butadiene ⌦ 68919-07-
3 ⌫ ⌦ 272-880-6 ⌫ 
583. Gases (petroleum), preflash tower off, 
crude distn. (Cas No 68919 -08-4), if they 
contain > 0,1 % w/w Butadiene ⌦ 68919-08-
4 ⌫ ⌦ 272-881-1 ⌫ 
584. 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 106   EN 585. Gases (petroleum), straight-run stabiliser 
off (Cas No 68919 -10-8), if they contain 
> 0,1 % w/w Butadiene ⌦ 68919-10-
8 ⌫ ⌦ 272-883-2 ⌫ 
586. Gases (petroleum), tar stripper off (Cas 
No 68919 -11-9), if they contain > 0,1 % 
w/w Butadiene ⌦ 68919-11-
9 ⌫ ⌦ 272-884-8 ⌫ 
587. Gases (petroleum), unifiner stripper off 
(Cas No 68919 -12-0), if they contain 
> 0,1 % w/w Butadiene ⌦ 68919-12-
0 ⌫ ⌦ 272-885-3 ⌫ 
588. Gases (petroleum), fluidised catalytic 
cracker splitter over heads (Cas No 68919 -
20-0), if they contain > 0,1 % w/w 
Butadiene ⌦ 68919-20-
0 ⌫ ⌦ 272-893-7 ⌫ 
589. 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 ⌫ 
590. 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 ⌫ 
591. Tail gas (petroleum), catalytic 
hydrodesulfurised naphtha separator (Cas 
No 68952 -79-4), if it contains > 0,1 % 
w/w Butadiene ⌦ 68952-79-
4 ⌫ ⌦ 273-173-5 ⌫ 
592. 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 ⌫ 
593. Tail gas (petroleum), thermal-cracked 
distillate, gas oil and naphtha absorber (Cas No 68952
-81-8), if it contains 
> 0,1 % w/w Butadiene ⌦ 68952-81-
8 ⌫ ⌦ 273-175-6 ⌫ 
594. Tail gas (petroleum), thermal cracked 
hydrocarbon fractionation stabiliser, petroleum coking (Cas No 68952
-82-9), if 
it contains > 0,1 % w/w Butadiene ⌦ 68952-82-
9 ⌫ ⌦ 273-176-1 ⌫ 
595. 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 107   EN desulfuriser overhead fractionation (Cas 
No 68955 -33-9), if they contain > 0,1 % 
w/w Butadiene 9 ⌫ 
597. 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 ⌫ 
598. 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 ⌫ 
599. Hydrocarbons, C 4 (Cas No 87741 -01-3), if 
they contain > 0,1 % w/w Butadiene ⌦ 87741-01-
3 ⌫ ⌦ 289-339-5 ⌫ 
600. Alkanes, C 1-4, C 3-rich (Cas No 90622 -55-
2), if they contain > 0,1 % w/w Butadiene ⌦ 90622-55-
2 ⌫ ⌦ 292-456-4 ⌫ 
601. 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 ⌫ 
602. Gases (petroleum), gas oil 
hydrodesulfurisation effluent (Cas No 
92045 -16-4), if they contain > 0,1 % w/w 
Butadiene ⌦ 92045-16-
4 ⌫ ⌦ 295-398-8 ⌫ 
603. Gases (petroleum), gas oil 
hydrodesulfurisation purge (Cas No 
92045 -17-5), if they contain > 0,1 % w/w 
Butadiene ⌦ 92045-17-
5 ⌫ ⌦ 295-399-3 ⌫ 
604. 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 ⌫ 
605. Gases (petroleum), naphtha steam 
cracking high-pressure residual (Cas No 
92045 -19-7), if they contain > 0,1 % w/w 
Butadiene ⌦ 92045-19-
7 ⌫ ⌦ 295-401-2 ⌫ 
606. Gases (petroleum), residue visbreaking off 
(Cas No 92045 -20-0), if they contain 
> 0,1 % w/w Butadiene ⌦ 92045-20-
0 ⌫ ⌦ 295-402-8 ⌫ 
607. Gases (petroleum), steam-cracker C 3-rich 
(Cas No 92045 -22-2), if they contain 
> 0,1 % w/w Butadiene ⌦ 92045-22-
2 ⌫ ⌦ 295-404-9 ⌫ 
608. Hydrocarbons, C 4, steam-cracker distillate ⌦ 92045-23- ⌦ 295-405-4 ⌫  
EN 108   EN (Cas No 92045 -23-3), if they contain 
> 0,1 % w/w Butadiene 3 ⌫ 
609. Petroleum gases, liquefied, sweetened, C 4 
fraction (Cas No 92045 -80-2), if they 
contain > 0,1 % w/w Butadiene ⌦ 92045-80-
2 ⌫ ⌦ 295-463-0 ⌫ 
610. Hydrocarbons, C 4, 1,3-butadiene- and 
isobutene-free (Cas No 95465 -89-7), if 
they contain > 0,1 % w/w Butadiene ⌦ 95465-89-
7 ⌫ ⌦ 306-004-1 ⌫ 
611. Raffinates (petroleum), steam-cracked C 4 
fraction cuprous ammonium acetate extn. , C
3-5 and C 3-5 unsatd. , butadiene-free (Cas 
No 97722 -19-5), if they contain > 0,1 % 
w/w Butadiene ⌦ 97722-19-
5 ⌫ ⌦ 307-769-4 ⌫ 
612. Benzo[def]chrysene (=benzo[a]pyrene) 
(Cas No 50 -32-8) ⌦ 50-32-8 ⌫ ⌦ 200-028-5 ⌫ 
613. Pitch, coal tar-petroleum (Cas No 68187 -
57-5), if it contains > 0,005 % w/w 
benzo[a]pyrene ⌦ 68187-57-
5 ⌫ ⌦ 269-109-0 ⌫ 
614. Distillates (coal-petroleum), condensed-
ring arom. (Cas No 68188 -48-7), if they 
contain > 0,005 % w/w benzo[a]pyrene ⌦ 68188-48-
7 ⌫ ⌦ 269-159-3 ⌫ 
617. Creosote oil, acenaphthene fraction, 
acenaphthene-free (Cas No 90640 -85-0), 
if it contains > 0,005 % w/w benzo[a]pyrene ⌦ 90640-85-
0 ⌫ ⌦ 292-606-9 ⌫ 
618. Pitch, coal tar, low-temp. (Cas No 90669 -
57-1), if it contains > 0,005 % w/w 
benzo[a]pyrene ⌦ 90669-57-
1 ⌫ ⌦ 292-651-4 ⌫ 
619. Pitch, coal tar, lo w-temp., heat-treated 
(Cas No 90669 -58-2), if it contains 
> 0,005 % w/w benzo[a]pyrene ⌦ 90669-58-
2 ⌫ ⌦ 292-653-5 ⌫ 
620. Pitch, coal tar, low-temp., oxidised (Cas 
No 90669 -59-3), if it contains > 0,005 % 
w/w benzo[a]pyrene ⌦ 90669-59-
3 ⌫ ⌦ 292-654-0 ⌫ 
621. Extract residues (coal), brown (Cas No 
91697 -23-3), if they contain > 0,005 % 
w/w benzo[a]pyrene ⌦ 91697-23-
3 ⌫ ⌦ 294-285-0 ⌫ 
622. Paraffin waxes (coa l), brown-coal high-
temp. tar (Cas No 92045 -71-1), if they ⌦ 92045-71-
1 ⌫ ⌦ 295-454-1 ⌫  
EN 109   EN contain > 0,005 % w/w benzo[a]pyrene 
623. Paraffin waxes (coa l), brown-coal high-
temp. tar, hydrotreated (Cas No 92045 -72-
2), if they contain > 0,005 % w/w 
benzo[a]pyrene ⌦ 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 ⌫ ⌦ 295-549-8 ⌫ 
625. Pitch, coal tar, hi gh-temp. , secondary 
(Cas No 94114 -13-3), if it contains 
> 0,005 % w/w benzo[a]pyrene ⌦ 94114-13-
3 ⌫ ⌦ 302-650-3 ⌫ 
626. Residues (coal), liq. solvent extn. (Cas No  
94114 -46-2), if they contain > 0,005 % 
w/w benzo[a]pyrene ⌦ 94114-46-
2 ⌫ ⌦ 302-681-2 ⌫ 
627. Coal liquids, liq. solv ent extn. soln. (Cas 
No 94114 -47-3), if they contain > 0,005 % 
w/w benzo[a]pyrene ⌦ 94114-47-
3 ⌫ ⌦ 302-682-8 ⌫ 
628. Coal liquids, liq. solvent extn. (Cas No 
94114 -48-4), if they contain > 0,005 % 
w/w benzo[a]pyrene ⌦ 94114-48-
4 ⌫ ⌦ 302-683-3 ⌫ 
629. Paraffin waxes (coa l), brown-coal high-
temp. tar, carbon-treated (Cas No 97926 -
76-6), if they contain > 0,005 % w/w 
benzo[a]pyrene ⌦ 97926-76-
6 ⌫ ⌦ 308-296-6 ⌫ 
630. Paraffin waxes (coa l), brown-coal high-
temp tar, clay-treated (Cas No 97926 -77-
7), if they contain > 0,005 % w/w 
benzo[a]pyrene ⌦ 97926-77-
7 ⌫ ⌦ 308-297-1 ⌫ 
631. Paraffin waxes (coa l), brown-coal high-
temp tar, silicic acid-treated (Cas No 
97926 -78-8), if they contain > 0,005 % 
w/w benzo[a]pyrene ⌦ 97926-78-
8 ⌫ ⌦ 308-298-7 ⌫ 
632. Absorption oils, bicyclo arom. and 
heterocylic hydrocarbon  fraction (Cas No 
101316 -45-4), if they contain > 0,005 % 
w/w benzo[a]pyrene ⌦ 101316-45-
4 ⌫ ⌦ 309-851-5 ⌫ 
633. Aromatic hydrocarbons, C 20-28, polycyclic, 
mixed coal-tar pitch-polyethylene polypropylene pyrolysis-derived (Cas No 
101794 -74-5), if they contain > 0,005 % ⌦ 101794-74-
5 ⌫ ⌦ 309-956-6 ⌫  
EN 110   EN w/w benzo[a]pyrene 
634. Aromatic hydrocarbons, C 20-28, polycyclic, 
mixed coal-tar pitch-polyethylene pyrolysis-derived (Cas No 101794
-75-6), 
if they contain > 0,005 % w/w benzo[a]pyrene ⌦ 101794-75-
6 ⌫ ⌦ 309-957-1 ⌫ 
635. Aromatic hydrocarbons, C 20-28, polycyclic, 
mixed coal-tar pitch-polystyrene pyrolysis-derived (
Cas No 101794 -76-7), 
if they contain > 0,005 % w/w benzo[a]pyrene ⌦ 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. 1,2-Dibromo-3-chloropropane (Cas No 
96-12-8) ⌦ 96-12-8 ⌫ ⌦ 202-479-3 ⌫ 
647. 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 111   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 (Ca s 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. 1-Chloro-2,3-epoxypropane (Ca s No 106 -
89-8) ⌦ 106-89-8 ⌫ ⌦ 203-439-8 ⌫ 
658. R-1-Chloro-2,3-epoxypropane (Cas No 
51594 -55-9) ⌦ 51594-55-
9 ⌫ ⌦ 603-166-00-
8 ⌫ 
659. 1,2-Epoxy-3-phenoxypropane (Cas No 
122-60-1) ⌦ 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 ⌫ 
 
 
Ð 2007/1/EC Art. 1 and Annex pt. 
3 (adapted) 
  
663.  (2RS,3RS)-3-(2-C hlorophenyl)-2-(4-
fluorophenyl)-[1H-1,2,4-triazol-1-yl)methyl]oxirane; Ee
poxiconazole (CAS 
No 133855 -98-8) ⌦ 133855-98-
8 ⌫ ⌦ 613-175-00-
9 ⌫ 
 
 
Ð 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 112   EN 666. 2-Ethoxyethanol (Cas No 110 -80-5) ⌦ 110-80-5 ⌫ ⌦ 203-804-1 ⌫ 
667. Oxybis[chloromethane], bis 
(Chloromethyl) ether (Cas No 542 -88-1) ⌦ 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. bis(2-Methyoxyethyl) ether (Cas No 111 -
96-6) ⌦ 111-96-6 ⌫ ⌦ 203-924-4 ⌫ 
677. bis(2-Ethylhexyl) phthalate (Cas No 117 -
81-7) ⌦ 117-81-7 ⌫ ⌦ 204-211-0 ⌫ 
678. bis(2-Methoxyethyl) phthalate (Cas N o 
117-82-8) ⌦ 117-82-8 ⌫ ⌦ 204-212-6 ⌫ 
679. 2-Methoxypropyl acetate (Cas No 70657 -
70-4) ⌦ 70657-70-
4 ⌫ ⌦ 274-724-2 ⌫ 
680. 2-Ethylhexyl[[[3,5-bi s(1,1-dimethylethyl)-
4-hydroxyphenyl]-methyl]thio]acetate (Cas No 80387
-97-9) ⌦ 80387-97-
9 ⌫ ⌦ 279-452-8 ⌫ 
681. 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 113   EN 686. 4-Nitrobiphenyl (Cas No 92 -93-3) ⌦ 92-93-3 ⌫ ⌦ 202-204-7 ⌫ 
 
Ð 2005/80/EC Art. 1 and Annex 
.1(b) (adapted) 
  
687. dinitrotoluene, tech nical grade (Cas No 
121-14-2) ⌦ 121-14-2 ⌫ ⌦ 204-450-0 ⌫ 
 
 
Ð 2004/93/EC Art. 1 and Annex .2 
(adapted) 
Î1 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 (Ca s 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 114   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 (Cas No 
1116 -54-7) ⌦ 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) dianiline hydrochloride (Cas No 569
-61-9) ⌦ 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. Benzidine dihydrochloride (Cas No 531 -
85-1) ⌦ 531-85-1 ⌫ ⌦ 208-519-6 ⌫ 
714. [[1,1 ′-Biphenyl]-4,4 ′-diyl]diammonium 
sulphate (Cas No 531 -86-2) ⌦ 531-86-2 ⌫ ⌦ 208-520-1 ⌫ 
715. 3,3 ′-Dichlorobenzidine dihydrochloride 
(Cas No 612 -83-9) ⌦ 612-83-9 ⌫ ⌦ 210-323-0 ⌫ 
716. Benzidine sulphate (Cas No 21136 -70-9) ⌦ 21136-70-
9 ⌫ ⌦ 244-236-4 ⌫ 
717. Benzidine acetate (Cas No 36341 -27-2) ⌦ 36341-27-
2 ⌫ ⌦ 252-984-8 ⌫ 
718. 3,3 ′-Dichlorobenzidine dihydrogen 
bis(sulphate) (Cas No 64969 -34-2) ⌦ 64969-34-
2 ⌫ ⌦ 265-293-1 ⌫ 
719. 3,3 ′-Dichlorobenzidine sulphate (Cas No 
74332 -73-3) ⌦ 74332-73-
3 ⌫ ⌦ 277-822-3 ⌫ 
720. Benzidine based azo dyes    
EN 115   EN 721. 4,4 ′-Bi-o-toluidine (Cas No 119 -93-7) ⌦ 119-93-7 ⌫ ⌦ 204-358-0 ⌫ 
722. 4,4 ′-Bi-o-toluidine dihydrochloride (Cas 
No 612 -82-8) ⌦ 612-82-8 ⌫ ⌦ 210-322-5 ⌫ 
723. [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 sulphate (Cas No 
74753 -18-7) ⌦ 74753-18-
7 ⌫ ⌦ 277-985-0 ⌫ 
725. o-Tolu idine 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-O NN-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) ⌦ 24602-86-
6 ⌫ ⌦ 246-347-3 ⌫ 
738. Vinclozolin (Cas No 50471 -44-8) ⌦ 50471-44-
8 ⌫ ⌦ 256-599-6 ⌫ 
739. Fluazifop-butyl (Cas No 69806 -50-4) ⌦ 69806-50-
4 ⌫ ⌦ 274-125-6 ⌫ 
740. Flusilazole (Cas No 85509 -19-9) ⌦ 85509-19-
9 ⌫ ⌦ 014-017-00-
6 ⌫  
EN 116   EN 741. 1,3,5-Tris(oxiranylm ethyl)-1,3,5-triazine-
2,4,6(1 H,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. N,N-Dimethylacetamide (Cas No 127 -19-
5) ⌦ 127-19-5 ⌫ ⌦ 204-826-4 ⌫ 
748. 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 (Cas No 
13360 -57-1) ⌦ 13360-57-
1 ⌫ ⌦ 236-412-4 ⌫ 
753. Sulfallate (Cas No 95 -06-7) ⌦ 95-06-7 ⌫ ⌦ 202-388-9 ⌫ 
754. A mixture of: 4-[[bis-(4-
Fluorophenyl)methylsilyl]methyl]-4 H-
1,2,4-triazole and 1-[[bis-(4-fluorophenyl)methylsilyl]methyl]-1 H-
1,2,4-triazole (EC No 403
-250-2)  ⌦ 403-250-2 ⌫ 
755. (+/–)-Tetrahydrofurfuryl –(R)-2-[4-(6-
chloroquinoxalin-2-yloxy)phenyloxy]propionate (Cas No 
119738 -06-6) ⌦ 119738-06-
6 ⌫ ⌦ 607-373-00-
4 ⌫ 
756. 6-Hydroxy-1-(3-Isopropoxypropyl)-4-
methyl-2-oxo-5-[4-(phenylazo)phenylazo]-1,2-dihydro-3-pyridinecar bonitrile (Cas No 
85136 -74-9) ⌦ 85136-74-
9 ⌫ ⌦ 611-057-00-
1 ⌫ 
757. (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 117   EN methylethyl)ammonium] formate (Cas No 
108225 -03-2) 
758. Trisodium [4 ′-(8-acetylamino-3,6-
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)  ⌦ 413-590-3 ⌫ 
759. A mixture of: N-[3-Hydroxy-2-(2-
methylacryloylaminomethoxy)propoxymethyl]-2-methylacrylamide and N-[
2,3-bis-
(2-Methylacryloylaminomethoxy)propoxymethyl]-2-methylacrylamide and methacrylamide and 2-methyl- N-(2-
methylacryloylaminomethoxymethyl)-acrylamide and N-(2,3-
dihydroxypropoxymethyl)-2-methylacrylamide (EC No 412
-790-8)  ⌦ 412-790-8 ⌫ 
760. 1,3,5-tris-[(2 S and 2 R)-2,3-Epoxypropyl]-
1,3,5-triazine-2,4,6-(1 H,3H,5H)-trione 
(Cas No 59653 -74-6) ⌦ 59653-74-
6 ⌫ ⌦ 616-091-00-
0 ⌫ 
761. Erionite (Cas No 12510 -42-8) ⌦ 12510-42-
8 ⌫ ⌦ 650-012-00-
0 ⌫ 
762. Asbestos (Cas No 12001 -28-4) ⌦ 12001-28-
4 ⌫ ⌦ 650-013-00-
6 ⌫ 
763. Petroleum (Cas No 8002 -05-9) ⌦ 8002-05-9 ⌫ ⌦ 232-298-5 ⌫ 
764. Distillates (petroleum), heavy 
hydrocracked (Cas No 64741 -76-0), if they 
contain > 3 % w/w DMSO extract ⌦ 64741-76-
0 ⌫ ⌦ 265-077-7 ⌫ 
765. Distillates (petroleum), solvent-refined 
heavy paraffinic (Cas No 64741 -88-4), if 
they contain > 3 % w/w DMSO extract ⌦ 64741-88-
4 ⌫ ⌦ 265-090-8 ⌫ 
766. Distillates (petroleum), solvent-refined 
light paraffinic (Cas No 64741 -89-5), if 
they contain > 3 % w/w DMSO extract ⌦ 64741-89-
5 ⌫ ⌦ 265-091-3 ⌫ 
767. Residual oils (petroleum), solvent 
deasphalted (Cas No 64741 -95-3), if they 
contain > 3 % w/w DMSO extract ⌦ 64741-95-
3 ⌫ ⌦ 265-096-0 ⌫ 
768. Distillates (petroleum), solvent-refined ⌦ 64741-96- ⌦ 265-097-6 ⌫  
EN 118   EN heavy naphthenic (Cas No 64741 -96-4), if 
they contain > 3 % w/w DMSO extract 4 ⌫ 
769. Distillates (petroleum), solvent-refined 
light naphthenic (Cas No 64741 -97-5), if 
they contain > 3 % w/w DMSO extract ⌦ 64741-97-
5 ⌫ ⌦ 265-098-1 ⌫ 
770. Residual oils (petroleum), solvent-refined 
(Cas No 64742 -01-4), if they contain 
> 3 % w/w DMSO extract ⌦ 64742-01-
4 ⌫ ⌦ 265-101-6 ⌫ 
771. 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 ⌫ 
772. 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 ⌫ 
773. Residual oils (petro leum), clay-treated 
(Cas No 64742 -41-2), if they contain 
> 3 % w/w DMSO extract ⌦ 64742-41-
2 ⌫ ⌦ 265-143-5 ⌫ 
774. 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 ⌫ 
775. 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 ⌫ 
776. Distillates (petroleum ), hydrotreated heavy 
naphthenic (Cas No 64742 -52-5), if they 
contain > 3% w/w DMSO extract ⌦ 64742-52-
5 ⌫ ⌦ 265-155-0 ⌫ 
777. Distillates (petroleum ), hydrotreated light 
naphthenic (Cas No 64742 -53-6), if they 
contain > 3 % w/w DMSO extract ⌦ 64742-53-
6 ⌫ ⌦ 265-156-6 ⌫ 
778. Distillates (petroleum ), hydrotreated heavy 
paraffinic (Cas No 64742 -54-7), if they 
contain > 3 % w/w DMSO extract ⌦ 64742-54-
7 ⌫ ⌦ 265-157-1 ⌫ 
779. Distillates (petroleum ), hydrotreated light 
paraffinic (Cas No 64742 -55-8), if they 
contain > 3 % w/w DMSO extract ⌦ 64742-55-
8 ⌫ ⌦ 265-158-7 ⌫ 
780. Distillates (petrole um), solvent-dewaxed 
light paraffinic (Cas No 64742 -56-9), if 
they contain > 3 % w/w DMSO extract ⌦ 64742-56-
9 ⌫ ⌦ 265-159-2 ⌫  
EN 119   EN 781. Residual oils (petroleum), hydrotreated 
(Cas No 64742 -57-0), if they contain 
> 3 % w/w DMSO extract ⌦ 64742-57-
0 ⌫ ⌦ 265-160-8 ⌫ 
782. Residual oils (petroleum), solvent-
dewaxed, (Cas No 6 4742 -62-7), if they 
contain > 3 % w/w DMSO extract ⌦ 64742-62-
7 ⌫ ⌦ 265-166-0 ⌫ 
783. Distillates (petrole um), solvent-dewaxed 
heavy naphthenic (Cas No 64742 -63-8), if 
they contain > 3 % w/w DMSO extract ⌦ 64742-63-
8 ⌫ ⌦ 265-167-6 ⌫ 
784. Distillates (petrole um), solvent-dewaxed 
light naphthenic (Cas No 64742 -64-9), if 
they contain > 3 % w/w DMSO extract ⌦ 64742-64-
9 ⌫ ⌦ 265-168-1 ⌫ 
785. Distillates (petrole um), solvent-dewaxed 
heavy paraffinic (Cas No 64742 -65-0), if 
they contain > 3 % w/w DMSO extract ⌦ 64742-65-
0 ⌫ ⌦ 265-169-7 ⌫ 
786. Foots oil (petrole um) (Cas No 64742 -67-
2), if it contains > 3 % w/w DMSO extract ⌦ 64742-67-
2 ⌫ ⌦ 265-171-8 ⌫ 
787. Naphthenic oils (petroleum), catalytic 
dewaxed heavy (Cas No 64742 -68-3), if 
they contain > 3 % w/w DMSO extract ⌦ 64742-68-
3 ⌫ ⌦ 265-172-3 ⌫ 
788. 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 ⌫ 
789. Paraffin oils (petroleum), catalytic 
dewaxed heavy (Cas No 64742 -70-7), if 
they contain > 3 % w/w DMSO extract ⌦ 64742-70-
7 ⌫ ⌦ 265-174-4 ⌫ 
790. Paraffin oils (petroleum), catalytic 
dewaxed light (Cas No 64742 -71-8), if 
they contain > 3 % w/w DMSO extract ⌦ 64742-71-
8 ⌫ ⌦ 265-176-5 ⌫ 
791. 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 ⌫ 
792. 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 ⌫ 
793. 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 120   EN DMSO extract 
794. Extracts (petroleum), solvent-refined 
heavy paraffinic distillate solvent (Cas No 
68783 -04-0), if they contain > 3 % w/w 
DMSO extract ⌦ 68783-04-
0 ⌫ ⌦ 272-180-0 ⌫ 
795. Extracts (petroleum ), heavy paraffinic 
distillates, solvent-deasphalted (Cas No 
68814 -89-1), if they contain > 3 % w/w 
DMSO extract ⌦ 68814-89-
1 ⌫ ⌦ 272-342-0 ⌫ 
796. Lubricating oils (petroleum), C 20-50, 
hydrotreated neutral oil-based, high-viscosity (Cas No 72623
-85-9), if they 
contain > 3 % w/w DMSO extract ⌦ 72623-85-
9 ⌫ ⌦ 276-736-3 ⌫ 
797. Lubricating oils (petroleum), C 15-30, 
hydrotreated neutral oil-based (Cas No 
72623 - 86-0), if they contain > 3 % w/w 
DMSO extract ⌦ 72623- 86-
0 ⌫ ⌦ 276-737-9 ⌫ 
798. Lubricating oils (petroleum), C 20-50, 
hydrotreated neutral oil-based (Cas No 
72623 - 87-1), if they contain > 3 % w/w 
DMSO extract ⌦ 72623- 87-
1 ⌫ ⌦ 276-738-4 ⌫ 
799. Lubricating oils, (Cas No 74869 -22-0), if 
they contain > 3 % w/w DMSO extract ⌦ 74869-22-
0 ⌫ ⌦ 278-012-2 ⌫ 
800. 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 ⌫ 
801. 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 ⌫ 
802. Distillates (petroleum), solvent dewaxed 
heavy paraffinic, clay-treated (Cas No 
90640 -94-1), if they contain > 3 % w/w 
DMSO extract ⌦ 90640-94-
1 ⌫ ⌦ 292-616-3 ⌫ 
803. Hydrocarbons, C 20-50, solvent dewaxed 
heavy paraffinic, hydr otreated (Cas No 
90640 -95-2), if they contain > 3 % w/w 
DMSO extract ⌦ 90640-95-
2 ⌫ ⌦ 292-617-9 ⌫ 
804. 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 121   EN DMSO extract 
805. Distillates (petroleum), solvent dewaxed 
light paraffinic, hydr otreated (Cas No 
90640 -97-4), if they contain > 3 % w/w 
DMSO extract ⌦ 90640-97-
4 ⌫ ⌦ 292-620-5 ⌫ 
806. Extracts (petroleum ), heavy naphthenic 
distillate solvent, hydrotreated (Cas No 
90641 -07-9), if they contain > 3 % w/w 
DMSO extract ⌦ 90641-07-
9 ⌫ ⌦ 292-631-5 ⌫ 
807. Extracts (petroleum ), heavy paraffinic 
distillate solvent, hydrotreated (Cas No 
90641 -08-0), if they contain > 3 % w/w 
DMSO extract ⌦ 90641-08-
0 ⌫ ⌦ 292-632-0 ⌫ 
808. Extracts (petroleum), light paraffinic 
distillate solvent, hydrotreated (Cas No 
90641 -09-1), if they contain > 3 % w/w 
DMSO extract ⌦ 90641-09-
1 ⌫ ⌦ 292-633-6 ⌫ 
809. 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 ⌫ 
810. Residual oils (petroleum), catalytic 
dewaxed (Cas No 91770 -57-9), if they 
contain > 3 % w/w DMSO extract ⌦ 91770-57-
9 ⌫ ⌦ 294-843-3 ⌫ 
811. Distillates (petroleum), dewaxed heavy 
paraffinic, hydrotreated, (Cas No 91995 -
39-0) if they contai n > 3 % w/w DMSO 
extract ⌦ 91995-39-
0 ⌫ ⌦ 295-300-3 ⌫ 
812. Distillates (petroleum), dewaxed light 
paraffinic, hydrotreated (Cas No 91995 -
40-3), if they contain > 3 % w/w DMSO 
extract ⌦ 91995-40-
3 ⌫ ⌦ 295-301-9 ⌫ 
813. Distillates (petroleum), hydrocracked 
solvent-refined, dewaxed (Cas No 91995 -
45-8), if they contain > 3 % w/w DMSO 
extract ⌦ 91995-45-
8 ⌫ ⌦ 295-306-6 ⌫ 
814. Distillates (petroleum), solvent-refined 
light naphthenic, hydrotreated (Cas No 
91995 -54-9), if they contain > 3 % w/w 
DMSO extract ⌦ 91995-54-
9 ⌫ ⌦ 295-316-0 ⌫ 
815. Extracts (petroleum ), hydrotreated light ⌦ 91995- 73- ⌦ 295-335-4 ⌫  
EN 122   EN paraffinic distillate solvent (Cas No 91995 - 
73-2), if they contain > 3 % w/w DMSO 
extract 2 ⌫ 
816. Extracts (petroleum ), light naphthenic 
distillate solvent, hydrodesulfurised (Cas 
No 91995 -75-4), if they contain > 3 % w/w 
DMSO extract ⌦ 91995-75-
4 ⌫ ⌦ 295-338-0 ⌫ 
817. Extracts (petroleum), light paraffinic 
distillate solvent, acid-treated (Cas No 
91995 -76-5), if they contain > 3 % w/w 
DMSO extract ⌦ 91995-76-
5 ⌫ ⌦ 295-339-6 ⌫ 
818. Extracts (petroleum), light paraffinic 
distillate solvent, hydrodesulfurised (Cas 
No 91995 -77-6), if they contain > 3 % w/w 
DMSO extract ⌦ 91995-77-
6 ⌫ ⌦ 295-340-1 ⌫ 
819. Extracts (petroleum), light vacuum gas oil 
solvent, hydrotreated (Cas No 91995 -79-
8), if they contain > 3 % w/w DMSO 
extract ⌦ 91995-79-
8 ⌫ ⌦ 295-342-2 ⌫ 
820. Foots oil (petroleum), hydrotreated (Cas 
No 92045 -12-0), if it contains > 3 % w/w 
DMSO extract ⌦ 92045-12-
0 ⌫ ⌦ 295-394-6 ⌫ 
821. Lubricating oils (petroleum), C 17-35, 
solvent-extd. , dewaxed, hydrotreated (Cas 
No 92045 -42-6), if they contain > 3 % w/w 
DMSO extract ⌦ 92045-42-
6 ⌫ ⌦ 295-423-2 ⌫ 
822. Lubricating oils (pet roleum), hydrocracked 
nonarom solvent-deparaffined (Cas No 
92045 -43-7), if they contain > 3 % w/w 
DMSO extract ⌦ 92045-43-
7 ⌫ ⌦ 295-424-8 ⌫ 
823. Residual oils (petroleum), hydrocracked 
acid-treated solvent-dewaxed (Cas No 
92061 -86-4), if they contain > 3 % w/w 
DMSO extract ⌦ 92061-86-
4 ⌫ ⌦ 295-499-7 ⌫ 
824. 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 ⌫ 
825. Extracts (petroleum ), heavy paraffinic 
distillate solvent, cl ay-treated (Cas No 
92704 - 08-0), if they contain > 3 % w/w 
DMSO extract ⌦ 92704- 08-
0 ⌫ ⌦ 296-437-1 ⌫  
EN 123   EN 826. 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 ⌫ 
827. 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 ⌫ 
828. Extracts (petroleum), solvent-dewaxed 
heavy paraffinic distillate solvent, hydrodesulfurised (Cas No 93763
-11-2), if 
they contain > 3 % w/w DMSO extract ⌦ 93763-11-
2 ⌫ ⌦ 297-829-5 ⌫ 
829. Hydrocarbons, hydrocracked paraffinic 
distn. residues, solven t-dewaxed (Cas No 
93763 -38-3), if they contain > 3 % w/w 
DMSO extract ⌦ 93763-38-
3 ⌫ ⌦ 297-857-8 ⌫ 
830. Foots oil (petroleum), acid-treated (Cas No 
93924 -31-3), if it contains > 3 % w/w 
DMSO extract ⌦ 93924-31-
3 ⌫ ⌦ 300-225-7 ⌫ 
831. Foots oil (petroleum), clay-treated (Cas No 
93924 -32-4), if it contains > 3 % w/w 
DMSO extract ⌦ 93924-32-
4 ⌫ ⌦ 300-226-2 ⌫ 
832. Hydrocarbons, C 20-50, residual oil 
hydrogenation vacuum distillate (Cas No 
93924 -61-9), if they contain > 3 % w/w 
DMSO extract ⌦ 93924-61-
9 ⌫ ⌦ 300-257-1 ⌫ 
833. Distillates (petroleum), solvent-refined 
hydrotreated heavy, hydrogenated (Cas No 
94733 -08-1), if they contain > 3 % w/w 
DMSO extract ⌦ 94733-08-
1 ⌫ ⌦ 305-588-5 ⌫ 
834. Distillates (petroleum), solvent-refined 
hydrocracked light (Cas No 94733 -09-2), 
if they contain > 3 % w/w DMSO extract ⌦ 94733-09-
2 ⌫ ⌦ 305-589-0 ⌫ 
835. Lubricating oils (petroleum), C 18-40, 
solvent-dewaxed hydrocracked distillate-based (Cas No 94733
-15-0), if they contain 
> 3 % w/w DMSO extract ⌦ 94733-15-
0 ⌫ ⌦ 305-594-8 ⌫ 
836. Lubricating oils (petroleum), C 18-40, 
solvent-dewaxed hydrogenated raffinate-based (Cas No 94733
-16-1), if they contain 
> 3 % w/w DMSO extract ⌦ 94733-16-
1 ⌫ ⌦ 305-595-3 ⌫  
EN 124   EN 837. Hydrocarbons, C 13-30, arom. -rich, solvent-
extd. naphthenic dist illate (Cas No 95371 -
04-3), if they contain > 3 % w/w DMSO 
extract ⌦ 95371-04-
3 ⌫ ⌦ 305-971-7 ⌫ 
838. Hydrocarbons, C 16-32, arom. rich, solvent-
extd. naphthenic dist illate (Cas No 95371 -
05-4), if they contain > 3 % w/w DMSO 
extract ⌦ 95371-05-
4 ⌫ ⌦ 305-972-2 ⌫ 
839. Hydrocarbons, C 37-68, dewaxed 
deasphalted hydrotreated vacuum distn. Residues (Cas No 95371
-07-6), if they 
contain > 3 % w/w DMSO extract ⌦ 95371-07-
6 ⌫ ⌦ 305-974-3 ⌫ 
840. Hydrocarbons, C 37-65, hydrotreated 
deasphalted vacuum distn. Residues (Cas 
No 95371 -08-7), if they contain > 3 % w/w 
DMSO extract ⌦ 95371-08-
7 ⌫ ⌦ 305-975-9 ⌫ 
841. Distillates (petroleum), hydrocracked 
solvent-refined light (Cas No 97488 -73-8), 
if they contain > 3 % w/w DMSO extract ⌦ 97488-73-
8 ⌫ ⌦ 307-010-7 ⌫ 
842. Distillates (petroleum), solvent-refined 
hydrogenated heavy (Cas No 97488 -74-9), 
if they contain > 3 % w/w DMSO extract ⌦ 97488-74-
9 ⌫ ⌦ 307-011-2 ⌫ 
843. Lubricating oils (petroleum), C 18-27, 
hydrocracked solvent-dewaxed (Cas No 
97488 -95-4), if they contain > 3 % w/w 
DMSO extract ⌦ 97488-95-
4 ⌫ ⌦ 307-034-8 ⌫ 
844. Hydrocarbons, C 17-30, hydrotreated 
solvent-deasphalted atm. distn. residue, distn. lights (Cas No 97675
-87-1), if they 
contain > 3 % w/w DMSO extract ⌦ 97675-87-
1 ⌫ ⌦ 307-661-7 ⌫ 
845. Hydrocarbons, C 17-40, hydrotreated 
solvent-deasphalted distn. residue, vacuum distn. lights (Cas No 97722
-06-0), if they 
contain > 3 % w/w DMSO extract ⌦ 97722-06-
0 ⌫ ⌦ 307-755-8 ⌫ 
846. Hydrocarbons, C 13-27, solvent-extd. light 
naphthenic (Cas No 97722 -09-3), if they 
contain > 3 % w/w DMSO extract ⌦ 97722-09-
3 ⌫ ⌦ 307-758-4 ⌫ 
847. Hydrocarbons, C 14-29, solvent-extd. light 
naphthenic (Cas No 97722 -10-6), if they 
contain > 3 % w/w DMSO extract ⌦ 97722-10-
6 ⌫ ⌦ 307-760-5 ⌫  
EN 125   EN 848. Foots oil (petroleum ), carbon-treated (Cas 
No 97862 -76-5), if it contains > 3 % w/w 
DMSO extract ⌦ 97862-76-
5 ⌫ ⌦ 308-126-0 ⌫ 
849. 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 ⌫ 
850. Hydrocarbons, C 27-42, dearomatised (Cas 
No 97862 -81-2), if they contain > 3 % w/w 
DMSO extract ⌦ 97862-81-
2 ⌫ ⌦ 308-131-8 ⌫ 
851. Hydrocarbons, C 17-30, hydrotreated 
distillates, distn. Lights (Cas No 97862 -82-
3), if they contain > 3 % w/w DMSO 
extract ⌦ 97862-82-
3 ⌫ ⌦ 308-132-3 ⌫ 
852. Hydrocarbons, C 27-45, naphthenic vacuum 
distn. (Cas No 97862 -83-4), if they contain 
> 3 % w/w DMSO extract ⌦ 97862-83-
4 ⌫ ⌦ 308-133-9 ⌫ 
853. Hydrocarbons, C 27-45, dearomatised (Cas 
No 97926 -68-6), if they contain > 3 % w/w 
DMSO extract ⌦ 97926-68-
6 ⌫ ⌦ 308-287-7 ⌫ 
854. Hydrocarbons, C 20-58, hydrotreated (Cas 
No 9792 6-70-0), if they contain > 3 % w/w 
DMSO extract ⌦ 97926-70-
0 ⌫ ⌦ 308-289-8 ⌫ 
855. Hydrocarbons, C 27-42, naphthenic (Cas No 
97926 -71-1), if they contain > 3 % w/w 
DMSO extract ⌦ 97926-71-
1 ⌫ ⌦ 308-290-3 ⌫ 
856. Extracts (petroleum), light paraffinic 
distillate solvent, carbon-treated (Cas No 
100684 -02-4), if they contain > 3 % w/w 
DMSO extract ⌦ 100684-02-
4 ⌫ ⌦ 309-672-2 ⌫ 
857. Extracts (petroleum), light paraffinic 
distillate solvent, cl ay-treated (Cas No 
100684 - 03-5), if they contain > 3 % w/w 
DMSO extract ⌦ 100684- 03-
5 ⌫ ⌦ 309-673-8 ⌫ 
858. Extracts (petroleum), light vacuum, gas oil 
solvent, carbon-treated (Cas No 100684 -
04-6), if they contain > 3 % w/w DMSO 
extract ⌦ 100684-04-
6 ⌫ ⌦ 309-674-3 ⌫ 
859. 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 126   EN extract 
860. Residual oils (petroleum), carbon-treated 
solvent-dewaxed (Cas N o 100684 -37-5), if 
they contain > 3 % w/w DMSO extract ⌦ 100684-37-
5 ⌫ ⌦ 309-710-8 ⌫ 
861. Residual oils (petro leum), clay-treated 
solvent-dewaxed (Cas No 100684 -38-6), if 
they contain > 3 % w/w DMSO extract ⌦ 100684-38-
6 ⌫ ⌦ 309-711-3 ⌫ 
862. Lubricating oils  (petroleum), C >25, solvent-
extd., deasphalted, dewaxed, hydrogenated (Cas No 101316
-69-2), if they contain 
> 3 % w/w DMSO extract ⌦ 101316-69-
2 ⌫ ⌦ 309-874-0 ⌫ 
863. Lubricating oils (petroleum), C 17-32, 
solvent-extd. , dewaxed, hydrogenated (Cas No 101316
-70-5), if they contain 
> 3 % w/w DMSO extract ⌦ 101316-70-
5 ⌫ ⌦ 309-875-6 ⌫ 
864. Lubricating oils (petroleum), C 20-35, 
solvent-extd. , dewaxed, hydrogenated (Cas No 101316
-71-6), if they contain 
> 3 % w/w DMSO extract ⌦ 101316-71-
6 ⌫ ⌦ 309-876-1 ⌫ 
865. Lubricating oils (petroleum), C 24-50, 
solvent-extd. , dewaxed, hydrogenated (Cas No 101316
-72-7), if they contain 
> 3 % w/w DMSO extract ⌦ 101316-72-
7 ⌫ ⌦ 309-877-7 ⌫ 
866. Distillates (petrole um), sweetened middle 
(Cas No 64741 -86-2), except if the full 
refining history is known and it can be shown that the substanc e from which it is 
produced is not a carcinogen ⌦ 64741-86-
2 ⌫ ⌦ 265-088-7 ⌫ 
867. 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 ⌦ 64741-90-
8 ⌫ ⌦ 265-092-9 ⌫ 
868. Distillates (petroleum), solvent-refined 
middle (Cas No 64741 -91-9), except if the 
full refining history is  known and it can be 
shown that the substanc e from which it is 
produced is not a carcinogen ⌦ 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 127   EN the substance from which it is produced is 
not a carcinogen 
870. 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 substanc e from which it is 
produced is not a carcinogen ⌦ 64742-13-
8 ⌫ ⌦ 265-113-1 ⌫ 
871. 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 substanc e from which it is 
produced is not a carcinogen ⌦ 64742-14-
9 ⌫ ⌦ 265-114-7 ⌫ 
872. Gas oils (petroleum), chemically 
neutralised (Cas No 64742 -29-6), except if 
the full refining history is known and it can be shown that the subs tance from which it 
is produced is not a carcinogen ⌦ 64742-29-
6 ⌫ ⌦ 265-129-9 ⌫ 
873. Distillates (petroleum), chemically 
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 it is produced is not a carcinogen ⌦ 64742-30-
9 ⌫ ⌦ 265-130-4 ⌫ 
874. 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 substanc e from which it is 
produced is not a carcinogen ⌦ 64742-38-
7 ⌫ ⌦ 265-139-3 ⌫ 
875. Distillates (petro leum), hydrotreated 
middle (Cas No 64742 -46-7), except if the 
full refining history is  known and it can be 
shown that the substanc e from which it is 
produced is not a carcinogen ⌦ 64742-46-
7 ⌫ ⌦ 265-148-2 ⌫ 
876. Gas oils (petroleum), hydrodesulfurised 
(Cas No 64742 -79-6), except if the full 
refining history is known and it can be shown that the substanc e from which it is 
produced is not a carcinogen ⌦ 64742-79-
6 ⌫ ⌦ 265-182-8 ⌫ 
877. Distillates (petroleum), hydrodesulfurised 
middle (Cas No 64742 -80-9), except if the 
full refining history is  known and it can be 
shown that the substanc e from which it is ⌦ 64742-80-
9 ⌫ ⌦ 265-183-3 ⌫  
EN 128   EN produced is not a carcinogen 
878. Distillates (petroleum), catalytic reformer 
fractionator residue, hi gh-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 ⌦ 68477-29-
2 ⌫ ⌦ 270-719-4 ⌫ 
879. 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 substanc e from which it is 
produced is not a carcinogen ⌦ 68477-30-
5 ⌫ ⌦ 270-721-5 ⌫ 
880. 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 ⌦ 68477-31-
6 ⌫ ⌦ 270-722-0 ⌫ 
881. Alkanes, C 12-26-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 ⌦ 90622-53-
0 ⌫ ⌦ 292-454-3 ⌫ 
882. Distillates (petroleum), highly refined 
middle (Cas No 90640 -93-0), except if the 
full refining history is  known and it can be 
shown that the substanc e from which it is 
produced is not a carcinogen ⌦ 90640-93-
0 ⌫ ⌦ 292-615-8 ⌫ 
883. 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 it is produced is not a carcinogen ⌦ 91995-34-
5 ⌫ ⌦ 295-294-2 ⌫ 
884. Gas oils, paraffinic (Cas No 93924 -33-5), 
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 ⌦ 93924-33-
5 ⌫ ⌦ 300-227-8 ⌫ 
885. Naphtha (petroleum), solvent-refined 
hydrodesulfurised heavy (Cas No 97488 -
96-5), except if the full refining history is ⌦ 97488-96-
5 ⌫ ⌦ 307-035-3 ⌫  
EN 129   EN known and it can be shown that the 
substance from which it is produced is not a carcinogen 
886. Hydrocarbons, C 16-20, hydrotreated middle 
distillate, distn. Li ghts (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 ⌦ 97675- 85-
9 ⌫ ⌦ 307-659-6 ⌫ 
887. Hydrocarbons, C 12-20, 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 ⌦ 97675-86-
0 ⌫ ⌦ 307-660-1 ⌫ 
888. Hydrocarbons, C 11-17, solvent-extd. light 
naphthenic (Cas No 97722 -08-2), except if 
the full refining history is known and it can 
be shown that the subs tance from which it 
is produced is not a carcinogen ⌦ 97722-08-
2 ⌫ ⌦ 307-757-9 ⌫ 
889. 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 ⌦ 97862-78-
7 ⌫ ⌦ 308-128-1 ⌫ 
890. 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 subs tance from which it 
is produced is not a carcinogen ⌦ 100683-97-
4 ⌫ ⌦ 309-667-5 ⌫ 
891. Distillates (petroleum), intermediate 
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 ⌦ 100683-98-
5 ⌫ ⌦ 309-668-0 ⌫ 
892. Distillates (petroleum), intermediate 
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 ⌦ 100683-99-
6 ⌫ ⌦ 309-669-6 ⌫  
EN 130   EN 893. 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 it is produced is not a carcinogen ⌦ 74869-21-
9 ⌫ ⌦ 278-011-7 ⌫ 
894. 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 ⌦ 64742-61-
6 ⌫ ⌦ 265-165-5 ⌫ 
895. 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 ⌦ 90669-77-
5 ⌫ ⌦ 292-659-8 ⌫ 
896. 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 ⌦ 90669-78-
6 ⌫ ⌦ 292-660-3 ⌫ 
897. 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 ⌦ 92062-09-
4 ⌫ ⌦ 295-523-6 ⌫ 
898. 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 ⌦ 92062-10-
7 ⌫ ⌦ 295-524-1 ⌫ 
899. Slack wax (petroleum), low-melting, 
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 ⌦ 92062-11-
8 ⌫ ⌦ 295-525-7 ⌫ 
900. Slack wax (petroleum), low-melting, 
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 it is produced is not a carcinogen ⌦ 97863-04-
2 ⌫ ⌦ 308-155-9 ⌫ 
901. Slack wax (petroleum), low-melting, clay- ⌦ 97863-05- ⌦ 308-156-4 ⌫  
EN 131   EN treated (Cas No 97863 -05-3), except if the 
full refining history is  known and it can be 
shown that the substanc e from which it is 
produced is not a carcinogen 3 ⌫ 
902. 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 ⌦ 97863-06-
4 ⌫ ⌦ 308-158-5 ⌫ 
903. 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 substanc e from which it is 
produced is not a carcinogen ⌦ 100684-49-
9 ⌫ ⌦ 309-723-9 ⌫ 
904. Petrolatum (Cas No 8009 -03-8), except if 
the full refining history is known and it can be shown that the subs tance from which it 
is produced is not a carcinogen ⌦ 8009-03-8 ⌫ ⌦ 232-373-2 ⌫ 
905. 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 ⌦ 64743-01-
7 ⌫ ⌦ 265-206-7 ⌫ 
906. Petrolatum (petroleum), alumina-treated 
(Cas No 85029 -74-9), except if the full 
refining history is known and it can be shown that the substanc e from which it is 
produced is not a carcinogen ⌦ 85029-74-
9 ⌫ ⌦ 285-098-5 ⌫ 
907. 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 ⌦ 92045-77-
7 ⌫ ⌦ 295-459-9 ⌫ 
908. Petrolatum (petroleum), carbon-treated 
(Cas No 97862 -97-0), except if the full 
refining history is known and it can be shown that the substanc e from which it is 
produced is not a carcinogen ⌦ 97862-97-
0 ⌫ ⌦ 308-149-6 ⌫ 
909. 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 substanc e from which it is ⌦ 97862-98-
1 ⌫ ⌦ 308-150-1 ⌫  
EN 132   EN produced is not a carcinogen 
910. Petrolatum (petroleum), clay-treated (Cas 
No 100684 -33-1), except if the full 
refining history is known and it can be shown that the substanc e from which it is 
produced is not a carcinogen ⌦ 100684-33-
1 ⌫ ⌦ 309-706-6 ⌫ 
911. Distillates (petrole um), light catalytic 
cracked (Cas No 64741 -59-9) ⌦ 64741-59-
9 ⌫ ⌦ 265-060-4 ⌫ 
912. Distillates (petroleum), intermediate 
catalytic cracked (Cas No 64741 -60-2) ⌦ 64741-60-
2 ⌫ ⌦ 265-062-5 ⌫ 
913. Distillates (petroleum), light thermal 
cracked (Cas No 64741 -82-8) ⌦ 64741-82-
8 ⌫ ⌦ 265-084-5 ⌫ 
914. Distillates (petroleum), hydrodesulfurised 
light catalytic cracked (Cas No 68333 -25-
5) ⌦ 68333-25-
5 ⌫ ⌦ 269-781-5 ⌫ 
915. Distillates (petroleum ), light steam-cracked 
naphtha (Cas No 68475 -80-9) ⌦ 68475-80-
9 ⌫ ⌦ 270-662-5 ⌫ 
916. Distillates (petroleum), cracked steam-
cracked petroleum distillates (Cas No 
68477 -38-3) ⌦ 68477-38-
3 ⌫ ⌦ 270-727-8 ⌫ 
917. Gas oils (petroleum),  steam-cracked (Cas 
No 68527 -18-4) ⌦ 68527-18-
4 ⌫ ⌦ 271-260-2 ⌫ 
918. Distillates (petroleum), hydrodesulfurised 
thermal cracked middle (Cas No 85116 -
53-6) ⌦ 85116-53-
6 ⌫ ⌦ 285-505-6 ⌫ 
919. Gas oils (petroleum), thermal-cracked, 
hydrodesulfurised (Cas No 92045 -29-9) ⌦ 92045-29-
9 ⌫ ⌦ 295-411-7 ⌫ 
920. Residues (petroleum), hydrogenated 
steam-cracked naphtha (Cas No 92062 -00-
5) ⌦ 92062-00-
5 ⌫ ⌦ 295-514-7 ⌫ 
921. Residues (petroleum), steam-cracked 
naphtha distn. (Cas No 92062 -04-9) ⌦ 92062-04-
9 ⌫ ⌦ 295-517-3 ⌫ 
922. Distillates (petrole um), light catalytic 
cracked, thermally degraded (Cas No 
92201 -60-0) ⌦ 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 133   EN 924. Gas oils (petroleum), light vacuum, 
thermal-cracked hydrodesulfurised (Cas 
No 97926 -59-5) ⌦ 97926-59-
5 ⌫ ⌦ 308-278-8 ⌫ 
925. Distillates (petroleum), hydrodesulfurised 
middle coker (Cas No 101316 -59-0) ⌦ 101316-59-
0 ⌫ ⌦ 309-865-1 ⌫ 
926. Distillates (petroleum), heavy steam-
cracked (Cas No 101631 -14-5) ⌦ 101631-14-
5 ⌫ ⌦ 309-939-3 ⌫ 
927. Residues (petroleum), atm. Tower (Cas No 
64741 -45-3) ⌦ 64741-45-
3 ⌫ ⌦ 265-045-2 ⌫ 
928. Gas oils (petroleum), heavy vacuum (Cas 
No 64741 -57-7) ⌦ 64741-57-
7 ⌫ ⌦ 265-058-3 ⌫ 
929. Distillates (petrole um), heavy catalytic 
cracked (Cas No 64741 -61-3) ⌦ 64741-61-
3 ⌫ ⌦ 265-063-0 ⌫ 
930. Clarified oils (pet roleum), catalytic 
cracked (Cas No 64741 -62-4) ⌦ 64741-62-
4 ⌫ ⌦ 265-064-6 ⌫ 
931. Residues (petroleum), catalytic reformer 
fractionator (Cas No 64741 -67-9) ⌦ 64741-67-
9 ⌫ ⌦ 265-069-3 ⌫ 
932. Residues (petroleum),  hydrocracked (Cas 
No 64741 -75-9) ⌦ 64741-75-
9 ⌫ ⌦ 265-076-1 ⌫ 
933. Residues (petroleum), thermal cracked 
(Cas No 64741 -80-6) ⌦ 64741-80-
6 ⌫ ⌦ 265-081-9 ⌫ 
934. Distillates (petroleum), heavy thermal 
cracked (Cas No 64741 -81-7) ⌦ 64741-81-
7 ⌫ ⌦ 265-082-4 ⌫ 
935. Gas oils (petroleum), hydrotreated vacuum 
(Cas No 64742 -59-2) ⌦ 64742-59-
2 ⌫ ⌦ 265-162-9 ⌫ 
936. Residues (petroleum), hydrodesulfurised 
atmospheric tower (Cas No 64742 -78-5) ⌦ 64742-78-
5 ⌫ ⌦ 265-181-2 ⌫ 
937. Gas oils (petroleum), hydrodesulfurised 
heavy vacuum (Cas No 64742 -86-5) ⌦ 64742-86-
5 ⌫ ⌦ 265-189-6 ⌫ 
938. Residues (petroleum), steam-cracked (Cas 
No 647 42-90-1) ⌦ 64742-90-
1 ⌫ ⌦ 265-193-8 ⌫ 
939. Residues (petroleum), atmospheric (Cas 
No 68333 -22-2) ⌦ 68333-22-
2 ⌫ ⌦ 269-777-3 ⌫ 
940. Clarified oils (petroleum), 
hydrodesulfurised catalytic cracked (Cas ⌦ 68333-26-
6 ⌫ ⌦ 269-782-0 ⌫  
EN 134   EN No 68333 -26-6) 
941. Distillates (petroleum), hydrodesulfurised 
intermediate catalytic cracked (Cas No 
68333 -27-7) ⌦ 68333-27-
7 ⌫ ⌦ 269-783-6 ⌫ 
942. 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) ⌦ 68476-33-
5 ⌫ ⌦ 270-675-6 ⌫ 
945. Residues (petroleum), catalytic reformer 
fractionator residue distn. (Cas No 68478 -
13-7) ⌦ 68478-13-
7 ⌫ ⌦ 270-792-2 ⌫ 
946. Residues (petroleum), heavy coker gas oil 
and vacuum gas oil (Cas No 68478 -17-1) ⌦ 68478-17-
1 ⌫ ⌦ 270-796-4 ⌫ 
947. Residues (petroleum), heavy coker and 
light vacuum (Cas No 68512 -61-8) ⌦ 68512-61-
8 ⌫ ⌦ 270-983-0 ⌫ 
948. Residues (petroleum), light vacuum (Cas 
No 68512 -62-9) ⌦ 68512-62-
9 ⌫ ⌦ 270-984-6 ⌫ 
949. Residues (petroleum), steam-cracked light 
(Cas No 6851 3-69-9) ⌦ 68513-69-
9 ⌫ ⌦ 271-013-9 ⌫ 
950. Fuel oil, No 6 (Cas No 68553 -00-4) ⌦ 68553-00-
4 ⌫ ⌦ 271-384-7 ⌫ 
951. Residues (petroleum), topping plant, low-
sulfur (Cas No 68607 -30-7) ⌦ 68607-30-
7 ⌫ ⌦ 271-763-7 ⌫ 
952. Gas oils (petroleum), heavy atmospheric 
(Cas No 68783 -08-4) ⌦ 68783-08-
4 ⌫ ⌦ 272-184-2 ⌫ 
953. Residues (petroleum), coker scrubber, 
condensed-ring-arom. -contg (Cas No 
68783 -13-1) ⌦ 68783-13-
1 ⌫ ⌦ 272-187-9 ⌫ 
954. Distillates (petroleum), petroleum residues 
vacuum (Cas No 68955 -27-1) ⌦ 68955-27-
1 ⌫ ⌦ 273-263-4 ⌫ 
955. Residues (petroleum), steam-cracked, 
resinous (Cas No 68955 -36-2) ⌦ 68955-36-
2 ⌫ ⌦ 273-272-3 ⌫  
EN 135   EN 956. Distillates (petroleum), intermediate 
vacuum (Cas No 70592 -76-6) ⌦ 70592-76-
6 ⌫ ⌦ 274-683-0 ⌫ 
957. Distillates (petroleum ), light vacuum (Cas 
No 70592 -77-7) ⌦ 70592-77-
7 ⌫ ⌦ 274-684-6 ⌫ 
958. Distillates (petroleum), vacuum (Cas No 
70592 -78-8) ⌦ 70592-78-
8 ⌫ ⌦ 274-685-1 ⌫ 
959. Gas oils (petroleum), hydrodesulfurised 
coker heavy vacuum (Cas No 85117 -03-9) ⌦ 85117-03-
9 ⌫ ⌦ 285-555-9 ⌫ 
960. Residues (petroleum), steam-cracked, 
distillates (Cas No 90669 -75-3) ⌦ 90669-75-
3 ⌫ ⌦ 292-657-7 ⌫ 
961. Residues (petroleum), vacuum, light (Cas 
No 90669 -76-4) ⌦ 90669-76-
4 ⌫ ⌦ 292-658-2 ⌫ 
962. Fuel oil, heavy, high-sulfur (Cas No 
92045 -14-2) ⌦ 92045-14-
2 ⌫ ⌦ 295-396-7 ⌫ 
963. Residues (petroleum), catalytic cracking 
(Cas No 92061 -97-7) ⌦ 92061-97-
7 ⌫ ⌦ 295-511-0 ⌫ 
964. Distillates (petroleum), intermediate 
catalytic cracked, thermally degraded (Cas 
No 92201 -59-7) ⌦ 92201-59-
7 ⌫ ⌦ 295-990-6 ⌫ 
965. Residual oils (petroleum) (Cas No 93821 -
66-0) ⌦ 93821-66-
0 ⌫ ⌦ 298-754-0 ⌫ 
966. Residues, steam cracked, thermally treated 
(Cas No 98219 -64-8) ⌦ 98219-64-
8 ⌫ ⌦ 308-733-0 ⌫ 
967. Distillates (petroleum), hydrodesulfurised 
full-range middle (Cas No 101316 -57-8) ⌦ 101316-57-
8 ⌫ ⌦ 309-863-0 ⌫ 
968. Distillates (petrole um), light paraffinic 
(Cas No 64741 -50-0) ⌦ 64741-50-
0 ⌫ ⌦ 265-051-5 ⌫ 
969. Distillates (petroleum), heavy paraffinic 
(Cas No 64741 -51-1) ⌦ 64741-51-
1 ⌫ ⌦ 265-052-0 ⌫ 
970. Distillates (petroleum), light naphthenic 
(Cas No 64741 -52-2) ⌦ 64741-52-
2 ⌫ ⌦ 265-053-6 ⌫ 
971. Distillates (petroleum), heavy naphthenic 
(Cas No 64741 -53-3) ⌦ 64741-53-
3 ⌫ ⌦ 265-054-1 ⌫ 
972. Distillates (petroleum), acid-treated heavy 
naphthenic (Cas No 64742 -18-3) ⌦ 64742-18-
3 ⌫ ⌦ 265-117-3 ⌫  
EN 136   EN 973. Distillates (petroleum ), acid-treated light 
naphthenic (Cas No 64742 -19-4) ⌦ 64742-19-
4 ⌫ ⌦ 265-118-9 ⌫ 
974. Distillates (petroleum), acid-treated heavy 
paraffinic (Cas No 64742 -20-7) ⌦ 64742-20-
7 ⌫ ⌦ 265-119-4 ⌫ 
975. Distillates (petroleum ), acid-treated light 
paraffinic (Cas No 64742 -21-8) ⌦ 64742-21-
8 ⌫ ⌦ 265-121-5 ⌫ 
976. Distillates (petroleum), chemically 
neutralised heavy pa raffinic (Cas No 
64742 -27-4) ⌦ 64742-27-
4 ⌫ ⌦ 265-127-8 ⌫ 
977. Distillates (petroleum), chemically 
neutralised light pa raffinic (Cas No 64742 -
28-5) ⌦ 64742-28-
5 ⌫ ⌦ 265-128-3 ⌫ 
978. Distillates (petroleum), chemically 
neutralised heavy naphthenic (Cas No 
64742 -34-3) ⌦ 64742-34-
3 ⌫ ⌦ 265-135-1 ⌫ 
979. Distillates (petroleum), chemically 
neutralised light na phthenic (Cas No 
64742 -35-4) ⌦ 64742-35-
4 ⌫ ⌦ 265-136-7 ⌫ 
980. Extracts (petroleum ), light naphthenic 
distillate solvent (Cas No 64742 -03-6) ⌦ 64742-03-
6 ⌫ ⌦ 265-102-1 ⌫ 
981. Extracts (petroleum ), heavy paraffinic 
distillate solvent (Cas No 64742 -04-7) ⌦ 64742-04-
7 ⌫ ⌦ 265-103-7 ⌫ 
982. Extracts (petroleum), light paraffinic 
distillate solvent (Cas No 64742 -05-8) ⌦ 64742-05-
8 ⌫ ⌦ 265-104-2 ⌫ 
983. Extracts (petroleum ), heavy naphthenic 
distillate solvent (Cas No 64742 -11-6) ⌦ 64742-11-
6 ⌫ ⌦ 265-111-0 ⌫ 
984. Extracts (petroleum), light vacuum gas oil 
solvent (Cas No 91995 -78-7) ⌦ 91995-78-
7 ⌫ ⌦ 295-341-7 ⌫ 
985. Hydrocarbons, C 26-55, arom. rich (Cas No 
97722 -04-8) ⌦ 97722-04-
8 ⌫ ⌦ 307-753-7 ⌫ 
986. Disodium 3,3 ′-[[1,1′-biphenyl]-4,4 ′-
diylbis(azo)] bis(4- aminonaphthalene-1- 
sulphonate) (Cas No 573 -58-0) ⌦ 573-58-0 ⌫ ⌦ 209-358-4 ⌫ 
987. Disodium 4-amino-3-[[4 ′-[(2,4-
diaminophenyl)azo] [1,1 ′-biphenyl]-4-
yl]azo]-5-hydroxy-6-(phenylazo)naphthalene-2,7-disulphonate ⌦ 1937-37-7 ⌫ ⌦ 217-710-3 ⌫  
EN 137   EN (Cas No 1937 -37-7) 
988. Tetrasodium 3,3 ′-[[1,1′-biphenyl]-4,4 ′-
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 (Ca s 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. (+/–)-2-(2,4-Dichlorophenyl)-3-(1 H-1,2,4-
triazol-1-yl)propyl-1,1,2,2-tetrafluoroethylether (Cas No 112281
-77-
3) ⌦ 112281-77-
3 ⌫ ⌦ 613-174-00-
3 ⌫ 
1002. 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 ⌫ 
1003. 5,6,12,13-Tetrachloroanthra(2,1,9-
def:6,5,10- d’e’f’ )diisoquinoline-
1,3,8,10(2 H,9H)-tetrone (Cas No 115662 -
06-1) ⌦ 115662-06-
1 ⌫ ⌦ 616-066-00-
4 ⌫  
EN 138   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-
7 ⌫ ⌦ 235-008-5 ⌫ 
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 (Cas No 
125051 -32-3) ⌦ 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-
1) ⌦ 1314-62-1 ⌫ ⌦ 215-239-8 ⌫ 
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 131 71-21-6) ⌦ 13171-21-
6 ⌫ ⌦ 236-116-5 ⌫ 
1014. N-(Trichloromethylthio)phthalimide (Cas 
No 133 -07-3) ⌦ 133-07-3 ⌫ ⌦ 205-088-6 ⌫ 
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-
0 ⌫ ⌦ 607-310-00-
0 ⌫  
EN 139   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) ⌦ 15972-60-
8 ⌫ ⌦ 240-110-8 ⌫ 
1029. UVCB condensation product of: tetrakis-
hydroxymethylphosphonium chloride, urea and distilled hydrogenated C
16-18 tallow 
alkylamine (Cas No 166242 -53-1) ⌦ 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-hydroxy benzonitrile (Cas 
No 1689 -84-5) ⌦ 1689-84-5 ⌫ ⌦ 216-882-7 ⌫ 
1032. 2,6-Dibromo-4-cyanophenyl octanoate 
(Cas No 1689 -99-2) ⌦ 1689-99-2 ⌫ ⌦ 216-885-3 ⌫ 
1033. [4-[[4-(Dimethylamino)phenyl][4-[ethyl(3-
sulphonatobenzyl)amino]phenyl]methylene]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-2 H-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 140   EN 5 ⌫ 0 ⌫ 
1040. [(p-Tolyloxy)methyl]oxirane (Cas No 
2186 -24-5) ⌦ 2186-24-5 ⌫ ⌦ 218-574-8 ⌫ 
1041. [(m-Tolyloxy)methyl]oxirane (Cas No 
2186 -25-6) ⌦ 2186-25-6 ⌫ ⌦ 218-575-3 ⌫ 
1042. 2,3-Epoxypropyl o-toly l 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-
8 ⌫ ⌦ 245-740-7 ⌫ 
1048. Dodecachloropentacyclo[5.2.1. 02,6. 
03,905,8]decane (Cas No 2385 -85-5) ⌦ 2385-85-5 ⌫ ⌦ 219-196-6 ⌫ 
1049. Propyzamide (C as No 23950 -58-5) ⌦ 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 (-)-(1 R,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 141   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) ⌦ 36734-19-
7 ⌫ ⌦ 253-178-9 ⌫ 
1063. 4-Cyano-2,6-diiodophenyl octanoate (Cas 
No 3861 -47-0) ⌦ 3861-47-0 ⌫ ⌦ 223-375-4 ⌫ 
1064. 5-(2,4-Dioxo-1,2,3,4-
tetrahydropyrimidine)-3-fluro-2-hydroxymethylterahydrofuran (Cas No 
41107 -56-6) ⌦ 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-(1 H)-
ammonium N-ethoxycarbonyl- N-(p-
olylsulfonyl)azanide (EC No 418 -350-1)  ⌦ 418-350-1 ⌫ 
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-
0) ⌦ 540-25-0 ⌫ ⌦ 208-741-3 ⌫ 
1071. 2-(4-tert-Butylphenyl)ethanol (Cas No 
5406 -86-0) ⌦ 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 142   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 bromide 
(Cas No 65756 -41-4) ⌦ 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 ⌦ 68334-30-
5 ⌫ ⌦ 269-822-7 ⌫ 
1087. Fuel oil, no. 2 (Cas No 68476 -30-2) ⌦ 68476-30-
2 ⌫ ⌦ 270-671-4 ⌫ 
1088. Fuel oil, no. 4 (Cas No 68476 -31-3) ⌦ 68476-31-
3 ⌫ ⌦ 270-673-5 ⌫ 
1089. Fuels, diesel, no. 2 (Cas No 68476 -34-6) ⌦ 68476-34-
6 ⌫ ⌦ 270-676-1 ⌫ 
1090. 2,2-Dibromo-2-nitroe thanol (Cas No 
69094 -18-4) ⌦ 69094-18-
4 ⌫ ⌦ 609-056-00-
6 ⌫ 
1091. 1-Ethyl-1-methylpyrrolidinium bromide 
(Cas No 69227 -51-6) ⌦ 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 143   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-1 H-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. Î1 CI. Solvent y Yellow 14 (CAS No 842 -
07-9) Í ⌦ 842-07-9 ⌫ ⌦ 212-668-2 ⌫ 
1108. Chlozolinate (Cas No 84332 -86-5) ⌦ 84332-86-
5 ⌫ ⌦ 282-714-4 ⌫ 
1109. Alkanes, C 10-13, chloro (Cas No 85535 -84-
8) ⌦ 85535-84-
8 ⌫ ⌦ 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-
8) ⌦ 88-10-8 ⌫ ⌦ 201-798-5 ⌫ 
1113. 1-Vinyl-2-pyrrolidone (Cas No 88 -12-0) ⌦ 88-12-0 ⌫ ⌦ 201-800-4 ⌫ 
1114. Myclobutanil; 2-(4-chlorophenyl)-2-(1 H-
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 (Ca s No 90 -41-5) ⌦ 90-41-5 ⌫ ⌦ 201-990-9 ⌫  
EN 144   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) ⌦ 26471-62-
5 ⌫ ⌦ 247-722-4 ⌫ 
1121. Fuels, jet aircraft, coal solvent extn. , 
hydrocracked hydrogenated (Cas No 
94114 -58-6) ⌦ 94114-58-
6 ⌫ ⌦ 302-694-3 ⌫ 
1122. Fuels, diesel, coal solvent extn. , 
hydrocracked hydrogenated (Cas No 
94114 -59-7) ⌦ 94114-59-
7 ⌫ ⌦ 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, C 16-20, 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. Î1 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 (Na
2O + K 2O + CaO + 
MgO + BaO) content greater than 18 % by weight] Í   
1128. Î1 Reaction product of acetophenone, 
formaldehyde, cyclohexylamine, methanol and acetic acid (EC No 406
-230-1) Í  ⌦ 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  ⌦ 602-042-00-
0 ⌫ 
1131. Î1 Trisodium bis(7-acetamido-2-(4-nitro-  ⌦ 400-810-8 ⌫  
EN 145   EN 2-oxidophenylazo)-3-sulfonato-1-
naphtholato)chromate(1-) (EC No  400-
810-8 ) Í 
1132. Î1 A mixture of: 4-allyl-2,6-bis(2,3-
epoxypropyl)phenol, 4-allyl-6-(3-(6-(3-(6-(3-(4-allyl-2,6-bi s(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 (EC No 417
-470-
1) Í  ⌦ 417-470-1 ⌫ 
 
Ð 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 ⌫ 
 
Ð 2005/80/EC Art. 1 and Annex 
.1(c) (adapted) 
Î1 2006/65/EC Art. 1 and Annex 
.1 
Î2 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 146   EN (2-methyl-1,3-butadiene) 
1139 1-bromopropane 
n-propyl bromide 106-94-5  ⌦ 203-445-0 ⌫ 
1140 chloroprene (stabilized) 
(2-chlorobuta-1,3-diene) 126-99-8 ⌦ 204-818-0 ⌫ 
1141 1,2,3-trichloropropane 96-18-4  ⌦ 202-486-1 ⌫ 
1142 ethylene glycol dimethyl ether 
(EGDME) 110-71-4  ⌦ 203-794-9 ⌫ 
1143 dinocap (ISO) 39300-45-3  ⌦ 254-408-0 ⌫ 
1144 diaminotoluene, technical product -mixture 
of [4-methyl- 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; octabr omo derivate 32536-52-0 ⌦ 251-087-9 ⌫ 
1147 1,2-bis(2-methoxyethoxy)ethane 
triethylene glycol dimethyl ether 
(TEGDME) 112-49-2  ⌦ 203-977-3 ⌫ 
1148 tetrahydrothiopyran-3-c arboxaldehyde 61571-06-0   
1149 4,4 ′-bis(dimethylamino)benzophenone 
(Michler's ketone) 90-94-8  ⌦ 202-027-5 ⌫ 
1150 oxiranemethanol, 4-methylbenzene-
sulfonate, (S)- 70987-78-9   
1,2-benzenedicarboxylic acid, 
dipentylester, branched and linear [1] 84777-06-0 [1]  ⌦ 284-032-2 ⌫ 
n-pentyl-isopentylphthalate [2]  -[2]   
di-n-pentyl phthalate [3] 131-18-0 [3]  ⌦ 205-017-9 ⌫ 1151 
diisopentylphthalate [4] 605-50-5 [4]  ⌦ 210-088-4 ⌫ 
                                                 
36 for the individual ingredient see reference number 364 in Annex II. 
37 for the individual ingredient see reference number 413 in Annex II.  
EN 147   EN 1152 benzyl butyl phthalate (BBP) 85-68-7  ⌦ 201-622-7 ⌫ 
1153 1,2-benzenedicarboxylic acid di-C 7-11, 
branched and linear alkylesters 68515-42-4  ⌦ 271-084-6 ⌫ 
1154 a mixture of: disodium 4-(3-
ethoxycarbonyl-4-(5-(3-ethoxycarbonyl-5-hydroxy-1-(4-sulfonatophenyl) pyrazol-4-yl)penta-2,4-dieny lidene)-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  ⌦ EC No 402-
660-9 ⌫ 
1155 (methylenebis(4,1-phenylenazo(1-(3-
(dimethylamino)propyl)-1,2-dihydro-6-hydroxy-4-methyl-2-oxopyridine-5,3-diyl)))-1,1 ′-dipyridinium dichloride 
dihydrochloride  ⌦ EC No 401-
500-5 ⌫ 
1156 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 420-
580-2 ⌫ 
1157 azafenidin 68049-83-2   
2,4,5-trimethylaniline [1] 137-17-7 [1]  ⌦ 205-282-0 ⌫ 1158 
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 
(p-cresidine) 120-71-8 ⌦ 204-419-1 ⌫ 
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 148   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 ⌫ 
nonylphenol [1] 25154-52-3 [1] ⌦ 246-672-0 ⌫ 1168 
4-nonylphenol, branched [2] 84852-15-3 [2] ⌦ 284-325-5 ⌫ 
1169 1,1,2-trichloroethane 79-00-5 ⌦ 201-166-9 ⌫ 
1170  pentachloroethane  76 -01-7 200 -925-1  
1171 vinylidene chloride 
(1,1-dichloroethylene) 75-35-4 ⌦ 200-864-0 ⌫ 
1172 allyl chloride 
(3-chloropropene) 107-05-1 ⌦ 203-457-6 ⌫ 
1173 1,4-dichlorobenzene 
(p-dichlorobenzene) 106-46-7 ⌦ 203-400-5 ⌫ 
1174 bis(2-chloroethyl) ether 111-44-4 ⌦ 203-870-1 ⌫ 
1175 Phenol 108-95-2 ⌦ 203-632-7 ⌫ 
1176 bisphenol A 
(4,4′-isopropylidenediphenol) 80-05-7 ⌦ 201-245-8 ⌫ 
1177 trioxymethylene 
(1,3,5-trioxan) 110-88-3 ⌦ 203-812-5 ⌫ 
1178 propargite (ISO) 2312-35-8 ⌦ 219-006-1 ⌫ 
1179 1-chloro-4-nitrobenzene 100-00-5 ⌦ 202-809-6 ⌫ 
1180 molinate (ISO) 2212-67-1 ⌦ 218-661-0 ⌫ 
1181 fenpropimorph 67564-91-4 ⌦ 266-719-9 ⌫  
EN 149   EN 1183 methyl isocyanate 624-83-9 ⌦ 210-866-3 ⌫ 
1184 N,N-dimethylanilinium 
tetrakis(pentafluorophenyl)borate 118612-00-3  
1185 O,O ′-(ethenylmethylsilylene) di[(4-
methylpentan-2-one) oxime] EC No 421 -870-1 ⌦ 421-870-1 ⌫ 
1186 a 2:1 mixture of: 4-(7-hydroxy-2,4,4-
trimethyl-2-chromanyl)resorcinol-4-yl-tris(6-diazo-5,6-di hydro-5-oxonaphthalen-
1-sulfonate) and 4-(7-hydroxy-2,4,4-trimethyl-2-chromanyl)resorcinolbis(6-diazo-5,6-dihydro-5-oxonaphthalen-1-sulfonate) 140698-96-0  
1187 a mixture of: reaction product of 4,4 ′-
methylenebis[2-(4-hydroxybenzyl)-3,6-dimethylphenol] and 6-diazo-5,6-dihydro-5-oxo-naphthalenesulfonate (1:2) and reaction product of 4,4 ′-methylenebis[2-(4-
hydroxybenzyl)-3,6-dimethylphenol] and 6-diazo-5,6-dihydro-5-oxonaphthalenesulfonate (1:3) EC No 417
-980-4 ⌦ 417-980-4 ⌫ 
malachite green hydrochloride [1] 569-64-2 [1] ⌦ 209-322-8 ⌫ 1188 
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 163879-69-4  
1194 2-{4-(2-ammoniopropylamino)-6-[4-
hydroxy-3-(5-methyl-2-methoxy-4-sulfamoylphenylazo)-2-sulfonatonaphth-7-EC No 424
-260-3 ⌦ 424-260-3 ⌫  
EN 150   EN ylamino]-1,3,5-triazin-2-ylamino}-2-
aminopropyl formate 
5-nitro- o-toluidine [1] 99-55-8 [1] ⌦ 202-765-8 ⌫ 1195 
5-nitro- o-toluidine hydrochlo ride [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-
dimethylurea) 15545-48-9 ⌦ 239-592-2 ⌫ 
1201 N-[2-(3-acetyl-5-nitrothiophen-2-ylazo)-5-
diethylaminophenyl] acetamide EC No 416 -860-9 ⌦ 416-860-9 ⌫ 
1202 1,3-bis(vinylsulfonylacet amido)-propane 93629-90-4 ⌦ 616-142-00-
7 ⌫ 
1203 p-phenetidine (4-ethoxyaniline) 156-43-4 ⌦ 205-855-5 ⌫ 
1204 m-phenylenediamine and its salts 108-45-2 ⌦ 203-584-7 ⌫ 
1205 residues (coal tar), creosote oil distn., if it 
contains > 0,005 % w/w benzo[a]pyrene 92061-93-3 ⌦ 295-506-3 ⌫ 
1206 creosote oil, acenaphthene fraction, wash 
oil, if it contains > 0,005 % w/w benzo[a]pyrene 90640-84-9 ⌦ 292-605-3 ⌫ 
1207 creosote oil, if it contains > 0,005 % w/w 
benzo[a]pyrene 61789-28-4 ⌦ 263-047-8 ⌫ 
1208 creosote, if it contains > 0,005 % w/w 
benzo[a]pyrene 8001-58-9 ⌦ 232-287-5 ⌫ 
1209 creosote oil, high-boi ling distillate, wash 
oil, if it contains > 0,005 % w/w benzo[a]pyrene 70321-79-8 ⌦ 274-565-9 ⌫ 
1210 extract residues (coal), creosote oil acid, 
wash oil extract residue, if it contains > 0,005 % w/w benzo[a]pyrene 122384-77-4 ⌦ 310-189-4 ⌫ 
1211 creosote oil, low-boiling distillate, wash 
oil, if it contains > 0,005 % w/w 70321-80-1 ⌦ 274-566-4 ⌫  
EN 151   EN benzo[a]pyrene 
Î1 1
212 
Í Î1 6-Methoxy-2,3-Pyridinediamine and 
its HCl salt, when used as a substance in hair dye products Í   
Î1 1
213 
Í Î1 2,3-Naphthalenediol, when used as a 
substance in hair dye products Í   
Î1 1
214 
Í Î1 2,4-Diaminodiphenylamine, when 
used as a substance in hair dye products Í   
Î1 1
215 
Í Î1 2,6-Bis(2-Hydroxyethoxy)-3,5-
Pyridinediamine and its HCl salt, when used as a substance in hair dye products Í   
Î1 1
216 
Í Î1 2-Methoxymethyl- p-Aminophenol and 
its HCl salt, when used as a substance in hair dye products Í   
Î1 1
217 
Í Î1 4,5-Diamino-1-Methylpyrazole and its 
HCl salt, when used as a substance in hair dye products Í   
Î1 1
218 
Í Î1 4,5-Diamino-1-((4-
Chlorophenyl)Methyl)-1H-Pyrazole Sulfate, when used as a substance in hair dye products Í   
Î1 1
219 
Í Î1 4-Chloro-2-Aminophenol, when used 
as a substance in hair dye products Í   
Î1 1
220 
Í Î1 4-Hydroxyindole, when used as a 
substance in hair dye products Í   
Î1 1
221 
Í Î1 4-Methoxytoluene-2,5-Diamine and its 
HCl salt, when used as a substance in hair dye products Í   
Î1 1
222 
Í Î1 5-Amino-4-Fluoro-2-Methylphenol 
Sulfate, when used as a substance in hair dye products Í   
Î1 1
223 
Í Î1 N,N-Diethyl- m-Aminophenol, when 
used as a substance in hair dye products Í    
EN 152   EN Î1 1
224 
Í Î1 N,N-Dimethyl-2,6-Pyridinediamine 
and its HCl salt, when used as a substance in hair dye products Í   
Î1 1
225 
Í Î1 N-Cyclopentyl- m-Aminophenol, when 
used as a substance in hair dye products Í   
Î1 1
226 
Í Î1 N-(2-Methoxyethyl)- p-
phenylenediamine and its HCl salt, when used as a substance in hair dye products Í   
Î1 1
227 
Í Î1 2,4-Diamino-5-methylphenetol and its 
HCl salt, when used as a substance in hair dye products Í   
Î1 1
228 
Í Î1 1,7-Naphthalenediol, when used as a 
substance in hair dye products Í   
Î1 1
229 
Í Î1 3,4-Diaminobenzoic acid, when used 
as a substance in hair dye products Í   
Î1 1
230 
Í Î1 2-Aminomethyl- p-aminophenol and its 
HCl salt, when used as a substance in hair dye products Í   
Î1 1
231 
Í Î1 Solvent Red 1 (CI 12150), when used 
as a substance in hair dye products Í   
Î1 1
232 
Í Î1 Acid Orange 24 (CI 20170), when 
used as a substance in hair dye products Í   
Î1 1
233 
Í Î1 Acid Red 73 (CI 27290), when used as 
a substance in hair dye products Í   
Î2 1
234 
Í Î2 PEG-3,2′,2′-di-p-Phenylenediamine Í   
Î2 1
235 
Í Î2 6-Nitro-o-Toluidine Í   
Î2 1
236 
Í Î2 HC Yellow No 11 Í    
EN 153   EN Î2 1
237 
Í Î2 HC Orange No 3 Í   
Î2 1
238 
Í Î2 HC Green No 1 Í   
Î2 1
239 
Í Î2 HC Red No 8 and its salts Í   
Î2 1
240 
Í Î2 Tetrahydro-6-nitroquinoxaline and its 
salts Í   
Î2 1
241 
Í Î2 Disperse Red 15, except as impurity in 
Disperse Violet 1 Í   
Î2 1
242 
Í Î2 4-amino-3-fluorophenol Í   
Î2 1
243 
Í Î2 N,N′-dihexadecyl-N,N ′-bis(2-
hydroxyethyl)propanediamide 
Bishydroxyethyl Biscetyl Malonamide Í   
 
 
Ð 2007/54/EC Art1 and Annex 1 
pt. 1 (adapted) 
1244 1-Methyl-2,4,5-trihydroxybenzene (CAS 
No 1124 -09-0) and its salts, when used as a 
substance in hair dye products ⌦ 1124-09-0 ⌫  
1245 2,6-Dihydroxy-4-methylpyridine ( CAS No 
4664 -16-8) and its salts, when used as a 
substance in hair dye products ⌦ 4664-16-8 ⌫  
1246 5-Hydroxy-1,4-benzodioxane (CAS No 
10288 -36-5) and its salts, when used as a 
substance in hair dye products ⌦ 10288-36-
5 ⌫  
1247 3,4-Methylenedioxyphenol (CAS No 533 -
31-3) and its salts, when used as a 
substance in hair dye products ⌦ 533-31-3 ⌫  
1248 3,4-Methylenedioxyaniline (CAS No 
14268 -66-7) and its salts, when used as a 
substance in hair dye products ⌦ 14268-66-
7 ⌫   
EN 154   EN 1249 Hydroxypyridinone (CAS No 822 -89-9) 
and its salts, when used as a substance in hair dye products ⌦ 822-89-9 ⌫  
1250 3-Nitro-4-aminophenoxyethanol (CAS No 
50982 -74-6) and its salts, when used as a 
substance in hair dye products ⌦ 50982-74-
6 ⌫  
1251 2-methoxy-4-nitrophenol (CAS No 3251 -
56-7) (4-Nitroguaiacol) a nd its salts, when 
used as a substance in hair dye products ⌦ 3251-56-7 ⌫  
1252 C.I. Acid Black 131 (CAS No 12219 -01-1) 
and its salts, when used as a substance in 
hair dye products ⌦ 12219-01-
1 ⌫  
1253 1,3,5-Trihydroxybenzene (CAS No 108 -73-
6) (Phloroglucinol) and its salts, when used 
as a substance in hair dye products ⌦ 108-73-6 ⌫  
1254 1,2,4-Benzenetriaceta te (CAS No 613 -03-
6) and its salts, when used as a substance in 
hair dye products ⌦ 613-03-6 ⌫  
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 ⌦ 68478-64-
8158571-58-5 ⌫  
1256 N-Methyl-1,4-diaminoanthraquinone, 
reaction products with  epichlorohydrin and 
monoethanolamine (CAS No 158571 -57-4) 
(HC Blue No. 4) and it s salts, when used as 
a substance in hair dye products ⌦ 158571-57-
4 ⌫  
1257 4-Aminobenzenesulfonic acid (CAS No 
121-57-3) and its salts, when used as a 
substance in hair dye products ⌦ 121-57-3 ⌫  
1258 3,3'-(Sulfonylbis(2-nitro-4,1-
phenylene)imino)bis(6-(phenylamino)) benzenesulfonic acid and its salts, when used as a substance in hair dye products   
1259 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   
1260 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 ⌦ 23355-64-
8 ⌫   
EN 155   EN 1261 Benzothiazolium, 2-[[4-[ethyl(2-
hydroxyethyl)amino]phenyl]azo]-6-methoxy-3-methyl- and its salts, when used as a substance in hair dye products   
1262 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 ⌦ 13515-40-
7 ⌫  
1263 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 ⌦ 6358-85-6 ⌫  
1264 2,2'-(1,2-Ethenediyl)bis[5-((4-
ethoxyphenyl)azo]benzenesulfonic acid) and its salts, when used as a substance in 
hair dye products   
1265 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  ⌦ 4197-25-5 ⌫  
1266 3(or5)-[[4-[(7-amino-1-hydroxy-3-
sulphonato-2-naphthyl)azo]-1-naphthyl]azo]salicylic acid and its salts, when used as a substance in hair dye products   
1267 2-Naphthalenesulfonic acid, 7-
(benzoylamino)-4-hydroxy-3-[[4-[(4-sulfophenyl)azo]phenyl]azo]- and its salts, when used as a substance in hair dye products   
1268 (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   
1269 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    
1270 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 ⌦ 25188-41-
4 ⌫   
EN 156   EN 1271 Ethanaminium, N-(4-[bis[4-
(diethylamino)phenyl]methylene]-2,5-cyclohexadien-1-ylidene)-N-ethyl- and its salts, when used as a substance in hair dye products   
1272 3H-Indolium, 2-[[(4-
methoxyphenyl)methylhydrazono]methyl]-1,3,3-trimethyl- and its salts, when used as a substance in hair dye products   
1273 3H-Indolium, 2-(2-((2,4-
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 ⌦ 11099-03-
9 ⌫  
1275 Phenoxazin-5-ium, 3,7-bis(diethylamino)-, 
(CAS No 47367 -75-9) and its salts, when 
used as a substance in hair dye products  ⌦ 47367-75-
9 ⌫  
1276 Benzo[a]phenoxazin-7-ium, 9-
(dimethylamino)-, and its salts, when used as a substance in hair dye products   
1277 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 ⌦ 2478-20-8 ⌫  
1278 1-Amino-4-[[4-
[(dimethylamino)methyl]phenyl]amino]anthraquinone (CAS No 12217
-43-5) and its 
salts, when used as a substance in hair dye products ⌦ 12217-43-
5 ⌫  
1279 Laccaic Acid (CI Natural Red 25 ) (CAS 
No 60687 -93-6) and its salts, when used as 
a substance in hair dye products ⌦ 60687-93-
6 ⌫  
1280 Benzenesulfonic acid, 5-[(2,4-
dinitrophenyl)amino]-2-(phenylamino)-, (CAS No 15347
-52-1) and its salts, when 
used as a substance in hair dye products ⌦ 15347-52-
1 ⌫  
1281 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 ⌦ 730-40-5 ⌫  
1282 4-Nitro-m-phenylenediamine (CAS No 
5131 -58-8) and its salts, when used as a 
substance in hair dye products ⌦ 5131-58-8 ⌫  
1283 1-Amino-4-(methylamino)-9,10-
anthracenedione (CAS No 1220 -94-6) 
(Disperse Violet 4) and its salts, when used ⌦ 1220-94-6 ⌫   
EN 157   EN 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 ⌦ 2973-21-9 ⌫  
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 ⌦ 56932-44-
6 ⌫  
1286 N1-(Tris(hydroxymethyl))methyl-4-nitro-
1,2-phenylenediamine (CAS No 56932 -45-
7) (HC Yellow No. 3) and its salts, when 
used as a substance in hair dye products ⌦ 56932-45-
7 ⌫  
1287 2-Nitro-N-hydroxyethyl -p-anisidine (CAS 
No 57524 -53-5) and its salts, when used as 
a substance in hair dye products ⌦ 57524-53-
5 ⌫  
1288 N,N'-Dimethyl-N-Hydroxyethyl-3-nitro-p-
phenylenediamine (CAS No 10228 -03-2) 
and its salts, when used as a substance in hair dye products ⌦ 10228-03-
2 ⌫  
1289 3-(N-Methyl-N-(4-methylamino-3-
nitrophenyl)amino)propa ne-1,2-diol (CAS 
No 93633 -79-5) and its salts, when used as 
a substance in hair dye products  ⌦ 93633-79-
5 ⌫  
1290 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 ⌦ 2788-74-1 ⌫  
1291 (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   
1292 5-((4-(Dimethylamino)phenyl)azo)-1,4-
dimethyl-1H-1,2,4-triazolium and its salts, when used as a substance in hair dye products   
1293 m-Phenylenediamine, 4-(phenylazo)-, 
(CAS No 495 -54-5) and its salts, when 
used as a substance in hair dye products ⌦ 495-54-5 ⌫  
1294 1,3-Benzenediamine, 4-methyl-6-
(phenylazo)- and its salts, when used as a substance in hair dye products   
1295 2,7-Naphthalenedisulfonic acid, 5-
(acetylamino)-4-hydroxy-3-((2-methylphenyl)azo)- and its salts, when used as a substance in hair dye products    
EN 158   EN 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 ⌦ 4482-25-1 ⌫  
1297 Benzenaminium, 3-[[4-
[[diamino(phenylazo)phenyl]azo]-2-methylphenyl]azo]-N,N,N-trimethyl- and its salts, when used as  a substance in hair 
dye products   
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   
1300 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 ⌦ 86722-66-
9 ⌫  
1301 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 ⌦ 2872-48-2 ⌫  
1302 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 ⌦ 3179-90-6 ⌫  
1303 1-[(3-Aminopropyl)amino]-4-
(methylamino)anthraquinone and its salts, when used as a substance in hair dye products   
1304 N-[6-[(2-Chloro- 4-hydroxyphenyl)imino]-
4-methoxy-3-oxo-1,4-cyclohexadien-1-yl]acetamide (CAS No 6
6612 -11-1) (HC 
Yellow No. 8) and its salts, when used as a 
substance in hair dye products ⌦ 66612-11-
1 ⌫  
1305 [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 ⌦ 56330-88-
2 ⌫   
EN 159   EN 1306 Phenothiazin-5-ium, 3,7-
bis(dimethylamino)- and its salts, when used as a substance in hair dye products    
1307 4,6-Bis(2-Hydroxyethoxy)-m-
Phenylenediamine and its salts, when used as a substance in hair dye products   
1308 5-Amino-2,6-Dimethoxy-3-
Hydroxypyridine (CAS No 104333 -03-1) 
and its salts, when used as a substance in hair dye products ⌦ 104333-03-
1 ⌫  
1309 4,4'-Diaminodiphenylamine (CAS No 537 -
65-5) and its salts, when used as a 
substance in hair dye products ⌦ 537-65-5 ⌫  
1310 4-Diethylamino-o-toluidine (CAS No 148 -
71-0) and its salts, when used as a 
substance in hair dye products ⌦ 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 ⌦ 93-05-0 ⌫  
1312 N,N-Dimethyl-p-phenylenediamine (CAS 
No 99 -98-9) and its salts, when used as a 
substance in hair dye products ⌦ 99-98-9 ⌫  
1313 Toluene-3,4-Diamine (CAS No 496 -72-0) 
and its salts, when used as a substance in hair dye products ⌦ 496-72-0 ⌫  
1314 2,4-Diamino-5-methylphenoxyethanol 
(CAS No 141614 -05-3) and its salts, when 
used as a substance in hair dye products ⌦ 141614-05-
3 ⌫  
1315 6-Amino-o-cresol (CAS No 17672 -22-9) 
and its salts, when used as a substance in hair dye products ⌦ 17672-22-
9 ⌫  
1316 Hydroxyethylaminomethyl-p-aminophenol 
(CAS No 110952 -46-0) and its salts, when 
used as a substance in hair dye products ⌦ 110952-46-
0 ⌫  
1317 2-Amino-3-nitrophenol (CAS No 603 -85-0) 
and its salts, when used as a substance in hair dye products ⌦ 603-85-0 ⌫  
1318 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 ⌦ 50610-28-
1 ⌫  
1319 2-Nitro-p-phenylenediamine (CAS No 
5307 -14-2) and its salts, when used as a 
substance in hair dye products ⌦ 5307-14-2 ⌫  
1320 Hydroxyethyl-2,6-dinitr o-p-anisidine (CAS 
No 12 2252 -11-3) and its salts, when used 
as a substance in hair dye products ⌦ 122252-11-
3 ⌫   
EN 160   EN 1321 6-Nitro-2,5-pyridinediamine (CAS No 
69825 -83-8) and its salts, when used as a 
substance in hair dye products ⌦ 69825-83-
8 ⌫  
1322 Phenazinium, 3,7-diamino-2,8-dimethyl-5-
phenyl- and its salts, when used as a substance in hair dye products   
1323 3-Hydroxy-4-[(2-hydroxynaphthyl)azo]-7-
nitronaphthalene-1-s ulphonic acid (CAS 
No 16279 -54-2) and its salts, when used as 
a substance in hair dye products ⌦ 16279-54-
2 ⌫  
1324 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 ⌦ 104333-00-
8 ⌫  
1325 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 ⌦ 59320-13-
7 ⌫  
1326 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 ⌦ 173994-75-
7 ⌫  
1327 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 ⌦ 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 161   EN  
Ð 76/768/EEC 
ANNEX III  
 
Ð 82/368/EEC (adapted) 
PART  1 
LIST OF SUBSTANCES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS AND 
CON DITIONS  LAID DOWN 
Substance ⌦ identification ⌫  Restrictions Refer
ence 
numb
er ⌦ Chemical 
name/INN ⌫  ⌦ Name of Common 
Ingredients glossary ⌫ ⌦ CAS 
number ⌫  ⌦ EINECS
/ELINCS number ⌫  ⌦ Product type, 
body parts ⌫ 
Field of 
application  
and/or use  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  e h f i  
EN 162   EN  
Ð 76/768/EEC (adapted) 
Î1 82/368/EEC 
Î2 2000/6/EC Art. 1 and Annex .2(I) 
Î3 2005/80/EC Art. 1 and Annex .2(b) 
Î4 88/233/EEC 
Î5 2005/80/EC Art. 1 and Annex .2(c) 
Î6 92/86/EEC 
Î7 93/47/EEC 
Î8 83/341/EEC 
Î9 87/137/EEC 
Î10 2003/83/EC Art. 1 and Annex .2(a) 
Î11 96/41/EC 
Î12 2002/34/EC Art. 1 and Annex .2(ii) 
Î13 2002/34/EC Art. 1 and Annex .2(iii) 
Î14 2005/80/EC Art. 1 and Annex .2(a) 
Î15 86/179/EEC 
Î16 83/191/EEC 
Î17 84/415/EEC 
Î18 85/391/EEC 
Î19 2004/93/EC Art. 1 and Annex .3 
Î20 91/184/EEC 
Î21 98/62/EC 
Î22 94/32/EC 
Î23 94/32/EC amended by Corrigendum, OJ L 273, 25.10.1994, p. 38 
Î24 2003/83/EC Art. 1 and Annex .2(b) 
Î25 2000/6/EC Art. 1 and Annex .2(III) 
Î26 2002/34/EC Art. 1 and Annex .2(iv) 
Î27 2003/15/EC Art. 1.10 
Î28 2003/83/EC Art. 1 and Annex .2(c) 
Î29 2004/88/EC Art. 1 and Annex .2  
EN 163   EN Î30 2007/17/EC Art. 1 and Annex pt. 1 
Î31 2007/53/EC Art. 1 and Annex 
Î32 2007/54/EC Art. 1 and Annex .2 
 
Ö new 
 
Î2 (a) 
Talc Í Î2 (a) 5 % 
(by mass/mass 
as boric 
acid) Í Î2 (a) 
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) Í Î2 (a) 
Not to be used for 
children under 3 
years of age 
Not to be used on 
peeling or irritated skin Í Î31a
Í Î3 Boric acid, borates 
and tetraborates with the exception of 
substance No […] in 
Annex II Í ⌦ Boric acid ⌫   
Î
2 (b) 
Products for 
all hygiène  Í 
⌦ Oral 
products ⌫ Î2 (b) 0,1 % 
(by mass/mass  
as boric acid) Í Î
2 (b) 
Not to be used 
in products for children under 3 years of age Í Î
2 (b) 
Not to be 
swallowed 
Not to be used for 
children under 3  
EN 164   EN years of age Í 
Î2 (c) Other 
products (excluding bath products and hair waving products) Í Î
2 (c) 3 % 
(by mass/mass  
as boric acid) Í Î
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) Í Î2 (c) 
Not to be used for 
children under 3 years of age 
Not to be used on 
peeling or irritated skin Í 
Î2 (a) Bath 
products Í Î2 (a) 18 % 
(by mass/mass 
as boric acid) Í Î
2 (a) Not to 
be used in products for children under 3 years of age Í Î
2 (a) Not to be 
used of  bathing  for 
children under 3 years of age Í Î2 1
b Í Î2 Tetraborates Í ⌦ Sodium borate ⌫   
Î2 (b) Hair 
waving  
products Í Î2 (b) 8 % 
(by mass/mass 
as boric 
acid) Í  Î2 (b) Rinse 
well Í 
Î4 2Î4 Thioglycollic acid ⌦ Thioglycollic   Î4 (a) Hair   Î4  
EN 165   EN waving or 
straightening  
products: Í 
Î4 — 8 % 
ready for use pH 7 to 9,5 Í Î
4 — general 
use Í  
Î4 — 11 % 
ready for use pH 7 to 9,5 Í Î
4 — 
professional use Í a Í 
Î4 (b) 
Depilatories 
Í Î4 — 5 % 
ready for usepH 7 to 12,7 Í 
 and its salts Í acid ⌫ 
Î4 (c) Other 
hair-caire 
products 
which are 
removed after 
application  Í 
⌦ Hair rinse-
off products ⌫ Î
4 — 2 % 
ready for use pH to 9,5 
The 
abovementioned percentages are calculated as thioglycollic acid Í  
          ⌦ 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 166   EN For professional 
use only 
(b) and (c):  
Contains 
thioglycolate  
Follow the 
instructions  
Keep out of reach 
of children  Í 
 
 
   
Î4 2
b Í Î4 Thioglycollic acid 
esters Í ⌦ Glyceryl 
thioglycolate ⌫   Î4 Hair 
waving or straightening products: Í 
Î
4 — 8 % 
ready for use pH 6 to 9,5 Í 
   Î
4 — general 
use Í 
    ⌦ 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 167   EN  
        
 
        
        
 
       medical advice 
- Wear suitable 
gloves ⌫ 
⌦ Warnings: ⌫ 
Î
4 - Contains 
thioglycolate 
- Follow the 
instructions 
- Keep out of 
reach of 
children Í 
Î4 — For 
professional use only Í  
EN 168   EN  
    
  
 
  Î4 — 11 % 
ready for use pH 6 to 9,5 Í 
Î
4 The 
abovementioned percentages are calculated as thioglycollic acid Í Î
4 — 
professional use Í 
Î
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 169   EN - In the event of 
contact with 
eyes, rinse 
immediately 
with plenty of 
water and seek 
medical advice  
- Wear suitable 
gloves  Í 
Î1 3 
Í Î1 Oxalic acid, its 
esters and alcaline salts Í ⌦ Oxalic acid ⌫   Î
1 Hair care  
products Í Î1 5 % Í ⌦professional 
use ⌫  Î1 For 
professional use only Í 
Î1 4 
Í Î1 Ammonia Í ⌦ Ammonia ⌫    Î1 6 % 
calculated as  
(as NH 3) Í  Î1 Above 2  %: 
contains 
ammonia  Í 
Î1 5 
Í Î1 Tosylchloramide 
sodium (INN)  (*) Í ⌦ Chloramine-t ⌫    Î1 0·2 % Í   
Î1 6 
Í Î1 Chlorates of alkali 
metals Í ⌦ Sodium chlorate, 
potassium chlorate ⌫   Î1 (a) 
Toothpaste 
(b) Other 
uses ⌦ produ
cts ⌫ Í Î1 (a) 5 % 
(b) 3 % Í   
Î1 7 
Í Î1 Dichloromethane 
Í ⌦ Dichloromethane 
⌫    Î1 35 % 
(when mixed Î1 0,·2 % as 
maximum impurity   
EN 170   EN with 1,1,1-
trichloroethane, total concentration must not exceed 35 %) Í content Í 
Î1 8 
Í Î1 Oxidizing 
colouring agents for hair dyeing Í Î
1 6 % 
calculated  (as 
free base)  Í   
  Î1 (a) general 
use Í 
⌦ No use on 
eyebrows ⌫ Î1 (a) Can cause 
an allergic reaction. Î
6 ---
 Í Contains 
phenylenediamines. Do not use to dye eyelashes or eyebrows Í  Î5Í 
Î32 p-
Phenylenediamine, its N-substituted derivatives and its salts; Nsubstituted derivatives of o-Phenylenediamine
42, 
with the exception of those derivatives listed 
elsewhere in this 
Annex and under reference numbers 1309, 1311, and 1312 in Annex II Í ⌦ p-
Phenylenediamine, p-Phenylenediamine HCI, p-Phenylenediamine sulfate ⌫   
  Î
1 (b) 
professional use Í Î
1 (b) For 
professional use only. Contains phenylenediamines. Can cause an allergic reaction. Î
6 ---
 ÍÎ 7 Wear 
suitable  
EN 171   EN gloves. Í Í 
Î1 Oxidizing 
colouring agents for hair dyeing Í Î
1 10 % 
calculated  (as 
free base)  Í   Î1 9 
Í 
  Î1 (a) general 
use Í 
⌦ No use on 
eyelashes or eyebrows ⌫  Î
1 (a) Can cause 
an allergic reaction. Î
6 ---
 Í Contains 
phenylenediamines. Do not use to dye eyelashes or eyebrows Í 
 Î8Í 
Î32 Methylphenylened
iamines, their N-substituted derivatives and their salts
38 with 
the exception of substances under reference numbers 364, 1310 and 1313 in Annex II Í ⌦ Toluene-2,2-
diamine; toluene-2,5-diamine sulphate ⌫   
  Î
1 (b) 
professional use Í Î
1 (b) For 
professional use only. Contains phenylenediamines. Can cause en allergic reaction. Î
6 ---
 ÍÎ 7 Wear 
suitable gloves. Í Í  
EN 172   EN Î1 Oxidizing 
colouring agents for hair dyeing Í Î
1 10 % 
calculated  (as 
free base)  Í   
  Î1 (a) general 
use Í Î1 (a) Can cause 
an allergic reaction. Î
6 ---
 Í Contains 
diaminophenols.  
Do not use to dye eyelashes or eyebrows Í Î1 1
0 Í Î1 Diaminophenols38 
Í ⌦ 2,4-
Diaminophenol, 2,4-diaminophenol HCL ⌫   
  Î
1 (b) 
professional use Í Î
1 (b) For 
professional use only. Contains 
diaminophenols.  
Can cause allergic reaction. Î
6 ---
 Í 
Î7 Wear suitable 
gloves. Í Í 
Î9 1
1 Í Î9 Dichlorophen 
(*) Í ⌦ Dichlorophene ⌫    Î9 0,5 % Í  Î9 Contains 
dichlorophen  Í 
⌦ Dichlorophene
                                                 
38 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.  
EN 173   EN  ⌫ 
Î6 (a) Hair- 
⌦ products 
⌫ caire  
preparations  
Í Î6 12 % of  
H2O2 (40 
volumes), present or released Í  Î
7 (a): Wear 
suitable gloves Í 
Î6 (b) Skin- 
⌦ products 
⌫ care 
preparatio ns 
Í Î6 4 % of  
H2O2, present 
or released Í  Î6 (a) (b) (c): 
Contains hydrogen peroxide. Í 
Î6 (c) Nail 
⌦ products 
⌫ hardening  
preparations  
Í Î6 2 % of 
H2O2, present 
or released Í  Î6 Avoid contact 
with eyes. 
Rinse immediately 
if product comes into contact with them Í Î6 1
2 Í Î6 Hydrogen 
peroxide, and other compounds or mixtures that release hydrogen peroxide, including carbamide peroxide and zinc peroxide Í ⌦ Hydrogen 
peroxide ⌫   
Î
6 (d) Oral 
hygiene  
products Í Î6 0,1 % of 
H2O2, present 
or released Í   
Î1 1Î1 Formaldehyde Í ⌦ Formaldehyde ⌫   Î1 Nail Î1 5 % ⌦ For Î1 Protect  
EN 174   EN 3 Í 
⌦ 39 
⌫ ⌦ products 
⌫ 
hardeners  Í calculated  (as 
formaldehyde)
 Í purposes other 
than inhibiting the development of micro-organisms in the product. This purpose has to be 
apparent from 
the presentation of the product. ⌫ cuticles with 
grease or oil. Contains formaldehyde
40. 
Í 
Î10 1
4 Í Î10 Hydroquinone41 
Í ⌦ Hydroquinone ⌫   Î10 (a) 
Oxidising colouring agent for hair-
dying: Í Î
10 0,3 % Í ⌦ No use on 
eyelashes or eyebrows ⌫  Î
10 (a) 
 1.  
- Do not use to 
dye eyelashes or 
eyebrows Í 
Î10- Rinse the 
eyes immediately if the product comes into contact 
                                                 
39 ⌦ As a preservative, see Annex V, No. 5. ⌫ 
40 Only if the concentr ation exceeds 0,05 %. 
41 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.  
EN 175   EN with them 
- Contains 
Hydroquinone Í 
 Î10 1. 
General use  Í Î10 - Rinse the 
eyes immediately 
if the product 
comes into contact 
with them  
Contains 
hydroquinone  Í 
Î10 2. 
Professional 
use Í  Î10 2. 
- For professional 
use only  
- Contains 
hydroquinone  
- Rinse the eyes 
immediately if the 
product comes 
into contact with 
them  Í  
Î10 (b) 
Artificial nail systems Í Î
10 0,02 % 
(after mixing for use) Í Î
10 Profession
al use only  Í Î10 (b) 
- For professional 
use only  
EN 176   EN - Avoid skin 
contact 
- Read directions 
for use carefully Í 
Î11 (a) Nail 
cuticle solvent Í Î
11 (a) 5 % 
by weight42 Í  Î11 (a) Contains 
alkali. Avoid contact with eyes. Can cause blindness. Keep out of reach of children Í 
Î11 (b) Hair 
straightener Í Î11 (b) Í  Î11 (b) Í Î11 1
5a Í Î11 Potassium or 
sodium hydroxide Í ⌦ Potassium 
hydroxide, sodium hydroxide ⌫   
 Î
11 1. 2 % by 
weight43 Í Î11 1. General 
use Í Î11 1. Contains 
alkali. Avoid contact with eyes. Can cause blindness. Keep out of reach of children Í 
                                                 
42 Î1 The quantity of sodium, potassium or lithium hydroxide is expressed as weight of sodium hydroxide. In cases of mixtures, the s um should not exceed the limits given in 
column d. Í 
43 Î1 The quantity of sodium, potassium or lithium hydroxide is expressed as weight of sodium hydroxide. In cases of mixtures, the s um should not exceed the limits given in 
column d. Í  
EN 177   EN  Î11 2. 4,5 % 
by weight44 Í Î11 2. 
Professional use Í Î
11 2. For 
professional use only. Avoid contact with eyes. Can cause blindness. Í 
Î11 (c) pH 
adjuster 
depilatories Í Î11 (c) Up to 
pH 12,7 Í  Î11 (c) Keep out 
of reach of children. Avoid contact with eyes Í  
Î11 (d) Other 
uses as pH adjuster Í Î
11 (d) Up to 
pH 11 Í   
Î12 (a) Hair 
straighteners 
Í Î12 (a) Í  Î12 (a) Í Î12 1
5b Í Î12 Lithium 
hydroxide Í ⌦ Lithium 
hydroxide ⌫   
 Î12 1. 
2 %45 by 
weight  Í Î12 1. General 
use Í Î12 1. Contains 
alkali 
Avoid contact 
with eyes 
                                                 
44 Î1 The quantity of sodium, potassium or lithium hydroxide is expressed as weight of sodium hydroxide. In cases of mixtures, the s um should not exceed the limits given in 
column d. Í 
45 Î3 The concentration of sodium, potassium or lithium hydroxide is ex pressed as weight of sodium hydroxide. In case of mixtures, t he sum should not exceed the limits 
given in column d. Í  
EN 178   EN Can cause 
blindness 
Keep out of reach 
of children Í 
 Î12 2. 
4,5 %46 by 
weight  Í Î12 2. 
Professional use Í Î
12 2. For 
professional use 
only 
Avoid contact 
with eyes 
Can cause 
blindness Í 
Î12 (b) pH 
adjuster — for 
depilatories Í  Î12 (b) pH 
value ⌦ < ⌫ 
not to exceed 
pH 12,7 Í Î12 (b) Contains 
alkali 
Keep out of reach 
of children 
Avoid contact 
with eyes Í 
Î12 (c) Other 
uses — as pH adjuster (for rinse-off  Î
12 (c) pH 
value ⌦ < ⌫ 
not to exceed  
                                                 
46 Î3 The concentration of sodium, potassium or lithium hydroxide is ex pressed as weight of sodium hydroxide. In case of mixtures, t he sum should not exceed the limits 
given in column d. Í  
EN 179   EN products 
only) Í pH 11 Í 
Î12 ⌦ (a) ⌫ 
Hair straighteners containing two components: calcium hydroxide and a guanidine salt Í Î
12 (a) 7 % 
by weight of  
(as calcium 
hydroxide) Í  Î12 (a) Contains 
alkali 
Avoid contact 
with eyes 
Keep out of reach 
of children 
Can cause 
blindness Í 
Î12 (b) pH 
ajuster — for depilatories Í  Î
12 (b) pH 
value not to 
exceed pH  
⌦ < ⌫ 
12,7 Í Î12 (b) Contains 
alkali 
Keep out of reach 
of children 
Avoid contact 
with eyes Í Î12 1
5c Í Î12 Calcium 
hydroxide Í ⌦ Calcium 
hydroxide ⌫   
Î12 (c) Other 
uses (e.g. pH adjuster, processing aid) Í  Î
12 (c) pH 
value not to 
exceed pH  
⌦ < ⌫ 11 Í  
Î13 1
6 Í Î13 1-Naphthol and its 
salts Í ⌦ 1-Naphtol ⌫   Î13 Oxidising 
colouring agents for hair Î
13 2,0 % Í Î13 In 
combination with hydrogen Î
13 Can cause 
allergice   
EN 180   EN dyen ing Í peroxide the 
maximum use concentration upon application is 1,0 % Í reaction Í 
Î1 1
7 Í Î1 Sodium nitrite Í ⌦ Sodium nitrite ⌫   Î1 Rust 
inhibitor Í Î1 0,2 % Í Î1 Do not use 
with secondary and/or tertiary amines or other substances forming nitrosamines Í  
Î1 1
8 Í Î1 Nitromethane Í ⌦ Nitromethane ⌫   Î1 Rust 
inhibitor Í Î1 0,3 % Í   
Î14 -
-- Í Î14 --- Í Î14 --- Í Î14 --- Í  Î14 --- Í 
      
Î1 (a) 
Shampoos Í Î1 (a) 0,5 % 
calculated  (as 
quinine base)
 Í   Î1 2
1 Í ⌦ Cinchonan-9-ol, 6'-
methoxy-, (8.alpha., 9R) and its salts ⌫  Î
1Quinine Í   
Î1 (b) Hair 
lotions Í Î1 (b) 0,2 % 
calculated  (as 
quinine base)
 Í    
EN 181   EN Î1 (a) 
Oxidizing colouring agent for hair dyeing Í Î
1 (a) 5 % Í  Î1 (a) Í Î1 2
2 Í 
  Î1 1. general 
use Í Î1 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 Í 
 Î1 Resorcinol47 Í ⌦ Resorcinol ⌫   
  Î1 2. 
professional use Í Î
1 2. For 
professional use only. Contains resorcinol. 
Rinse eyes 
immediately if product comes 
                                                 
47 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.  
EN 182   EN into contact with 
them Í 
Î1 (b) Hair 
lotions and shampoos Í Î
1 (b) 
0,5 % Í  Î1 (b) Contains 
resorcinol Í 
Î1 (a) Alkali 
sulphides Í ⌦ Barium sulfide ⌫   Î1 (a) 
Depilatories 
Í Î1 (a) 2 % 
calculated  (as 
sulphur) pH ≤ 12,7 Í  Î
1 (a) Keep out 
of reach of children. Avoid contact with eyes Í Î1 2
3 Í 
Î1 (b) Alkaline earth 
sulphides Í ⌦ Barium sulfide ⌫   Î1 (b) 
Depilatories 
Í Î1 (b) 6 % 
calculated  (as 
sulphur) pH ≤ 12,7 Í  Î
1 (b) Keep out 
of reach of children. Avoid contact with eyes Í 
Î1 2
4 Í Î1 Water-soluble zinc 
salts with the exception of zinc 4-hydroxy-benzenesulphonate and zinc pyrithione Í ⌦ Zinc acetate, zinc 
chloride, zinc glucomate, zinc glutamate ⌫    Î
1 1 % 
calculated  (as 
zinc)  Í   
Î1 2
5 Í Î1 Zinc 4-
hydroxybenzene sulphonate Í ⌦ Zinc 
phenolsulfonate ⌫   Î
1 Deodorant
s, antiperspirants and astringent lotions Í Î
1 6 % 
calculated  (as 
% of  
anhydrous substance) Í  Î
1 Avoid contact 
with eyes Í 
Î1 2Î1 Sodium     Î1 Oral Î1 0,15 %  Î1 Contains  
EN 183   EN 6 Í Ammonium 
monofluorophosphate 
Í hygiene  
products Í calculated  (as 
F). When mixed with other fluorine compounds permitted under this Annex, total F concentration 
must not 
exceed 0,15 % Í ammonium 
monofluorophosphate Í 
Î
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.” Í  
Î1 2⌦ Disodium Î1 Sodium   Î1 Ditto Í Î1 0,15 %  Î1 Contains  
EN 184   EN 7 Í fluorophosphate ⌫ monofluorophosphate
Í Ditto Í sodium 
monofluorophosphate Í 
Î
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.” Í  
Î1 2⌦ Dipotassium Î1 Potassium   Î1 Ditto Í Î1 0,15 %  Î1 Contains  
EN 185   EN 8 Í fluorophosphate ⌫ monofluorophosphate
Í Ditto Í potassium 
monofluorophosphateÍ 
Î
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.” Í  
Î1 2⌦ Calcium Î1 Calcium   Î1 Ditto Í Î1 0,15 %  Î1 Contains  
EN 186   EN 9 Í fluorophosphate ⌫ monofluorophosphate 
Í Ditto Í calcium 
monofluorophosphate Í 
Î
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.” Í  
Î1 3⌦ Calcium Î1 Calcium   Î1 Ditto Í Î1 0,15 %  Î1 Contains  
EN 187   EN 0 Í fluoride ⌫  fluoride Í Ditto Í calcium 
fluoride Í 
Î31 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.” Í  
Î1 3
1 Í ⌦ Sodium 
fluoride ⌫  Î1 Sodium 
fluoride Í   Î1 Ditto Í Î1 0,15 %  Î1 Contains 
sodium  
EN 188   EN Ditto Í fluoride Í 
Î31 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.” Í  
Î1 3
2 Í ⌦ Potassium 
fluoride ⌫  Î1 Potassium 
fluorideÍ    Î1 Ditto Í Î1 0,15 % 
Ditto Í  Î1 Contains 
potassium fluoride Í  
EN 189   EN Î1 3
3 Í Î1 Ammonium 
fluoride Í ⌦ Ammonium 
fluoride ⌫    Î1 Ditto Í Î1 0,15 % 
Ditto Í  Î1 Contains 
ammonium fluoride Í 
Î
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.” Í   
EN 190   EN Î1 3
4 Í Î1 Aluminium 
fluoride Í ⌦ Aluminium 
fluoride ⌫    Î1 Ditto Í Î1 0,15 % 
Ditto Í  Î1 Contains 
aluminium fluoride Í 
Î
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.” Í   
EN 191   EN Î1 3
5 Í ⌦ Tin difluoride ⌫ Î1 Stannous 
fluoride Í   Î1 Ditto Í Î1 0,15 % 
Ditto Í  Î1 Contains 
stannous fluoride Í 
Î
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.” Í   
EN 192   EN Î1 3
6 Í Î1 Hexadecyl 
ammonium fluoride Í ⌦ Cetylamine 
hydrofluoride ⌫   Î1 Ditto Í Î1 0,15 % 
Ditto Í  Î1 Contains 
hexadecyl 
ammonium 
fluoride  Í 
⌦ Cetylamine 
hydrofluoride ⌫  
Î31 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 193   EN consult a dentist or 
doctor.” Í  
Î1 3
7 Í Î1 3-(N-Hexadecyl- N-
2-hydroxyethylammonio) propylbis (2-hydroxyethyl) ammonium difluoride Í ⌦ Olaflur ⌫   Î
1 Ditto Í Î1 0,15 % 
Ditto Í  Î1 Contains 3 -
(N-Hexadecyl -N-
2-
hydroxye thylamm
onio) propylbis (2 -
hydroxyethyl) 
ammonium 
difluoride  Í 
⌦ Olaflur ⌫  
Î31 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 194   EN minimize 
swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.” Í  
Î1 3
8 Í Î1 N,N',N' -
Tris(polyoxyethylene)-N-
hexadecylpropylenediamine dihydrofluoride Í ⌦ Palprityl 
trihydroxyethyl propylenediamine dihydrofluorid ⌫   Î
1 Ditto Í Î1 0,15 % 
Ditto Í  Î1 Contains 
NN'N' -
tris(polyoxyethyle
ne)-N-
hexadecylpropyle
nediamine 
dihydrofluoride  Í 
⌦ Palprityl 
trihydroxyethyl propylenediamine 
dihydrofluorid ⌫ 
Î
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 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.” Í  
Î1 3
9 Í ⌦ 9-Octadecenamine, 
hydrofluoride ⌫ Î1 Octadecenyl-
ammonium fluorideÍ    Î
1 Ditto Í Î1 0,15 % 
Ditto Í  Î1 Contains 
octadecenyl-ammonium 
fluoride Í 
Î
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 196   EN 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.” Í  
Î1 4
0 Í ⌦ Disodium 
hexafluorosilicate ⌫ Î1 Sodium 
fluorosilicate Í    Î1 Ditto Í Î1 0,15 % 
Ditto Í  Î1 Contains 
sodium fluorosilicate Í 
Î
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 197   EN “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.” Í  
Î1 4
1 Í ⌦ Dipotassium 
hexafluorosilicate ⌫ Î1 Potassium 
fluorosilicate Í   Î1 Ditto Í Î1 0,15 % 
Ditto Í  Î1 Contains 
potassium fluorosilicate Í 
Î
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 198   EN 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.” Í  
Î1 4
2 Í ⌦ Ammonium 
hexafluorosilicate ⌫ Î1 Ammonium 
fluorosilicate Í   Î1 Ditto Í Î1 0,15 % 
Ditto Í  Î1 Contains 
ammonium fluorosilicate Í 
Î
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.” Í  
Î1 4
3 Í ⌦ Magnesium 
hexafluorosilicate ⌫ Î1 Magnesium 
fluorosilicate Í   Î1 Ditto Í Î1 0,15 % 
Ditto Í  Î1 Containes 
(SIC!  Contains)  
magnesium fluorosilicate Í 
Î
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 200   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.” Í  
Î15 4
4 Í Î15 1,3-Bis 
(hydroxymethyl)imidazolidine-2-thione Í ⌦ Dimethylol 
ethylene thiourea ⌫   Î
15 (a) Hair- 
⌦ products 
⌫ care 
preparations  
(b) Nail- 
⌦ products 
⌫ care 
preparations  
Í Î15 (a) Up to  
2 % 
(b) Up to  
2 % Í Î15 (a) 
Prohibited  
⌦ No use ⌫ 
in aerosol dispensers (sprays) 
(b) The
 pH of 
the product as 
applied must be 
less ⌦ < ⌫ 
than 4 Í Î15 Contains 1,3 -
bis 
(hydroxymethyl) 
immidazolidine -2-
thione  Í 
⌦ Dimethylol 
ethylene 
thiourea ⌫  
Î1 4
5 Í 
⌦ 48 
⌫ Î1 Benzyl alcohol Í ⌦ Benzyl 
alcohol ⌫  ⌦ 100-
51-6 ⌫ ⌦ 202-
859-9 ⌫ Î1 Solvents, 
perfumes and flavourings Í ⌦ For 
purposes other than inhibiting the   
                                                 
48 ⌦ As preservative, see Annex V, No. 34. ⌫  
EN 201   EN development 
of micro-organisms in the product. This purpose has to be apparent from the presentation of 
the 
product. ⌫ 
Î16 4
6 Í Î16 6-
Methylcoumarin Í ⌦ 6-
Methylcoumarin ⌫    Î16 Oral 
hygiene  
products Í Î16 0,003 % 
Í   
Î17 4
7 Í ⌦ 3-
Pyridinemethanol, hydrofluoride ⌫ Î
17 Nicomethanol 
hydrofluoride Í   Î17 Oral 
hygiene  
products Í Î17 0,15 % 
calculated  (as 
F) 
When mixed 
with other fluorine compounds permitted under this Annex, total F concentration must not 
exceed 
0,15 % Í  Î
17 Contains 
nicomethanol hydrofluoride Í 
Î
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 202   EN “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.” Í  
Î17 4
8 Í Î17 Silver nitrate Í ⌦ Silver nitrate ⌫    Î17 Solely  for 
products 
intended  
⌦ Only ⌫ 
for colouring 
eyelashes and eyebrows Í Î
17 4 % Í  Î17 Contains 
silver nitrate 
Rinse the eyes 
immediately if 
product comes 
into contact with them Í 
 
Î18 4
9 Í ⌦ Selenium 
sulfide ⌫ Î18 Selenium 
disulphide Í   Î18 Antidandr
uff shampoos Í Î
18 1 % Í  Î18 Contains 
selenium disulphide 
Avoid contact 
with eyes or  
EN 203   EN damaged skin Í 
Î18 5
0 Í Î18 Aluminium 
zirconium chloride hydroxyde complexes 
Al
xZr(OH) yClz and the 
aluminium zirconium chloride sydroxide glycine complexes Í    Î
18 Antipersp
irants Í Î18 20 % (as 
anhydrous aluminium zirconium chloride hydroxide) 
5,4 % (as 
zirconium) Í Î
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) Í Î
18 Do not apply 
to irritated or damaged skin Í 
Î4 5
1 Í Î4 Quinolin-8-ol and 
bis (8-hydroxy-quinolium) sulphate Í ⌦ Oxyquinoline and 
oxyquinoline sulfate ⌫   Î
4 Stabilizer 
for hydrogen peroxide in 
rinse-off hair- 
⌦ products Î
4 0,3 % 
calculated  (as 
base)  Í    
EN 204   EN ⌫ care  
preparations  
Í 
 Î4 Stabilizer 
for hydrogen peroxide in ⌦ leave-on 
hair products ⌫ 
non
-rinse -off 
hair-care 
preparations  
Í Î4 0,03 % 
calculated  (as 
base)  Í   
Î9 5
2 Í Î9 Methanol Í ⌦ Methyl alcohol ⌫   Î9 Denaturant 
for ethanol and isopropyl alcohol Í Î
9 5 % 
calculated  (as 
a % ethanol and isopropyl al
cohol) Í   
Î4 (a) Hair- 
⌦ product ⌫ 
care Í Î4 1,5 % 
expressed  (as 
etidronic acid) Í   
Î4 5
3 Í Î4 (1-
Hhydroxyethylidene-
di-phosphonic acid and its salts) Í ⌦ Etidronic acid ⌫   
Î
4 (b) 
Soap Í Î4 0,2 % 
expressed as etidronic acid Í    
EN 205   EN Î4 5
4 Í 
⌦ 49 
⌫ Î4 — ⌦ Use 
only in ⌫ 
rinse-off products only
 Í Î4 2 % Í  
 Î4 1-Phenoxy-propan-
2-ol Í ⌦ Phenoxyisopropan
ol ⌫   
Î4 — 
Prohibited  
⌦ No use ⌫ 
in oral hygiene  
products Í  Î4 As a 
preservative, 
see Annex VI, 
Part 1 , No 
43 Í 
⌦ 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. ⌫  
Î19 -
-- Í Î19 --- Í Î19 --- Í Î19 --- Í  Î19 --- Í 
Î20 5
6 Í Î20 Magnesium 
fluoride Í ⌦ Magnesium 
fluoride ⌫    Î20 Dental  
⌦ Oral ⌫ 
hygiene  
products Í Î20 0,15 % 
calculated  (as 
F). When mixed with other fluorine 
compounds  Î
20 Contains 
magnesium fluoride Í 
                                                 
49 ⌦ As a preservative, see Annex V, No 43. ⌫  
EN 206   EN  permitted 
under this Annex, total F concentration must not exceed 0,15 % Í 
Î21 5
7 Í Î21 (a) 
Toothpaste  Í 
⌦ Oral 
products ⌫ Î21 3,5 %, 
calculated  (as 
strontium) . 
When mixed with other permitted strontium products the total strontium content must 
not exceed 
3,5 % Í  Î
21 Contains 
strontium chloride. Frequent use by children is not advisable Í 
 Î21 Strontium chloride 
hexahydrate Í ⌦ Strontium 
chloride ⌫    
Î21 (b) 
Shampoo and face care
 
products Í Î21 2,1 %, 
calculated  (as 
strontium) . 
When mixed with other permitted strontium 
products the 
total strontium content must not exceed    
EN 207   EN 2,1 % Í 
Î6 5
8 Í Î6 Strontium acetate 
hemihydrate Í ⌦ Strontium 
acetate ⌫   Î6 Toothpaste
 Í ⌦ Oral 
products ⌫ Î6 3,5 %, 
calculated  (as 
strontium) . 
When mixed with other permitted strontium products the total strontium content must not exceed 3,5 % Í  Î
6 Contains 
strontium acetate. Frequent use by children is not advisable Í 
Î
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 208   EN consult a dentist or 
doctor.” Í  
Î22 5
9 Í Î22 Talc: Hydrated 
magnesium silicate Í ⌦ Talc ⌫   Î22 (a) 
Powdery products intended to be used for children under three years of age 
(b) other 
products Í   Î
23 (a) Keep 
powder away from children's nose and mouth Í 
Î24 6
0 Í Î24 Fatty acid 
dialkylamides and dialkanolamides Í     Î
24 Maximu
m secondary amine content: 0,5 % Í Î
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 209   EN nitrite-free 
containers Í 
Î24 6
1 Í Î24 Monoalkylamines, 
monoalkanolamines and their salts Í ⌦ Ethanolamine, 
Isopropanolimine, Methyl thioglycolate, Methyethanolamine 
⌫    Î
24 Maximu
m secondary amine content: 0,5 % Í Î
24 - Do not 
use with nitrosating systems 
– Minimum 
purity: 99 % 
– Maximum 
secondary amine content: 0,5 % (applies to raw materials) 
– Maximum 
nitrosamine 
content: 50 µg/kg 
– Keep in 
nitrite-free containers 
Í  
Î24 6
2 Í Î24 Trialkylamines, 
trialkanolamines and ⌦ Triethanolamine, 
Triisopropanolamine,   Î24 (a) 
⌦ Leave-on Î24 (a) 
2,5 % Í Î24 (a) (b) 
– Do not use   
EN 210   EN their salts Í Trilaurylamine ⌫ products ⌫ 
Non-rinse -off 
products  
(b) Other 
products  Í 
⌦ Rinse-off 
products ⌫ with 
nitrosating systems 
– Minimum 
purity: 99 % 
– Maximum 
secondary amine content: 
0,5 % 
(applies to raw materials) 
– Maximum 
nitrosamine content: 50 µg/kg 
– Keep in 
nitrite-free containers 
Í 
Î22 6
3 Í Î22 Strontium 
hydroxide Í ⌦ Strontium 
hydroxide ⌫   Î22 pH-
regulator in depilatory products Í Î
22 3,5 % 
calculated  (as 
strontium) , 
max. pH of 12,7 Í  Î
22 - Keep out of 
reach of children 
- Avoid contact 
with the eyes Í  
EN 211   EN Î22 6
4 Í Î22 Strontium 
peroxide Í ⌦ Strontium 
peroxide ⌫   Î22 Rinse-off 
hair products care
 
preparations   
professional 
use Í Î22 4,5 % 
calculated  (as 
strontium) in 
the ready -for-
use 
preparation  Í Î22 All 
products must meet the hydrogen peroxide release requirements Í 
⌦ professional 
use ⌫  Î
22 - Avoid 
contact with eyes 
- Rinse eyes 
immediately if product comes into contact with them 
- For professional 
use only 
- Wear suitable 
gloves Í 
Î25 6
5 Í Î25 Benzalkonium 
Chloride, bromide and saccharinate Í 
⌦ 
50 ⌫    Î25 (a) Rinse-
off hair (head) care
 
products Í Î25 (a) 3 % 
(as benzalkonium chloride) Í Î
25 (a) In the 
final products the concentrations of benzalkonium 
chloride, 
bromide and saccharinate with an alkyl chain of C
14, or 
less must not exceed 0,1 % (as Î
25 (a) Avoid 
contact with the eyes Í 
                                                 
50 ⌦ As a preservative, see Annex V, No. 54. ⌫  
EN 212   EN benzalkonium 
chloride) Í 
⌦ 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. ⌫ 
Î25 (b) Other 
products  Í Î25 (b) 0,1 % 
(as 
benzalkonium 
chloride)  Í  Î25 (b) Avoid 
contact with the 
eyes Í 
Î26 (a) Body-
care leave-on 
products Í  Î26 (a) 
Maximum residual acrylamide content 0,1 mg/kg Í  
Î26 6
6 Í Î26 Polyacrylamides 
Í    
Î26 (b) Other 
cosmetic   Î26 (b) 
Maximum   
EN 213   EN products Í residual 
acrylamide content 0,5 mg/kg Í 
Î27 6
7 Í ⌦ 2-
Benzylideneheptanal 
⌫ Î27 Amyl 
cinnamal Í 122-40-7    Î27 The 
presence of the substance must be indicated in the list of ingredients referred to in Article 14
6(1)(g) when 
its concentration exceeds: 
– 0,001 % in 
leave-on 
products 
– 0,01 % in 
rinse-off products Í  
Î27 6
8 Í Î27 Benzyl alcohol Í ⌦ Benzyl alcohol ⌫ 100-51-6     Î27 The 
presence of the substance must be indicated in 
the list of 
ingredients   
EN 214   EN referred to in 
Article 14
6(1)(g) when 
its concentration exceeds: 
– 0,001 % in 
leave-on products 
– 0,01 % in 
rinse-off products Í 
Î27 6
9 Í ⌦ Cinnamyl 
alcohol ⌫ Î27 Cinnamyl 
alcohol Í 104-54-1    Î27 The 
presence of the substance must be indicated in the list of 
ingredients 
referred to in Article 14
6(1)(g) when 
its concentration exceeds: 
– 0,001 % in 
leave-on products   
EN 215   EN – 0,01 % in 
rinse-off products Í 
Î27 7
0 Í  Î27 Citral Í 5392-40-
5    Î27 The 
presence of the substance must be indicated in the list of ingredients referred to in Article 14
6(1)(g) when 
its concentration exceeds: 
– 0,001 % in 
leave-on 
products 
– 0,01 % in 
rinse-off products Í  
Î27 7
1 Í ⌦ Phenol, 2-methoxy-
4-(2-propenyl) ⌫ Î27 Eugenol Í 97-53-0    Î27 The 
presence of the substance must be indicated in the list of 
ingredients 
referred to in   
EN 216   EN Article 
146(1)(g) when 
its concentration exceeds: 
– 0,001 % in 
leave-on products 
– 0,01 % in 
rinse-off 
products Í 
Î27 7
2 Í ⌦ 7-Hydroxy-
citronellal ⌫ Î27 Hydroxy-
citronellal Í 107-75-5    Î27 The 
presence of the substance must be indicated in the list of ingredients 
referred to in 
Article 14
6(1)(g) when 
its concentration exceeds: 
– 0,001 % in 
leave-on products 
– 0,01 % in   
EN 217   EN rinse-off 
products Í 
Î27 7
3 Í  ⌦ Phenol, 2-
methoxy-4-(1-propenyl)- ⌫ Î
27 Isoeugenol Í 97-54-1    Î27 The 
presence of the substance must be indicated in the list of ingredients referred to in Article 14
6(1)(g) when 
its concentration exceeds: 
– 0,001 % in 
leave-on products 
– 0,01 % in 
rinse-off products Í  
Î27 7
4 Í ⌦ 2-Pentyl-3-
phenylprop-2-en-1-ol ⌫ Î
27 Amylcin namyl 
alcoholÍ 101-85-9    Î27 The 
presence of the substance must be indicated in the list of ingredients 
referred to in 
Article   
EN 218   EN 146(1)(g) when 
its concentration exceeds: 
– 0,001 % in 
leave-on products 
– 0,01 % in 
rinse-off 
products Í 
Î27 7
5 Í  ⌦ Benzyl 
salicylate ⌫ Î27 Benzyl 
salicylate Í 118-58-1    Î27 The 
presence of the substance must be indicated in the list of ingredients referred to in 
Article 
14
6(1)(g) when 
its concentration exceeds: 
– 0,001 % in 
leave-on products 
– 0,01 % in 
rinse-off   
EN 219   EN products Í 
Î27 7
6 Í ⌦ Cinnamaldehyde 
⌫ Î27 Cinnamal Í 104-55-2    Î27 The 
presence of the substance must be indicated in the list of ingredients referred to in Article 14
6(1)(g) when 
its concentration exceeds: 
– 0,001 % in 
leave-on products 
– 0,01 % in 
rinse-off 
products Í  
Î27 7
7 Í ⌦ Coumarin ⌫ Î27 Coumarin Í 91-64-5    Î27 The 
presence of the substance must be indicated in the list of ingredients referred to in 
Article 
14
6(1)(g) when   
EN 220   EN its 
concentration exceeds: 
– 0,001 % in 
leave-on products 
– 0,01 % in 
rinse-off products Í 
Î27 7
8 Í ⌦ 2,6-Octadien-1-ol, 
3,7-dimethyl-, (2E)- ⌫ Î27 Geraniol Í 106-24-1    Î27 The 
presence of the substance must be indicated in the list of ingredients referred to in Article 
14
6(1)(g) when 
its concentration exceeds: 
– 0,001 % in 
leave-on products 
– 0,01 % in 
rinse-off products Í   
EN 221   EN Î27 7
9 Í Î27 Hydroxy-
methylpentylcyclohexenecarboxaldehyde Í ⌦ Hydroxy-
isohexyl 
3-cyclohexene carboxaldehyde ⌫ 31906-
04-4 ⌦ , 
51414-25-6 ⌫    Î
27 The 
presence of the substance must be indicated in the list of ingredients referred to in Article 14
6(1)(g) when 
its 
concentration exceeds: 
– 0,001 % in 
leave-on products 
– 0,01 % in 
rinse-off products Í  
Î27 8
0 Í Î27 Anisyl alcohol Í ⌦ Anisyl alcohol, 
anise alcohol alcohol ⌫ ⌦ 105-
13-5 ⌫    Î
27 The 
presence of the substance must be indicated in the list of ingredients referred to in Article 14
6(1)(g) when 
its concentration   
EN 222   EN exceeds: 
– 0,001 % in 
leave-on products 
– 0,01 % in 
rinse-off products Í 
Î27 8
1 Í  ⌦ 2-Propenoic acid, 
3-phenyl, phenylmethyl ester ⌫ Î
27 Benzyl 
cinnamate Í 103-41-3    Î27 The 
presence of the substance must be indicated in the list of ingredients referred to in Article 14
6(1)(g) when 
its 
concentration 
exceeds: 
– 0,001 % in 
leave-on products 
– 0,01 % in 
rinse-off products Í  
Î27 8⌦ 2,6,10-Dodecatrien- Î27 Farnesol  Í 4602-84-    Î27 The   
EN 223   EN 2 Í 1-ol, 3,7,11-trimethyl-
 ⌫ 0 presence of the 
substance must be indicated in the list of ingredients referred to in Article 14
6(1)(g) when 
its 
concentration 
exceeds: 
– 0,001 % in 
leave-on products 
– 0,01 % in 
rinse-off products Í 
Î27 8
3 Í Î27 2-(4-tert-
bButylbenzyl)propional
dehydeÍ ⌦ Butylphenyl 
methylpropional ⌫ 80-54-6    Î27 The 
presence of the substance must be indicated in the list of ingredients referred to in Article 14
6(1)(g) when 
its concentration exceeds:   
EN 224   EN – 0,001 % in 
leave-on products 
– 0,01 % in 
rinse-off products Í 
Î27 8
4 Í ⌦ 1,6-Octadien-3-ol, 
3,7-dimethyl- ⌫ Î27 Linalool Í 78-70-6    Î27 The 
presence of the substance must be indicated in the list of ingredients referred to in Article 14
6(1)(g) when 
its concentration 
exceeds: 
– 0,001 % in 
leave-on products 
– 0,01 % in 
rinse-off products Í  
Î27 8
5 Í ⌦ Benzyl 
benzoate ⌫ Î27 Benzyl 
benzoate Í 120-51-4    Î27 The 
presence of the 
substance must   
EN 225   EN be indicated in 
the list of ingredients referred to in Article 14
6(1)(g) when 
its concentration exceeds: 
– 0,001 % in 
leave-on products 
– 0,01 % in 
rinse-off products Í 
Î27 8
6 Í  ⌦ Citronellol ⌫ Î27 Citronellol Í 106-22-9    Î27 The 
presence of the 
substance must 
be indicated in the list of ingredients referred to in Article 14
6(1)(g) when 
its concentration exceeds: 
– 0,001 % in   
EN 226   EN leave-on 
products 
– 0,01 % in 
rinse-off products Í 
Î27 8
7 Í  Î27 Hexyl cinnam-
al Í 101-86-0    Î27 The 
presence of the substance must be indicated in the list of ingredients referred to in Article 14
6(1)(g) when 
its concentration exceeds: 
– 0,001 % in 
leave-on products 
– 0,01 % in 
rinse-off products Í  
Î27 8
8 Í Î27 d-Limonene Í  5989-27-
5    Î27 The 
presence of the substance must 
be indicated in   
EN 227   EN the list of 
ingredients referred to in Article 14
6(1)(g) when 
its concentration exceeds: 
– 0,001 % in 
leave-on 
products 
– 0,01 % in 
rinse-off products Í 
Î27 8
9 Í Î27 Methyl heptin 
carbonate  Í 
⌦ Methyl oct-2-
ynoate ⌫ ⌦ Methyl 2-
octynoate ⌫ 111-12-6    Î27 The 
presence of the substance must 
be indicated in 
the list of ingredients referred to in Article 14
6(1)(g) when 
its concentration exceeds: 
– 0,001 % in 
leave-on   
EN 228   EN products 
– 0,01 % in 
rinse-off productsÍ 
Î27 9
0 Í Î27 3-Methyl-4-(2,6,6-
tri-methyl-2-cyclohexen-1-yl)-3-buten-2-one Í ⌦ alpha-Isomethyl 
ionone ⌫ 127-51-5    Î
27 The 
presence of the substance must be indicated in the list of ingredients referred to in Article 14
6(1)(g) when 
its concentration exceeds: 
– 0,001 % in 
leave-on 
products 
– 0,01 % in 
rinse-off productsÍ  
Î27 9
1 Í Î27 Oak moss 
extract Í ⌦ Evernia prunastri 
extract ⌫ 90028-
68-5    Î27 The 
presence of the substance must be indicated in 
the list of   
EN 229   EN ingredients 
referred to in Article 14
6(1)(g) when 
its concentration exceeds: 
– 0,001 % in 
leave-on 
products 
– 0,01 % in 
rinse-off productsÍ 
Î27 9
2 Í Î27 Treemoss 
extract Í ⌦ Evernia furfuracea 
extract ⌫ 90028-
67-4    Î27 The 
presence of the substance must be indicated in 
the list of 
ingredients referred to in Article 14
6(1)(g) when 
its concentration exceeds: 
– 0,001 % in 
leave-on products   
EN 230   EN – 0,01 % in 
rinse-off productsÍ 
Î28 9
3 Í Î28 2,4-
Pyrimidinediamine, 3-oxide Í  ⌦ Diaminopyrimidin
e oxide ⌫ 74638-
76-9  Î
28 Hair 
⌦ products 
⌫ care 
formulations  
Í Î28 1,5 % Í   
Î28 9
4 Í ⌦ Dibenzoyl 
peroxide ⌫ Î28 Benzoyl 
peroxide Í 
   Î28 Artificial 
nail systems Í Î
28 0,7 % 
(after mixing) Í Î
28 Profession
al use only  Í Î28 - For 
professional use only 
- Avoid skin 
contact 
- Read directions 
for use carefully Í 
Î28 9
5 Í Î28 Hydroquinone 
methylether Í 
 ⌦ Mequinol ⌫   Î28 Artificial 
nail systems Í Î
28 0,02 % 
(after mixing for use) Í Î
28 Profession
al use only  Í Î28 - For 
professional use only 
- Avoid skin 
contact 
Read directions 
for use carefully Í  
EN 231   EN Î29 9
6 Í ⌦ 5-tert-Butyl-2,4,6-
trinitro-m-xylene ⌫ Î29 Musk xylene Í 81-15-2  Î29 All 
cosmetic products, with the exception of oral care
 
products Í Î29 (a) 
1,0 % in fine fragrance 
 (b) 
0,4 % in eau de toilette 
 (c) 
0,03 % in other 
products Í   
Î29 9
7 Í ⌦ 4’-tert-Butyl-2’,6’-
dimethyl-3’,5’-dinitroacetophenone 
⌫ Î
29Musk ketone Í 81-14-1  Î29 All 
cosmetic products, with the exception of oral care
 
products Í Î29 (a) 
1,4 % in fine fragrance 
 (b) 
0,56 % in eau de toilette 
 (c) 
0,042 % in 
other products Í   
Î30 9
8 Í51  ⌦ Salicylic acid ⌫  Î30Salicylic acid Í 69-72-7  Î30 a) Rinse-
off hair products Î
30 a) 3,0 % 
b) 2,0 % Í Î30 Not to be 
used in preparations for Î
30 Not to be 
used for children under three
 
                                                 
51 As a preservative, see Annex VI, Part 1 , No 3.  
EN 232   EN b) Other 
products Í 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. Í ⌦ 3 ⌫ years of 
age
52 Í 
Î30 9
9 Í53 Î30 Inorganic sulfites 
and bisulfites Í ⌦ Ammonium 
bisulfite, ammonium sulfite, potassium metabisulfite, potassium sulfite, sodium bisulfite, sodium hydrosulfite, sodium metabisulfite,   Î
30 a) 
Oxidative hair dye products 
b) Hair 
straightening products 
c) Self tanning Î
30 a) 0,67 % 
expressed  (as 
free SO 2) 
b) 6,7 % 
expressed  (as 
free SO 2) 
c) 0,45 % Î30 For 
purposes other than inhibiting the development of micro-organisms in the product. Î
30 Í 
                                                                                                                                                                                                                                                    
52 Solely for products which might be used for children under three years of age and which remain in prolonged contact with the s kin. 
53 As a preservative, see Annex VI, Part 1 , No 9.  
EN 233   EN sodium sulfite ⌫ products for 
the face 
d) Other self 
tanning products Í expressed
 (as 
free SO 2) 
d) 0,40 % 
expressed  (as 
free SO 2) Í This purpose 
has to be apparent from the presentation of the product. Í 
Î30 1
00 Í
54 ⌦ 1-(4-
Chlorophenyl)-3-(3,4-dichlorophenyl)urea ⌫ Î
30 Triclocarban Í 101-20-2  Î30 Rinse-off 
products Í Î30 1,5 % Í Î30 Purity 
criteria: 
3,3',4,4'-
Tetrachloroazobenzene ≤ 1 ppm 
3,3',4,4'-
Tetrachloroazoxybenzene ≤ 1 ppm 
For purposes 
other than 
inhibiting the development of micro-organisms in the product. This purpose has to be Î
30 Í 
                                                 
54 As a preservative, See Annex VI, Part 1 , No 23.  
EN 234   EN apparent from 
the presentation of the product. Í 
Î30 1
01 Í
55 ⌦ Pyrithione zinc ⌫ Î30 Zinc 
pyrithione Í 13463-
41-7  Î30 Leave-on 
hair products Í Î
30 0,1 % Í Î30 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. Í Î
30 Í 
102 ⌦ 1,2-Dimethoxy-4-
(2-propenyl)-benzene ⌫ ⌦ Methyl 
eugenol ⌫ ⌦ 93-
15-2 ⌫ ⌦ 202-
223-0 ⌫ ⌦ fine 
fragrance ⌫ 
⌦ eau de 
toilette ⌫ 
⌦ fragrance 
cream ⌫ 
⌦ in other ⌦ 0,01 % 
0,004 % 
0,002 %    
                                                 
55 As a preservative, see Annex VI, Part 1 , No 8.  
EN 235   EN leave-on 
products and oral ⌫ 
hygiene
 
⌦ products 
⌫ 
⌦ rinse-off 
products ⌫ 
 
except for 
normal content 
in the natur al 
essences used 
and provided 
that the 
concentration 
does not 
excee d 0,0002 %  
  0,001 % ⌫ 
   : 
  
EN 236   EN  
Ð 86/199/EEC (adapted) 
Î1 88/667/EEC 
Î2 2002/34/EC Art. 1 and Annex .3 
Î3 2007/67/EC Art. 1 
Î4 2002/34/EC Art. 1 and Annex .3 amende d by Corrigendum, OJ L 151, 19.6.2003, p. 44 
®1 PART 2 ­ 
LIST OF SUBSTANCES PROVISIONALLY ALLOWED  
Restrictions  Refere
nce 
numbe
r Substance  
Field of 
application 
and/or use  Maximum 
authorized 
concentration in 
the finished 
cosmetic 
product  Other limitations 
and requirements  Conditions of 
use and 
warnings which 
must be printed 
on the label  Allowed 
until 
          
       
     
Î2 10
53 Í Î2 4-Amino-3-
nitrophenol and its salts Í ⌦ 4-
Amino-3-nitrophenol ⌫ 610-
81-1  Î
2 (a) 
Oxidising colouring agents for hair dyeing Í Î
2 (a) 
3,0 % Í Î2 In 
combination with hydrogen peroxide the maximum use Î
2 (a) (b) Can 
cause allergic reaction Í 
   
EN 237   EN Î2 (b) Non-
oxidising colouring agents for hair dyeing Í Î
2 (b) 
3,0 % Í concentration 
upon application is 1,5 % Í 
⌦ No use 
after ⌫ 
Î
3 31.12.2009 
Í 
Î2 10
64 Í Î2 2,7-Naphthalenediol 
and its salts Í ⌦ Nap
hthalene-2,7-diol (CI 76645). 
⌫ 582-
17-2  Î
2 Oxidising 
colouring agents for hair dyeing Í Î
2 1,0 % Í Î2 In 
combination with hydrogen peroxide the maximum use concentration upon application is 0,5 % Í 
⌦ No use 
after ⌫ 
Î
3 31.12.2009 
Í   
Î2 10
75 Í Î2 m-Aminophenol and 
its salts Í ⌦ 3-
Aminophenol (CI 76545). 
⌫ 591-
27-5   Î
2 Oxidising 
colouring agents for hair dyeing Í Î
2 2,0 % Í Î2 In 
combination with hydrogen peroxide the maximum use concentration 
upon application 
is 1,0 % Í Î
2 Can cause 
allergic reaction Í 
   
EN 238   EN ⌦ No use 
after ⌫ 
Î3 31.12.2009 
Í 
Î2 10
86 Í Î2 2,6-Dihydroxy-3,4-
dimethylpyridine and its salts Í ⌦ 2,6-
Dihydroxy-3,4-dimethylpyridine 
⌫  84540-
47-6  Î
2 Oxidising 
colouring agents for hair dyeing Í Î
2 2,0 % Í Î2 In 
combination with hydrogen peroxide the maximum use concentration upon application is 1,0 % Í 
⌦ No use 
after ⌫ 
Î
3 31.12.2009 
Í   
Î2 (a) 
Oxidising colouring agents for hair dyeing Í Î
2 (a) 
5,2 % Í Î2 10
97 Í ⌦ 1-hydroxy-3-nitro-4-
(3-hydroxypropylamino)benzene and its salts ⌫ Î
2 4-
Hydroxypropylamino-3-nitrophenol Í 92952-
81-3  
Î
2 (b) Non-
oxidising colouring agents for hair dyeing Í Î
2 (b) 
2,6 % Í Î2 In 
combination with hydrogen peroxide the maximum use concentration upon application is 2,6 % Í 
⌦ No use 
after ⌫ 
Î
3 31.12.2009 Î2 (a) (b) Can 
cause allergic reaction Í 
   
EN 239   EN Í 
          
Î2 (a) 
Oxidising colouring agents for hair dyeing Í Î
2 (a) 
3,0 % Í Î2 11
19 Í ⌦ 1-[(2'-
methoxyethyl)amino]-2-nitro-4-[di-(2'-hydroxyethyl)amino]benzene and its salts ⌫ Î
2 HC 
Blue No 11Í 23920-
15-2  
Î
2 (b) Non-
oxidising colouring agents for hair dyeing Í Î
2 (b) 
2,0 % Í Î2 In 
combination with hydrogen peroxide the maximum use concentration upon application is 1,5 % Í 
⌦ No use 
after ⌫ 
Î
3 31.12.2009 
Í Î2 (a) (b) Can 
cause allergic reaction Í 
  
Î2 (a) 
Oxidising colouring agents for hair dyeing Í Î
2 (a) 
2,0 % Í Î2 11
20 Í ⌦ 1-methyl-3-nitro-4-
(.beta.-hydroxyethyl)aminobenzene and its salts ⌫ Î
2 Hyd
roxyethyl-2-nitro-p-toluidine 
Í 100418
-33-5  
Î
2 (b) Non-
oxidising colouring agents for hair dyeing Í Î
2 (b) 
1,0 % Í Î2 In 
combination with hydrogen peroxide the maximum use concentration upon application is 1,0 % Í 
⌦ No use 
after ⌫ 
Î
3 31.12.2009 
Í Î2 (a) (b) Can 
cause allergic reaction Í 
   
EN 240   EN Î2 (a) 
Oxidising colouring agents for hair dyeing Í Î
2 (a) 
3,0 % Í Î2 11
3 Í ⌦ 1-hydroxy-2-.beta.-
hydroxyethylamino-4,6-dinitrobenzene and its salts ⌫ Î
2 2-
Hydroxyethylpicramic acid Í 99610-
72-7  
Î
2 (b) Non-
oxidising colouring agents for hair dyeing Í Î
2 (b) 
2,0 % Í Î2 In 
combination with hydrogen peroxide the maximum use concentration upon application is 1,5 % Í 
⌦ No use 
after ⌫ 
Î
3 31.12.2009 
Í Î2 (a) (b) Can 
cause allergic reaction Í 
  
Î2 11
42 Í ⌦ 4-
methylaminophenol and its salts ⌫  Î
2 p-
Methylaminophenol Í 150-
75-4  Î
2 Oxidising 
colouring agent for hair dyeing Í Î
2 3,0 % Í Î2 In 
combination with hydrogen peroxide the maximum use 
concentration 
upon application is 1,5 % Í 
⌦ No use 
after ⌫ 
Î
3 31.12.2009 
Í Î2 Can cause 
allergic reaction Í 
  
          
Î2 11⌦ 1-(3-
hydroxypropylamino)-2-Î2 HC 
Violet 104226  Î2 Non-
oxidising Î2 2,0 % Í ⌦ No use 
after ⌫    
EN 241   EN 64 Í nitro-4-bis(2-
hydroxyethylamino)benzene and its salts ⌫ No 2 Í -19-9 colouring 
agent for hair dyeing Í Î
3 31.12.2009 
Í 
          
Î2 (a) 
Oxidising colouring agents for hair dyeing Í Î
2 (a) 
1,5 % Í Î2 11
86 Í ⌦ 1-(.beta.-
Hydroxyethyl)amino-2-nitro-4-N-ethyl-N-(.beta.-hydroxyethyl)aminobenzene and its salts ⌫ Î
2 HC 
Blue No 12 Í 104516
-93-0  
Î
2 (b) Non-
oxidising colouring agents for hair dyeing Í Î
2 (b) 
1,5 % Í Î2 In 
combination with hydrogen peroxide the maximum use concentration upon application is 0,75 % Í 
⌦ No use 
after ⌫ 
Î
3 31.12.2009 
Í Î2 (a) (b) Can 
cause allergic reaction Í 
  
Î2 11
98 Í ⌦ 4,4'-[1,3-
propanediylbis(oxy)]bis-, benzene-1,3-diamine and its salts ⌫ Î
2 1,3-
Bis-(2,4-diaminophenoxy)propane 
Í 81892-
72-0  Î
2 Oxidising 
colouring agents for hair dyeing Í Î
2 2,0 % Í Î2 In 
combination with hydrogen peroxide the maximum use concentration upon application is 1,0 % Í 
⌦ No use 
after ⌫ 
Î
3 31.12.2009 Î2 Can cause 
allergic reaction Í 
   
EN 242   EN Í 
Î2 12
09 Í Î4 3-Amino-2,4-
dichlorophenol and its salts Í ⌦ 3-
Amino-2,4-dichlorophenol 
⌫  61693-
43-4  Î
2 Oxidising 
colouring agents for hair dyeing Í Î
2 2,0 % Í Î2 In 
combination with hydrogen peroxide the maximum use concentration upon application is 1,0 % Í 
⌦ No use 
after ⌫ 
Î
3 31.12.2009 
Í Î2 Can cause 
allergic reaction Í 
  
Î2 12
10 Í ⌦ 3-methyl-1-phenyl-
5-pyrazolone and its salts ⌫ Î
2 Phe
nyl methyl pyrazolone Í 89-25-
8  Î
2 Oxidising 
colouring agents for hair dyeing Í Î
2 0,5 % Í Î2 In 
combination with hydrogen peroxide the maximum use concentration upon application is 0,25 % Í 
⌦ No use 
after ⌫ 
Î
3 31.12.2009 
Í   
Î2 12
21 Í ⌦ 5-[(2-
hydroxyethyl)amino]-o-Î2 2-
Methyl-55302-
96-0  Î2 Oxidising 
colouring Î2 2,0 % Í Î2 In 
combination with Î2 Can cause 
allergic   
EN 243   EN cresol. and its salts ⌫ 5-
hydroxyethylaminophenol Í agents for hair 
dyeing Í hydrogen 
peroxide the maximum use concentration upon application is 1,0 % Í 
⌦ No use 
after ⌫ 
Î
3 31.12.2009 
Í reaction Í 
 
Î2 12
32 Í ⌦ 3,4-dihydro-2H-1,4-
benzoxazin-6-ol and its salts ⌫ Î
2 Hyd
roxybenzomorpholine Í 26021-
57-8  Î
2 Oxidising 
colouring agents for hair dyeing Í Î
2 2,0 % Í Î2 In 
combination with hydrogen peroxide the maximum use concentration upon application 
is 1,0 % Í 
⌦ No use 
after ⌫ 
Î
3 31.12.2009 
Í Î2 Can cause 
allergic reaction Í 
  
Î2 12
4 Í ⌦ 1,5-bis(.beta.-
hydroxyethyl)amino-2-nitro-4-chlorobenzene 
and its salts ⌫ Î
2 HC 
Yellow No 10 
Í 109023
-83-8  Î
2 Non-
oxidising colouring 
agents for hair 
dyeing Í Î
2 0,2 % Í ⌦ No use 
after ⌫ 
Î3 31.12.2009 
Í    
EN 244   EN Î2 12
5 Í ⌦ 3,5-diamino-2,6-
dimethoxypyridine dihydrochloride. and its salts ⌫ Î
2 2,6-
Dimethoxy-3,5-pyridinediamine 
Í 85679-
78-3  Î
2 Oxidising 
colouring agents for hair dyeing Í Î
2 0,5 % Í Î2 In 
combination with hydrogen peroxide the maximum use concentration upon application is 0,25 % Í 
⌦ No use 
after ⌫ 
Î
3 31.12.2009 
Í Î2 Can cause 
allergic reaction Í 
  
Î2 12
6 Í ⌦ 1-(2-
aminoethyl)amino-4-(2-hydroxyethyl)oxy-2-nitrobenzene and its salts ⌫ Î
2 HC 
Orange No 2 Í 85765-
48-6  Î
2 Non-
oxidising colouring agents for hair dyeing Í Î
2 1,0 % Í ⌦ No use 
after ⌫ 
Î3 31.12.2009 
Í   
Î2 (a) 
Oxidising colouring agents for hair dyeing Í Î
2 (a) 
0,5 % Í Î2 12
7 Í ⌦ Ethanol, 2-[(4-
amino-2-methyl-5-nitrophenyl)amino]-and its salts ⌫ Î
2 HC 
Violet No 1 Í 82576-
75-8  
Î
2 (b) Non-
oxidising colouring agents for hair dyeing Í Î
2 (b) 
0,5 % Í Î2 In 
combination with hydrogen peroxide the maximum use concentration upon application is 0,25 % Í 
⌦ No use 
after ⌫ 
Î
3 31.12.2009    
EN 245   EN Í 
Î2 12
8 Í ⌦ 2-[3-(methylamino)-
4-nitrophenoxy]ethanol and its salts ⌫ Î
2 3-
Methylamino-4-nitro-phenoxyethanol 
Í 59820-
63-2  Î
2 Non-
oxidising colouring agents for hair dyeing Í Î
2 1,0 % Í ⌦ No use 
after ⌫ 
Î3 31.12.2009 
Í   
Î2 12
9 Í ⌦ 2-[(2-methoxy-4-
nitrophenyl)amino]ethanol and its salts ⌫ . Î
2 2-
Hydroxy-ethylamino-5-nitro-anisole 
Í 66095-
81-6  Î
2 Non-
oxidising colouring agents for hair dyeing Í Î
2 1,0 % Í ⌦ No use 
after ⌫ 
Î3 31.12.2009 
Í   
       
     
Î2 (a) 
Oxidising colouring agents for hair dyeing Í Î
2 (a) 
2,5 % Í Î2 13
1 Í ⌦ 2,2'-[(4-amino-3-
nitrophenyl)imino]bisethanol hydrochlorideand its salts ⌫ Î
4 HC 
Red No 13 Í 94158-
13-1  
Î
2 (b) Non-
oxidising colouring Î
2 (b) 
2,5 % Í Î2 In 
combination with hydrogen peroxide the maximum use concentration upon application is 1,25 % Í    
EN 246   EN agents for hair 
dyeing Í ⌦ No use 
after ⌫ 
Î3 31.12.2009 
Í 
Î2 13
2 Í ⌦ Naphthalene-1,5-diol 
(CI 76625). and its salts ⌫ Î
2 1,5-
Naphthalenediol 
Í 83-56-
7  Î
2 Oxidising 
colouring agents for hair dyeing Í Î
2 1,0 % Í ⌦ No use 
after ⌫ 
Î3 31.12.2009 
Í   
Î2 13
3 Í Î2 Hydroxypropyl bis 
(N-hydroxyethyl-p-phenylenediamine) and its salts Í  128729
-30-6  Î
2 Oxidising 
colouring agents for hair dyeing Í Î
2 3,0 % Í Î2 In 
combination with hydrogen peroxide the maximum use concentration upon application is 1,5 % Í 
⌦ No use 
after ⌫ 
Î
3 31.12.2009 
Í Î2 Can cause 
allergic reaction Í 
  
Î2 13
4 Í Î2 o-Aminophenol and 
its salts Í ⌦ o-
Aminophenol 
⌫ 95-55-
6  Î
2 Oxidising 
colouring agents for hair dyeing Í Î
2 2,0 % Í Î2 In 
combination with hydrogen peroxide the maximum use concentration upon application    
EN 247   EN is 1,0 % Í 
⌦ No use 
after ⌫ 
Î3 31.12.2009 
Í 
Î2 13
5 Í ⌦ 5-amino-o-cresol and 
its salts ⌫  Î2 4-
Amino-2-hydroxytoluene 
Í 2835-
95-2  Î
2 Oxidising 
colouring agents for hair dyeing Í Î
2 3,0 % Í Î2 In 
combination with hydrogen peroxide the maximum use concentration upon application is 1,5 % Í 
⌦ No use 
after ⌫ 
Î
3 31.12.2009 
Í   
Î2 13
6 Í ⌦ 2,4-
Diaminophenoxyethano and its salts ⌫  Î
4 2,4-
Diaminophenoxyethanol 
Í 66422-
95-5  Î
2 Oxidising 
colouring agents for hair dyeing Í Î
2 4,0 % Í Î2 In 
combination with hydrogen peroxide the maximum use concentration upon application is 2,0 % Í 
⌦ No use 
after ⌫    
EN 248   EN Î3 31.12.2009 
Í 
Î2 13
7 Í ⌦ 1,3-Benzenediol, 2-
methyl and its salts ⌫ - Î2 2-
Methylresorcinol Í 608-
25-3  Î
2 Oxidising 
colouring agents for hair dyeing Í Î
2 2,0 % Í Î2 In 
combination with hydrogen peroxide the maximum use concentration upon application is 1,0 % Í 
⌦ No use 
after ⌫ 
Î
3 31.12.2009 
Í   
Î2 13
8 Í ⌦ 4-Amino-m-cresol 
and its salts ⌫  Î2 4-
Amino-m-cresol 
Í 2835-
99-6  Î
2 Oxidising 
colouring agents for hair dyeing Í Î
2 3,0 % Í Î2 In 
combination with hydrogen peroxide the maximum use concentration upon application is 1,5 % Í 
⌦ No use 
after ⌫ 
Î
3 31.12.2009 
Í   
Î2 13⌦ 2-[(3-amino-4- Î2 2- 83763-  Î2 Oxidising Î2 3,0 % Í Î2 In    
EN 249   EN 9 Í methoxyphenyl)amino]e
thanol and its salts ⌫ . Amino-
4-hydroxyethylaminoanisole Í 47-7 colouring 
agents for hair dyeing Í combination with 
hydrogen peroxide the maximum use concentration upon application is 1,5 % Í 
⌦ No use 
after ⌫ 
Î
3 31.12.2009 
Í 
          
          
Î2 14
24 Í Î2 Hydroxyethyl-3,4-
methylenedioxyaniline and its salts Í ⌦ HCI 
⌫ 81329-
90-0  Î
2 Oxidising 
colouring agents for hair dyeing Í Î
2 3,0 % Í Î2 In 
combination with hydrogen peroxide the maximum use concentration upon application is 1,5 % Í 
⌦ No use 
after ⌫ 
Î
3 31.12.2009 
Í   
           
EN 250   EN        
     
Î2 14
57 Í ⌦ 2,2'-[[4-[(2-
hydroxyethyl)amino]-3-nitrophenyl]imino]bisethanol. and its salts ⌫ Î
2 HC 
Blue No 2 Í 33229-
34-4  Î
2 Non-
oxidising colouring agents for hair dyeing Í Î
2 2,8 % Í ⌦ No use 
after ⌫ 
Î3 31.12.2009 
Í   
Î2 (a) 
Oxidising colouring agents for hair dyeing Í Î
2 (a) 
6,0 % Í Î2 14
68 Í ⌦ 4-[(2-
hydroxyethyl)amino]-3-nitrophenol. and its salts ⌫ Î
2 3-
Nitro-p-hydroxyethylaminophenol Í 65235-
31-6  
Î
2 (b) Non-
oxidising colouring agents for hair dyeing Í Î
2 (b) 
6,0 % Í Î2 In 
combination with hydrogen peroxide the maximum use concentration upon application is 3,0 % Í 
⌦ No use 
after ⌫ 
Î
3 31.12.2009 
Í   
Î2 (a) 
Oxidising colouring agents for hair dyeing Í Î
2 (a) 
0,5 % Í Î2 14
79 Í ⌦ 1-(.beta.-
ureidoethyl)amino-4-nitrobenzene and its salts ⌫ Î
2 4-
Nitrophenyl aminoethylurea 
Í 27080-
42-8  
Î
2 (b) Non-
oxidising Î2 (b) Î2 In 
combination with hydrogen peroxide the maximum use concentration upon application    
EN 251   EN colouring 
agents for hair dyeing Í 0,5 % Í is 0,25 % Í 
⌦ No use 
after ⌫ 
Î
3 31.12.2009 
Í 
Î2 (a) 
Oxidising colouring agents for hair dyeing Í Î
2 (a) 
2,0 % Í Î2 14
850 Í ⌦ 1-amino-2-nitro-4-
(2',3'-dihydroxypropyl)amino-5-chlorobenzene and 1,4-bis-(2',3'-dihydroxypropyl)amino-2-nitro-5-chlorobenzene 
And 1,4-bis-(2',3'-
dihydroxypropyl)amino-2-nitro-5-chlorobenzene and its salts ⌫ Î
2 HC 
Red No 10 and HC Red No 11 Í 95576-
89-9 and 95576-92-4  
Î
2 (b) Non-
oxidising colouring agents for hair dyeing Í Î
2 (b) 
1,0 % Í Î2 In 
combination with hydrogen peroxide the maximum use concentration upon application is 1,0 % Í 
⌦ No use 
after ⌫ 
Î
3 31.12.2009 
Í   
       
     
       
     
           
EN 252   EN        
     
Î2 (a) 
Oxidising colouring agents for hair dyeing Í Î
2 (a) 
3,0 % Í Î2 15
355 Í ⌦ Phenol, 2-chloro-6-
(ethylamino)-4-nitro- and its salts ⌫ Î
2 2-
Chloro-6-ethylamino-4-nitrophenol Í 131657
-78-8  
Î
2 (b) Non-
oxidising colouring agents for hair dyeing Í Î
2 (b) 
3,0 % Í Î2 In 
combination with hydrogen peroxide the maximum use concentration upon application is 1,5 % Í 
⌦ No use 
after ⌫ 
Î
3 31.12.2009 
Í   
Î2 (a) 
Oxidising colouring agents for hair dyeing Í Î
2 (a) 
2,0 % Í Î2 15
456 Í Î2 2-Amino-6-chloro-
4-nitrophenol and its salts Í ⌦ 2-
Amino-6-chloro-4-nitrophenol ⌫  6358-
09-4)   
Î
2 (b) Non-
oxidising colouring agents for hair dyeing Í Î
2 (b) 
2,0 % Í Î2 In 
combination with hydrogen peroxide the maximum use concentration upon application is 1,0 % Í 
⌦ No use 
after ⌫ 
Î
3 31.12.2009 
Í    
EN 253   EN Î2 (a) 
Oxidising colouring agents for hair dyeing Í Î
2 (a) 
0,5 % Í Î2 15
57 Í ⌦ [4-[[4-anilino-1-
naphthyl][4-(dimethylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride (CI 44045). and its salts ⌫ Î
2 Basi
c Blue 26 (CI 44045) 
Í 2580-
56-5  
Î
2 (b) Non-
oxidising colouring agents for hair dyeing Í Î
2 (b) 
0,5 % Í Î2 In 
combination with hydrogen peroxide the maximum use concentration upon application is 0,25 % Í 
⌦ No use 
after ⌫ 
Î
3 31.12.2009 
Í   
Î2 15
658 Í ⌦ Disodium 5-amino-
4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate (CI 17200). and its salts ⌫ Î
2 Acid 
Red 33 (CI 17200) 
Í 3567-
66-6  Î
2 Non-
oxidising colouring agents for hair dyeing Í Î
2 2,0 % Í ⌦ No use 
after ⌫ 
Î3 31.12.2009 
Í   
Î2 15
759 Í ⌦ Disodium 3-[(2,4-
dimethyl-5-sulphonatophenyl)azo]-4-hydroxynaphthalene-1-sulphonate (14700). and its salts ⌫ Î
2 Pon
ceau SX (CI 14700) 
Í 4548-
53-2  Î
2 Non-
oxidising colouring agents for hair dyeing Í Î
2 2,0 % Í ⌦ No use 
after ⌫ 
Î3 31.12.2009 
Í   
Î2 15
860 Í ⌦ (4-(4-
Aminophenyl)(4-iminocyclohexa-2,5-dienylidene)methyl)-2-methylaniline Î
2 Basi
c Violet 14 (CI 42510) 632-
99-5  Î
2 (a) 
Oxidising colouring agents for hair Î
2 (a) 
0,3 % Í Î2 In 
combination with hydrogen peroxide the maximum use    
EN 254   EN dyeing Í hydrochloride (CI 
42510). and its salts ⌫ Í 
Î2 (b) Non-
oxidising colouring agents for hair dyeing Í Î
2 (b) 
0,3 % Í concentration 
upon application is 0,15 % Í 
⌦ No use 
after ⌫ 
Î
3 31.12.2009 
Í 
  
EN 255   EN  
Ð 76/768/EEC 
ANNEX IV  
 
Ð 86/179/EEC (adapted) 
Î1 88/667/EEC 
Î2 90/121/EEC 
®1 PART  1 ­ 
LIST OF ⌦ COLORANTS ⌫ COLOURING AGENTS  ALLOWED FOR USE  IN COSMETIC PRODUCTS56 
⌦ PREAMBLE ⌫ 
⌦ Without prejudice to other prov isions in this Directive, a colorant expressed as salt shall include la kes 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 exclusi vely in cosmetic products intended to 
come into contact only briefly with the skin.  
                                                 
56 Lakes or salts of these colouring agents using substances not prohibited under Annex II or not excluded under Annex V from t he scope of this Directive  are equally allowed.   
EN 256   EN  
⌦ Substance identification ⌫ ⌦ Conditions ⌫ Field of applicatio n ⌦ 
Refe
renc
e 
num
ber 
°⌫ 
 ⌦ Chemical Name ⌫ 
  Colour index 
Number 
⌦ as 
contained in 
glossary ⌫ 
or 
denomination⌦ CAS 
number ⌫⌦ EINECS/
ELINCS number ⌫ Colour ⌦ Product type, 
Body parts ⌫ 
Field of 
application  
1 
2 
3 
4 ⌦ Maximum 
concentration 
⌫ Other 
limitations and 
requirements57 ⌦ Wordin
g of 
conditions 
of use and 
warnings 
⌫ 
a b  c  d  e  f  g  h  i  j  
⌦ 1
 ⌫ ⌦ Sodium tris(1,2-
naphthoquinone 1-oximato-O,O')ferrate(1-) ⌫ 10006   Green X
 ⌦ Rinse-off 
products ⌫    
                                                 
57 Colouring agents whose number is preceded by the letter ‘E’ in accordance whith the EEC  Directive of 1962 concerning foodstuff s and colouring matters must fulfil the 
purity requirements laid down in those D irectives. They continue to be subject to the general criteria se t out in Annex III to the 1962 Directive concerning colouring matters 
where the letter ‘E’ has been deleted therefrom.   
EN 257   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 ⌫    
⌦ 3
 ⌫ ⌦ Disodium 5,7-dinitro-8-
oxidonaphthalene-2-sulphonate and its insoluble barium, strontium and zirconium lakes, salts and pigments ⌫ 10316
58   Yellow X  ⌦ No use in 
eye products ⌫    
⌦ 4
 ⌫ ⌦ 2-[(4-methyl-2-
nitrophenyl)azo]-3-oxo-N-phenylbutyramide ⌫ 11680   Yellow X
 ⌦ No use in 
products applied on mucous membranes ⌫    
⌦ 5
 ⌫ ⌦ 2-[(4-chloro-2-
nitrophenyl)azo]-N-(2-chlorophenyl)-3-oxobutyramide ⌫ 11710   Yellow X
 ⌦ No use in 
products applied on mucous membranes ⌫    
⌦ 6
 ⌫ ⌦ 2-[(4-methoxy-2-
nitrophenyl)azo]-3-oxo-N-(o-tolyl)butyramide ⌫ 11725   Orange X
 ⌦ Rinse-off 
products ⌫    
                                                 
58 The insoluble barium, strontium and zirconium lakes, salts and pigment s 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.   
EN 258   EN ⌦ 7
 ⌫ ⌦ 4-
(phenylazo)resorcinol ⌫ 11920   Orange X     
⌦ 8
 ⌫ ⌦ 4-[(4-
ethoxyphenyl)azo]naphthol ⌫ 12010   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 ⌫ 12085
59   Red X  3 % maximum 
concentration 
in the finished 
product    
⌦ 
10 
⌫ ⌦ 1-(4-methyl-2-
nitrophenylazo)-2-naphthol ⌫ 12120   Red X
 ⌦ Rinse-off 
products ⌫    
⌦ 1
1 ⌫ ⌦ 3-hydroxy-N-(o-tolyl)-
4-[(2,4,5-trichlorophenyl)azo]naphthalene-2-carboxamide ⌫ 12370   Red X
 ⌦ Rinse-off 
products ⌫    
⌦ 1
2 ⌫ ⌦ N-(4-chloro-2-
methylphenyl)-4-[(4-chloro-2-12420   Red X
 ⌦ Rinse-off 
products ⌫    
                                                 
59 The insoluble barium, strontium and zirconium lakes, salts and pigments of these colouring age nts shall also be permitted. They must pass the test for insolubility which will 
be determined by the procedure laid down in Article 8.   
EN 259   EN methylphenyl)azo]-3-
hydroxynaphthalene-2-carboxamide ⌫ 
⌦ 1
3 ⌫ ⌦ 4-[(2,5-
dichlorophenyl)azo]-N-(2,5-dimethoxyphenyl)-3-hydroxynaphthalene-2-carboxamide ⌫ 12480   Brown X
 ⌦ Rinse-off 
products ⌫    
⌦ 1
4 ⌫ ⌦ N-(5-chloro-2,4-
dimethoxyphenyl)-4-[[5-[(diethylamino)sulphonyl]-2-methoxyphenyl]azo]-3-hydroxynaphthalene-2-carboxamide ⌫ 12490   Red X
    
⌦ 1
5 ⌫ ⌦ 2,4-dihydro-5-methyl-
2-phenyl-4-(phenylazo)-3H-pyrazol-3-one ⌫ 12700   Yellow X
 ⌦ Rinse-off 
products ⌫    
⌦ 1
6 ⌫ ⌦ Disodium 2-amino-5-
[(4-sulphonatophenyl)azo]benzenesulphonate ⌫ 13015   Yellow X
  E 105   
⌦ 1
7 ⌫ ⌦ Sodium 4-(2,4-
dihydroxyphenylazo)benzenesulphonate ⌫  14270   Orange X
  E 103   
⌦ 1
8 ⌫ ⌦ Disodium 3-[(2,4-
dimethyl-5-14700   Red X      
EN 260   EN sulphonatophenyl)azo]-4-
hydroxynaphthalene-1-sulphonate ⌫ 
⌦ 1
9 ⌫ ⌦ Disodium 4-hydroxy-3-
[(4-sulphonatonaphthyl)azo]naphthalenesulphonate ⌫ 14720   Red X
  E 122  ⌦ Purity 
criteria as set out in Commission Directive 95/45/EC (E 122) ⌫  
⌦ 2
0 ⌫ ⌦ Disodium 6-[(2,4-
dimethyl-6-sulphonatophenyl)azo]-5-hydroxynaphthalene-1-sulphonate ⌫  14815   Red X
  E 125   
⌦ 2
1 ⌫ ⌦Sodium 4-[(2-hydroxy-
1-naphthyl)azo]benzenesulphonate and its insoluble barium, strontium and zirconium lakes, salts and pigments ⌫  15510
60   Orange X  ⌦ No use in 
eye products ⌫    
⌦ 2
2 ⌫ ⌦ Calcium disodium 
bis[2-chloro-5-[(2-15525   Red X     
                                                 
60 The insoluble barium, strontium and zirconium lakes, salts and pigments of these colouring agents shall also be permit ted. They must pass the test for insolubility which will 
be determined by the procedure laid down in Article 8.   
EN 261   EN hydroxy-1-naphthyl)azo]-
4-sulphonatobenzoate] ⌫ 
⌦ 2
3 ⌫ ⌦ Barium bis[4-[(2-
hydroxy-1-naphthyl)azo]-2-methylbenzenesulphonate].
⌫  15580   Red X
    
⌦ 2
4 ⌫ ⌦ Sodium 4(-2-hydroxy-
1-naphthylazo)naphthalenesulphonate ⌫ 15620   Red X
 ⌦ Rinse-off 
products ⌫    
⌦ 2
5 ⌫ ⌦ Sodium 2-[(2-
hydroxynaphthyl)azo]naphthalenesulphonate and its insoluble barium, strontium and zirconium lakes, salts and pigments ⌫ 15630
61   Red X  3 % maximu m 
concentration 
in the finished 
product    
⌦ 2
6 ⌫ ⌦ Calcium bis[3-hydroxy-
4-(phenylazo)-2-naphthoate] ⌫ 15800   Red X
 ⌦ No use in 
products applied on mucous membranes ⌫    
⌦ 2⌦ Disodium 3-hydroxy-4-1585062   Red X   ⌦ Purity  
                                                 
61 The insoluble barium, strontium and zirconium lakes, salts and pigments of these colouring agents shall also be permitted. The y must pass the test for insolubility which will 
be determined by the procedure laid down in Article 8.   
EN 262   EN 7 ⌫ [(4-methyl-2-
sulphonatophenyl)azo]-2-naphthoate and its insoluble barium, strontium and zirconium lakes, salts and pigments ⌫ criteria as set 
out in Commission Directive 95/45/EC (E 180) ⌫ 
⌦ 2
8 ⌫ ⌦ Disodium 4-[(5-chloro-
4-methyl-2-sulphonatophenyl)azo]-3-hydroxy-2-naphthoate and its insoluble barium, strontium and zirconium lakes, salts and pigments ⌫ 15865
63   Red X     
⌦ 2
9 ⌫ ⌦ Calcium 3-hydroxy-4-
[(1-sulphonato-2-naphthyl)azo]-2-naphthoate 
⌫ 15880   Red X
    
⌦ 3
0 ⌫  ⌦ Disodium 6-hydroxy-
5-[(3-sulphonatophenyl)azo]naphthalene-2-sulphonate ⌫ 15980   Orange X
  E 111   
                                                                                                                                                                                                                                                    
62 The insoluble barium, strontium and zirconium lakes, salts and pigments of these colouring agents shall also be permitted. The y must pass the test for insolubility wh ich will 
be determined by the procedure laid down in Article 8.  
63 The insoluble barium, strontium and zirconium lakes, salts and pigments of these colouring agents shall also be permitted. The y must pass the test for insolubility which will 
be determined b y the procedure laid down in Article 8.   
EN 263   EN ⌦ 3
1 ⌫ ⌦Disodium 6-hydroxy-5-
[(4-sulphonatophenyl)azo]naphthalene-2-sulphonate and its insoluble barium, strontium and zirconium lakes, salts and pigments 
⌫ 15985
64   Yellow X   E 110  ⌦ Purity 
criteria as set out in Commission Directive 95/45/EC (E 110) ⌫  
⌦ 3
2 ⌫ 
⌦Disodium 6-hydroxy-5-
[(2-methoxy-4-sulphonato-m-tolyl)azo] naphthalene-2-sulphonate ⌫ 16035   Red X
  ⌦ Purity 
criteria as set out in Commission Directive 95/45/EC (E 129) ⌫  
⌦ 3
3 ⌫ 
⌦ Trisodium 3-hydroxy-
4-(4'-sulphonatonaphthylazo)naphthalene-2,7-disulphonate 
⌫ 16185   Red X
  E 123  ⌦ Purity 
criteria as set out in Commission Directive 95/45/EC (E 123) ⌫  
⌦ 3
4 ⌫ ⌦Disodium 7-hydroxy-8-
phenylazonaphthalene-1,3-16230   Orange X  ⌦ No use in 
products applied on mucous    
                                                 
64 The insoluble barium, strontium and zirconium lakes, salts and pigments of these colouring agents shall also be permitted. The y must pass the test for insolubility which will 
be determined by the procedure laid dow n in Article 8.   
EN 264   EN disulphonate ⌫ membranes ⌫ 
⌦ 3
5 ⌫ ⌦ Trisodium 1-(1-
naphthylazo)-2-hydroxynaphthalene-4',6,8-trisulphonate its insoluble barium, strontium and zirconium lakes, salts and pigments ⌫ 16255
65   Red X   E 124  ⌦ Purity 
criteria as set out in Commission Directive 95/45/EC (E 124) ⌫  
⌦ 3
6 ⌫ ⌦ Tetrasodium 7-
hydroxy-8-[(4-sulphonato-1-naphthyl)azo]naphthalene-1,3,6-trisulphonate ⌫ 16290   Red X
  E 126   
⌦ 3
7 ⌫ ⌦ Disodium 5-amino-4-
hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate and its insoluble barium, strontium and zirconium lakes, salts and pigments ⌫ 17200Î
2 66 
Í   Red X     
⌦ 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 The insoluble barium, strontium and zirconium lakes, salts and pigments of these colouring agents shall also be permitted. The y must pass the test for insolubility which will 
be determined by the procedure laid down in Article 8.  
66 The in soluble 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.   
EN 265   EN 2,7-disulphonate ⌫ membranes ⌫ Commission 
Directive 95/45/EC (E128) ⌫ 
⌦ 3
9 ⌫ ⌦ 2,7-
naphthalenedisulfonic acid, 3-((4-cyclohexyl-2-methylphenyl)azo)-4-hydroxy-5-(((4-methylphenyl)sulfonyl)amino)-, disodium salt ⌫ 18130   Red X
 ⌦ Rinse-off 
products ⌫    
⌦ 4
0 ⌫ ⌦ Hydrogen bis[2-[(4,5-
dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]benzoato(2-)]chromate(1-) ⌫ 18690   Yellow X
 ⌦ Rinse-off 
products ⌫    
⌦ 4
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-) ⌫ 18736   Red X
 ⌦ Rinse-off 
products ⌫    
⌦ 4
2 ⌫ ⌦ Sodium 4-(3-hydroxy-
5-methyl-4-phenylazopyrazol-2-
yl)benzenesulphonate ⌫ 18820   Yellow X
 ⌦ Rinse-off 
products ⌫     
EN 266   EN ⌦ 4
3 ⌫ ⌦ Disodium 2,5-dichloro-
4-(5-hydroxy-3-methyl-4-(sulphophenylazo)pyrazol-1-yl)benzenesulphonate ⌫ 18965   Yellow X
    
⌦ 4
4 ⌫ ⌦ Trisodium 5-hydroxy-
1-(4-sulphophenyl)-4-(4-sulphophenylazo)pyrazole-3-carboxylate and its insoluble barium, strontium and zirconium lakes, salts and pigments ⌫ 19140
67   Yellow X   E 102  ⌦ Purity 
criteria as set out in Commission Directive 95/45/EC (E 102) ⌫  
⌦ 4
5 ⌫ ⌦ N,N'-(3,3'-
dimethyl[1,1'-biphenyl]-4,4'-diyl)bis[2-[(2,4-dichlorophenyl)azo]-3-oxobutyramide] ⌫ 20040   Yellow X
 ⌦ Rinse-off 
products ⌫  Mm aximum 
3,3'-dimethylbenzidine concentration in the colouring agent: 5 ppm  
⌦ 4
6 ⌫ ⌦ Sodium 4-amino-5-
hydroxy-3-(4-nitrophenylazo)-6-(phenylazo)naphthalene-2,7-disulphonate ⌫ 20470   Black X
 ⌦ Rinse-off 
products ⌫    
⌦ 4⌦ 2,2'-[(3,3'-dichloro[1,1'- 21100   Yellow X  ⌦ Rinse-off  m Maximum  
                                                 
67 The insoluble barium, strontiu m and zirconium lakes, salts and pigments of these colouring agents shall also be permitted. They must pass the test for insolu bility which will 
be determined by the procedure laid down in Article 8.   
EN 267   EN 7 ⌫ biphenyl]-4,4'-
diyl)bis(azo)]bis[N-(2,4-dimethylphenyl)-3-oxobutyramide] ⌫ products ⌫ 3,3'-
dimethylbenzidine concentration in the colouring agent: 5 ppm 
⌦ 4
8 ⌫ ⌦ 2,2'-[(3,3'-dichloro[1,1'-
biphenyl]-4,4'-diyl)bis(azo)]bis[N-(4-chloro-2,5-dimethoxyphenyl)-3-oxobutyramide] ⌫ 21108   Yellow X
 ⌦ Rinse-off 
products ⌫ Ditto  m Maximum 
3,3'-dimethylbenzidine concentration in the colouring agent: 5 ppm  
⌦ 4
9 ⌫ ⌦ 2,2'-
[cyclohexylidenebis[(2-methyl-4,1-phenylene)azo]]bis[4-cyclohexylphenol] ⌫ 21230   Yellow X
 ⌦ No use in 
products applied on mucous membranes ⌫    
⌦ 5
0 ⌫ ⌦ Disodium 4,6-
dihydroxy-3-[[4-[1-[4-[[1-hydroxy-7-[(phenylsulphonyl)oxy]-3-sulphonato-2-naphthyl]azo]phenyl]cyclohexyl]phenyl]azo]naphthalene-2-sulphonate ⌫ 24790   Red X
 ⌦ Rinse-off 
products ⌫     
EN 268   EN  
Ð 76/768/EEC (adapted) 
Î1 92/86/EEC 
Î2 86/179/EEC 
Î3 90/121/EEC 
Î4 87/137/EEC 
Î5 88/233/EEC 
⌦ 5
1 ⌫ ⌦ 1-(4-
(phenylazo)phenylazo)-2-
naphthol ⌫ Î1 26100 Í   Î1 Red 
Í Î1 X Í ⌦ No 
use in products 
applied on 
mucous membranes ⌫  Î
1 Purity 
criteria: 
aniline ≤ 0,2 % 
2-naphtol ≤ 0,2 % 
4-aminoazobenzene ≤ 0,1 % 
1-(phenylazo)-2-naphtol ≤ 3 % 
1-[2-(phenylazo)phenylazo]-2-napthalenol ≤ 2 % Í  
⌦ 5
2 ⌫ ⌦ Tetrasodium 6-amino-
4-hydroxy-3-[[7-sulphonato-4-[(4-sulphonatophenyl)azo]-1-
naphthyl]azo]naphthalene-
2,7-disulphonate ⌫ Î
2 27755 Í   Î2 Blac
k Í Î2 X Í  Î2 E 152  Í  
⌦ 5⌦ Tetrasodium 1-
acetamido-2-hydroxy-3-(4-Î2 28440 Í   Î2 BlacÎ2 X Í  Î2 E 151  Í 
⌦ Purity   
EN 269   EN 3 ⌫ ((4-sulphonatophenylazo)-
7-sulphonato-1-naphthylazo))naphthalene-4,6-disulphonate ⌫ k Í criteria as set 
out in Commission Directive 95/45/EC (E 151) ⌫ 
⌦ 5
4 ⌫ ⌦ Benzenesulfonic acid, 
2,2'-(1,2-ethenediyl)bis[5-nitro-, disodium salt, reaction products with 4-[(4-aminophenyl)azo]benzenesulfonic acid, sodium salts ⌫ Î
2 40215 Í   Î2 Ora
nge Í Î2 X Í 
⌦ Rinse-off 
products ⌫    
⌦ 5
5 ⌫ ⌦ .beta.,.beta.-
carotene ⌫ Î2 40800 Í   Î2 Ora
nge Í Î2 X Í  ⌦ Purity 
criteria as set out in Commission Directive 95/45/EC (E 160a) ⌫  
⌦ 5
6 ⌫ ⌦ 8'-apo-.beta.-caroten-8'-
al ⌫ Î2 40820 Í   Î2 Ora
nge Í Î2 X Í  Î2 E 160 e  Í 
⌦ Purity 
criteria as set out in Commission Directive 95/45/EC (E   
EN 270   EN 160c) ⌫ 
⌦ 5
7 ⌫ ⌦ Ethyl 8'-apo-.beta.-
caroten-8'-oate ⌫ Î2 40825 Í   Î2 Ora
nge Í Î2 X Í  Î2 E 160 f  Í 
⌦ Purity 
criteria as set out in Commission Directive 95/45/EC (E 160f) ⌫  
⌦ 5
8 ⌫ ⌦ Canthaxanthin ⌫ Î2 40850 Í   Î2 Ora
nge Í Î2 X Í  Î2 E 161 
g Í⌦  Purity 
criteria as set out in Commission Directive 95/45/EC (E 161g) ⌫  
⌦ 5
9 ⌫ ⌦ Ammonium, (4-(alpha-
(p-(diethylamino)phenyl)-2,4-disulfobenzylidene)-2,5-cyclohexadien-1-ylidene)diethyl-, hydroxide, monosodium sal
t ⌫ Î2 42045 Í   Î2 Blue
 Í Î3 X Í ⌦ No 
use in products applied on mucous membranes ⌫     
EN 271   EN ⌦ 6
0 ⌫ ⌦ 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 ⌫ Î
2 4205168 
Í   Î2 Blue
 Í Î2 X Í  Î2 E 131  Í 
⌦ Purity 
criteria as set out in Commission Directive 95/45/EC (E 131) ⌫  
⌦ 6
1 ⌫ ⌦ 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 ⌫ Î
2 42053 Í   Î2 Gree
n Í Î2 X Í    
⌦ 6
2 ⌫ ⌦ Hydrogen (benzyl)[4-
[[4-[benzylethylamino]phenyl](2,4-Î
2 42080 Í   Î2 Blue
 Í Î2 X Í 
⌦ Rinse-off 
products ⌫    
                                                 
68 The insoluble barium, strontium and zirconium lakes, s alts 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.   
EN 272   EN disulphonatophenyl)methyl
ene]cyclohexa-2,5-dien-1-ylidene](ethyl)ammonium, sodium salt ⌫ 
⌦ 6
3 ⌫ ⌦ 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 sal
t ⌫ Î2 42090 Í   Î2 Blue
 Í Î2 X Í  ⌦ Purity 
criteria as set out in Commission Directive 95/45/EC (E 133) ⌫  
⌦ 6
4 ⌫ ⌦ Hydrogen [4-[(2-
chlorophenyl)[4-[ethyl(3-sulphonatobenzyl)amino]phenyl]methylene]cyclohexa-2,5-dien-1-ylidene](ethyl)(3-sulphonatobenzyl)ammonium, sodium salt ⌫ Î
2 42100 Í   Î2 Gree
n Í Î2 X Í 
⌦ Rinse-off 
products ⌫    
⌦ 6
5 ⌫ ⌦ Hydrogen [4-[(2-
chlorophenyl)[4-[ethyl(3-sulphonatobenzyl)amino]-o-tolyl]methylene]-3-methylcyclohexa-2,5-dien-1-ylidene](ethyl)(3-sulphonatobenzyl)ammoniÎ
2 42170 Í   Î2 Gree
n Í Î2 X Í 
⌦ Rinse-off 
products ⌫     
EN 273   EN um, sodium salt ⌫ 
⌦ 6
6 ⌫ ⌦ (4-(4-aminophenyl)(4-
iminocyclohexa-2,5-dienylidene)methyl)-2-methylaniline hydrochloride ⌫ Î
2 42510 Í   Î2 Viol
et Í Î2 X Í ⌦ No 
use in products applied on mucous membranes ⌫    
⌦ 6
7 ⌫ ⌦ 4-[(4-amino-m-
tolyl)(4-imino-3-methylcyclohexa-2,5-dien-1-ylidene)methyl]-o-toluidine monohydrochloride ⌫ Î
2 42520 Í   Î2 Viol
et Í Î2 X Í 
⌦ Rinse-off 
products ⌫  Î2 5 ppm 
maximum 
concentration in 
the finished 
product  Í  
⌦ 6
8 ⌫ ⌦ Hydrogen [4-[[4-
(diethylamino)phenyl][4-[ethyl[(3-sulphonatobenzyl)amino]-o-tolyl]methylene]-3-methylcyclohexa-2,5-dien-1-ylidene](ethyl)(3-sulphonatobenzyl)ammonium, sodium salt ⌫ Î
2 42735 Í   Î2 Blue
 Í Î2 X Í ⌦ No 
use in products applied on mucous membranes ⌫    
⌦ 6
9 ⌫ ⌦ [4-[[4-anilino-1-
naphthyl][4-(dimethylamino)phenyl]methylene]cyclohexa-2,5-dien-1-
ylidene]dimethylammoniuÎ
2 44045 Í   Î2 Blue
 Í Î3 X Í ⌦ No 
use in products applied on mucous membranes ⌫     
EN 274   EN m chloride ⌫ 
⌦ 7
0 ⌫ ⌦ Hydrogen [4-[4-
(dimethylamino)-.alpha.-(2-hydroxy-3,6-disulphonato-1-naphthyl)benzylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium, monosodium salt ⌫ Î
2 44090 Í   Î2 Gree
n Í Î2 X Í  Î2 E 142  Í 
⌦ Purity 
criteria as set out in Commission Directive 95/45/EC (E 142) ⌫  
⌦ 7
1 ⌫ ⌦ Hydrogen 3,6-
bis(diethylamino)-9-(2,4-disulphonatophenyl)xanthylium, sodium salt ⌫ Î
2 45100 Í   Î2 Red 
Í Î2 X Í 
⌦ Rinse-off 
products ⌫    
⌦ 7
2 ⌫ ⌦ Hydrogen 9-(2-
carboxylatophenyl)-3-(2-methylanilino)-6-(2-methyl-4-sulphoanilino)xanthylium, monosodium salt ⌫ Î
2 45190 Í   Î2 Viol
et Í Î2 X Í 
⌦ Rinse-off 
products ⌫    
⌦ 7
3 ⌫ ⌦ Hydrogen 9-(2,4-
disulphonatophenyl)-3,6-bis(ethylamino)-2,7-dimethylxanthylium, monosodium salt ⌫ Î
2 45220 Í   Î2 Red 
Í Î2 X Í 
⌦ Rinse-off 
products ⌫    
⌦ 7
4 ⌫ ⌦ Disodium 2-(3-oxo-6-
oxidoxanthen-9-Î2 45350 Í   Î2 Yell
ow Í Î2 X Í Î2 6 % 
maximum    
EN 275   EN yl)benzoate ⌫ concentration 
in the finished 
product  Í 
⌦ 7
5 ⌫ ⌦ 4',5'-dibromo-3',6'-
dihydroxyspiro[isobenzofuran-1(3H),9'-[9H]xanthene]-3-one and its insoluble barium, strontium and zirconium lakes, salts and pigments ⌫ Î
2 4537069 
Í   Î2 Ora
nge Í Î2 X Í  Î2 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 Í  
⌦ 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 
⌫ Î
2 4538070 
Í   Î2 Red 
Í Î2 X Í Î2 ditto  Í Î2 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 Í  
                                                 
69 The insoluble barium, strontium and zirconium lakes, salts and pigments of the se 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.   
EN 276   EN ⌦ 7
7 ⌫ ⌦ 3',6'-dihydroxy-4',5'-
dinitrospiro[isobenzofuran-1(3H),9'-[9H]xanthene]-3-one ⌫ Î
2 45396 Í   Î2 Ora
nge Í Î2 X Í Î2 ⌦ 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 % Í ⌦ Only in free 
acid form, when used in lip products ⌫  
⌦ 7
8 ⌫ ⌦ Dipotassium 3,6-
dichloro-2-(2,4,5,7-tetrabromo-6-oxido-3-oxoxanthen-9-yl)benzoate ⌫ Î
2 45405 Í   Î2 Red 
Í Î2 X Í ⌦ No 
use in eye products ⌫  Î
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 Í  
                                                                                                                                                                                                                                                    
70 The insoluble barium, strontium and zirconium lakes, salts and pigments of these colouring agents shal l also be permitted. They must pass the test for insolubility which will 
be determined by the procedure laid down in Article 8.   
EN 277   EN ⌦ 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 ⌫ Î
2 4541071 
Í   Î2 Red 
Í Î2 X Í Î2 ditto  Í Î2 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 Í  
⌦ 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 ⌫ Î
2 4543072 
Í   Î2 Red 
Í Î2 X Í  Î2 E 127 
ditto Í 
⌦ Purity 
criteria as set out in Commission Directive 95/45/EC (E 127) ⌫ 
⌦ Not more 
than 1 % 2-(6-hydroxy-3-oxo- 
                                                 
71 The insoluble barium, strontium and zirconium lakes, salts and pigments of these colouring agents shall also be permitted. The y must pass the test for insolubility which will 
be determined by the procedure laid down in Article 8.  
72 The insoluble barium, strontium and zirconium lakes, salts and pigments of these colouring agents shall also be permitted. The y must pass the test for  insolubility which will 
be determined by the procedure laid down in Article 8.   
EN 278   EN 3H-xanthen-9-
yl) benzoic acid and 3% 2-(iodo-6-hydroxy-3-oro-3H-xanthen-9-yl) benzoic acid. ⌫ 
⌦ 8
1 ⌫ ⌦ 1,3-
Isobenzofurandione, reaction products with methylquinoline and quinoline ⌫ Î
2 47000 Í   Î2 Yell
ow Í Î2 X Í ⌦ No 
use in products applied on mucous membranes ⌫    
⌦ 8
2 ⌫ ⌦ 1H-Indene-1,3(2H)-
dione, 2-(2-quinolinyl)-, sulfonated, sodium salts ⌫ Î
2 47005 Í   Î2 Yell
ow Í Î2 X Í  Î2 E 104  Í 
⌦ Purity 
criteria as set out in Commission Directive 95/45/EC (E 104) ⌫  
⌦ 8
3 ⌫ ⌦ Hydrogen 9-[(3-
methoxyphenyl)amino]-7-phenyl-5-(phenylamino)-4,10-disulphonatobenzo[a]phenazinium, sodium salt ⌫ Î
2 50325 Í   Î2 Viol
et Í Î2 X Í 
⌦ Rinse-off 
products ⌫     
EN 279   EN ⌦ 8
4 ⌫ ⌦ Sulfonated nigrosine 
color ⌫ Î2 50420 Í   Î2 Blac
k Í Î2 X Í ⌦ No 
use in products applied on mucous membranes ⌫    
⌦ 8
5 ⌫ ⌦ 8,18-dichloro-5,15-
diethyl-5,15-dihydrodiindolo[3,2-b:3',2'-m]triphenodioxazine ⌫ Î
2 51319 Í   Î2 Viol
et Í Î2 X Í 
⌦ Rinse-off 
products ⌫    
⌦ 8
6 ⌫ ⌦ 1,2-
dihydroxyanthraquinone 
⌫ Î2 58000 Í   Î2 Red 
Í Î2 X Í    
⌦ 8
7 ⌫ ⌦ Trisodium 8-
hydroxypyrene-1,3,6-trisulphonate ⌫ Î
2 59040 Í   Î2 Gree
n Í Î2 X Í ⌦ No 
use in products applied on mucous membranes ⌫    
⌦ 8
8 ⌫ ⌦ 1-anilino-4-
hydroxyanthraquinone ⌫  Î2 60724 Í   Î2 Viol
et Í Î2 X Í 
⌦ Rinse-off 
products ⌫    
⌦ 8
9 ⌫ ⌦ 1-hydroxy-4-(p-
toluidino)anthraquinone 
⌫ Î2 60725 Í   Î2 Viol
et Í Î2 X Í     
EN 280   EN ⌦ 9
0 ⌫ ⌦ Sodium 4-[(9,10-
dihydro-4-hydroxy-9,10-dioxo-1-anthryl)amino]toluene-3-sulphonate ⌫ Î
2 60730 Í   Î2 Viol
et Í Î2 X Í ⌦ No 
use in products applied on mucous membranes ⌫    
⌦ 9
1 ⌫ ⌦ 1,4-bis(p-
tolylamino)anthraquinone 
⌫ Î2 61565 Í   Î2 Gree
n Í Î2 X Í    
⌦ 9
2 ⌫ ⌦ Disodium 2,2'-(9,10-
dioxoanthracene-1,4-diyldiimino)bis(5-methylsulphonate) ⌫ Î
2 61570 Í   Î2 Gree
n Í Î2 X Í    
⌦ 9
3 ⌫ ⌦ Sodium 3,3'-(9,10-
dioxoanthracene-1,4-diyldiimino)bis(2,4,6-trimethylbenzenesulphonate) ⌫ Î
2 61585 Í   Î2 Blue
 Í Î2 X Í 
⌦ Rinse-off 
products ⌫    
⌦ 9
4 ⌫ ⌦ Sodium 1-amino-4-
(cyclohexylamino)-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate ⌫ Î
2 62045 Í   Î2 Blue
 Í Î2 X Í 
⌦ Rinse-off 
products ⌫    
⌦ 9
5 ⌫ ⌦ 6,15-
dihydroanthrazine-5,9,14,18-tetrone ⌫ Î
2 69800 Í   Î2 Blue
 Í Î2 X Í  Î2 E 130  Í   
EN 281   EN ⌦ 9
6 ⌫ ⌦ 7,16-dichloro-6,15-
dihydroanthrazine-5,9,14,18-tetrone ⌫ Î
2 69825 Í   Î2 Blue
 Í Î2 X Í    
⌦ 9
7 ⌫ ⌦ Bisbenzimidazo[2,1-
b:2',1'-i]benzo[lmn][3,8]phenanthroline-8,17-dione ⌫ Î
2 71105 Í   Î2 Ora
nge Í Î2 X Í ⌦ No 
use in products applied on mucous membranes ⌫    
⌦ 9
8 ⌫ ⌦ 2-(1,3-dihydro-3-oxo-
2H-indazol-2-ylidene)-1,2-dihydro-3H-indol-3-one ⌫ Î
2 73000 Í   Î2 Blue
 Í Î2 X Í    
⌦ 9
9 ⌫ ⌦ Disodium 5,5'-(2-(1,3-
dihydro-3-oxo-2H-indazol-2-ylidene)-1,2-dihydro-3H-indol-3-one)disulphonate ⌫ Î
2 73015 Í   Î2 Blue
 Í Î2 X Í  Î2 E 132  Í 
⌦ Purity 
criteria as set out in Commission Directive 95/45/EC (E 132) ⌫  
⌦ 1
00 
⌫ ⌦ 6-chloro-2-(6-chloro-4-
methyl-3-oxobenzo[b]thien-2(3H)-ylidene)-4-methylbenzo[b]thiophene-3(2H)-one ⌫ Î
2 73360 Í   Î2 Red 
Í Î2 X Í     
EN 282   EN ⌦ 1
01 
⌫ ⌦ 5-chloro-2-(5-chloro-7-
methyl-3-oxobenzo[b]thien-2(3H)-ylidene)-7-methylbenzo[b]thiophene-3(2H)-one ⌫ Î
2 73385 Í   Î2 Viol
et Í Î2 X Í    
⌦ 1
02 
⌫ ⌦ 5,12-dihydroquino[2,3-
b]acridine-7,14-dione ⌫ Î2 73900 Í   Î2 Viol
et Í Î2 X Í 
⌦ Rinse-off 
products ⌫    
⌦ 1
03 
⌫ ⌦ 5,12-dihydro-2,9-
dimethylquino[2,3-b]acridine-7,14-dione ⌫ Î
2 73915 Í   Î2 Red 
Í Î2 X Í 
⌦ Rinse-off 
products ⌫    
⌦ 1
04 
⌫ ⌦ 29H,31H-
phthalocyanine ⌫ Î2 74100 Í   Î2 Blue
 Í Î2 X Í 
⌦ Rinse-off 
products ⌫    
⌦ 1
05 
⌫ ⌦ 29H,31H-
phthalocyaninato(2-)-N29,N30,N31,N32 copper ⌫ Î
2 74160 Í   Î2 Blue
 Í Î2 X Í    
⌦ 1
06 
⌫ ⌦ Disodium [29H,31H-
phthalocyaninedisulphonato(4-)-N29,N30,N31,N32]cuprate(2-) ⌫ Î
2 74180 Í   Î2 Blue
 Í Î2 X Í 
⌦ Rinse-off 
products ⌫    
⌦ 1
07 ⌦ Polychloro copper Î2 74260 Í   Î2 GreeÎ2 X Í ⌦ No 
use in eye     
EN 283   EN ⌫ phthalocyanine ⌫ n Í products ⌫ 
⌦ 1
08 
⌫ ⌦ 8,8'-diapo-.psi.,.psi.-
carotenedioic acid ⌫ Î2 75100 Í   Î2 Yell
ow Í Î2 X Í    
⌦ 1
09 
⌫ ⌦ Annatto ⌫ Î2 75120 Í   Î2 Ora
nge Í Î2 X Í  Î2 E 160 b  Í 
⌦ Purity 
criteria as set out in Commission Directive 95/45/EC (E 160b) ⌫  
⌦ 1
10 
⌫ ⌦ Psi,psi-carotene ⌫ Î2 75125 Í   Î2 Yell
ow Í Î2 X Í  Î2 E 160 d  Í 
⌦ Purity 
criteria as set out in Commission Directive 95/45/EC (E 160d) ⌫  
⌦ 1
11 
⌫ ⌦ β-β-carotene ⌫ Î2 75130 Í   Î2 Ora
nge Í Î2 X Í  Î2 E 160 a  Í 
⌦ Purity 
criteria as set out in Commission Directive 
95/45/EC (E 
160e) ⌫   
EN 284   EN ⌦ 1
12 
⌫ ⌦ (3R)-beta-4-caroten-3-
ol ⌫ Î2 75135 Í   Î2 Yell
ow Í Î2 X Í  Î2 E 161 d  Í  
⌦ 1
13 
⌫ ⌦ 2-Amino-1,7-dihydro-
6H-purin-6-one ⌫ Î2 75170 Í   Î2 Whi
te Í Î2 X Í    
⌦ 1
14 
⌫ ⌦ 1,7-bis(4-hydroxy-3-
methoxyphenyl)hepta-1,6-diene-3,5-dione ⌫ Î
2 75300 Í   Î2 Yell
ow Í Î2 X Í  Î2 E 100  Í 
⌦ Purity 
criteria as set out in Commission Directive 
95/45/EC (E 
100) ⌫  
⌦ 1
15 
⌫ ⌦ Carmine ⌫ Î2 75470 Í   Î2 Red 
Í Î2 X Í  Î2 E 120  Í 
⌦ Purity 
criteria as set out in Commission Directive 95/45/EC (E 120) ⌫  
⌦1
16 
⌫ ⌦ Trisodium (2S-trans)-
[18-carboxy-20-(carboxymethyl)-13-ethyl-2,3-dihydro-3,7,12,17-tetramethyl-8-vinyl-Î
2 75810 Í   Î2 Gree
n Í Î2 X Í  Î2 E 14 0 and E 
141 Í 
⌦ Purity 
criteria as set out in   
EN 285   EN 21H,23H-porphine-2-
propionato(5-)-N21,N22,N23,N24]cuprate(3-) ⌫ Commission 
Directive 95/45/EC (E 140, E 141) ⌫ 
⌦ 1
17 
⌫ ⌦ Aluminium ⌫ Î2 77000 Í   Î2 Whi
te Í Î2 X Í  Î2 E 173  Í 
⌦ Purity 
criteria as set out in Commission Directive 95/45/EC (E 173) ⌫  
⌦ 1
18 
⌫ ⌦ Aluminium hydroxide 
sulphate ⌫ Î2 77002 Í   Î2 Whi
te Í Î2 X Í    
⌦ 1
19 
⌫ ⌦ Natural hydrated 
aluminium silicate, Al2O3.2SiO2.2H2O, containing calcium, magnesium or iron carbonates, ferric hydroxide, quartz-sand, mica, etc. as impurities ⌫ Î
2 77004 Í   Î2 Whi
te Í Î2 X Í    
⌦ 1
20 
⌫ ⌦ Lazurite ⌫ Î2 77007 Í   Î2 Blue
 Í Î2 X Í    
⌦ 1⌦ Aluminum silicate Î2 77015 Í   Î2 Red Î2 X Í     
EN 286   EN 21 
⌫ coloured with ferric 
oxide ⌫ Í 
⌦ 1
22 
⌫ ⌦ Barium sulfate ⌫ Î2 77120 Í   Î2 Whi
te Í Î2 X Í    
⌦ 1
23 
⌫ ⌦ Bismuth chloride 
oxide ⌫ Î2 77163 Í   Î2 Whi
te Í Î2 X Í    
⌦ 1
24 
⌫ ⌦ Calcium carbonate ⌫ Î2 77220 Í   Î2 Whi
te Í Î2 X Í  Î2 E 170  Í 
⌦ Purity 
criteria as set out in Commission Directive 95/45/EC (E 170) ⌫  
⌦ 1
25 
⌫ ⌦ Calcium sulfate ⌫ Î2 77231 Í   Î2 Whi
te Í Î2 X Í    
⌦ 1
26 
⌫ ⌦ Carbon black ⌫ Î2 77266 Í   Î2 Blac
k Í Î2 X Í  ⌦ Purity 
criteria as set out in Commission Directive 95/45/EC (E 153) ⌫   
EN 287   EN ⌦ 1
27 
⌫ ⌦ Charcoal, bone. A fine 
black powder obtained by burning animal bones in a closed container. It consists primarily of calcium phosphate and carbon ⌫ Î
2 77267 Í   Î2 Blac
k Í Î2 X Í    
⌦ 1
28 
⌫ ⌦ Coke black ⌫ Î2 77268:1 
Í   Î2 Blac
k Í Î2 X Í  Î2 E 153  Í 
⌦ Purity 
criteria as set out in Commission Directive 95/45/EC ⌫  
⌦ 1
29 
⌫ ⌦ Chromium (III) 
oxide ⌫ Î4 77288 Í   Î4 Gree
n Í Î4 X Í  Î4 free from 
chromate ion Í 
⌦ 1
30 
⌫ ⌦ Chromium (III) 
hydroxide ⌫ Î4 77289 Í   Î4 Gree
n Í Î4 X Í  Î4 free from 
chromate ion Í 
⌦ 1
31 
⌫ ⌦ Cobalt Aluminum 
Oxide  ⌫ Î2 77346 Í   Î2 Gree
n Í Î2 X Í    
⌦ 1
32 
⌫ ⌦ Copper ⌫ Î2 77400 Í   Î2 Bro
wn Í Î2 X Í     
EN 288   EN ⌦ 1
33 
⌫ ⌦ Gold ⌫ Î2 77480 Í   Î2 Bro
wn Í Î2 X Í  ⌦ Purity 
criteria as set out in Commission Directive 95/45/EC ⌫  
⌦ 1
34 
⌫ ⌦ Iron oxide ⌫ Î2 77489 Í   Î2 Ora
nge Í Î2 X Í  Î2 E 172  Í 
⌦ Purity 
criteria as set out in Commission Directive 95/45/EC (E 172) ⌫  
⌦ 1
35 
⌫ ⌦ Diiron trioxide ⌫ Î2 77491 Í   Î2 Red 
Í Î2 X Í  Î2 E 172  Í 
⌦ Purity 
criteria as set out in Commission Directive 95/42/EC (E 172) ⌫  
⌦ 1
36 
⌫ ⌦ Iron hydroxide oxide 
yellow⌫ Î2 77492 Í ⌦ 51274-
00-1 ⌫ ⌦ 257-098-
5 ⌫ Î2 Yell
ow Í Î2 X Í  Î2 E 172  Í 
⌦ Purity 
criteria as set out in Commission Directive   
EN 289   EN 95/45/EC (E 
173) ⌫ 
⌦ 1
37 
⌫ ⌦ Triiron tetraoxide ⌫ Î2 77499 Í   Î2 Blac
k Í Î2 X Í  Î2 E 172  Í 
⌦ Purity 
criteria as set out in Commission Directive 95/45/EC (E 172) ⌫  
⌦ 1
38 
⌫ ⌦ Ferric Ammonium 
Ferrocyanide  ⌫ Î2 77510 Í   Î2 Blue
 Í Î2 X Í  Î2 free from 
cyanide ions Í  
⌦ 1
39 
⌫ ⌦ Magnesium 
carbonate ⌫ Î2 77713 Í   Î2 Whi
te Í Î2 X Í    
⌦ 1
40 
⌫ ⌦ Ammonium 
manganese(3+) diphosphate ⌫ Î
2 77742 Í   Î2 Viol
et Í Î2 X Í    
⌦ 1
41 
⌫ ⌦ Trimanganese 
bis(orthophosphate) ⌫ Î2 77745 Í   Î2 Red 
Í Î2 X Í    
⌦ 1
42 
⌫ ⌦ Silver ⌫ Î2 77820 Í   Î2 Whi
te Í Î2 X Í  Î2 E 174  Í 
⌦ Purity 
criteria as set out in   
EN 290   EN Commission 
Directive 95/45/EC (E 174) ⌫ 
⌦ 1
43 
73 
⌫ ⌦ Titanium dioxide ⌫ Î2 77891 Í   Î2 Whi
te Í Î2 X Í  Î2 E 171  Í 
⌦ Purity 
criteria as set out in Commission Directive 95/45/EC (E 171) ⌫  
⌦ 1
44 
⌫ ⌦ Zinc oxide ⌫ Î2 77947 Í   Î2 Whi
te Í Î2 X Í    
⌦ 1
45 
⌫ ⌦ Riboflavin ⌫ Î2 Lactoflav
in Í   Î2 Yell
ow Í Î2 X Í  Î2 E 101  Í 
⌦ Purity 
criteria as set out in Commission Directive 95/45/EC (E 101) ⌫  
⌦ 1
46 ⌦ Caramel ⌫  Î2 Caramel 
Í   Î2 Bro
wn Í Î2 X Í  Î2 E 150  Í 
⌦ Purity  
                                                 
73 ⌦ As UV-Filter, see Annex VI, No. 27. ⌫  
EN 291   EN ⌫ criteria as set 
out in Commission Directive 95/45/EC (E 150) ⌫ 
⌦ 1
47 
⌫ ⌦ (3R,3'S,5'R)-3,3'-
dihydroxy-.beta.,.kappa.-caroten-6'-one ⌫ Î
2 Capsanth
in, capsorubin 
Í   Î
2 Ora
nge Í Î2 X Í  Î2 E 160 c  Í 
⌦ Purity 
criteria as set out in Commission Directive 95/45/EC (E 160c) ⌫  
⌦ 1
48 
⌫ ⌦ Beta vulgaris 
extract ⌫ Î2 Beetroot 
red Í   Î2 Red 
Í Î2 X Í  Î2 E 162  Í 
⌦ Purity 
criteria as set out in Commission Directive 95/45/EC (E 162) ⌫  
⌦ 1
49 
⌫ ⌦ Anthocyanins ⌫ Î2 Anthocya
nins Í   Î2 Red 
Í Î2 X Í  Î2 E 163  Í 
⌦ Obtained by 
the physical processing of edible fruits or vegetables, purity criteria as   
EN 292   EN set out in 
Commission Directive 95/45/EC (E 163) ⌫ 
⌦ 1
50 
⌫ ⌦ Aluminium, zinc, 
magnesium and calcium stearates ⌫ Î
2 aluminu
m stearate; zinc stearate; magnesium stearate and calcium stearate Í   Î
2 Whi
te Í Î2 X Í    
⌦ 1
51 
⌫ ⌦ Phenol, 4,4'-(3H-2,1-
benzoxathiol-3-ylidene)bis[2-bromo-3-methyl-6-(1-methylethyl)-, S,S-dioxide ⌫ Î
2 Bromoth
ymol blue Í   Î2 Blue
 Í Î2 X Í 
⌦ Rinse-off 
products ⌫    
⌦ 1
52 
⌫ ⌦ Phenol, 4,4'-(3H-2,1-
benzoxathiol-3-ylidene)bis[2,6-dibromo-3-methyl-,S,S-dioxide ⌫ Î
2 Bromocr
esol green Í   Î2 Gree
n Í Î2 X Í 
⌦ Rinse-off 
products ⌫    
⌦ 1
53 
⌫ ⌦ Sodium 4-[(4,5-
dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-3-hydroxynaphthalene-1-
sulphonate ⌫ Î
5 Acid red 
195 Í   Î5 Red 
Í Î5 X Í ⌦ No 
use in products applied on mucous membranes ⌫     
EN 293   EN  
 
Ð 86/179/EEC (adapted) 
PART  2 
LIST OF COLOURING AGENTS PROVI SIONALLY ALLOWED FOR USE IN 
COSMETIC PRODUCTS74 
Field of application  
Field of application  Colour index 
number or 
denomination  Colour  
1 2  3  4  Other 
limitations 
and 
requirements
75 Authorization 
valid until  
        
        
        
        
        
        
        
        
        
                                                 
74 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.  
75 Colouring agents whose number is preceded by the letter ‘E’ in  accordance with the EEC Directiv e of 1962 concerning foodstuffs  and colouring matters must fulfil the 
purity requirements l aid down in those Directives. They continue to be subject to the general criteria set out in Annex III to the 1962 Directive co ncerning colouring matters 
where the letter ‘E’ has been deleted therefrom.   
EN 294   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 exclusivel y in cosmetic products intended to 
come into contact only briefly with the skin.  
  
EN 295   EN  
Ð 76/768/EEC 
ANNEX V  
LIST OF SUBSTANCES EXCLUDED FROM THE SCOPE OF THE DIRECTIVE  
 
Ð 94/32/EC 
 5. Strontium and its compounds, with the exception of strontiu m lactate, strontium nitrate and strontium polycarboxylate liste d in Anne x II, 
strontium sulphide, strontium chloride, st rontium acetate, strontium hydroxide, stront ium peroxide, under th e conditions laid d own in Annex 
III, Part 1 and of strontium lakes, pigments and salt s of the colouring agents listed with the reference (3) in Annex IV, Part 1. 
EN 296   EN  
Ð 86/199/EEC (adapted) 
Î1 2007/17/EC Art. 1 and Annex pt. 2(b) 
Î2 2007/17/EC Art. 1 and Annex pt. 2(c) 
Î3 2007/17/EC Art. 1 and Annex pt. 2(d) 
ANNEX VVI 
LIST OF PRESERVATIVES ⌦ ALLOWED IN  ⌫ WHICH  COSMETIC PRODUCT S MAY CONTAIN  
PREAMBLE 
 1. Preservatives are substances which may be added to cosme tic 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 cosm etic products in concentration other than those laid down in thi s 
Annex for other specific purposes apparent from the presentation of the products, e .g. as deodorants in soaps or as anti -dandru ff agents in 
shampoos.  
 3. Other substances used in the formulati on of cosmetic products may also have anti -microbial properties and thus help in the preservation of 
the products, as, for instance, many essential oi ls and some alcohols. These substances ar e 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 a nd ethanolamines;  salts of the anions 
chloride, bromide, sulphate, acetate. 
– ‘Esters’ is taken to mean: esters of met hyl, ethyl, propyl, isopropyl , butyl, isobutyl, phenyl. 
 25 . All finished products containing formalde hyde or substances in this Annex and whic h release formaldehyde must be labelled wit h the 
warning ‘contains formaldehyde’ where the concentration of formaldehyde in the finished product exceeds 0,05 %.  
EN 297   EN PART  1 
LIST OF PRESERVATIVES ALLOWED  
Substance ⌦ identification ⌫ ⌦ Conditions ⌫ Refere
nce 
numbe
r ⌦ Chemical 
name/INN 
⌫ ⌦ 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  c g d h e i 
Î2 Rinse-off 
products, except oral care
 
products:  Î2 2,5 % 
(acid) 
Í Î2 1 
Í Î2 Benzoic 
acid and its sodium salt 
Í  ⌦ Benzoic acid 
Sodium Benzoate ⌫  65-85-0 
532-32-1  ⌦ 200-
618-2  
208-534-8 
⌫ 
Oral care
 
products:  Î2 1,7 % 
(acid) Í Î2 Í Î2 Í  
EN 298   EN Leave-on 
products:  
Í Î2 0,5 % 
(acid)Í 
Î2 1a 
Í Î2 Salts of 
benzoic acid other than that listed under reference number 1 and esters of benzoic acid Í ⌦ 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 ⌫ ⌦ 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 ⌫  Î
2 0,5 % 
(acid) Í Î2 Í Î2 Í 
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 ⌫ ⌦ 201-
176-3, 241-503-7, 223-795-8, 209-166-0, 206-323-5, 205-290-4⌫  2 % (acid)    
EN 299   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 ⌫ ⌦ 200-
712-3, 212-525-4, 242-669-3, 261-963-2, 200-198-0, 209-421-6, 218-531-3 ⌫  0,5 % (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 
4 h Hexa-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 ⌫ ⌦ 203-
768-7, 231-321-6, 231-819-3, 246-376-1 ⌫  0,6 % (acid)   
⌦Oral products 
⌫for oral 
hygiene)  0,1 % 
(expressed as  
free formaldehyde) 5 ⌦ 
78 
⌫ Formaldehyd
e, paraformaldehyde Î
1 (*) Í ⌦ Formaldehyde ⌫ ⌦ 50-00-0, 
30525-89-4 ⌫ ⌦ 200-
001-8 ⌫ 
⌦Other 
products ⌫(except for 
products for oral 
hygiene)  0,2 % 
(expressed as  
free formaldehyde) ⌦No use 
⌫Prohibited
 
in aerosol dispensers (sprays)   
                                                 
76 ⌦ For other uses than preservative, see Annex III, no. 98 . ⌫ 
77 Solely for products which might be used for children under 3 years of age and which remain in prolonged contact with the skin.  
78 ⌦ For other uses than preservative, see Annex III, No. 13 . ⌫  
EN 300   EN 7 ⌦ Biphenyl-
2-ol, ⌫ 
Biphen yl-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)    
Î3 Hair 
products  Î3 1,0 % Í Î3 8 
Í 
⌦ 79 
⌫ ⌦ Pyrithion
e zinc ⌫ Î3 Zinc 
pyrithione (*)  Í Î3 13463-41-
7 Í ⌦ 236-
671-3 ⌫ 
Other products 
Í Î3 0,5 %Í Î3 ⌦ Only 
in ⌫ rRinse-
off products only
. 
No use in 
⌦ oral ⌫ 
products for 
oral 
hygiene . Í Î3 Í 
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 ⌫  0,2 % 
expressed as
 
(as free SO 2)   
                                                 
79 ⌦ For other uses than preservative, see Annex III. No. 101 . ⌫ 
80 ⌦ For other uses than preservative, see Annex III, No. 99 . ⌫  
EN 301   EN 11 ⌦ Chlorobut
anol ⌫ Chlorobutanol (INN)  ⌦ 57-15-8 ⌫ ⌦ 200-
317-6 ⌫  0,5 % Prohibited  
⌦ No use ⌫ 
in aerosol dispensers (sprays) 
 Contains 
chlorobutanol 
12 4-
Hydroxybenzoic acid and its salts and 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 ⌫ ⌦ 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 ⌫  0,4 % (as
 acid) 
for 1 ester, 
0,8 % (as  acid) 
for mixtures of esters    
EN 302   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)  
 
Ð 76/768/EEC (adapted) 
Î1 94/32/EC 
Î2 86/199/EEC 
Î3 89/174/EEC 
Î4 87/137/EEC 
Î5 88/233/EEC 
Î6 2007/17/EC Art. 1 and Annex pt. 2(b) 
Î7 91/184/EEC 
Î8 92/86/EEC 
Î9 96/41/EC 
Î10 2005/42/EC Art. 1 and Annex .3(a) 
Î11 98/62/EC 
Î12 2000/6/EC Art. 1 and Annex .3(I) 
Î13 2007/22/EC Art. 1 and Annex pt. 2(b) 
Î14 2005/42/EC Art. 1 and Annex .3(b) 
Î1 14 
Í Î1 Formic 
acid and its sodium salt Í ⌦ Formic acid, sodium 
formate ⌫ ⌦ 64-18-6, 
141-53-7 ⌫ ⌦ 200-
579-1, 205-488-0 ⌫  Î
1 0,5 % 
(expressed  as 
acid) Í   
Î2 15 
Í Î2 3,3‘-
Dibromo-4,4‘-hexamethyleDibromohexamidine 
⌦ Isethionate ⌫ ⌦ 93856-83-
8 ⌫ ⌦ 299-
116-4 ⌫  Î
2 0,1 % Í    
EN 303   EN nedioxydi-
benzamidine and its salts (including isethionate) 
Í 
Î2 16 
Í Î2 Thiomers
al (INN)  Í ⌦ Thimerosal ⌫ ⌦ 54-64-8 ⌫ ⌦ 200-
210-4 ⌫ ⌦ Eye 
products ⌫ Î2 0,007 % 
(of Hg) 
If mixed with 
other mercurial compounds authorized by this Directive, the maximum concentration of Hg remains 
fixed at 
0,007 % Í Î
2 For eye 
make -up and 
eye make -up 
remover 
only Í Î2 Contain
s thiomersal 
Í 
Î2 17 
Í Î2 Phenylm
ercuric salts (including borate) Í ⌦ Phenyl Mercuric 
Acetate, Phenyl Mercuric Benzoate ⌫ ⌦ 62-38-4, 94-
43-9 ⌫ ⌦ 200-
532-5, 202-331-8 ⌫ ⌦ Eye 
products ⌫ Î
2 Ditto  Í 
⌦ 0,007 % 
(of Hg) 
If mixed with 
other mercurial compounds 
authorized by Î
2 Ditto  Í Î2 Contain
s phenylmercuric compounds 
Í  
EN 304   EN this Directive, 
the maximum concentration of Hg remains fixed at 0,007 ⌫ %  
Î2 18 
Í Î2 Undec-
10-enoic acid and ⌦ its ⌫ 
salts Í ⌦ 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 ⌫  Î
2 0,2 % (as  
acid) Í Î2 See Annex 
VI, Part 2, No 
8 Í  
Î2 19 
Í Î2 Hexetidin
e (INN)  Í 5- 
⌦ Pyrimidin
amine, 1,3-bis(2-ethylhexyl)hexahydro-5-methyl- ⌫ ⌦ Hexetidine ⌫ ⌦ 141-94-
6 ⌫ ⌦ 205-
513-5 ⌫  Î
2 0,1 % Í   
Î2 20 
Í Î2 5-Bromo-
5-nitro-1,3-dioxane Í ⌦ 5-Bromo-5-nitro-1,3-
dioxane ⌫ ⌦ 30007-47-
7 ⌫ ⌦ 250-
001-7 ⌫ ⌦ Rinse-off 
products ⌫ Î
2 0,1 % Í Î2 Rinse -off 
products only  
Avoid 
formation of nitrosamines 
Î
3 --- Í Í   
EN 305   EN Î2 21 
Í Î2 Bronopol 
(INN)  Í  ⌦ 2-Bromo-2-
nitropropane-1,3-diol ⌫⌦ 52-51-7 ⌫ ⌦ 200-
143-0 ⌫  Î2 0,1 % Í Î2 Avoid 
formation of nitrosamines 
Í  
Î2 22 
Í Î2 2,4-
Dichlorobenzyl alcohol Í ⌦ Dichlorobenzyl 
Alcohol ⌫ ⌦ 1777-82-
8 ⌫ ⌦ 217-
210-5 ⌫  Î
2 0,15 % Í   
Î2 23 
Í 
⌦ 81 
⌫ ⌦1-(4-
Chlorophenyl)-3-(3,4-dichlorophenyl)urea ⌫ Î
2 Triclocarban (INN)  
(*) Í ⌦ 101-20-
2 ⌫ ⌦ 202-
924-1 ⌫  Î2 0,2 % Í Î2 Purity 
criteria: 
3,3',4,4'-
Tetrachloroazobenzene <1 ppm 
3,3',4,4'-
Tetrachloroazoxybenzene <1 ppm Í  
Î2 24 
Í Î2 4-Chloro-
m-cresol Í ⌦ p-Chloro-m-
Cresol ⌫ ⌦ 59-50-7 ⌫ ⌦ 200-
431-6 ⌫ Î2 Prohibited  
No use in products ⌦ applied on 
mucuous membranes ⌫ 
the products Î2 0,2 % Í Î2 Prohibited 
in the products 
intended to 
come into 
contact with 
mucous 
membranes  Í  
                                                 
81 ⌦ For other uses than preservative, see Annex III, No. 100 . ⌫  
EN 306   EN intended to come 
into contact with 
mucous 
membr anes Í  
Î2 25 
Í Î2 Tric olosa
n (INN)  Í 
⌦ 5-Chloro-
2-(2,4-dichlorophenoxy)phenol 
⌫ ⌦ Triclosan ⌫ ⌦ 3380-34-
5 ⌫ ⌦ 222-
182-2 ⌫  Î
2 0,3 % Í   
Î2 26 
Í Î2 4-Chloro-
3,5-
xylenol Í ⌦ Chloroxylenol ⌫ ⌦ 88-04-0 ⌫ ⌦ 201-
793-8 ⌫  Î2 0,5 % Í   
Î2 27 
Í Î2 3,3'-Bis 
(1-
hydroxymeth
yl-2,5-
dioxoimidazo
lidin-4-yl)-
1,1'-
methylenediu
rea Í 
⌦ N,N''-
methylenebis[N'-[3-(hydroxymethyl)-2,5-dioxoimidazoÎ
2 Imidazolidinyl 
urea Í ⌦ 39236-46-
9 ⌫ ⌦ 254-
372-6 ⌫  Î2 0,6 % Í    
EN 307   EN lidin-4-
yl]urea] ⌫  
Î2 28 
Í Î2 Poly (1 -
hexamethyle
nebiguanide 
hydrochlorid
e Í 
⌦ Poly(met
hylene), .alpha.,.omega.-bis[[[(aminoiminomethyl)amino]iminomethyl]amino]-, dihydrochlori
de ⌫ ⌦ Polyaminopropyl 
biguanide ⌫ ⌦ 70170-61-5, 
28757-47-3, 133029-32-0 ⌫   Î
2 0,3 % Í   
Î2 29 
Í Î2 2-
Phenoxyethanol Í ⌦ Phenoxyethanol ⌫ ⌦ 122-99-
6 ⌫ ⌦ 204-
589-7 ⌫  Î
2 1,0 % Í   
Î2 30 
Í Î2 ⌦ Meth
enamine ⌫ 
Hexamethyle
netetr amine  ) 
(INN)  Í ⌦ Methenamine ⌫ ⌦ 100-97-
0 ⌫ ⌦ 202-
905-8 ⌫  Î2 0,15 % Í   
Î2 31 Î2 Methena ⌦ Quaternium-15 ⌫ ⌦ 4080-31- ⌦ 223-  Î2 0,2 % Í    
EN 308   EN Í mine 3-
chloroallylochloride (INN)
 Í 3 ⌫ 805-0 ⌫ 
Î2 32 
Í Î2 1-(4-
Chlorophenoxy)-1-(imidazol-1-yl)-3,3-dimethylbutan-2-one Í ⌦ Climbazole ⌫ ⌦ 38083-17-
9 ⌫ ⌦ 253-
775-4 ⌫  Î
2 0,5 % Í   
Î2 33 
Í Î2 1,3-Bis 
(hydroxymethyl)-5,5-dimethylimidazolidine-2,4-dione Í ⌦ DMDM 
Hydantoin ⌫ ⌦ 6440-58-
0 ⌫ ⌦ 229-
222-8 ⌫  Î
2 0,6 % Í   
Î2 34 
Í 
⌦ 82 
⌫  Î2 Benzyl 
alcohol (*)
 Í ⌦ Benzyl alcohol ⌫ ⌦ 100-51-
6 ⌫ ⌦ 202-
859-9 ⌫  Î2 1,0 % Í   
Î2 35 
Í Î2 1-
Hydroxy-4-⌦ 1-Hydroxy-4-
methyl-6-(2,4,4-⌦ 50650-76-5, 
68890-66-4 ⌫ ⌦ 272-
574-2 ⌫ ⌦ Rinse-off 
products ⌫ Î2 1,0 % Products 
rinsed off   
                                                 
82 ⌦ For other uses than preservative, cf. Annex III, No. 45, 68. ⌫  
EN 309   EN methyl-6-
(2,4,4-trimethylpentyl) 2-pyridon and its monoethanolamine salt Í trimethylpentyl) 2-
pyridon, Piroctone Olamine ⌫ ⌦ Other 
products ⌫ 0,5 % Í For other 
products  
Î2 37 
Í Î2 6,6-
Dibromo -4,4-
dichloro2,2‘ -
methylene -
diphenol  Í 
⌦ 2,2'-
methylenebis(6-bromo-4-chlorophenol) ⌫ Î
2 Bromochlorophene  
Í ⌦ 15435-29-
7 ⌫ ⌦ 239-
446-8 ⌫  Î2 0,1 % Í   
Î2 38 
Í Î2 4-
Isopropyl-m-cresol Í ⌦ Isopropyl Cresols ⌫⌦ 3228-02-
2 ⌫ ⌦ 221-
761-7 ⌫  Î
2 0,1 % Í   
Î2 39 
Í Î2 Mixture 
of 5-Chloro-2-methyl-isothiazol-3(2H)-one and 2-methylisothiazol-3(2H)-one with ⌦ Methylchloroisothiaz
olinone and Methylisothiazolinone 
⌫ ⌦ 26172-55-4, 
2682-20-4, 55965-84-9 ⌫ ⌦ 247-
500-7, 220-239-6 ⌫  Î
2 Î3 0,0015 
% Í(of a 
mixture in the ratio 3:1 of 5-chloro-2-methylisothiazol 3(2H)-one and 2-methylisothiaz   
EN 310   EN magnesium 
chloride and magnesium nitrate Í ol-3 (2H)-
one Í 
Î4 40 
Í Î4 2-
Benzyl-4-chlorophenol 
Í Chlorophene ⌦ 120-32-
1 ⌫ ⌦ 204-
385-8 ⌫  Î
4 0.,2 % Í   
Î5 41 
Í Î5 2-
Chloroacetamide Í ⌦ Chloroacetamide ⌫ ⌦ 79-07-2 ⌫ ⌦ 201-
174-2 ⌫  Î
5 0,3 % Í  Î5 Contain
s chloroacetamide Í 
Î5 42 
Í ⌦ N,N"-
bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediamidine ⌫ 
Î
5 Chlorhex
idine  (INN)  
and its digluconate, diacetate and dihydrochloride Í ⌦ 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 ⌫  Î
5 0,3 % 
expressed  (as 
chlorhexidine)
Í    
EN 311   EN Î5 43 
Í 
⌦ 83 
⌫ Î5 1-
Phenoxypropan-2-ol Í 
Î
6 (*) Í ⌦ Phenoxyisopropanol 
⌫ ⌦ 770-35-
4 ⌫ ⌦ 212-
222-7 ⌫  Î5 1,0 % Í Î5 Only for 
rinse-off products Í  
Î7 44 
Í Î7 Alkyl 
(C12-C22) trimethyl ammonium bromide and chloride 
(*) Í ⌦ 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 ⌫  Î
7 0,1 % Í   
Î7 45 
Í Î7 4,4-
dimethyl-1,3-oxazolidine 
Í ⌦ Dimethyl 
Oxazolidine ⌫ ⌦ 51200-87-
4 ⌫ ⌦ 257-
048-2 ⌫  Î
7 0,1 % Í Î7 pH of the 
finished  
product > 6 Í  
Î7 46 
Í Î7 N-
(Hydroxymethyl)-N-(dihydroxymethyl-1,3-dioxo-2,5-imidazolidinyl-4)-N'-(hydroxymet⌦ Diazolidinyl 
Urea ⌫ ⌦ 78491-02-
8 ⌫ ⌦ 278-
928-2 ⌫  Î
7 0,5 % Í   
                                                 
83 ⌦ For other uses than preservative, see Annex III, No. 54. ⌫  
EN 312   EN hyl) urea Í 
Î8 47 
Í Î8 1,6-Di 
(4-
amidinophen
oxy)-n-
hexane   
⌦ Benzenec
arboximidamide, 4,4'-(1,6-hexanediylbis(oxy))bis- ⌫ 
and its salts 
(including isethionate and p-hydroxybenzoate) Í Hexamidine, 
⌦ Hexamidine 
diisethionate, Hexamidine paraben ⌫ ⌦ 3811-75-4, 
659-40-5, 93841-83-9 ⌫ ⌦ 211-
533-5, 299-055-3 ⌫  Î
8 0,1 %Í   
Î1 48 
Í Î1 Glutarald
ehyde (Pentane-1,5-dial) Í ⌦ Glutaral ⌫ ⌦ 111-30-
8 ⌫ ⌦ 203-
856-5 ⌫  Î
1 0,1 % Í Î1 ⌦ No 
use ⌫ 
Prohibited  in 
aerosols (sprays) Í 
 Î
1 Contain
s glutaraldehy
de 
⌦ glutaral 
⌫ (where 
glutaraldehyde concentratio
n in the 
finished  
EN 313   EN product 
exceeds 0,05 %) Í 
Î1 49 
Í Î1 5-Ethyl-
3,7-dioxa-1-azabicyclo [3.3.0] octane Í ⌦ 7- 
ethylbicyclooxazolidine 
⌫ ⌦ 7747-35-
5 ⌫ ⌦ 231-
810-4 ⌫  Î
1 0,3 %Í Î1 Prohibited  
⌦ No use ⌫ 
in oral hygiene  
products and in products intended
 to 
come into 
contact with  
⌦ applied 
on ⌫ mucous 
membranes Í  
Î9 50 
Í Î9 3-(p-
chlorophenoxy)-propane-1,2 diol Í Î
9 Chlorphenesin Í ⌦ 104-29-
0 ⌫ ⌦ 203-
192-6 ⌫  Î9 0,3 % Í   
Î9 51 
Í Î9 Sodium 
hydroxymethylamino acetate Í Î
9 Sodium 
Hydroxymethylglycinate Í ⌦ 70161-44-
3 ⌫ ⌦ 274-
357-8 ⌫  Î
9 0,5 % Í   
Î9 52 
Í Î9 Silver 
chloride deposited on titanium dioxide Í ⌦ Silver chloride ⌫ ⌦ 7783-90-
6 ⌫ ⌦ 232-
033-3 ⌫  Î
9 0,004 % 
calculated as  
(as AgCl)  Í Î9 20 % 
AgCl (w/w) on TiO
2. 
Prohibited  
⌦ No use ⌫ 
in products for   
EN 314   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  Í 
Î10 53
 Í Î10 Benzeth
onium 
Chloride  
(INCI)  Í 
⌦ Benzene
methanaminium, N,N-dimethyl-N-[2-[2-[4-(1,1,3,3,-tetramethylbutyl)phenoxy]ethoxy]ethyl]-, chloride ⌫ Î
10 Benzethonium 
Chloride Í ⌦ 121-54-
0 ⌫ ⌦ 204-
479-9 ⌫  Î10 0,1 % Í Î10 (a) Rinse-
off products, 
(b) Leave-on 
products other 
than for  oral 
⌦ products 
⌫ care use  Í  
EN 315   EN Î11 54
 Í 
⌦ 84 
⌫ Î11 Benzalk
onium chloride, bromide and saccharinate (+)
 Í 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 ⌫  Î
11 0,1% 
calculated  (as 
benzalkonium chloride)
 Í  Î11 Avoid 
contact with eyes Í 
Î12 55
 Í ⌦ Methanol, 
(phenylmethoxy-) ⌫ Î
12 Benzylhemiformal 
Í ⌦ 14548-60-
8 ⌫ ⌦ 238-
588-8 ⌫ Î12 Only for  
⌦ Rinse off ⌫ 
products to be 
removed by 
rinsing  Í Î12 0,15 % 
Í   
Î13 56
 Í Î13 (IPBC)  
3-iodo-2-propynylbutylcarbamate 
Í Î
13 iIodopropynyl 
butylcarbamate Í 55406-53-6  259-627-5  Î13 (a) rinse-
off products: 0,02 % 
(b) leave-on 
products: 0,01 %, except in deodorants/antiperspirants: 0,0075 % Í Î
13 Not to be 
used in oral hygiene
 and 
lip care  
products 
(a) Not to be 
used in preparations
⌦ products 
⌫ for 
children under Î13 (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 ⌦ For other uses than preservative, cf. Annex III, No. 65 . ⌫ 
85 Concerns any products aimed to be applied on a large part of the body. 
86 Solely for products, other than bath products/shower gels and shampoo, which might be used for children under 3 years of age.  
EN 316   EN 3 three  years 
of age, except in bath products/shower gels and shampoo 
(b) - Not to be 
used in body 
lotion and 
body cream
85 
- Not to be 
used in ⌦ products 
⌫ 
preparations
 
for children under 3
 three 
years of age Í of 
age””
87 Í 
Î14 57
 Í Î14 (INCI)  
Í ⌦ 2-
methyl-2H-isothiazol-3-one ⌫ Î
14 Methylisothiazolino
ne Í ⌦ 2682-20-
4 ⌫ ⌦ 220-
239-6 ⌫  Î14 0,01 % 
Í   
                                                                                                                                                                                                                                                    
87 Solely for products which might be used for children under 3 years of age.  
EN 317   EN  
 
Ð 86/199/EEC (adapted) 
PART  2 
LIST OF PRESERVATIVES PROVISIONALLY ALLOWED  
Reference 
number  Substance  Maximum 
authorized 
concentration  Limitations 
and 
requirements  Conditions of use 
and warnings 
which must be 
printed on the 
label  Allowed 
until 
      
      
      
      
      
      
      
      
      
      
      
      
      
      
      
      
       
EN 318   EN       
      
      
  
EN 319   EN  
Ð 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 th e skin from certain harmful ef fects of these rays.  
These UV filters may be added to other cosmetic products with in the limits and under the conditions laid down in this Annex.  
Other UV filters used in cosmetic products solely fo r the purpose of protecting the product against UV rays ar e not included in this list.  
PART  1 
List of permitted UV filters whic h cosmetic products may contain  
⌦ Conditions ⌫ Substances  ⌦ identification ⌫ Ref
ere
nce
⌦ 
nu
mb
er
⌫ 
No ⌦ 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   
EN 320   EN a b c  d  e  f  c g d h e i 
1 4-
Aminobenzoic acid ⌦ PABA ⌫ ⌦ 150-13-0 ⌫ ⌦ 205-753-
0 ⌫  5 %   
2 N,N,N-
Trimethyl-4-(2-oxoborn-3-ylidenemethyl) anilinium methyl 
sulfph
ate ⌦ Camphor 
Benzalkonium Methosulfate ⌫ ⌦ 52793-97-2 ⌫ ⌦ 258-190-
8 ⌫  6 %   
3 ⌦ Benzoic 
acid, 2-hydroxy-, 3,3,5-trimethylcyclohexyl ester/Homosalate ⌫ 
Homos
aolate 
(INN)   Homosalate ⌦ 118-56-9 ⌫ ⌦ 204-260-
8 ⌫  10 %   
4 ⌦ 2-Hydroxy-
4-methoxybenzop⌦ Benzophenone
-3 ⌫ ⌦ 131-57-7 ⌫ ⌦ 205-031-
5 ⌫  10 %  Contains 
⌦ Benzoph
enone-3 ⌫  
EN 321   EN henone/Oxyben
zone ⌫ 
Oxybenzone  
(INN)  oxybenzone
88 
6 2-
Pphenylbenzimi
dazole-5-sulfph
onic acid 
and its potassium, sodium and triethanolamine salts ⌦ /Ensulizole 
⌫ ⌦ Phenylbenzimi
dazole Sulfonic Acid ⌫ ⌦ 27503-81-7 ⌫ ⌦ 248-502-
0 ⌫  8 % 
(expressed
 as 
acid)   
                                                 
88 Not requiered if concentration is 0,5 % or less and when it is used only for product protection purposes.  
EN 322   EN  
Ð 76/768/EEC (adapted) 
Î1 94/32/EC 
Î2 93/47/EEC 
Î3 95/34/EC 
Î4 96/41/EC 
Î5 97/45/EC 
Î6 98/62/EC 
Î7 2000/6/EC Art. 1 and Annex .4(I) 
Î8 2002/34/EC Art. 1 and Annex .4 
Î9 2005/9/EC Art. 1 and Annex  
Î1 7 
Í Î1 3,3'-(1,4-
Phenylenedimethylene) bis (7, 7-dimethyl-2-oxobicyclo-[2,
.2,.1]hept-
1-yl-methanesulfonic acid) and its salts Í 
⌦ /Ecamsule 
⌫ ⌦ Terephthalylid
ene Dicamphor Sulfonic Acid ⌫ ⌦ 92761-26-7, 
90457-82-2 ⌫ ⌦ 410-960-
6 ⌫  Î
1 10 % 
(expressed as 
acid) Í   
Î2 8 
Í Î2 1-(4-tert-
butylphenyl)-
3-(4-
methoxyphenyl)propane-⌦ Butyl 
Methoxydibenzoyl
methane ⌫ ⌦ 70356-09-1 ⌫ ⌦ 274-581-
6 ⌫  Î
2 5 % Í    
EN 323   EN 1,3-dione Í 
Î1 9 
Í Î1 alpha-(2-
Oxoborn-3-ylidene)-toluene-4-sulphonic acid and its salts Í 
⌦ /Avobenz
one ⌫ ⌦ Benzylidene 
Camphor Sulfonic Acid ⌫ ⌦ 56039-58-8 ⌫   Î
1 6 % 
(expressed as 
acid) Í   
Î3 1
0 Í Î3 2-cyano-
3,3-diphenyl acrylic acid, 2-ethylhexyl ester Í 
⌦ /Octocrile
ne ⌫ ⌦ Octocrylene 
⌫ ⌦ 6197-30-4 ⌫ ⌦ 228-250-
8 ⌫  Î
3 10 % 
(expressed as 
acid) Í   
Î4 1
1 Í Î4 Polymer 
of N-{(2 and 4)-[(2-oxoborn-3-ylidene)methyl]benzyl}acrylamide Í ⌦ Polyacrylamid
omethyl Benzylidene Camphor ⌫ ⌦ 113783-61-
2 ⌫   Î
4 6 % Í   
Î5 1
2 Í ⌦ 2-
Ethylhexyl 4-methoxycinnamate ⌫ Î
5 Ethylhexyl 
Mmethoxycinnam
ate Í ⌦ 5466-77-3 ⌫ ⌦ 226-775-
7 ⌫  Î5 10 % Í    
EN 324   EN Î6 1
3 Í Î6 Ethoxylat
ed Eethyl-4-
aAminobenzo
ate Í Î6 PEG-25 
PABA Í ⌦ 116242-27-
4 ⌫   Î6 10 % Í   
Î6 1
4 Í Î6 Isopentyl
-4-methoxycinnamate Í Î
6 Isoamyl p-
mMethoxycinnam
ate Í ⌦ 71617-10-2 ⌫ ⌦ 275-702-
5 ⌫  Î6 10 % Í   
Î6 1
5 Í Î6 2,4,6-
Trianilino-(p-C
carbo-2‘-
Eethylhexyl-
1‘-oxy)-1,3,5-Triazine (Octyl 
Triazone)  Í ⌦ Ethylhexyl 
Triazone ⌫ ⌦ 88122-99-0 ⌫ ⌦ 402-070-
1 ⌫  Î6 5 % Í   
Î6 1
6 Í Î6 Phenol,2-
(2H-B
benzotriazol
-2-yl)-4-mM
ethyl-6-
(2-mM ethyl-
3-(1,3,3,3-Tetramethyl-I
1-
(tTrimethylsil
yl)oO xy)-
Ddisiloxanyl)⌦ Drometrizole 
Trisiloxane ⌫ ⌦ 155633-54-
8 ⌫   Î6 15 % Í    
EN 325   EN Ppropyl)Í 
Î6 1
7 Í Î6 Benzoic 
acid, 4,4-((6-((((
1,1-
dimethylethyl)amino)carbonyl)phenyl)amino) 1,3,5-triazine-2,4-diyl)diimino)bis-,bis-
(2-
ethylhexyl) ester) Í  ⌦ Diethylhexyl 
Butamido Triazone ⌫ ⌦ 154702-15-
5 ⌫   Î
6 10 % Í   
Î6 1
8 Í Î6 3-(4‘ -
Methylbenzx
ylidene)-d-1 camphor Í⌦  /Enzac
amene ⌫ Î
6 4-
Methylbenzylidene Camphor Í ⌦ 38102-62-4, 
36861-47-9 ⌫ ⌦ 253-242-
6 ⌫  Î
6 4 % Í   
Î6 1
9 Í Î6 3-
Benzylidene camphor Í Î
6 3-Benzylidene 
Camphor Í ⌦ 15087-24-8 ⌫ ⌦ 239-139-
9 ⌫  Î6 2 % Í   
Î6 2
0 Í Î6 2-
Ethylhexyl salicylate (Octyl
-
salicylate)  Í ⌦ Ethylhexyl 
Salicylate ⌫ ⌦ 118-60-5 ⌫ ⌦ 204-263-
4 ⌫  Î6 5 % Í    
EN 326   EN Î7 2
1 Í Î7 4-
Dimethyl -
amino -
benzoate of 
ethyl -2-hexyl 
(octyl 
dimethyl 
PABA)  Í 
⌦ 2-
Ethylhexyl 4-
(dimethylamino)benzoate 
⌫ ⌦ Ethylhexyl 
d
Dimethyl 
PABA ⌫ ⌦ 21245-02-3 ⌫ ⌦ 244-289-
3 ⌫  Î7 8 % Í   
Î7 2
2 Í Î7 2-
Hydroxy-4-methoxybenzophenone-5-
sulfonic acid 
and its sodium salt Í 
⌦ /Sulisobe
nzone, Sulisobenzone sodium ⌫ ⌦ Benzophenone
-4, Benzophen one-5 ⌫ ⌦ 4065-45-6, 
6628-37-1 ⌫ ⌦ 223-772-
2 ⌫  Î
7 5 % (of  as 
acid) Í   
Î7 2
3 Í Î7 2,2'-
Methylene-
bis(-6-(2H-
benzotriazol-⌦ Methylene 
Bis-Benzotriazolyl 
Tetramethylbutylphenol ⌫ ⌦ 103597-45-
1 ⌫ ⌦ 604-052-00-
0, 403-800-
1 ⌫  Î
7 10 % Í    
EN 327   EN 2-yl)-4-
(tetramethyl-butyl)-1,1,3,3-phenol Í 
⌦ /Bisoctriz
ole ⌫ 
Î7 2
4 Í Î7 Monosod
ium 
⌦ Sodium 
⌫ salt of 2,-
2'-bis- (1,4-
phenylene)-
1H-benzimidazole-4,6-disulph
fonic 
acid) Í 
⌦ /Bisdisuli
zole disodium ⌫ ⌦ Disodium 
Phenyl Dibenzimidazole Tetrasulfonate ⌫ ⌦ 180898-37-
7 ⌫ ⌦ 429-750-
0 ⌫  Î
7 10 % (of  as 
acid) Í   
Î7 2
5 Í Î7 (1,3,5) -
Triazine -2,4-
bis((4-(2-ethyl-hexyloxy)-2-
hydroxy)-
phenyl)-6-(4-
methoxyphenyl)-1,3,5-⌦ Bis-
Ethylhexyloxyphenol Methoxyphenyl t
Triazine ⌫ ⌦ 187393-00-
6 ⌫   Î7 10 % Í    
EN 328   EN Triazine  Í 
Î8 2
6 Í Î8 Dimethic
odiethylbenzalmalonate (CAS No 207574-74-1) Í ⌦ Polysilicone-
15 ⌫ ⌦ 207574-74-
1 ⌫   Î
8 10 % Í   
Î8 2
7 Í 
⌦ 89 
⌫  Î8 Titanium 
dioxide Í ⌦ Titanium 
Dioxide ⌫ ⌦ 13463-67-7, 
1317-70-0, 1317-80-2 ⌫ ⌦ 236-675-
5205-280-1, 215-282-2 ⌫  Î
8 25 % Í   
Î9 2
8 Í Î9 Benzoic 
acid, 2-[- 4-
(diethylamino)-2-hydroxybenzoyl]-, hexylester Í Î
9 Diethylamino 
Hydroxybenzoyl Hexyl Benzoate Í Î
9 302776-68-
7 Í ⌦ 443-860-
6 ⌫  Î9 10 % in 
sunscreen products Í   
 
                                                 
89 ⌦ For use as colorants, see Annex IV, No. 143. ⌫  
EN 329   EN  
Ð 89/174/EEC (adapted) 
PART  2 
LIST OF UV FILTERS WHICH COSMETIC PRODUCTS MAY PROVISIONALLY CONTAIN  
Reference 
number  Substances  Maximum 
authorize d 
concentration  Other 
limitations 
and 
requirement
s Conditions of use 
and warnings 
which must be 
printed on the label  Allowed 
until 
      
      
      
      
      
      
      
      
      
      
      
      
      
      
  
EN 330   EN  
Ð 93/35/EEC (adapted) 
ANNEX VIII  VII 
 ⌦ Symbols used on packaging/container ⌫ 
⌦ 1. Reference to enclosed or attached information ⌫ 
 
 
Ð 2003/15/EC Art. 1.11 (adapted) 
ANNEX  VIIIa  
⌦ 2. Period-after-opening ⌫ 
 
.
   
EN 331   EN  
Ø new 
3. Date of minimum durability 
 
 
Ð 2003/15/EC Art. 1.11  
EN 332   EN  
Ð 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 valida ted by the European Centre on Validation of 
Alternative Methods (ECVAM) of the Joint Research Cent re available to meet the 
requirements of this ⌦ Regulation ⌫ Directive  and which are not listed in Annex V to 
Council Directive 67/548/EEC on th e approximation of laws, regu lations and administrative 
provisions relating to the classi fication, packaging and labelling of dangerous substances. As 
animal testing may not be replaced complete ly by an alternative method, it should be 
mentioned in Annex IX VIII whether the alternative method fully  or partially replaces animal 
testing. 
Reference number Validated alternative met hods Nature of replacement full or partial 
A B C 
  
EN 333   EN  
Ï 
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 Ju ly 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 334   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 335   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)  
Part B  
EN 336   EN List of time-limits for transpositio n into national law and application 
(referred to in Article 33) 
Directive Time-limit for transposition 
Council Directive 76/768/ EEC of 27 July 1976 30.01.1978 
Council Directive 79/661/ EEC of 24 July 1979 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 31.12.1984 
Commission Directive 84/415/EEC 18 July 1984 31.12.1985 
Commission Directive 85/391/EEC 16 July 1985 31.12.1986 
Commission Directive 86/179/ EEC of 28 February 1986 31.12.1986 
Commission Directive 86/199/EEC of 26 March 1986 31.12.1986 
Commission Directive 87/137/ EEC of 2 February 1987 31.12.1987 
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 14.06.1995 
Commission Directive 93/47/EC of 22 June 1993 30.06.1994 
Commission Directive 94/32/EC of 29 June 1994 30.06.1995  
EN 337   EN Commission Directive 95/34/EC of 10 July 1995 30.06.1996 
Commission Directive 96/41/EC of 25 June 1996 30.06.1997 
Commission Directive 97/1/EC of 10 January 1997 30.06.1997 
Commission Directive 97/18/EC of 17 April 1997 31.12.1997 
Commission Directive 97/45/EC of 14 July 1997 30.06.1998 
Commission Directive 98/16/EC of 5 March 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 Eur opean 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 338   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 339   EN ANNEX X  
CORRELATION TABLE  
Directive 76/768/EEC This Regulation 
Article 1 Article 2(1)(a) 
Article 2 Article 3 
Article 3 - 
Article 4(1) Article 11(1) 
Article 4(2) Article 13 
Article 4a Article 14 
Article 4b Article 12(1) 
Article 5 - 
Article 5a Article 28 
Article 6(1),(2) Artic le 15(1),(2),(3),(4) 
Article 6(3) Article 16 
Article 7(1) Article 6 
Article 7(2) Article 15(5), (7) 
Article 7(3) Article 10 
Article 7a (1) (h) Article 17 
Article 7a(1),(2),(3) Article 7, 8, Annex I 
Article 7a(4) Article 10 
Article 7a(5) Article 24, 29 
Article 8(1) Article 9 
Article 8(2) Article 26 
Article 8a - 
Article 9 Article 30 
Article 10 Article 27  
EN 340   EN Article 11 - 
Article 12 Article 22 
Article 13 Article 23 
Article 14 - 
Article 15 - 
Annex I Preamble, No. 10 
Annex II Annex II 
Annex III Annex III 
Annex IV Annex IV 
Annex V - 
Annex VI Annex V 
Annex VII Annex VI 
Annex VIII Annex VII 
Annex VIIIa Annex VII 
Annex IX Annex VIII 
- Annex IX 
- Annex X 
  
EN 341   EN LEGISLATIVE FINANCIAL STATEMENT  
1. NAME  OF THE  PROPOSAL: 
Proposal for a Regulation of the European Parliament and of th e 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 a nd of the financial impact: 
The action will start in 2009. While the budg et 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 342   EN 4. SUMMARY  OF RESOURCES 
4.1. Financial Resources 
4.1.1. Summary of commitment appropriations (CA) and payment appropriations (PA) 
EUR million (to 3 decimal places) 
Expenditure type Section 
no.   
Year 
n  
n + 1  
n + 2  
n + 3  
n + 4 n + 5  
and 
later  
Total 
Operational expenditure91         
Commitment Appropriations 
(CA) 8.1. a        
Payment Appropriations 
(PA)  b        
Administrative expenditure within reference amount92     
Technical & administrative 
assistance (NDA) 8.2.4. c 0.11 0.05 0.015 0.01 0.01 0.01 0.205 
TOTAL REFERENCE AMOUNT        
Commitment 
Appropriations  a+c 0.11 0.05 0.015 0.01 0.01 0.01 0.205 
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   
Human resources and 
associated expenditure 
(NDA) 8.2.5. d 0.02 0.005 0.005 0.005 0.005 0.005 0.045 
Administrative costs, other 
than human resources and 
associated costs, not included in reference 
amount (NDA) 8.2.6. e        
Total indicative financial cost of intervention 
TOTAL CA including cost 
of Human Resources  a+c
+d+
e 0.13 0.055 0.002 0.015 0.015 0.015 0.25 
TOTAL PA including cost 
of Human Resources  b+c
+d+
e 0.13 0.055 0.002 0.015 0.015 0.015 0.25 
                                                 
91 Expenditure that does not fall under Chap ter xx 01 of the Title xx concerned. 
92 Expenditure within article xx 01 04 of Title xx. 
93 Expenditure within chapter xx 01 other than articles xx 01 04 or xx 01 05.  
EN 343   EN Co-financing details 
n.a. 
4.1.2. Compatibility with Financial Programming 
8 Proposal is compatible with existing financial programming. 
4.1.3. Financial impact on Revenue 
8 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 th e 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 mu ltiple submission of identical information. 
In order to reduce administrative burd en, 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 por tal: 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 Commi ssion would make use of a (framework) 
contract for the technical IT-w ork.5.2. Value-added of Community 
involvement and coherence of the proposal  with other financial instruments and 
possible synergy 
The value-added of this measure has been assessed thoroughly in the impact 
assessment accompanying the Commissi on proposal. It reveals that the 
administrative burden would be reduced consid erably by this measure: It would save 
EU-businesses approx. EUR 45 Mil. per an num. 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.  
EN 344   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 porta l 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 fo r the implementation of the action. 
8 Centralised Management 
8 directly by the Commission 
 indirectly by delegation to: 
 executive Agencies 
 bodies set up by the Communities as  referred to in art. 185 of the 
Financial Regulation 
 national public-sector bodies/bodies with public-service mission 
 Shared or decentralised management 
 with Member states 
 with Third countries 
 Joint management with internatio nal organisations (please specify) 
Relevant comments: 
                                                 
94 If more than one method is indicated please prov ide additional details in the "Relevant comments" 
section of this point  
EN 345   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 stak eholders meeting held approx. 4-5 times 
per year) and the “Platform of market surv eillance authorities for cosmetic products” 
(PEMSAC, a forum for enforcing aut horities 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 s ubmitted together with the Commission 
proposal in Inter-Service Consultation. The impact assessment concludes that a 
centralised notification greatly contribute s to efficient in-market surveillance by 
competent authorities in the Member Stat es. 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 procedur e is a useful example for th e 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/governan ce/impact/cia_2007_en.htm. 
6.2.2. Measures taken following an intermediate/e x-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 el ectronic portal by the economic 
actors. 
7. A
NTI-FRAUD MEASURES   
EN 346   EN 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 (Headings of 
Objectives, actions and 
outputs should be 
provided) Type of output Av. 
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 No. 
outputs Total 
cost 
OPERATIONAL OBJECTIVE No.1 
95……… N.A.                
Action 1……………….                 
-  O u t p u t  1                  
-  O u t p u t  2                  
Action 2……………….                  
-  O u t p u t  1                  
Sub-total 
Objective 1                 
OPERATIONAL 
OBJECTIVE No.2 
1………                 
Action                 
                                                 
95 As described under Section 5.3  
EN 347   EN 1……………….  
-  O u t p u t  1                  
Sub-total 
Objective 2                 
OPERATIONAL 
OBJECTIVE No.n 
1                 
Sub-total Objective n                 
TOTAL COST                  
EN 348   EN 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 Officials or 
temporary 
staff96 (XX 01 
01) B*, 
C*/AST       
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/interf ace within a framework contract initiated 
by DIGIT or, if necessary, through a ca ll for tender launched by this DG. 
8.2.3. Sources of human resources (statutory) 
8 Posts to be redeployed using existi ng resources within the managing service 
(internal redeployment) 
                                                 
96 Cost of which is NOT covered by the reference amount 
97 Cost of which is NOT covered by the reference amount 
98 Cost of which is included within the reference amount  
EN 349   EN 8.2.4. Other Administrative expenditure  included in reference amount (XX 01 04/05 – 
Expenditure on administrative management) 
EUR million (to 3 decimal places) 
Budget line 
(number and heading) Year 
n Year 
n+1 Year 
n+2 Year 
n+3 Year 
n+4 Year 
n+5  
and 
later TOTAL 
1 Technical and administrative 
assistance (including related staff costs)        
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 resour ces and associated costs not  included in the reference 
amount 
EUR million (to 3 decimal places) 
Type of human resources Year n Year n+1 Year n+2 Year n+3 Year n+4 Year n+5 
and later 
Officials and temporary staff 
(XX 01 01) 0.02 0.005 0.005 0.005 0.005 0.005 
Staff financed by Art XX 01 
02 (auxiliary, END, contract 
staff, etc.) 
(specify budget line)       
Total cost of Human 
Resources and associated 
costs (NOT in reference amount) 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 legisla tive financial statement for the Executive Agency(ies) 
concerned.  
EN 350   EN 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 of an 
administrative nature (specify 
including reference to budget line)         
Total Administrative expenditure, 
other than human resources and associated costs (NOT included in 
reference amount)       
 
 
Calculation - Other administrative expenditure not  included in reference amount  
[…] 
 
                                                 
100 Specify the type of committee and the group to which it belongs.