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S.I. No. 870/2004 -- European Communities (Cosmetic Products) Regulations, 2004

S.I. No. 870/2004 -- European Communities (Cosmetic Products) Regulations, 2004 2004 870

STATUTORY INSTRUMENTS

S.I. No. 870 of 2004

EUROPEAN COMMUNITIES (COSMETIC PRODUCTS) REGULATIONS, 2004

S.I. No. 870 of 2004

European Communities (Cosmetic Products) Regulations 2004

Arrangement of Regulations

Regulation

1.

Citation.

2.

Commencement.

3.

Saver.

4.

Interpretation.

5.

Designation of competent authority.

6.

Exemptions.

7.

Prohibition, if likely to cause damage to public health.

8.

Prohibitions and restrictions on use of certain ingredients.

9.

Provisions referring to animal testing.

10.

Labelling requirements.

11.

Prohibition of misleading claims and signs.

12.

Information to be retained by manufacturers, etc.

13.

Notification of place of manufacture or first importation into the Community where within the State.

14.

Authorisations for the use of ingredients not otherwise permitted.

15.

Non-disclosure of identity of ingredient for reasons of trade secrecy.

16.

Prohibition of sales to consumers of cosmetic products not in compliance with these Regulations.

17.

Availability of information for prompt medical treatment in case of difficulties.

18.

Offences and penalties.

19.

Enforcement.

20.

Handling of samples taken by authorised officers

21.

Prosecution of offences.

22.

Prescribed methods for official testing.

23.

Evidential value of certificate given by analyst.

Schedule 1

Illustrative list by category of cosmetic products.

Schedule 2

List of substances which cosmetic products must not contain.

Schedule 3 - Part 1

List of substances which cosmetic products must not contain except subject to the restrictions and conditions laid down.

Schedule 3 - Part 2

List of substances provisionally allowed in cosmetic products subject to the restrictions and conditions laid down.

Schedule 4 - Part 1

List of colouring agents allowed for use in cosmetic products.

Schedule 4 - Part 2

List of colouring agents provisionally allowed for use in cosmetic products.

Schedule 5

List of substances excluded from the scope of the Regulations.

Schedule 6 - Part 1

List of preservatives allowed for use in cosmetic products.

Schedule 6 - Part 2

List of preservatives provisionally allowed.

Schedule 7 - Part 1

List of permitted UV filters which cosmetic products may contain.

Schedule 7 - Part 2

List of UV filters which cosmetic products may provisionally contain.

Schedule 8 - Part 1

Open jar symbol required for the purposes of Regulation 10(1)(d) (showing the period after opening during which the product can be used without harm to the consumer).

Schedule 8 - Part 2

Symbol required for the purposes of Regulations 10(1)(e) and 10(5) of the Regulations (showing where particular precautions in use and the list of ingredients used may be found).

Schedule 9 - Parts 1 and 2

Lists of alternative methods to animal testing.

Schedule 10 - Part 1

Particulars to be included with a request to permit the non-disclosure of the identity of an ingredient for reasons of trade secrecy.

Schedule 10 - Part 2

Registration number.

Schedule 11

Form of certificate to be given by analyst stating results of test, examination or analysis.

Schedule 12

Commencement of Regulations in the case of cosmetic products containing certain substances.

S.I. No. 870 of 2004

European Communities (Cosmetic Products) Regulations 2004

I, Mary Harney, Minister for Health and Children, in exercise of the powers conferred on me by section 3 of the European Communities Act, 1972 (No. 27 of 1972 ), for the purpose of giving full effect to Council Directive 76/768/EEC(1) of 27 July 1976 (as amended), on the approximation of the laws of the Member States relating to cosmetic products and for giving full effect to Commission Directive 95/17/EC(2) of 19 June 1995, hereby make the following regulations:

Citation

1.         These Regulations may be cited as the European Communities (Cosmetic Products) Regulations 2004.

Commencement

2.         (1)    These Regulations shall come into operation on the 31st day of December 2004.

(2)    The European Communities (Cosmetic Products) Regulations 1997 to 2003 are hereby revoked.

Saver

3.         Notwithstanding Regulation 2, the European Communities (Cosmetic Products) Regulations 1997 to 2003 and not these Regulations, shall apply to cosmetic products containing the substances referred to in the Schedules to the 1997 to 2003 Regulations and referred to in column 2 of Schedule 12 herein until the date opposite each such substance specified in column 3 insofar as the placing on the market of such a cosmetic product is concerned and until the dates specified in column 4 insofar as the sale or supply to a consumer is concerned.

Interpretation

4.         (1)      In these Regulations:

agent” means an agent established within the Community appointed by a manufacturer of a cosmetic product to act on his behalf in relation to these Regulations;

alternative method” means a testing method which is listed in Schedule 9;

authorised officer” shall be construed in accordance with paragraph (1) of Regulation 19;

Commission” means the Commission of the European Community;

common ingredients nomenclature” means the labelling nomenclature designated in the inventory of ingredients employed in cosmetic products, drawn up in accordance with the provisions of the Directive and contained in Commission Decision 96/335/EC(3) , as amended or substituted from time to time;

Community” means the European Community and shall be construed as including reference to those States which are contracting parties to the EEA Agreement;

cosmetic product” means any substance or preparation intended to be placed in contact with the various external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity, with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odours and/or protecting them or keeping them in good condition. The product categories to be considered as cosmetic products within the meaning of this definition are listed in Schedule 1;

Dangerous Substances Directive” means Council Directive 67/548/EEC of 27th June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances(4) as amended);

decorative cosmetic products” includes cosmetic products of the following categories, namely, lipstick, lip pencil, eye shadow, eye liner, eye pencil, liquid foundation, powder, blusher, mascara and nail polish;

Directive” means Council Directive 76/768/EEC(1) , as amended by Directives 79/661/EEC(5) , 82/368/EEC(6) , 83/574/EEC(7) , 88/667/EEC(8) , 89/679/EEC(9) , 93/35/EEC(10) and 2003/15/EC(11) and by Commission Directives 82/147/EEC(12) , 83/191/EEC(13) , 83/341/EEC(14) , 83/496/EEC(15) , 84/415/EEC(16) , 85/391/EEC(17) , 86/179/EEC(18) , 86/199/EEC(19) , 87/137/EEC(20) , 88/233/EEC(21) , 89/174/EEC(22) , 90/121/EEC(23) , 91/184/EEC(24) , 92/8/EEC(25) , 92/86/EEC(26) , 93/47/EEC(27) , 94/32/EC(28) , 95/34/EC(29) , 96/41/EC(30) , 97/1/EC(31) , 97/45/EC(32) , 98/16/EC(33) , 98/62/EC(34) , 2000/6/EC(35) , 2000/11/EC(36) , 2002/34/EC(37) , 2003/1/EC(38) , 2003/16/EC(39) , 2003/80/EC(40) , 2003/83/EC(41) , 2004/87/EC(42) , 2004/88/EC(43) , 2004/93/EC(44) , and 2004/94/EC(45) ;

“EEA Agreement” means the Agreement on the European Economic Area signed in Oporto on the 2nd day of May 1992 as adjusted by the Protocol to that Agreement done at Brussels on the 17th day of March 1993(46) ;

European Communities (Cosmetic Products) Regulations 1997 to 2003” means the European Communities (Cosmetic Products) Regulations, 1997 (S.I. No. 87 of 1997), the European Communities (Cosmetic Products) (Amendment) Regulations, 1998 (S.I. No. 213 of 1998 ), the European Communities (Cosmetic Products) (Amendment No. 2) Regulations 2000 (S.I. No. 150 of 2000 ), the European Communities (Cosmetic Products) (Amendment No. 3) Regulations 2000 (S.I. No. 203 of 2000 ), the European Communities (Cosmetic Products) (Amendment No. 4) Regulations 2000 (S.I. No. 227 of 2000 ) and European Communities (Cosmetic Products) (Amendment No. 5) Regulations 2003 (S.I. No. 553 of 2003 );

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;

ingredient” means any chemical substance or preparation of synthetic or natural origin, except for perfume and aromatic compositions, used in the composition of a cosmetic product;

Member State” means a Member State of the European Community and shall be construed as including reference to those States that are Contracting Parties to the EEA Agreement;

Minister” means the Minister for Health and Children;

place on the market” includes the sale or supply, the keeping or offering for sale, supply or distribution or inviting the making of an offer to purchase;

premises” includes any place, vehicle, ship or other vessel, aircraft or other means of transport or any container used to transport;

preservative” means a substance which is added to a cosmetic product for the primary purpose of inhibiting the development of micro-organisms in that product;

prototype” means a first model or design that has not been produced in batches, and from which the finished cosmetic product is copied or finally developed;

responsible person” means, in relation to a relevant cosmetic product,

(a)  the manufacturer of that product;

(b)  the manufacturer's agent;

(c)  the person to whose order that cosmetic product is manufactured; or

(d)  where the manufacturer or the person to whose order the cosmetic product is manufactured is not established in the Community and either --

(i)  the manufacturer has not appointed an agent; or

(ii)  the manufacturer's agent is not the supplier of that cosmetic product,

the person who first supplies the cosmetic product in the Community;

sale” includes offering or keeping for sale;

supply” includes offering or keeping for supply or agreeing to supply;

UV filter” means a substance which is added to a sunscreen cosmetic product for the primary purpose of filtering certain ultra violet rays in order to protect the skin from certain harmful effects of such rays.

(2)     A word or expression which is used in these Regulations and which is also used in the Directive has, unless the context otherwise requires, the same meaning in these Regulations as it has in the Directive.

(3)     In these Regulations, unless the context otherwise indicates, any reference to a Regulation or Schedule shall be construed as a reference to a Regulation contained in these Regulations or, as the case may be, to a Schedule thereto; any reference in a Regulation to a paragraph shall be construed as a reference to a paragraph in that Regulation and in a paragraph, any reference to a sub-paragraph shall mean a reference to a sub-paragraph in that paragraph.

Designation of competent authority

5.         The Minister shall be the competent authority for all purposes of the Directive, Commission Directive 95/17/EC(2) of 19 June 1995 and these Regulations.

Exemptions

6.         These Regulations shall not apply to a cosmetic product containing any substance specified in Schedule 5.

Prohibition if likely to cause damage to human health

7.         (1)  Subject to paragraph (2), a person shall not place on the market any cosmetic product which is liable to cause damage to human health when it is applied under -

(a)  normal conditions of use, or

(b)  conditions of use which are reasonably foreseeable,

taking into account all the circumstances including the presentation of the cosmetic product, its labelling, any instructions for its use and disposal and any other indication or information provided by the manufacturer, his authorised agent or any other person who is responsible for the placing on the market of the cosmetic product.

(2)  Paragraph (1) shall apply only to the placing on the market of a cosmetic product by the manufacturer thereof in or by the importer thereof into the State or, in the case of a cosmetic product that is manufactured or imported into the State on behalf of another person, by that other person.

Prohibitions and restrictions on use of certain ingredients

8. (1)    Subject to the provisions of these Regulations, a person shall not place a cosmetic product on the market -

(a)        if it contains any substance specified Schedule 2;

(b)        if it contains any substance specified in Schedule 3 unless the requirements specified for that substance in the said Schedule are complied with;

(c)        (i)        if it contains any colouring agent not specified in Schedule 4; and

(ii)        if it contains any colouring agent specified in Schedule 4 unless the requirements specified for that colouring agent in that Schedule are complied with;

(d)        (i)        if it contains any preservative not specified in Schedule 6; and

(ii)        if it contains any preservative specified in Schedule 6 unless the requirements specified for that preservative in that Schedule are complied with;

(e)        (i)        if it contains any UV filter not specified in Schedule 7; and

(ii)        if it contains any UV filter specified in Schedule 7 unless the requirements specified for that UV filter in that Schedule are complied with;

(f)         if it contains any substance specified in Part 2 of any of Schedules 3, 4, 6 or 7 after the date specified in respect of such substance in the Column headed “Allowed until”.

(2)    Without prejudice to Regulation 7, the provisions of paragraph (1) shall not apply to the presence in cosmetic products of traces of any of the substances specified in Schedule 2 where such traces are technically unavoidable in the context of good manufacturing practice and could not reasonably have been removed during or after manufacture.

(3)    The provisions of paragraph (1)(c) shall not apply to cosmetic products containing colouring agents intended solely to colour hair.

Provisions referring to animal testing

9.   (1)  A person shall not test a finished cosmetic product on animals where such testing is undertaken in order that the said product might satisfy any requirements of these Regulations or of the Directive.

(2)  Subject to paragraph (3), a person shall not test any ingredient or combination of ingredients on animals where such testing is carried out in order to satisfy any requirements of these Regulations or of the Directive using a method other than an alternative method where --

(a)  an alternative method is listed in Part 1 or Part 2 of Schedule 9; and

(b)  the ingredient or combination of ingredients is tested after the date given in Part 1 or Part 2 of Schedule 9.

(3)  A person shall not test any ingredient or combination of ingredients on animals where such testing is undertaken in order to satisfy any requirements of these Regulations or of the Directive and which takes place after 11th March 2009.

(4)  Subject to paragraph 5, a person shall not place on the market any cosmetic product where the final formulation has been tested on animals in order to satisfy any requirements of these Regulations or of the Directive using a method other than an alternative method where --

(a)  an alternative method is listed in Part 1 or Part 2 of Schedule 9; and

(b)  the final formulation is tested after the date given in Part 1 or Part 2 of Schedule 9.

(5)  A person shall not place on the market any cosmetic product where the final formulation has been tested on animals in order to satisfy any requirements of these Regulations or of the Directive using a method other than an alternative method specified in Part 1 or Part 2 of Schedule 9 where such testing took place after --

(a)  11th March 2013 in relation to tests concerning repeated-dose toxicity, reproductive toxicity and toxicokinetics; or

(b)  11th March 2009 in relation to all other tests.

(6)  Subject to paragraph 7, a person shall not place on the market any cosmetic product which contains any ingredient or combination of ingredients which have been tested on animals in order to satisfy any requirements of these Regulations or of the Directive using a method other than an alternative method where --

(a)  an alternative method is listed in Part 1 or Part 2 of Schedule 9; and

(b)  the ingredient or combination of ingredients is tested after the date given in Part 1 or Part 2 of Schedule 9.

(7)  A person shall not place on the market any cosmetic product which contains any ingredient or combination of ingredients which has been tested on animals in order to satisfy any requirements of these Regulations or of the Directive using a method other than an alternative method specified in Part 1 or Part 2 of Schedule 9 where such testing took place after --

(a)  11th March 2013 in relation to tests concerning repeated-dose toxicity, reproductive toxicity and toxicokinetics; or

(b)  11th March 2009 in relation to all other tests.

(8)  The placing on the market of a cosmetic product in respect of which a claim that the product or any of its ingredients have not been tested on animals appears on the packaging or in any document, notice, label, ring or collar accompanying or referring to the product is only permitted if --

(a)  the manufacturer and his suppliers have not carried out any such tests on the finished product, its prototype or on any of the ingredients contained in the finished product or its prototype;

(b)  the manufacturer and his suppliers have not commissioned any such tests on the finished product, its prototype or on any of the ingredients contained in the finished product or its prototype;

(c)  the cosmetic product contains no ingredients which have been tested on animals by others for the purpose of developing new cosmetic products.

(9)  Paragraph (8) shall not apply to any cosmetic product placed on the market in the Community before 31 December 2004.

Labelling requirements

10.       (1)      Subject to the provisions of this Regulation, a person shall not place on the market a cosmetic product unless the container and packaging bears the following information in indelible, easily legible and visible lettering -

(a)        the name or style and the address or registered office of the manufacturer of the cosmetic product or of the person responsible for placing the product on the market. Such manufacturer or person responsible for placing the product on the market shall be established in a Member State of the Community. This information may be abbreviated provided that any such abbreviation does not prevent the manufacturer or the person concerned from being identified;

(b)        the nominal content at the time of packaging, given by weight or by volume, except in the case of packaging containing less than five grams or five millilitres, free samples and single-application packs. In the case of pre-packages normally sold as a number of items for which details of the weight or volume are not significant, the content need not be stated provided that the number of items is stated on the packaging. Such information need not be given if the number of items in the presentation is easy to see from the outside or if the product is normally only sold individually;

(c)        the date of minimum durability. This shall be 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 said date shall be clearly expressed and shall consist of either the month and year or the day, month and year in that order. Where this requirement is applicable, the information shall be supplemented by an indication of the conditions which must be satisfied to guarantee the stated durability. The indication of the date of durability shall not be mandatory for cosmetic products with a minimum durability of 30 months;

(d)        an indication of the period of time after opening for which the product can be used without any harm to the consumer in the case of cosmetic products with a minimum durability of 30 months. This information shall be indicated by the open jar symbol given in Part 1 of Schedule 8 together with an indication of the period of time after opening followed by the period which shall be expressed in months and/or years;

(e)        any particular precautions to be observed in use, especially those listed in Schedules 3, 4, 6, and 7 in the columns headed “Conditions of use and warnings which must be printed on the label”. Such information shall include any special precautionary information on the cosmetic product for professional use. Where this is impossible for practical reasons, an enclosed leaflet, label, tape or card must contain that information and to which the consumer is referred either by abbreviated information or by use of the symbol given in Part 2 of Schedule 8. Any such reference shall appear on the container and on the packaging;

(f)         the batch number of manufacture or the reference for identifying the goods. Where this is impossible for practical reasons because the cosmetic products are too small, such information need appear only on the packaging;

(g)        the function of the cosmetic product, unless it is clear from the presentation thereof;

(h)        a list of ingredients in descending order of weight as determined at the time at which the said ingredients were added to the product. That list shall be preceded by the word “ingredients”.

(2)      (a)       The particulars referred to in sub-paragraphs (b), (c), (d) (e) and (g) of paragraph (1) shall be in the Irish or in the English language, provided always that this shall not prohibit the additional use of other languages.

(b)        The particulars referred to in sub-paragraph (h) of paragraph (1) shall be in a language easily understood by the consumer and may be indicated on the packaging alone.

(3)      In relation to the requirements of sub-paragraph (h) of paragraph (1) -

(a)  the following shall not be regarded as ingredients -

(i)       impurities in the raw materials used;

(ii)      subsidiary technical materials used in the manufacture of a cosmetic product but not present in the final product;

(iii)     materials used in strictly necessary quantities as solvents or as carriers for perfume and aromatic compositions;

(b)        perfume and aromatic compositions and their raw materials shall be referred to by the word “perfume” or “aroma”. However, the presence of substances, the mention of which is required under the column that is headed “other limitations and requirements” in Schedule 3, shall be indicated in the list irrespective of their function in the product.

(c)        ingredients in concentrations of less than 1 per cent may be listed in any order after those in concentrations of 1 per cent or more;

(d)        colouring agents may be listed in any order after the other ingredients in accordance with their Colour Index Number or denomination adopted in Schedule 4;

(e)        for decorative cosmetic products marketed in several colour shades, all colouring agents used in the range may be listed, provided that the words “may contain” or the symbol “+/-” are added;

(f)        an ingredient shall be identified by the common name as contained in the common ingredients nomenclature or, in the absence of such name, by its chemical name, its INCI name, its CTFA name, its European Pharmacopoeial name, its International Non-Proprietary Name as recommended by the World Health Organisation, its EINEC, IUPAC, CAS reference or Colour Index Number;

(g)        the registration number, allocated by a competent authority designated under Regulation 10 of Commission Directive 95/17/EC(47) in the grant of a request made in accordance with the provisions of the said Directive, shall be used to identify the ingredient in respect of which such request was granted.

(4)  Subject to paragraph (5), where a cosmetic product has no packaging or it is impossible for practical reasons for the list of ingredients referred to in paragraph (1)(h) to appear on the packaging, the list shall appear on the container; and where a cosmetic product is supplied or delivered pursuant to any supply in neither a container nor packaging, the list shall appear on the container in which the product is exposed for sale or supply, or on a notice in immediate proximity to that container.

(5)  Subject to paragraph (6), where it is impossible for practical reasons for the list of ingredients referred to in paragraph (1)(h) to appear on the packaging or container of a cosmetic product, it shall appear on a leaflet, label, tag, tape or card enclosed with the product, to which the consumer is referred either by abbreviated information or by the symbol given in Part 2 of Schedule 8, which must appear on the packaging and where it is impracticable for reasons of size and shape for the list so to appear, it shall appear on a label, tag, tape or card attached to the cosmetic product.

(6)  In the case of soap, bath balls and other small products, where it is impracticable for reasons of size or shape for the list of ingredients referred to in paragraph (1) above to appear on an enclosed leaflet or on a label, tag, tape or card enclosed with or attached to the product, it shall appear on a notice in immediate proximity to the container in which the cosmetic product is exposed for sale or supply.

(7)  Where two or more cosmetic products are sold or supplied together as a single item, each product being in a separate container and the containers being enclosed together in packaging which bears clear and conspicuous instructions to the effect that the products must be mixed together in specified proportions before use, the particulars referred to in paragraph (1)(e) shall appear on an enclosed leaflet and an indication shall appear on both the containers and the packaging referring the consumer to the information in the leaflet.

(8)  Where a cosmetic product other than soap is sold, supplied or delivered in neither a container nor packaging, the particulars referred to in paragraph (1) shall appear on the container in which the product is exposed for sale or supply or on a notice in immediate proximity to that container.

(9)  Paragraphs (1)(d) and (3)(b) shall not apply to cosmetic products placed on the market in the Community prior to 11 March 2005.

Prohibition of misleading claims and signs

11.       A person shall not place a cosmetic product on the market if the text, names, trade marks, pictures, and figurative and other signs employed in the labelling, presentation for sale and advertising of the product suggest a characteristic which the product in question does not possess.

Information to be retained by manufacturers, etc.

12.       (1)      Subject to the provisions of this Regulation, where a cosmetic product is manufactured or placed on the market in the State, the responsible person shall, for control purposes, keep readily accessible to the enforcement authority, at the address or registered office specified on the container or packaging of the cosmetic products in accordance with Regulation 10(1)(a), the following information -

(a)  the qualitative and quantitative composition of the product, except to the extent that the product is composed of any perfume or perfume composition, in which case the responsible person shall only be required to keep the name and code number of the perfume or perfume composition and the identity of the supplier;

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

(c)  the method of manufacture which shall be in accordance with good manufacturing practice, that is to say that the cosmetic product shall be manufactured in such a way that under normal foreseeable conditions of use it shall not endanger human health or safety;

(d)  (i)  an assessment of the safety for human health of the finished product taking into consideration the matters specified in paragraph 2; and

(ii)  a specific assessment of the safety for human health of the finished product in respect of cosmetic products intended for use on children under the age of 3 and for cosmetic products intended exclusively for use in external intimate hygiene;

(e)  the name and address of the person or persons, qualified in accordance with paragraph (5), responsible for the assessments referred to in sub-paragraphs (d);

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

(g)  proof of the effect claimed for the cosmetic product, where justified by the nature of the effect or product; and

(h)  data on any animal testing performed by the manufacturer, his agents or suppliers, relating to the development or safety evaluation of the product or its ingredients, including any animal testing performed to meet the legislative or regulatory requirements of countries that are not Member States.

(2)      The assessments referred to in sub-paragraphs (d) of paragraph (1) shall be carried out in accordance with the principles of good laboratory practice referred to in article 1 of Council Directive 2004/10/EC(48) of 11 February 2004 and shall take particular account of the following --

(a)  the general toxicological profile of each ingredient used;

(b)  the chemical structure of each ingredient;

(c)  the level of exposure of each ingredient;

(d)  the specific exposure characteristics of the areas on which the cosmetic product will be applied; and

(e)  the specific exposure characteristics of the class of individuals for whom the cosmetic product is intended.

(3)      Subject to paragraph (4), where a cosmetic product is manufactured or placed on the market in the State the responsible person shall ensure that the information specified in sub-paragraphs (a) and (f) of paragraph 1 shall be made readily accessible to the public by any appropriate means.

(4)      For the purposes of paragraph (3), the quantitative information required under sub-paragraph (a) of paragraph (1) shall be limited to information relating to dangerous substances covered by the Dangerous Substances Directive.

(5)      The person referred to in sub-paragraph (e) of paragraph (1) shall hold a diploma, as defined in the European Communities (General System for the Recognition of Higher Education Diplomas) Regulations 1991 (S.I. No. 1 of 1991 ), in the field of pharmacy, toxicology, dermatology, medicine or appropriate biological or other relevant science.

(6)      Where the responsible person is the manufacturer or the person who first imports the cosmetic product into the Community, he or she shall possess appropriate experience or an appropriate level of professional qualification in accordance with the legislation and practice of the State if it is the place of manufacture or first importation for the product concerned.

(7)      Where the manufacturer manufactures a cosmetic product at two or more places within the Community and one of those places is within the State, the responsible person may choose a single place of manufacture within the Community where the information referred to in paragraph (1) will be kept available, provided that, if requested by the duly authorised authority in the State, he or she informs the said authority of the location at which the said information is to be kept.

(8)      Where the information referred to in paragraph (1) is to be kept available to an authorised authority within the State, it shall be easily accessible and be in English or a language that is readily understood by the said authority.

(9)      Sub-paragraphs (d) and (h) of paragraph (1) and paragraph (2) shall not apply in respect of cosmetic products placed on the market in the Community prior to 31 December 2004.

Notification of place of manufacture or first importation into the Community where within the State

13.       Where the place of manufacture or place of initial importation into the Community of a cosmetic product is within the State, the responsible person shall notify the competent authority of the address of the place of manufacture or, as the case may be, of the place of initial importation into the Community of that cosmetic product before its first sale or supply in the Community.

Authorisations for the use of ingredients not otherwise permitted

14.       (1)      Notwithstanding the provisions of Regulation 8 and subject to paragraphs (2), (3) and (4), the competent authority may grant, to any person who applies in the form and manner required by him, an authorisation to place a cosmetic product on the market containing a substance not otherwise permitted by virtue of these Regulations.

(2)      An authorisation granted under paragraph (1) shall be limited in duration to a maximum period of three years and shall be subject to such conditions as the competent authority may specify and, in particular, to conditions -

(a)        specifying the cosmetic product or class of cosmetic product in which the said substance may be used;

(b)        specifying the maximum concentration of the said substance which may be contained in the cosmetic product; and

(c)        specifying a distinctive indication which the said cosmetic product or class of cosmetic product must bear.

(3)      The period specified in an authorisation for the purpose of paragraph (2) shall be extended until a decision is made following a request, pursuant to Article 8a (3) of the Directive, for the inclusion of the substance to which the said authorisation relates in a list of permitted substances.

(4)      There shall be paid to the competent authority a fee of €750.00 in respect of each application for an authorisation under paragraph (1).

Non-disclosure of identify of ingredient for reasons of trade secrecy

15.       (1)      Subject to the provisions of this Regulation and without prejudice to Regulation 7, the competent authority may grant a request made by a responsible person (hereinafter in this Regulation referred to as the applicant), who for reasons of trade secrecy, wishes not to include one or more ingredients on the list referred to in Regulation 10(1)(h) to that effect.

(2)      A request made under this Regulation shall include the particulars set out in Part 1 of Schedule 10.

(3)      Within four months of the receipt of a request in respect of which the requirements of paragraph (2) are satisfied, the competent authority shall examine the request and inform the applicant in writing of his decision. In exceptional cases, the competent authority may inform the applicant in writing that an additional period of two months will be required for the examination of the request.

(4)      Where the competent authority grants a request made under this Regulation, he or she shall, in notifying his decision, also notify the applicant of the registration number which will replace the ingredient in question in the list referred to in Regulation 10(1)(h). The said registration number shall be allocated to the product in the manner specified in Part 2 of Schedule 10.

(5)      (a)       Subject to sub-paragraph (b) of this Regulation, a request granted under paragraph (1) shall be valid for a period of five years.

(b)       If the person to whom the request was granted considers that there are exceptional reasons for justifying an extension of the said period of validity, he or she may submit a reasoned request for such extension to the competent authority. In those circumstances the competent authority may grant the request which shall extend the period by not more than three years.

(6)      All amendments to the information provided under paragraph (2) shall be communicated forthwith to the competent authority. All changes to the names of the cosmetic products containing the ingredient shall be communicated to the competent authority at least 15-days before those products are placed on the market under their new name.

(7)      Having regard to the amendments referred to in paragraph (6) or any new information which may become available, the competent authority may, particularly if there are compelling reasons of public health, withdraw his approval of a request granted under this Regulation.

(8)      Any refusal to grant a request made, or any withdrawal of an approval that may have been granted, under this Regulation shall include a statement of the reasons for such refusal or withdrawal with a clear explanation of the appeal procedures and their time limits.

(9)      There shall be paid to the competent authority a fee of €750.00 in respect of each request made under this Regulation.

Prohibition of sales to consumers of cosmetic products not in compliance with the Regulations

16.       A cosmetic product shall not be sold by retail or otherwise supplied to a consumer unless it complies with the provisions of these Regulations relating to the placing of a cosmetic product on the market.

Availability of information for prompt medical treatment in cases of difficulties

17.       (1)      For the purposes of prompt and appropriate medical treatment, the competent authority may request that appropriate and adequate information on substances used in cosmetic products be made available and the responsible person on receipt of such request shall make such information available forthwith to such authority.

(2)      The information made available in response to a request made under paragraph (1) shall only be used for the purposes of such medical treatment.

Offences and penalties

18.   (1)      A person who contravenes any provision of these Regulations, or any condition attached to an authorisation granted under Regulation 14, shall be guilty of an offence.

(2)      A person guilty of an offence under these Regulation shall be liable on summary conviction to a fine not exceeding €3,000 or to imprisonment for a term not exceeding six months or both.

(3)      Where an offence under these Regulations is committed by a body corporate and is proved to have been so committed with the consent, connivance or approval of or to have been attributable to the wilful neglect on the part of any person, being a director, manager, secretary or other officer of the body corporate or a person who was purporting to act in any such capacity, that person, as well as the body corporate shall be guilty of an offence and shall be liable to be proceeded against and punished as if he or she was guilty of the first mentioned offence.

(4)      For the purposes of these Regulations, every contravention of a Regulation shall be deemed a separate contravention and every contravention of a paragraph or a subparagraph shall also be deemed to be a separate contravention and shall carry the same penalty as for a single contravention of any Regulation of these Regulations.

Enforcement

19.      (1)    (a)  The Minister may appoint such and so many officers as he or she thinks fit to be authorised officers for the purposes of these Regulations.

(b)  The Chief Executive Officer of each health board may appoint such and so many officers as he or she thinks fit to be authorised officers for the purposes of these Regulations.

(c)  The Irish Medicines Board may appoint such and so many officers as it thinks fit to be authorised officers for the purposes of these Regulations.

(d)  The Minister for Enterprise, Trade and Employment may appoint such and so many officers as he or she thinks fit to be authorised officers for the purposes of Regulation 10(1)(b) and Regulation 11 of these Regulations.

(2)        (a) An authorised officer shall be furnished with a warrant of his appointment.

(b) When exercising a power conferred on him under this Regulation, an authorised officer shall, if required by a person thereby affected, produce the warrant to that person for inspection.

(3)        Subject to paragraphs (4) and (5) an authorised officer may for the purpose of ensuring that these Regulations are being complied with -

(a)      at all reasonable times, enter and search a premises of any class or description at which he or she has reasonable grounds for believing that any trade, business or activity connected with the manufacture, packaging, labelling, placing on the market, distribution or supply of cosmetic products is or has been carried on,

(b)      require any person in charge at such premises, or connected with any equipment or other device at such premises, to produce to him or her any books, documents or records relating to cosmetic products and, in the case of such information in a non legible form, to produce it in permanent legible form, and to give to him or her such information as he or she may reasonably require in relation to such products,

(c)      inspect and take copies of, or take extracts from, any such books, documents or records relating to cosmetic products, including in the case of information in a non-legible form, a copy of or extract from such information in permanent legible form,

(d)      remove any such books, records or documents from such premises and detain them for such period as he or she reasonably considers to be necessary for the purposes of his or her functions under this Regulation;

(e)      inspect any substance or product which is stored, or offered or kept for sale or supply at such premises,

(f)       inspect and copy or extract information from any data within the meaning of the Data Protection Acts 1988 and 2003,

(g)      take (without payment) samples of any cosmetic product or substance stored, or offered or kept for supply at such premises for test, examination or analysis,

(h)      seize and detain any cosmetic product, substance or article,

(i)       secure for later inspection the premises or part of it.

(4)        An authorised officer shall not other than with the consent of the occupier enter a private dwelling unless he or she has obtained a warrant from the District Court under paragraph (7) authorising such entry.

(5)        An authorised officer, for the purpose of exercising any of the powers conferred on him by paragraph (3), may require any other person, having authority to do so, to break open any container or package, or to open any vending machine, or to permit him to do so.

(6)        Where an authorised officer seizes any cosmetic product, substance, article or document in the exercise of a power conferred on him by paragraph (3), he or she shall inform the person from whom it is seized, and, in the case of any cosmetic product seized from a vending machine, the person whose name and address are stated on the machine, or if no name and address are so stated, the occupier of the premises on which the machine stands or to which it is affixed, of that fact.

(7)        If a judge of the District Court is satisfied, on the sworn information of an authorised officer, that there are reasonable grounds to authorise entry into any premises referred to in paragraph (4), the judge may issue a warrant authorising such an authorised officer, accompanied, if appropriate, by other authorised officers and/or by a member or members of the Garda Síochána, at any time or times within one month from the date of issue of the warrant, on production of the warrant requested, to enter those premises or part thereof and to exercise any of the powers conferred on such an authorised officer under these Regulations.

(8)        A person shall not without reasonable excuse fail to comply with any requirement made by an authorised officer under this Regulation or in purported compliance with such a requirement give the authorised officer information which is false or misleading in a material respect.

(9)        A person shall not obstruct or interfere with an authorised officer in the exercise of his or her powers under this Regulation.

Handling of samples taken by authorised officers

20.       (1)  Where an authorised officer takes a sample of a cosmetic product or a sample of a substance, for the purposes of these Regulations, he or she shall divide the sample into three approximately equal parts, and place each part into separate containers which he or she shall forthwith seal and mark in such a manner as to identify it as part of the sample taken by that authorised officer.

(2)  Where an authorised officer has complied with paragraph (1) he or she shall --

(a)  offer one of the sealed containers to the owner or person for the time being in charge or possession of the cosmetic product or substance from which the sample concerned was taken,

(b)  retain one of the sealed containers, and

(c)  forward, or cause to be forwarded, one of the sealed containers for analysis by one of the persons referred to in Regulation 23(1)(a), (b), or (c).

(3)  Where a cosmetic product or a substance is contained in a container and its division into parts is (for whatever reason) not practicable, an authorised officer, who wishes to take samples of such cosmetic product or substance for the purposes of analysis, shall take possession of three such containers belonging to the same batch and each such container shall be deemed to be part of a sample for the purposes of paragraph (1) and the provisions of paragraphs (1) and (2) shall apply thereto accordingly.

Prosecution of offences

21.       An offence under these Regulations may be prosecuted by the Minister, the Irish Medicines Board, a health board in respect of an offence committed within its functional area or by the Minister for Enterprise, Trade and Employment in respect of offences arising from breaches of Regulation 10(1)(b) and Regulation 11 of these Regulations.

Prescribed methods for official testing

22.       The official testing of cosmetic products by, or under the direction of any of the persons specified in Regulation 23(1) shall be carried out in accordance with the methods described in Commission Directives 80/1335/EEC(49) , 82/434/EEC(50) , 83/514/EEC(51) , 85/490/EEC(52) , 87/143/EEC(53) , 90/207/EEC(54) , 93/73/EEC(55) , 95/32/EC(56) and 96/45/EC(57) insofar as such methods are applicable.

Evidential value of certificate given by analyst

23.       (1)  In any proceedings for an offence under these Regulations, a certificate purporting to be signed by --

(a)  the State Chemist, or such other chemist employed or engaged at the State Laboratory and authorised by the State Chemist to sign any such certificate, or

(b)  a public analyst appointed under section 10 of the Sale of Food and Drugs Act 1875 (38 & 39 Vic., c.63), or such other analyst authorised by such public analyst to sign any such certificate, or

(c)  a chemist or analyst appointed by the Irish Medicines Board or the Pharmaceutical Society of Ireland,

- stating the result of any test, examination or analysis of a sample shall, with regard to that sample, unless the contrary is shown, be evidence of the matters stated in the certificate.

(2)  The certificate referred to in paragraph (1) shall be in the form set out in Schedule 11 to these Regulations.

Schedule 1

Illustrative list by category of cosmetic products

( Regulation 4(1) )

-

creams, emulsions, lotions, gels and oils for the skin (hands, face, feet, etc.).

-

face masks (with the exception of peeling products).

-

tinted bases (liquids, pastes, powders).

-

make-up powders, after-bath powders, hygienic powders, etc.

-

toilet soaps, deodorant soaps, etc.

-

perfumes, toilet waters and eau de cologne.

-

bath and shower preparations (salts, foams, oils, gels, etc.).

-

depilatories.

-

deodorants and antiperspirants.

-

hair care products.

-

hair tints and bleaches.

-

products for waving, straightening and fixing.

-

setting products.

-

cleansing products (lotions, powders, shampoos).

-

conditioning products (lotions, creams, oils).

-

hairdressing products (lotions, lacquers, brilliantines).

-

shaving products (creams, foams, lotions, etc.).

-

products for making up and removing make-up from the face and the eyes.

-

products intended for application to the lips.

-

products for care of the teeth and the mouth.

-

products for nail care and make-up.

-

products for external intimate hygiene.

-

sunbathing products.

-

products for tanning without sun.

-

skin-whitening products.

-

anti-wrinkle products.

Schedule 2

List of substances which cosmetic products must not contain

( Regulation 8(1)(a) )

1.

N-5-Chlorobenzoxazol-2-ylacetamide.

2.

2-Acetoxyethyltrimethylammonium hydroxide (Acetylcholine) and its salts.

3.

Deanol aceglumate (INN).

4.

Spironolactone (INN).

5.

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

6.

Methotrexate (INN).

7.

Aminocaproic acid (INN) and its salts.

8.

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

9.

Thyropropic acid (INN) and its salts.

10.

Trichloroacetic acid.

11.

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

12.

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

13.

Adonis vernalis L. and its preparations.

14.

Epinephrine (INN).

15.

Rauwolfia serpentina alkaloids and their salts.

16.

Alkyne alcohols, their esters, ethers and salts.

17.

Isoprenaline (INN).

18.

Allyl isothiocyanate.

19.

Alloclamide (INN) and its salts.

20.

Nalorphine (INN), its salts and ethers.

21.

Sympathomimetic amines acting on the central nervous system, the following -

Amfecloral

Amfepentorex

Amfepramone

Aminorex

Amphetamine

Benzphetamine

Chlorphentermine

Clominorex

Clorforex

Dexamphetamine

Dimephenopane

Diphemethoxine

Doxapram

Ethylamphetamine

Fenbutrazate

Fencamfamin

Fenethylline

Fenfluramine

Fenmetramide

Fluminorex

Levamphetamine

Meclofenoxate

Mephentermine

Metampfepramone

Metamphetamine

Methylphenidate

Ortetamine

Paramethylamphetamine

Pemoline

Pentorex

Phacetoperane

Phenatine

Phendimetrazine

Phenmetrazine

Phentermine

Pipradol

Prolintane

Trifluorex

Xylopropamine

22.

Aniline, its salts and its halogenated and sulphonated derivatives.

23.

Betoxycaine (INN) and its salts.

24.

Zoxazolamine (INN).

25.

Procainamide (INN), its salts and derivatives.

26.

Benzidine.

27.

Tuaminoheptane (INN), its isomers and salts.

28.

Octodrine (INN) and its salts.

29.

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

30.

1,3-Dimethylpentylamine and its salts.

31.

4-Aminosalicylic acid and its salts.

32.

Toluidines, their isomers, salts and halogenated and sulphonated derivatives.

33.

Xylidines, their isomers, salts and halogenated and sulphonated derivatives.

34.

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

35.

Ammi majus and its galenical preparations.

36.

2,3-Dichloro-2-methylbutane.

37.

Substances with androgenic effect.

38.

Anthracene oil.

39.

Antibiotics.

40.

Antimony and its compounds.

41.

Apocynum cannabinum L. and its preparations.

42.

Apomorphine (5,6,6a,7-Tetrahydro-6-methyl-4H-dibenzo[de,g] quinoline-10,11-dihydric alcohol) and its salts.

43.

Arsenic and its compounds.

44.

Atropa belladonna L. and its preparations.

45.

Atropine, its salts and derivatives.

46.

Barium salts, with the exception of barium sulphate and barium sulphite under the conditions laid down in Schedule 3, Part 1, and the lakes, salts and pigments prepared from the colouring agents listed with the reference (3) in Schedule 4, Part 1 and in Schedule 4, Part 2.

47.

Benzene.

48.

Benzimidazol-2(3H)-one.

49.

Benzazepines and benzodiazepines

50.

1-Dimethylaminomethyl-1-methylpropyl benzoate (Amylocaine) and its salts.

51.

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

52.

Isocarboxazid (INN).

53.

Bendroflumethiazide (INN) and its derivatives.

54.

Beryllium and its compounds.

55.

Bromine, elemental.

56.

Bretylium tosilate (INN).

57.

Carbromal (INN).

58.

Bromisoval (INN).

59.

Brompheniramine (INN) and its salts.

60.

Benzilonium bromide (INN).

61.

Tetrylammonium bromide (INN).

62.

Brucine.

63.

Tetracaine (INN) and its salts.

64.

Mofebutazone (INN).

65.

Tolbutamide (INN).

66.

Carbutamide (INN).

67.

Phenylbutazone (INN).

68.

Cadmium and its compounds.

69.

Cantharides, Cantharis vesicatoria.

70.

(IR,2S)-Hexahydro-1,2-dimethyl-3,6-epoxyphthalic anhydride (Cantharidin).

71.

Phenprobamate (INN).

72.

Nitroderivatives of carbazol.

73.

Carbon disulphide.

74.

Catalase.

75.

Cephaeline and its salts.

76.

Chenopodium ambrosioides (essential oil).

77.

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

78.

Chlorine.

79.

Chlorpropamide (INN).

80.

Diphenoxylate (INN) hydrochloride.

81.

4-Phenylazophenylene-1,3-diamine citrate hydrochloride (Chrysoidine citrate hydrochloride).

82.

Chlorzoxazone (INN).

83.

2-Chloro-6-methylpyrimidin-4-yldimethylamine (Crimidine-ISO).

84.

Chlorprothixene (INN) and its salts.

85.

Clofenamide (INN).

86.

N,N-Bis(2-chloroethyl)methylamine N-oxide and its salts.

87.

Chlormethine (INN) and its salts.

88.

Cyclophosphamide (INN) and its salts.

89.

Mannomustine (INN) and its salts.

90.

Butanilicaine (INN) and its salts.

91.

Chlormezanone (INN).

92.

Triparanol (INN).

93.

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

94.

Chlorphenoxamine (INN).

95.

Phenaglycodol (INN).

96.

Chloroethane.

97.

Chromium; chromic acid and its salts.

98.

Claviceps purpurea Tul., its alkaloids and galenical preparations.

99.

Conium maculatum L. (its fruit, powder and galenical preparations).

100.

Glycyclamide (INN).

101.

Cobalt benzenesulphonate.

102.

Colchicine, its salts and derivatives

103.

Colchicoside and its derivatives.

104.

Colchicum autumnale L. and its galenical preparations.

105.

Convallatoxin.

106.

Anamirta cocculus L. (fruit).

107.

Croton tiglium (oil).

108.

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

109.

Curare and curarine.

110.

Synthetic curarizants.

111.

Hydrogen cyanide and its salts.

112.

2-α-Cyclohexylbenzyl(N,N,N',N'-tetraethyl) trimethylenediamine (Phenetamine).

113.

Cyclomenol (INN) and its salts.

114.

Sodium hexacyclonate (INN).

115.

Hexapropymate (INN).

116.

Dextropropoxyphene (INN).

117.

O,O'-Diacetyl-N-allyl-N-normorphine.

118.

Pipazetate (INN) and its salts.

119.

5-(α,β-Dibromo-phenethyl)-5-methylhydantoin

120.

N,N'-Pentamethylenebis(trimethylammonium salts), eg. Pentamethonium bromide (INN).

121.

N N'-[(Methylimino)diethylene]bis(ethyldimethylammonium) salts, eg. Azamethonium bromide (INN).

122.

Cyclarbamate (INN).

123.

Clofenotane (INN) DDT (ISO).

124.

N,N'-Hexamethylenebis(trimethylammonium salts), eg. Hexamethonium bromide (INN).

125.

Dichloroethanes (Ethylene chlorides).

126.

Dichloroethylenes (Acetylene chlorides).

127.

Lysergide (INN) and its salts.

128.

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

129.

Cinchocaine (INN) and its salts.

130.

3-Diethylaminopropyl cinnamate

131.

O,O'-Diethyl O-4-nitrophenyl phosphorothioate (Parathion-ISO).

132.

[Oxalylbis(iminoethylene)]bis[σ-chlorobenzyl)diethylammonium salts] eg. Ambenomium chloride(INN).

133.

Methyprylon (INN) and its salts.

134.

Digitaline and all heterosides of Digitalis purpurea L.

135.

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

136.

Dioxethedrin (INN) and its salts.

137.

Piprocurarium (INN).

138.

Propylphenazone (INN).

139.

Tetrabenazine (INN) and its salts

140.

Captodiame (INN).

141.

Mefeclorazine (INN) and its salts.

142.

Dimethylamine.

143.

1,1-Bis(dimethylaminomethyl)propyl benzoate and its salts (Amydricaine, Alypine).

144.

Methapyrilene (INN) and its salts.

145.

Metamfepramone (INN) and its salts.

146.

Amitriptyline (INN) and its salts.

147.

Metformin (INN) and its salts.

148.

Isosorbide dinitrate (INN).

149.

Malononitrile.

150.

Succinonitrile.

151.

Dinitrophenol isomers.

152.

Inproquone (INN).

153.

Dimevamide (INN) and its salts.

154.

Diphenylpyraline (INN) and its salts.

155.

Sulfinpyrazone (INN).

156.

N-(3-Carbamoyl-3,3-diphenylpropyl)-N,N-diisopropylmethylammonium salt, eg. Isopropamide iodide (INN).

157.

Benactyzine (INN).

158.

Benzatropine (INN) and its salts.

159.

Cyclizine (INN) and its salts.

160.

5,5-Diphenyl-4-imidazolidone

161.

Probenecid (INN)

162.

Disulfiram (INN) Thiram (ISO).

163.

Emetine, its salts and derivatives

164.

Ephedrine and its salts.

165.

Oxanamide (INN) and its derivatives.

166.

Eserine or physostigmine and its salts.

167.

Esters of 4-aminobenzoic acid, with the free amino group, with the exception of that given in Schedule 7, Part 2.

168.

Choline salts and their esters, eg. Choline chloride.

169.

Caramiphen (INN) and its salts.

170.

Diethyl 4-nitrophenyl phosphate.

171.

Metethoheptazine (INN) and its salts.

172.

Oxpheneridine (INN) and its salts.

173.

Ethoheptazine (INN) and its salts.

174.

Metheptazine (INN) and its salts.

175.

Methylphenidate (INN) and its salts.

176.

Doxylamine (INN) and its salts.

177.

Tolboxane (INN).

178.

4-Benzyloxyphenol and 4-ethoxyphenol

179.

Parethoxycaine (INN) and its salts.

180.

Fenozolone (INN).

181.

Glutethimide (INN) and its salts.

182.

Ethylene oxide.

183.

Bemegride (INN) and its salts.

184.

Valnoctamide (INN).

185.

Haloperidol (INN).

186.

Paramethasone (INN).

187.

Fluanisone (INN).

188.

Trifluperidol (INN).

189.

Fluoresone (INN).

190.

Fluorouracil (INN).

191.

Hydrofluoric acid, its normal salts, its complexes and hydrofluorides with the exception of those given in Schedule 3, Part 1.

192.

Furfuryltrimethylammonium salts, eg. Furtrethonium iodide (INN).

193.

Galantamine (INN).

194.

Progestogens.

195.

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

196.

(1R,4S,5R,8S)-1,2,3,4,10,10-Hexachloro-6,7-epoxy-1,4,4a,5,6,7,8,8a-octahydro-1,4:5,8 - dimethanonaphthalene (Endrin-ISO).

197.

Hexachloroethane.

198.

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

199.

Hydrastine, hydrastinine and their salts.

200.

Hydrazides and their salts.

201.

Hydrazine, its derivatives and their salts

202.

Octamoxin (INN) and its salts.

203.

Warfarin (INN) and its salts.

204.

Ethyl bis(4-hydoxy-2-oxo-1-benzopyran-3-yl) acetate and salts of the acid.

205.

Methocarbamol (INN).

206.

Propatylnitrate (INN).

207.

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

208.

Fenadiazole (INN).

209.

Nitroxoline (INN) and its salts.

210.

Hyoscyamine, its salts and derivatives.

211.

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

212.

Pemoline (INN) and its salts.

213.

Iodine.

214.

Decamethylenebis(trimethylammonium salts), eg. Decamethonium bromide (INN).

215.

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

216.

(2-Isopropylpent-4-enoyl)urea (Apronalide).

217.

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

218.

Lobelia inflata L. and its galenical preparations.

219.

Lobeline (INN) and its salts.

220.

Barbiturates.

221.

Mercury and its compounds, excluding those listed in Schedule 6, Part 1.

222.

3,4,5-Trimethoxyphenethylamine and its salts.

223.

Metaldehyde.

224.

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

225.

Coumetarol (INN).

226.

Dextromethorphan (INN) and its salts.

227.

2-Methylheptylamine and its salts.

228.

Isometheptene (INN) and its salts.

229.

Mecamylamine (INN).

230.

Guaifenesin (INN).

231.

Dicoumarol (INN).

232.

Phenmetrazine (INN), its derivatives and salts.

233.

Thiamazole (INN).

234.

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

235.

Carisoprodol (INN).

236.

Meprobamate (INN).

237.

Tefazoline (INN) and its salts.

238.

Arecoline.

239.

Poldine metilsulfate (INN).

240.

Hydroxyzine (INN).

241.

2-Naphthol

242.

1-and 2-Naphthylamines and their salts.

243.

3(1-Naphtylmethyl)-4-hydroxycoumarin.

244.

Naphazoline (INN) and its salts.

245.

Neostigmine and its salts (eg. Neostigmine bromide (INN))

246.

Nicotine and its salts.

247.

Amyl nitrites.

248.

Inorganic nitrites, with the exception of sodium nitrite.

249.

Nitrobenzene.

250.

Nitrocresols and their alkali metal salts.

251.

Nitrofurantoin (INN).

252.

Furazolidone (INN).

253.

Propane-1,2,3-triyl trinitrate.

254.

Acenocoumarol (INN).

255.

Alkali pentacyanonitrosylferrate (2-).

256.

Nitrostilbenes, their homologues and their derivatives

257.

Noradrenaline and its salts.

258.

Noscapine (INN) and its salts.

259.

Guanethidine (INN) and its salts.

260.

Oestrogens

261.

Oleandrin.

262.

Chlorthalidone (INN).

263.

Pelletierine and its salts.

264.

Pentachloroethane.

265.

Pentaerithrityl tetranitrate (INN).

266.

Petrichloral (INN).

267.

Octamylamine (INN) and its salts

268.

Picric acid

269.

Phenacemide (INN).

270.

Difencloxazine (INN).

271.

2-Phenylindane-1,3-dione (Phenindione).

272.

Ethylphenacemide (INN).

273.

Phenprocoumon (INN).

274.

Fenyramidol (INN).

275.

Triamterene (INN) and its salts.

276.

Tetraethylpyrophosphate TEPP (ISO).

277.

Tritolyl phosphate.

278.

Psilocybine (INN).

279.

Phosphorus and metal phosphides.

280.

Thalidomide (INN) and its salts.

281.

Physostigma venenosum Balf.

282.

Picrotoxin.

283.

Pilocarpine and its salts.

284.

α-Piperidin-2-yl-benzyl acetate, laevorotatory threo form (Levophacetoperane) and its salts.

285.

Pipradrol (INN) and its salts.

286.

Azacyclonol (INN) and its salts.

287.

Bietamiverine (INN).

288.

Butopiprine (INN) and its salts.

289.

Lead and its compounds.

290.

Coniine.

291.

Prunus laurocerasus L. (“Cherry laurel water”).

292.

Metyrapone (INN).

293.

Radioactive substances, as defined by Directive 96/29/Euratom1 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation.

294.

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

295.

Hyoscine, its salts and derivatives

296.

Gold salts.

297.

Selenium and its compounds, with the exception of Selenium disulphide under the conditions for that substance in Schedule 3, Part 1 (No. 49).

298.

Solanum nigrum L. and its galenical preparations

299.

Sparteine and its salts.

300.

Glucocorticoids.

301.

Datura stramonium L. and its galenical preparations

302.

Strophantines, their aglucones and their respective derivatives.

303.

Strophantus species and their galenical preparations.

304.

Strychnine and its salts.

305.

Strychnos species and their galenical preparations.

306.

Narcotics, natural and synthetic: all substances listed in Tables I and II of the single Convention on Narcotic Drugs signed in New York on 30 March 1961.

307.

Sulphonamides (sulphanylamide and its derivatives obtained by substitution of one or more H-atoms of the -NH2 groups) and their salts.

308.

Sultiame (INN).

309.

Neodymium and its salts.

310.

Thiotepa (INN).

311.

Pilocarpus jaborandi Holmes and its galenical preparations.

312.

Tellurium and its compounds.

313.

Xylometazoline (INN) and its salts.

314.

Tetrachloroethylene.

315.

Carbon tetrachloride.

316.

Hexaethyl tetraphosphate.

317.

Thallium and its compounds.

318.

Thevetia neriifolia Juss. glycoside extract.

319.

Ethionamide (INN).

320.

Phenothiazine (INN) and its compounds.

321.

Thiourea and its derivatives, with the exception of those listed in Schedule 3, Part 1.

322.

Mephenesin (INN) and its esters.

323.

Vaccines, toxins and serums listed in the Schedule to Council Directive 75/319/EEC (O.J. No. L147, 9.6.1975, p.13).

324.

Tranylcypromine (INN) and its salts.

325.

Tricloronitromethane (Chloropicrin)

326.

2,2,2-Tribromoethanol (Tribromoethyl alcohol)

327.

Trichlormethine(INN) and its salts.

328.

Tretamine(INN).

329.

Gallamine triethiodide (INN).

330.

Urginea scilla Stern. and its galenical preparations

331.

Veratrine, its salts and galenical preparations.

332.

Schoenocaulon officinale Lind. (its seeds and galenical preparations).

333.

Veratrum species and their preparations.

334.

Vinyl chloride monomer

335.

Ergocalciferol (INN) and Cholecalciferol (Vitamins D2 and D3).

336.

O-Alkyldithiocarbonic acids, salts of.

337.

Yohimbine and its salts.

338.

Dimethyl sulfoxide (INN).

339.

Diphenhydramine (INN) and its salts.

340.

4-tert-Butylphenol.

341.

4-tert-Butylpyrocatechol.

342.

Dihydrotachysterol (INN).

343.

Dioxane.

344.

Morpholine and its salts.

345.

Pyrethrum album L. and its galenical preparations.

346.

2-[4-Methoxybenzyl-N-(2-pyridyl)amino]ethyldimethylamine maleate.

347.

Tripelennamine (INN).

348.

Tetrachlorosalicylanilides.

349.

Dichlorosalicylanilides.

350.

Tetrabromosalicylanilides.

351.

Dibromosalicylanilides (eg. Metabromsalan (INN), and Dibromsalan(INN)).

352.

Bithionol (INN).

353.

Thiuram monosulphides.

354.

Thiuram disulphides.

355.

Dimethylformamide.

356.

4-Phenylbut-3-en-2-one.

357.

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

358.

Furocoumarines (eg. Trioxysalan (INN), 8-Methoxypsoralen and 5-Methoxypsoralen) except for the normal content found in natural essences. In sun protection and bronzing products, the furocoumarines content shall be below 1 mg/kg.

359.

Oil from the seeds of Laurus nobilis L.

360.

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

- 100ppm in the finished product;

- 50ppm in products for dental and oral hygiene, and provided that safrole is not present in toothpastes intended specifically for children.

361.

5,5'-di-isopropyl-2,2'-dimethylbiphenyl-4,4'-diyl dihypoiodite (INN)

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

363.

σ-Phenylenediamine and its salts

364.

4-Methyl-m-phenylenediamine and its salts.

365.

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

366.

Chloroform.

367.

2,3,7,8-Tetrachlorodibenzo-p-dioxin.

368.

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

369.

Pyrithione sodium (INN).

370.

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

371.

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

372.

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

373.

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

374.

Phytolacca spp. and their preparations.

375.

Tretinoin (INN) (Retinoic acid and its salts).

376.

1-Methoxy-2,4-diaminobenzene (2,4-Diaminoanisole - CI 76050) and its salts.

377.

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

378.

Colouring agent CI 12140.

379.

Colouring agent CI 26105.

380.

Colouring agents CI 42555, CI 42555-1 and CI 42555-2.

381.

Amyl-4-dimethylaminobenzoate, mixed isomers (Padamate-A (INN)).

382.

Entry deleted.

383.

2-Amino-4-nitrophenol.

384.

2-Amino-5-nitrophenol.

385.

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

386.

Colouring agent CI 42640.

387.

Colouring agent CI 13065.

388.

Colouring agent CI 42535.

389.

Colouring agent CI 61554.

390.

Antiandrogens with a steroidal structure.

391.

Zirconium and its compounds, with the exception of those zirconium substances listed under reference number 50 in Schedule 3, Part 1, and the zirconium lakes, pigments or salts of the colouring agents identified with the reference number (3) in Schedule 4, Part 1.

392.

Entry deleted.

393.

Acetonitrile.

394.

Tetrahydrozoline and its salts.

395.

Hydroxy-8-quinoline and its sulphate salt, except for the uses provided for under entry No. 51 in Schedule 3, Part 1.

396.

Dithio-2,2'-bispyridinedioxide 1,1' (additive with trihydrated magnesium sulphate) (Pyrithione disulphide + magnesium sulphate).

397.

Colouring agent CI 12075 and its lakes, pigments and salts.

398.

Colouring agents CI 45170 and CI 45170-1.

399.

Lidocaine.

400.

1,2-Epoxybutane.

401.

Colouring agent CI 15585.

402.

Strontium lactate.

403.

Strontium nitrate.

404.

Strontium polycarboxylate.

405.

Pramocaine.

406.

4-Ethoxy-m-phenylenediamine and its salts.

407.

2,4-Diaminophenylethanol and its salts.

408.

Catechol.

409.

Pyrogallol.

410.

Nitrosamines.

411.

Secondary alkyl-and alkanolamines and their salts.

412.

4-Amino-2-nitrophenol.

413.

2-Methyl-m-phenylenediamine.

414.

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

415.

Entry deleted.

416.

Cells, tissues and products of human origin.

417.

3,3-Bis(4-hydroxyphenyl) phtalide (Phenolphthalein (INN)).

418.

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

419.

From the date referred to in Article 22(1) of Regulation (EC) No 999/20012 of the European Parliament and of the Council, the specified risk materials as designated in Annex V to that Regulation and ingredients derived therefrom.

Until that date, the specified risk materials as designated in Annex XI Part A to Regulation (EC) No 999/2001, and ingredients derived therefrom.

However, tallow derivatives may be used provided that the following methods have been used and strictly certified by the producer:

-    transesterification or hydrolysis at at least: 200 °C, 40 bars (40,000 hPa) for 20 minutes (glycerol and fatty acids and esters),

-    saponification with NaOH 12M (glycerol and soap):

-    batch process: at 95 °C for 3 hours or

-    continuous process: at 140 °C, 2 bars (2 000 hPa) for 8 minutes or equivalent conditions.

420.

Crude and refined coal tars.

421.

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

422.

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

423.

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

424.

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

425.

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

426.

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

427.

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

428.

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

429.

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

430.

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

431.

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

432.

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

433.

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

434.

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

435.

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

436.

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

437.

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

438.

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

439.

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

440.

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

441.

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

442.

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

443.

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

444.

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

445.

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

446.

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

447.

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

448.

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

449.

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

450.

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

451.

Methyleugenol (CAS No. 93-15-2) except for normal content in the natural essences used and provided that the concentration does not exceed:

(a) 0.01% in fine fragrance

(b) 0.004% in eau de toilette

(c) 0.002% in fragrance cream

(d) 0.001% in rinse-off products

(e) 0.0002% in other leave-on products and oral hygiene products.

452.

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

453.

Cobalt dichloride (CAS No. 7646-79-9).

454.

Cobalt sulphate (CAS No 10124-43-3).

455.

Nickel monoxide (CAS No 1313-99-1).

456.

Dinickel trioxide (CAS No 1314-06-3).

457.

Nickel dioxide (CAS No 12035-36-8).

458.

Trinickel disulphide (CAS No 12035-72-2).

459.

Tetracarbonylnickel (CAS No 13463-39-3).

460.

Nickel sulphide (CAS No 16812-54-7).

461.

Potassium bromate (CAS No 7758-01-2).

462.

Carbon monoxide (CAS No 630-08-0).

463.

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

464.

Isobutane (CAS No 75-28-5), if it contains 0.1% w/w or more of Butadiene.

465.

Butane (CAS No 106-97-8), if it contains 0.1% w/w or more of Butadiene.

466.

Gases (petroleum), C3-4 (CAS No 68131-75-9), if they contain more than 0.1% w/w Butadiene.

467.

Tail gas (petroleum), catalytic cracked distillate and catalytic cracked naphtha fractionation absorber (CAS No 68307-98-2), if it contains more than 0.1% w/w Butadiene.

468.

Tail gas (petroleum), catalytic polymn. naphtha fractionation stabiliser (CAS No 68307-99-3), if it contains more than 0.1% w/w Butadiene.

469.

Tail gas (petroleum), catalytic reformed naphtha fractionation stabiliser, hydrogen sulfide-free (CAS No 68308-00-9), if it contains more than 0.1% w/w Butadiene.

470.

Tail gas (petroleum), cracked distillate hydrotreater stripper (CAS No 68308-01-0), if it contains more than 0.1% w/w Butadiene.

471.

Tail gas (petroleum), gas oil catalytic cracking absorber (CAS No 68308-03-2), if it contains more than 0.1% w/w Butadiene.

472.

Tail gas (petroleum), gas recovery plant (CAS No 68308-04-3), if it contains more than 0.1% w/w Butadiene.

473.

Tail gas (petroleum), gas recovery plant deethaniser (CAS No 68308-05-4), if it contains more than 0.1% w/w Butadiene.

474.

Tail gas (petroleum), hydrodesulfurised distillate and hydrodesulfurised naphtha fractionator, acid-free (CAS No 68308-06-5), if it contains more than 0.1% w/w Butadiene.

475.

Tail gas (petroleum), hydrodesulfurised vacuum gas oil stripper, hydrogen sulfide-free (CAS No 68308-07-6), if it contains more than 0.1% w/w Butadiene.

476.

Tail gas (petroleum), isomerised naphtha fractionation stabiliser (CAS No 68308-08-7), if it contains more than 0.1% w/w Butadiene.

477.

Tail gas (petroleum), light straight-run naphtha stabiliser, hydrogen sulfide-free (CAS No 68308-09-8), if it contains more than 0.1% w/w Butadiene.

478.

Tail gas (petroleum), straight-run distillate hydrodesulfurised, hydrogen sulfide-free (CAS No 68308-10-1), if it contains more than 0.1% w/w Butadiene.

479.

Tail gas (petroleum), propane-propylene alkylation feed prep deethaniser (CAS No 68308-11-2), if it contains more than 0.1% w/w Butadiene.

480.

Tail gas (petroleum), vacuum gas oil hydrodesulfurised, hydrogen sulfide-free (CAS No 68308-12-3), if it contains more than 0.1% w/w Butadiene.

481.

Gases (petroleum), catalytic cracked overheads (CAS No 68409-99-4), if they contain more than 0.1% w/w Butadiene.

482.

Alkanes, C1-2 (CAS No 68475-57-0), if they contain more than 0.1% w/w Butadiene.

483.

Alkanes, C2-3 (CAS No 68475-58-1), if they contain more than 0.1% w/w Butadiene.

484.

Alkanes, C3-4 (CAS No 68475-59-2), if they contain more than 0.1% w/w Butadiene.

485.

Alkanes, C4-5 (CAS No 68475-60-5), if they contain more than 0.1% w/w Butadiene.

486.

Fuel-gases (CAS No 68476-26-6), if they contain more than 0.1% w/w Butadiene.

487.

Fuel gases, crude oil distillates (CAS No 68476-29-9), if they contain more than 0.1% w/w Butadiene.

488.

Hydrocarbons, C3-4 (CAS No 68476-40-4), if they contain more than 0.1% w/w Butadiene.

489.

Hydrocarbons, C4-5 (CAS No 68476-42-6), if they contain more than 0.1% w/w Butadiene.

490.

Hydrocarbons, C2-4, C3-rich (CAS No 68476-49-3), if they contain more than 0.1% w/w Butadiene.

491.

Petroleum gases, liquefied (CAS No 68476-85-7), if they contain more than 0.1% w/w Butadiene.

492.

Petroleum gases, liquefied, sweetened (CAS No 68476-86-8), if they contain more than 0.1% w/w Butadiene.

493.

Gases (petroleum), C3-4, isobutane-rich (CAS No 68477-33-8), if they contain more than 0.1% w/w Butadiene.

494.

Distillates (petroleum), C3-6, piperylene-rich (CAS No 68477-35-0), if they contain more than 0.1% w/w Butadiene.

495.

Gases (petroleum), amine system feed (CAS No 68477-65-6), if they contain more than 0.1% w/w Butadiene.

496.

Gases (petroleum), benzene unit hydrodesulfurised off (CAS No 68477-66-7), if they contain more than 0.1% w/w Butadiene.

497.

Gases (petroleum), benzene unit recycle, hydrogen-rich (CAS No 68477-67-8), if they contain more than 0.1% w/w Butadiene.

498.

Gases (petroleum), blend oil, hydrogen-nitrogen-rich (CAS No 68477-68-9), if they contain more than 0.1% w/w Butadiene.

499.

Gases (petroleum), butane splitter overheads (CAS No 68477-69-0), if they contain more than 0.1% w/w Butadiene.

500.

Gases (petroleum), C2-3 (CAS No 68477-70-3), if they contain more than 0.1% w/w Butadiene.

501.

Gases (petroleum), catalytic-cracked gas oil depropaniser bottoms, C4-rich acid-free (CAS No 68477-71-4), if they contain more than 0.1% w/w Butadiene.

502.

Gases (petroleum), catalytic-cracked naphtha debutaniser bottoms, C 3-5-rich (CAS No 68477-72-5), if they contain more than 0.1% w/w Butadiene.

503.

Gases (petroleum), catalytic cracked naphtha depropaniser overhead, C3-rich acid-free (CAS No 68477-73-6), if they contain more than 0.1% w/w Butadiene.

504.

Gases (petroleum), catalytic cracker (CAS No 68477-74-7), if they contain more than 0.1% w/w Butadiene.

505.

Gases (petroleum), catalytic cracker, C1-5-rich (CAS No 68477-75-8), if they contain more than 0.1% w/w Butadiene.

506.

Gases (petroleum), catalytic polymd. naphtha stabiliser overhead, C2-4-rich (CAS No 68477-76-9), if they contain more than 0.1% w/w Butadiene.

507.

Gases (petroleum), catalytic reformed naphtha stripper overheads (CAS No 68477-77-0), if they contain more than 0.1% w/w Butadiene.

508.

Gases (petroleum), catalytic reformer, C1-4-rich (CAS No 68477-79-2), if they contain more than 0.1% w/w Butadiene.

509.

Gases (petroleum), C6-8 catalytic reformer recycle (CAS No 68477-80-5), if they contain more than 0.1% w/w Butadiene.

510.

Gases (petroleum), C6-8 catalytic reformer (CAS No 68477-81-6), if they contain more than 0.1% w/w Butadiene.

511.

Gases (petroleum), C6-8 catalytic reformer recycle, hydrogen-rich (CAS No 68477-82-7), if they contain more than 0.1% w/w Butadiene.

512.

Gases (petroleum), C3-5 olefinic-paraffinic alkylation feed (CAS No 68477-83-8), if they contain more than 0.1% w/w Butadiene.

513.

Gases (petroleum), C2-return stream (CAS No 68477-84-9), if they contain more than 0.1% w/w Butadiene.

514.

Gases (petroleum), C4-rich (CAS No 68477-85-0), if they contain more than 0.1% w/w Butadiene.

515.

Gases (petroleum), deethaniser overheads (CAS No 68477-86-1), if they contain more than 0.1% w/w Butadiene.

516.

Gases (petroleum), deisobutaniser tower overheads (CAS No 68477-87-2), if they contain more than 0.1% w/w Butadiene.

517.

Gases (petroleum), depropaniser dry, propene-rich (CAS No 68477-90-7), if they contain more than 0.1% w/w Butadiene.

518.

Gases (petroleum), depropaniser overheads (CAS No 68477-91-8), if they contain more than 0.1% w/w Butadiene.

519.

Gases (petroleum), dry sour, gas-concn.-unit-off (CAS No 68477-92-9), if they contain more than 0.1% w/w Butadiene.

520.

Gases (petroleum), gas concn. reabsorber distn. (CAS No 68477-93-0), if they contain more than 0.1% w/w Butadiene.

521.

Gases (petroleum), gas recovery plant depropaniser overheads (CAS No 68477-94-1), if they contain more than 0.1% w/w Butadiene.

522.

Gases (petroleum), Girbatol unit feed (CAS No 68477-95-2), if they contain more than 0.1% w/w Butadiene.

523.

Gases (petroleum), hydrogen absorber off (CAS No 68477-96-3), if they contain more than 0.1% w/w Butadiene.

524.

Gases (petroleum), hydrogen-rich (CAS No 68477-97-4), if they contain more than 0.1% w/w Butadiene.

525.

Gases (petroleum), hydrotreater blend oil recycle, hydrogen-nitrogen-rich (CAS No 68477-98-5), if they contain more than 0.1% w/w Butadiene.

526.

Gases (petroleum), isomerised naphtha fractionator, C4-rich, hydrogen sulfide-free (CAS No 68477-99-6), if they contain more than 0.1% w/w Butadiene.

527.

Gases (petroleum), recycle, hydrogen-rich (CAS No 68478-00-2), if they contain more than 0.1% w/w Butadiene.

528.

Gases (petroleum), reformer make-up, hydrogen-rich (CAS No 68478-01-3), if they contain more than 0.1% w/w Butadiene.

529.

Gases (petroleum), reforming hydrotreater (CAS No 68478-02-4), if they contain more than 0.1% w/w Butadiene.

530.

Gases (petroleum), reforming hydrotreater, hydrogen-methane-rich (CAS No 68478-03-5), if they contain more than 0.1% w/w Butadiene.

531.

Gases (petroleum), reforming hydrotreater make-up, hydrogen-rich (CAS No 68478-04-6), if they contain more than 0.1% w/w Butadiene.

532.

Gases (petroleum), thermal cracking distn. (CAS No 68478-05-7), if they contain more than 0.1% w/w Butadiene.

533.

Tail gas (petroleum), catalytic cracked clarified oil and thermal cracked vacuum residue fractionation reflux drum (CAS No 68478-21-7), if it contains more than 0.1% w/w Butadiene.

534.

Tail gas (petroleum), catalytic cracked naphtha stabilisation absorber (CAS No 68478-22-8), if it contains more than 0.1% w/w Butadiene.

535.

Tail gas (petroleum), catalytic cracker, catalytic reformer and hydrodesulfurised combined fractionater (CAS No 68478-24-0), if it contains more than 0.1% w/w Butadiene.

536.

Tail gas (petroleum), catalytic cracker refractionation absorber (CAS No 68478-25-1), if it contains more than 0.1% w/w Butadiene.

537.

Tail gas (petroleum), catalytic reformed naphtha fractionation stabiliser (CAS No 68478-26-2), if it contains more than 0.1% w/w Butadiene.

538.

Tail gas (petroleum), catalytic reformed naphtha separator (CAS No 68478-27-3), if it contains more than 0.1% w/w Butadiene.

539.

Tail gas (petroleum), catalytic reformed naphtha stabiliser (CAS No 68478-28-4), if it contains more than 0.1% w/w Butadiene.

540.

Tail gas (petroleum), cracked distillate hydrotreater separator (CAS No 68478-29-5), if it contains more than 0.1% w/w Butadiene.

541.

Tail gas (petroleum), hydrodesulfurised straight-run naphtha separator (CAS No 68478-30-8), if it contains more than 0.1% w/w Butadiene.

542.

Tail gas (petroleum), saturate gas plant mixed stream, C4-rich (CAS No 68478-32-0), if it contains more than 0.1% w/w Butadiene.

543.

Tail gas (petroleum), saturate gas recovery plant, C1-2-rich (CAS No 68478-33-1), if it contains more than 0.1% w/w Butadiene.

544.

Tail gas (petroleum), vacuum residues thermal cracker (CAS No 68478-34-2), if it contains more than 0.1% w/w Butadiene.

545.

Hydrocarbons, C3-4-rich, petroleum distillate (CAS No 68512-91-4), if they contain more than 0.1% w/w Butadiene.

546.

Gases (petroleum), catalytic reformed straight-run naphtha stabiliser overheads (CAS No 68513-14-4), if they contain more than 0.1% w/w Butadiene.

547.

Gases (petroleum), full-range straight-run naphtha dehexaniser off (CAS No 68513-15-5), if they contain more than 0.1% w/w Butadiene.

548.

Gases (petroleum), hydrocracking depropaniser off, hydrocarbon-rich (CAS No 68513-16-6), if they contain more than 0.1% w/w Butadiene.

549.

Gases (petroleum), light straight-run naphtha stabiliser off (CAS No 68513-17-7), if they contain more than 0.1% w/w Butadiene.

550.

Gases (petroleum), reformer effluent high-pressure flash drum off (CAS No 68513-18-8), if they contain more than 0.1% w/w Butadiene.

551.

Gases (petroleum), reformer effluent low-pressure flash drum off (CAS No 68513-19-9), if they contain more than 0.1% w/w Butadiene.

552.

Residues (petroleum), alkylation splitter, C4-rich (CAS No 68513-66-6), if they contain more than 0.1% w/w Butadiene.

553.

Hydrocarbons, C1-4 (CAS No 68514-31-8), if they contain more than 0.1% w/w Butadiene.

554.

Hydrocarbons, C1-4, sweetened (CAS No 68514-36-3), if they contain more than 0.1% w/w Butadiene.

555.

Gases (petroleum), oil refinery gas distn. off (CAS No 68527-15-1), if they contain more than 0.1% w/w Butadiene.

556.

Hydrocarbons, C1-3 (CAS No 68527-16-2), if they contain more than 0.1% w/w Butadiene.

557.

Hydrocarbons, C1-4, debutaniser fraction (CAS No 68527-19-5), if they contain more than 0.1% w/w Butadiene.

558.

Gases (petroleum), benzene unit hydrotreater depentaniser overheads (CAS No 68602-82-4), if they contain more than 0.1% w/w Butadiene.

559.

Gases (petroleum), C1-5, wet (CAS No 68602-83-5), if they contain more than 0.1% w/w Butadiene.

560.

Gases (petroleum), secondary absorber off, fluidised catalytic cracker overheads fractionator (CAS No 68602-84-6), if they contain more than 0.1% w/w Butadiene.

561.

Hydrocarbons, C2-4 (CAS No 68606-25-7), if they contain more than 0.1% w/w Butadiene.

562.

Hydrocarbons, C3 (CAS No 68606-26-8), if they contain more than 0.1% w/w Butadiene.

563.

Gases (petroleum), alkylation feed (CAS No 68606-27-9), if they contain more than 0.1% w/w Butadiene.

564.

Gases (petroleum), depropaniser bottoms fractionation off (CAS No 68606-34-8), if they contain more than 0.1% w/w Butadiene.

565.

Petroleum products, refinery gases (CAS No 68607-11-4), if they contain more than 0.1% w/w Butadiene.

566.

Gases (petroleum), hydrocracking low-pressure separator (CAS No 68783-06-2), if they contain more than 0.1% w/w Butadiene.

567.

Gases (petroleum), refinery blend (CAS No 68783-07-3), if they contain more than 0.1% w/w Butadiene.

568.

Gases (petroleum), catalytic cracking (CAS No 68783-64-2), if they contain more than 0.1% w/w Butadiene.

569.

Gases (petroleum), C2-4, sweetened (CAS No 68783-65-3), if they contain more than 0.1% w/w Butadiene.

570.

Gases (petroleum), refinery (CAS No 68814-67-5), if they contain more than 0.1% w/w Butadiene.

571.

Gases (petroleum), platformer products separator off (CAS No 68814-90-4), if they contain more than 0.1% w/w Butadiene.

572.

Gases (petroleum), hydrotreated sour kerosine depentaniser stabiliser off (CAS No 68911-58-0), if they contain more than 0.1% w/w Butadiene.

573.

Gases (petroleum), hydrotreated sour kerosine flash drum (CAS No 68911-59-1), if they contain more than 0.1% w/w Butadiene.

574.

Gases (petroleum), crude oil fractionation off (CAS No 68918-99-0), if they contain more than 0.1% w/w Butadiene.

575.

Gases (petroleum), dehexaniser off (CAS No 68919-00-6), if they contain more than 0.1% w/w Butadiene.

576.

Gases (petroleum), distillate unifiner desulfurisation tripper off (CAS No 68919-01-7), if they contain more than 0.1% w/w Butadiene.

577.

Gases (petroleum), fluidised catalytic cracker fractionation off (CAS No 68919-02-8) if they contain more than 0.1% w/w Butadiene.

578.

Gases (petroleum), fluidised catalytic cracker scrubbing secondary absorber off (CAS No 68919-03-9), if they contain more than 0.1% w/w Butadiene.

579.

Gases (petroleum), heavy distillate hydrotreater desulfurisation stripper off (CAS No 68919-04-0), if they contain more than 0.1% w/w Butadiene.

580.

Gases (petroleum), light straight run gasoline fractionation stabiliser off (CAS No 68919-05-1), if they contain more than 0.1% w/w Butadiene.

581.

Gases (petroleum), naphtha unifiner desulfurisation stripper off (CAS No 68919-06-2), if they contain more than 0.1% w/w Butadiene.

582.

Gases (petroleum), platformer stabiliser off, light ends fractionation (CAS No 68919-07-3), if they contain more than 0.1% w/w Butadiene.

583.

Gases (petroleum), preflash tower off, crude distn. (CAS No 68919-08-4), if they contain more than 0.1% w/w Butadiene.

584.

Gases (petroleum), straight-run naphtha catalytic reforming off (CAS No 68919-09-5), if they contain more than 0.1% w/w Butadiene.

585.

Gases (petroleum), straight-run stabiliser off (CAS No 68919-10-8), if they contain more than 0.1% w/w Butadiene.

586.

Gases (petroleum), tar stripper off (CAS No 68919-11-9), if they contain more than 0.1% w/w Butadiene.

587.

Gases (petroleum), unifiner stripper off (CAS No 68919-12-0), if they contain more than 0.1% w/w Butadiene.

588.

Gases (petroleum), fluidised catalytic cracker splitter overheads (CAS No 68919-20-0), if they contain more than 0.1% w/w Butadiene.

589.

Gases (petroleum), catalytic cracked naphtha debutanizer (CAS No 68952-76-1), if they contain more than 0.1% w/w Butadiene.

590.

Tail gas (petroleum), catalytic cracked distillate and naphtha stabiliser (CAS No 68952-77-2), if it contains more than 0.1% w/w Butadiene.

591.

Tail gas (petroleum), catalytic hydrodesulfurised naphtha separator (CAS No 68952-79-4), if it contains more than 0.1% w/w Butadiene.

592.

Tail gas (petroleum), straight-run naphtha hydrodesulfurised (CAS No 68952-80-7), if it contains more than 0.1% w/w Butadiene.

593.

Tail gas (petroleum), thermal-cracked distillate, gas oil and naphtha absorber (CAS No 68952-81-8), if it contains more than 0.1% w/w Butadiene.

594.

Tail gas (petroleum), thermal cracked hydrocarbon fractionation stabiliser, petroleum coking (CAS No 68952-82-9), if it contains more than 0.1% w/w Butadiene.

595.

Gases (petroleum), light steam-cracked, butadiene conc. (CAS No 68955-28-2), if they contain more than 0.1% w/w Butadiene.

596.

Gases (petroleum), sponge absorber off, fluidised catalytic cracker and gas oil desulfurised overhead fractionation (CAS No 68955-33-9), if they contain more than 0.1% w/w Butadiene.

597.

Gases (petroleum), straight-run naphtha catalytic reformer stabiliser overhead (CAS No 68955-34-0), if they contain more than 0.1% w/w Butadiene.

598.

Gases (petroleum), crude distn. and catalytic cracking (CAS No 68989-88-8), if they contain more than 0.1% w/w Butadiene.

599.

Hydrocarbons, C4 (CAS No 87741-01-3), if they contain more than 0.1% w/w Butadiene.

600.

Alkanes, C1-4, C3-rich (CAS No 90622-55-2), if they contain more than 0.1% w/w Butadiene.

601.

Gases (petroleum), gas oil diethanolamine scrubber off (CAS No 92045-15-3), if they contain more than 0.1% w/w Butadiene.

602.

Gases (petroleum), gas oil hydrodesulfurisation effluent (CAS No 92045-16-4), if they contain more than 0.1% w/w Butadiene.

603.

Gases (petroleum), gas oil hydrodesulfurisation purge (CAS No 92045-17-5), if they contain more than 0.1% w/w Butadiene.

604.

Gases (petroleum), hydrogenator effluent flash drum off (CAS No 92045-18-6), if they contain more than 0.1% w/w Butadiene.

605.

Gases (petroleum), naphtha steam cracking high-pressure residual (CAS No 92045-19-7), if they contain more than 0.1% w/w Butadiene.

606.

Gases (petroleum), residue visbreaking off (CAS No 92045-20-0), if they contain more than 0.1% w/w Butadiene.

607.

Gases (petroleum), steam-cracker C3-rich (CAS No 92045-22-2), if they contain more than 0.1% w/w Butadiene.

608.

Hydrocarbons, C4, steam-cracker distillate (CAS No 92045-23-3), if they contain more than 0.1% w/w Butadiene.

609.

Petroleum gases, liquefied, sweetened, C4 fraction (CAS No 92045-80-2), if they contain more than 0.1% w/w Butadiene.

610.

Hydrocarbons, C4, 1,3-butadiene- and isobutene-free (CAS No 95465-89-7), if they contain more than 0.1% w/w Butadiene.

611.

Raffinates (petroleum), steam-cracked C4 fraction cuprous ammonium acetate extn., C3-5 and C3-5 unsatd., butadiene-free (CAS No 97722-19-5), if they contain more than 0.1% w/w Butadiene.

612.

Benzo[def]chrysene (=benzo[a]pyrene) (CAS No 50-32-8).

613.

Pitch, coal tar-petroleum (CAS No 68187-57-5), if it contains more than 0.005 % w/w benzo[a]pyrene.

614.

Distillates (coal-petroleum), condensed-ring arom. (CAS No 68188-48-7), if they contain more than 0.005 % w/w benzo[a]pyrene.

615.

Distillates (coal tar), upper, fluorene-free (CAS No 84989-10-6), if they contain more than 0.005 % w/w benzo[a]pyrene.

616.

Distillates (coal tar), upper, fluorene-rich (CAS No 84989-11-7), if they contain more than 0.005 % w/w benzo[a]pyrene.

617.

Creosote oil, acenaphthene fraction, acenaphthene-free (CAS No 90640-85-0), if it contains more than 0.005 % w/w benzo[a]pyrene.

618.

Pitch, coal tar, low-temp. (CAS No 90669-57-1), if it contains more than 0.005 % w/w benzo[a]pyrene.

619.

Pitch, coal tar, low-temp., heat-treated (CAS No 90669-58-2), if it contains more than 0.005 % w/w benzo[a]pyrene.

620.

Pitch, coal tar, low-temp., oxidised (CAS No 90669-59-3), if it contains more than 0.005 % w/w benzo[a]pyrene.

621.

Extract residues (coal), brown (CAS No 91697-23-3), if they contain more than 0.005 % w/w benzo[a]pyrene.

622.

Paraffin waxes (coal), brown-coal high-temp. tar (CAS No 92045-71-1), if they contain more than 0.005 % w/w benzo[a]pyrene.

623.

Paraffin waxes (coal), brown-coal high-temp. tar, hydrotreated (CAS No 92045-72-2), if they contain more than 0.005 % w/w benzo[a]pyrene.

624.

Waste solids, coal-tar pitch coking (CAS No 92062-34-5), if they contain more than 0.005 % w/w benzo[a]pyrene.

625.

Pitch, coal tar, high-temp., secondary (CAS No 94114-13-3), if it contains more than 0.005 % w/w benzo[a]pyrene.

626.

Residues (coal), liq. solvent extn. (CAS No 94114-46-2), if they contain more than 0.005 % w/w benzo[a]pyrene.

627.

Coal liquids, liq. solvent extn. soln. (CAS No 94114-47-3), if they contain more than 0.005 % w/w benzo[a]pyrene.

628.

Coal liquids, liq. solvent extn. (CAS No 94114-48-4), if they contain more than 0.005 % w/w benzo[a]pyrene.

629.

Paraffin waxes (coal), brown-coal high-temp. tar, carbon-treated (CAS No 97926-76-6), if they contain more than 0.005 % w/w benzo[a]pyrene.

630.

Paraffin waxes (coal), brown-coal high-temp tar, clay-treated (CAS No 97926-77-7), if they contain more than 0.005 % w/w benzo[a]pyrene.

631.

Paraffin waxes (coal), brown-coal high-temp tar, silicic acid-treated (CAS No 97926-78-8), if they contain more than 0.005 % w/w benzo[a]pyrene.

632.

Absorption oils, bicyclo arom. and heterocylic hydrocarbon fraction (CAS No 101316-45-4), if they contain more than 0.005 % w/w benzo[a]pyrene.

633.

Aromatic hydrocarbons, C20-28, polycyclic, mixed coal-tar pitch-polyethylene polypropylene pyrolysis-derived (CAS No 101794-74-5), if they contain more than 0.005 % w/w benzo[a]pyrene.

634.

Aromatic hydrocarbons, C20-28, polycyclic, mixed coal-tar pitch-polyethylene pyrolysis-derived (CAS No 101794-75-6), if they contain more than 0.005 % w/w benzo[a]pyrene.

635.

Aromatic hydrocarbons, C20-28, polycyclic, mixed coal-tar pitch-polystyrene pyrolysis-derived (CAS No 101794-76-7), if they contain more than 0.005 % w/w benzo[a]pyrene.

636.

Pitch, coal tar, high-temp., heat-treated (CAS No 121575-60-8), if it contains more than 0.005 % w/w benzo[a]pyrene.

637.

Dibenz[a,h]anthracene (CAS No 53-70-3).

638.

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

639.

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

640.

Benzo[j]fluoranthene (CAS No 205-82-3).

641.

Benz(e)acephenanthrylene (CAS No 205-99-2).

642.

Benzo(k)fluoranthene (CAS No 207-08-9).

643.

Chrysene (CAS No 218-01-9).

644.

2-Bromopropane (CAS No 75-26-3).

645.

Trichloroethylene (CAS No 79-01-6).

646.

1,2-Dibromo-3-chloropropane (CAS No 96-12-8).

647.

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

648.

1,3-Dichloropropan-2-ol (CAS No 96-23-1).

649.

α,α,α-Trichlorotoluene (CAS No 98-07-7).

650.

α-Chlorotoluene (CAS No 100-44-7).

651.

1,2-Dibromoethane (CAS No 106-93-4).

652.

Hexachlorobenzene (CAS No 118-74-1).

653.

Bromoethylene (CAS No 593-60-2).

654.

1,4-Dichlorobut-2-ene (CAS No 764-41-0).

655.

Methyloxirane (CAS No 75-56-9).

656.

(Epoxyethyl)benzene (CAS No 96-09-3).

657.

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

658.

R-1-Chloro-2,3-epoxypropane (CAS No 51594-55-9).

659.

1,2-Epoxy-3-phenoxypropane (CAS No 122-60-1).

660.

2,3-Epoxypropan-1-ol (CAS No 556-52-5).

661.

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

662.

2,2'-Bioxirane (CAS No 1464-53-5).

663.

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

664.

Chloromethyl methyl ether (CAS No 107-30-2).

665.

2-Methoxyethanol (CAS No 109-86-4).

666.

2-Ethoxyethanol (CAS No 110-80-5).

667.

Oxybis[chloromethane], bis (Chloromethyl) ether (CAS No 542-88-1).

668.

2-Methoxypropanol (CAS No 1589-47-5).

669.

Propiolactone (CAS No 57-57-8).

670.

Dimethylcarbamoyl chloride (CAS No 79-44-7).

671.

Urethane (CAS No 51-79-6).

672.

2-Methoxyethyl acetate (CAS No 110-49-6).

673.

2-Ethoxyethyl acetate (CAS No 111-15-9).

674.

Methoxyacetic acid (CAS No 625-45-6).

675.

Dibutyl phthalate (CAS No 84-74-2).

676.

bis(2-Methyoxyethyl) ether (CAS No 111-96-6).

677.

bis(2-Ethylhexyl) phthalate (CAS No 117-81-7).

678.

bis(2-Methoxyethyl) phthalate (CAS No 117-82-8).

679.

2-Methoxypropyl acetate (CAS No 70657-70-4).

680.

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

681.

Acrylamide, unless regulated elsewhere in this Directive (CAS No 79-06-1).

682.

Acrylonitrile (CAS No 107-13-1).

683.

2-Nitropropane (CAS No 79-46-9).

684.

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

685.

2-Nitroanisole (CAS No 91-23-6).

686.

4-Nitrobiphenyl (CAS No 92-93-3).

687.

2,4-Dinitrotoluene (CAS No 121-14-2).

688.

Binapacryl (CAS No 485-31-4).

689.

2-Nitronaphthalene (CAS No 581-89-5).

690.

2,3-Dinitrotoluene (CAS No 602-01-7).

691.

5-Nitroacenaphthene (CAS No 602-87-9).

692.

2,6-Dinitrotoluene (CAS No 606-20-2).

693.

3,4-Dinitrotoluene (CAS No 610-39-9).

694.

3,5-Dinitrotoluene (CAS No 618-85-9).

695.

2,5-Dinitrotoluene (CAS No 619-15-8).

696.

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

697.

Nitrofen (CAS No 1836-75-5).

698.

Dinitrotoluene (CAS No 25321-14-6).

699.

Diazomethane (CAS No 334-88-3).

700.

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

701.

Dimethylnitrosoamine (CAS No 62-75-9).

702.

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

703.

Nitrosodipropylamine (CAS No 621-64-7).

704.

2,2'-(Nitrosoimino)bisethanol (CAS No 1116-54-7).

705.

4,4' -Methylenedianiline (CAS No 101-77-9).

706.

4,4' -(4-Iminocyclohexa-2,5-dienylidenemethylene) dianiline hydrochloride (CAS No 569-61-9).

707.

4,4'-Methylenedi-σ-toluidine (CAS No 838-88-0).

708.

σ -Anisidine (CAS No 90-04-0).

709.

3,3' -Dimethoxybenzidine (CAS No 119-90-4).

710.

Salts of σ-dianisidine.

711.

σ -Dianisidine based azo dyes.

712.

3,3' -Dichlorobenzidine (CAS No 91-94-1).

713.

Benzidine dihydrochloride (CAS No 531-85-1).

714.

[[1,1' -Biphenyl]-4,4' -diyl]diammonium sulphate (CAS No 531-86-2).

715.

3,3' -Dichlorobenzidine dihydrochloride (CAS No 612-83-9).

716.

Benzidine sulphate (CAS No 21136-70-9).

717.

Benzidine acetate (CAS No 36341-27-2).

718.

3,3' -Dichlorobenzidine dihydrogen bis(sulphate) (CAS No 64969-34-2).

719.

3,3' -Dichlorobenzidine sulphate (CAS No 74332-73-3).

720.

Benzidine based azo dyes.

721.

4,4'-Bi-σ-toluidine (CAS No 119-93-7).

722.

4,4'-Bi-σ-toluidine dihydrochloride (CAS No 612-82-8).

723.

[3,3'-Dimethyl[1,1'-biphenyl]-4,4'-diyl]diammonium bis(hydrogen sulphate) (CAS No 64969-36-4).

724.

4,4'-Bi-σ-toluidine sulphate (CAS No 74753-18-7).

725.

σ -Tolidine based dyes.

726.

Biphenyl-4-ylamine (CAS No 92-67-1) and its salts.

727.

Azobenzene (CAS No 103-33-3).

728.

(Methyl-ONN-azoxy)methyl acetate (CAS No 592-62-1).

729.

Cycloheximide (CAS No 66-81-9).

730.

2-Methylaziridine (CAS No 75-55-8).

731.

Imidazolidine-2-thione (CAS No 96-45-7).

732.

Furan (CAS No 110-00-9).

733.

Aziridine (CAS No 151-56-4).

734.

Captafol (2425-06-1).

735.

Carbadox (CAS No 6804-07-5).

736.

Flumioxazin (CAS No 103361-09-7).

737.

Tridemorph (CAS No 24602-86-6).

738.

Vinclozolin (CAS No 50471-44-8).

739.

Fluazifop-butyl (CAS No 69806-50-4).

740.

Flusilazole (CAS No 85509-19-9).

741.

1,3,5-Tris(oxiranylmethyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione (CAS No 2451-62-9).

742.

Thioacetamide (CAS No 62-55-5).

743.

N,N-Dimethylformamide (CAS No 68-12-2).

744.

Formamide (CAS No 75-12-7).

745.

N-Methylacetamide (CAS No 79-16-3).

746.

N-Methylformamide (CAS No 123-39-7).

747.

N,N-Dimethylacetamide (CAS No 127-19-5).

748.

Hexamethylphosphoric-triamide (CAS No 680-31-9).

749.

Diethyl sulphate (CAS No 64-67-5).

750.

Dimethyl sulphate (CAS No 77-78-1).

751.

1,3-Propanesultone (CAS No 1120-71-4).

752.

Dimethylsulphamoyl-chloride (CAS No 13360-57-1).

753.

Sulfallate (CAS No 95-06-7).

754.

A mixture of: 4-[[bis-(4-Fluorophenyl)methylsilyl]methyl]-4H-1,2,4-triazole and 1-[[bis-(4-fluorophenyl)methylsilyl]methyl]-1H-1,2,4-triazole (EC No 403-250-2).

755.

(+/-)-Tetrahydrofurfuryl-(R)-2-[4-(6-chloroquinoxalin-2-loxy)phenyloxy]propionate (CAS No 119738-06-6).

756.

6-Hydroxy-1-(3-Isopropoxypropyl)-4-methyl-2-oxo-5-[4-(phenylazo)phenylazo]-1,2-dihydro-3-pyridinecarbonitrile (CAS No 85136-74-9).

757.

(6-(4-Hydroxy-3-(2-methoxyphenylazo)-2-sulfonato-7-naphthylamino)-1,3,5-triazine-2,4-diyl)bis[(amino-1-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).

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-methylacryloylamino-methoxymethyl)-acrylamide and N-(2,3-dihydroxypropoxymethyl)-2-methylacrylamide (EC No 412-790-8).

760.

1,3,5-tris-[(2S and 2R)-2,3-Epoxypropyl]-1,3,5-triazine-2,4,6-(1H,3H,5H)-trione (CAS No 59653-74-6).

761.

Erionite (CAS No 12510-42-8).

762.

Asbestos (CAS No 12001-28-4).

763.

Petroleum (CAS No 8002-05-9).

764.

Distillates (petroleum), heavy hydrocracked (CAS No 64741-76-0), if they contain more than 3% w/w DMSO extract.

765.

Distillates (petroleum), solvent-refined heavy paraffinic (CAS No 64741-88-4), if they contain more than 3% w/w DMSO extract.

766.

Distillates (petroleum), solvent-refined light paraffinic (CAS No 64741-89-5), if they contain more than 3% w/w DMSO extract.

767.

Residual oils (petroleum), solvent deasphalted (CAS No 64741-95-3), if they contain more than 3% w/w DMSO extract.

768.

Distillates (petroleum), solvent-refined heavy naphthenic (CAS No 64741-96-4), if they contain more than 3% w/w DMSO extract.

769.

Distillates (petroleum), solvent-refined light naphthenic (CAS No 64741-97-5), if they contain more than 3% w/w DMSO extract.

770.

Residual oils (petroleum), solvent-refined (CAS No 64742-01-4), if they contain more than 3% w/w DMSO extract.

771.

Distillates (petroleum), clay-treated heavy paraffinic (CAS No 64742-36-5), if they contain more than 3% w/w DMSO extract.

772.

Distillates (petroleum), clay-treated light paraffinic (CAS No 64742-37-6), if they contain more than 3% w/w DMSO extract.

773.

Residual oils (petroleum), clay-treated (CAS No 64742-41-2), if they contain more than 3% w/w DMSO extract.

774.

Distillates (petroleum), clay-treated heavy naphthenic (CAS No 64742-44-5), if they contain more than 3% w/w DMSO extract.

775.

Distillates (petroleum), clay-treated light naphthenic (CAS No 64742-45-6), if they contain more than 3% w/w DMSO extract.

776.

Distillates (petroleum), hydrotreated heavy naphthenic (CAS No 64742-52-5), if they contain more than 3% w/w DMSO extract.

777.

Distillates (petroleum), hydrotreated light naphthenic (CAS No 64742-53-6), if they contain more than 3% w/w DMSO extract.

778.

Distillates (petroleum), hydrotreated heavy paraffinic (CAS No 64742-54-7), if they contain more than 3% w/w DMSO extract.

779.

Distillates (petroleum), hydrotreated light paraffinic (CAS No 64742-55-8), if they contain more than 3% w/w DMSO extract.

780.

Distillates (petroleum), solvent-dewaxed light paraffinic (CAS No 64742-56-9), if they contain more than 3% w/w DMSO extract.

781.

Residual oils (petroleum), hydrotreated (CAS No 64742-57-0), if they contain more than 3% w/w DMSO extract.

782.

Residual oils (petroleum), solvent-dewaxed (CAS No 64742-62-7), if they contain more than 3% w/w DMSO extract.

783.

Distillates (petroleum), solvent-dewaxed heavy naphthenic (CAS No 64742-63-8), if they contain more than 3% w/w DMSO extract.

784.

Distillates (petroleum), solvent-dewaxed light naphthenic (CAS No 64742-64-9), if they contain more than 3% w/w DMSO extract.

785.

Distillates (petroleum), solvent-dewaxed heavy paraffinic (CAS No 64742-65-0), if they contain more than 3% w/w DMSO extract.

786.

Foots oil (petroleum) (CAS No 64742-67-2), if it contains more than 3% w/w DMSO extract.

787.

Naphthenic oils (petroleum), catalytic dewaxed heavy (CAS No 64742-68-3), if they contain more than 3% w/w DMSO extract.

788.

Naphthenic oils (petroleum), catalytic dewaxed light (CAS No 64742-69-4), if they contain more than 3% w/w DMSO extract.

789.

Paraffin oils (petroleum), catalytic dewaxed heavy (CAS No 64742-70-7), if they contain more than 3% w/w DMSO extract.

790.

Paraffin oils (petroleum), catalytic dewaxed light (CAS No 64742-71-8), if they contain more than 3% w/w DMSO extract.

791.

Naphthenic oils (petroleum), complex dewaxed heavy (CAS No 64742-75-2), if they contain more than 3% w/w DMSO extract.

792.

Naphthenic oils (petroleum), complex dewaxed light (CAS No 64742-76-3), if they contain more than 3% w/w DMSO extract.

793.

Extracts (petroleum), heavy naphthenic distillate solvent, arom. conc. (CAS No 68783-00-6), if they contain more than 3% w/w DMSO extract.

794.

Extracts (petroleum), solvent-refined heavy paraffinic distillate solvent (CAS No 68783-04-0), if they contain more than 3% w/w DMSO extract.

795.

Extracts (petroleum), heavy paraffinic distillates, solvent-deasphalted (CAS No 68814-89-1), if they contain more than 3% w/w DMSO extract.

796.

Lubricating oils (petroleum), C20-50, hydrotreated neutral oil-based, high-viscosity (CAS No 72623-85-9), if they contain more than 3% w/w DMSO extract.

797.

Lubricating oils (petroleum), C15-30, hydrotreated neutral oil-based (CAS No 72623-86-0), if they contain more than 3% w/w DMSO extract.

798.

Lubricating oils (petroleum), C20-50, hydrotreated neutral oil-based (CAS No 72623-87-1), if they contain more than 3% w/w DMSO extract.

799.

Lubricating oils (CAS No 74869-22-0), if they contain more than 3% w/w DMSO extract.

800.

Distillates (petroleum), complex dewaxed heavy paraffinic (CAS No 90640-91-8), if they contain more than 3% w/w DMSO extract.

801.

Distillates (petroleum), complex dewaxed light paraffinic (CAS No 90640-92-9), if they contain more than 3% w/w DMSO extract.

802.

Distillates (petroleum), solvent dewaxed heavy paraffinic, clay-treated (CAS No 90640-94-1), if they contain more than 3% w/w DMSO extract.

803.

Hydrocarbons, C20-50, solvent dewaxed heavy paraffinic, hydrotreated (CAS No 90640-95-2), if they contain more than 3% w/w DMSO extract.

804.

Distillates (petroleum), solvent dewaxed light paraffinic, clay-treated (CAS No 90640-96-3), if they contain more than 3% w/w DMSO extract.

805.

Distillates (petroleum), solvent dewaxed light paraffinic, hydrotreated (CAS No 90640-97-4), if they contain more than 3% w/w DMSO extract.

806.

Extracts (petroleum), heavy naphthenic distillate solvent, hydrotreated (CAS No 90641-07-9), if they contain more than 3% w/w DMSO extract.

807.

Extracts (petroleum), heavy paraffinic distillate solvent, hydrotreated (CAS No 90641-08-0), if they contain more than 3% w/w DMSO extract.

808.

Extracts (petroleum), light paraffinic distillate solvent, hydrotreated (CAS No 90641-09-1), if they contain more than 3% w/w DMSO extract.

809.

Residual oils (petroleum), hydrotreated solvent dewaxed (CAS No 90669-74-2), if they contain more than 3% w/w DMSO extract.

810.

Residual oils (petroleum), catalytic dewaxed (CAS No 91770-57-9), if they contain more than 3% w/w DMSO extract.

811.

Distillates (petroleum), dewaxed heavy paraffinic, hydrotreated (CAS No 91995-39-0) if they contain more than 3% w/w DMSO extract.

812.

Distillates (petroleum), dewaxed light paraffinic, hydrotreated (CAS No 91995-40-3), if they contain more than 3% w/w DMSO extract.

813.

Distillates (petroleum), hydrocracked solvent-refined, dewaxed (CAS No 91995-45-8), if they contain more than 3% w/w DMSO extract.

814.

Distillates (petroleum), solvent-refined light naphthenic, hydrotreated (CAS No 91995-54-9), if they contain more than 3% w/w DMSO extract.

815.

Extracts (petroleum), hydrotreated light paraffinic distillate solvent (CAS No 91995-73-2), if they contain more than 3% w/w DMSO extract.

816.

Extracts (petroleum), light naphthenic distillate solvent, hydrodesulfurised (CAS No 91995-75-4), if they contain more than 3% w/w DMSO extract.

817.

Extracts (petroleum), light paraffinic distillate solvent, acid-treated (CAS No 91995-76-5), if they contain more than 3% w/w DMSO extract.

818.

Extracts (petroleum), light paraffinic distillate solvent, hydrodesulfurised (CAS No 91995-77-6), if they contain more than 3% w/w DMSO extract.

819.

Extracts (petroleum), light vacuum gas oil solvent, hydrotreated (CAS No 91995-79-8), if they contain more than 3% w/w DMSO extract.

820.

Foots oil (petroleum), hydrotreated (CAS No 92045-12-0), if it contains more than 3% w/w DMSO extract.

821.

Lubricating oils (petroleum), C17-35, solvent-extd., dewaxed, hydrotreated (CAS No 92045-42-6), if they contain more than 3% w/w DMSO extract.

822.

Lubricating oils (petroleum), hydrocracked nonarom solvent-deparaffined (CAS No 92045-43-7), if they contain more than 3% w/w DMSO extract.

823.

Residual oils (petroleum), hydrocracked acid-treated solvent-dewaxed (CAS No 92061-86-4), if they contain more than 3% w/w DMSO extract.

824.

Paraffin oils (petroleum), solvent-refined dewaxed heavy (CAS No 92129-09-4), if they contain more than 3% w/w DMSO extract.

825.

Extracts (petroleum), heavy paraffinic distillate solvent, clay-treated (CAS No 92704-08-0), if they contain more than 3% w/w DMSO extract.

826.

Lubricating oils (petroleum), base oils, paraffinic (CAS No 93572-43-1), if they contain more than 3% w/w DMSO extract.

827.

Extracts (petroleum), heavy naphthenic distillate solvent, hydrodesulfurised (CAS No 93763-10-1), if they contain more than 3% w/w DMSO extract.

828.

Extracts (petroleum), solvent-dewaxed heavy paraffinic distillate solvent, hydrodesulfurised (CAS No 93763-11-2), if they contain more than 3% w/w DMSO extract.

829.

Hydrocarbons, hydrocracked paraffinic distn. residues, solvent-dewaxed (CAS No 93763-38-3), if they contain more than 3% w/w DMSO extract.

830.

Foots oil (petroleum), acid-treated (CAS No 93924-31-3), if it contains more than 3% w/w DMSO extract.

831.

Foots oil (petroleum), clay-treated (CAS No 93924-32-4), if it contains more than 3% w/w DMSO extract.

832.

Hydrocarbons, C20-50, residual oil hydrogenation vacuum distillate (CAS No 93924-61-9), if they contain more than 3% w/w DMSO extract.

833.

Distillates (petroleum), solvent-refined hydrotreated heavy, hydrogenated (CAS No 94733-08-1), if they contain more than 3% w/w DMSO extract.

834.

Distillates (petroleum), solvent-refined hydrocracked light (CAS No 94733-09-2), if they contain more than 3% w/w DMSO extract.

835.

Lubricating oils (petroleum), C18-40, solvent-dewaxed hydrocracked distillate-based (CAS No 94733-15-0), if they contain more than 3% w/w DMSO extract.

836.

Lubricating oils (petroleum), C18-40, solvent-dewaxed hydrogenated raffinate-based (CAS No 94733-16-1), if they contain more than 3% w/w DMSO extract.

837.

Hydrocarbons, C13-30, arom.-rich, solvent-extd. naphthenic distillate (CAS No 95371-04-3), if they contain more than 3% w/w DMSO extract.

838.

Hydrocarbons, C16-32, arom. rich, solvent-extd. naphthenic distillate (CAS No 95371-05-4), if they contain more than 3% w/w DMSO extract.

839.

Hydrocarbons, C37-68, dewaxed deasphalted hydrotreated vacuum distn. Residues (CAS No 95371-07-6), if they contain more than 3% w/w DMSO extract.

840.

Hydrocarbons, C37-65, hydrotreated deasphalted vacuum distn. Residues (CAS No 95371-08-7), if they contain more than 3% w/w DMSO extract.

841.

Distillates (petroleum), hydrocracked solvent-refined light (CAS No 97488-73-8), if they contain more than 3% w/w DMSO extract.

842.

Distillates (petroleum), solvent-refined hydrogenated heavy (CAS No 97488-74-9), if they contain more than 3% w/w DMSO extract.

843.

Lubricating oils (petroleum), C18-27, hydrocracked solvent-dewaxed (CAS No 97488-95-4), if they contain more than 3% w/w DMSO extract.

844.

Hydrocarbons, C17-30, hydrotreated solvent-deasphalted atm. distn. residue, distn. lights (CAS No 97675-87-1), if they contain more than 3% w/w DMSO extract.

845.

Hydrocarbons, C17-40, hydrotreated solvent-deasphalted distn. residue, vacuum distn. lights (CAS No 97722-06-0), if they contain more than 3% w/w DMSO extract.

846.

Hydrocarbons, C13-27, solvent-extd. light naphthenic (CAS No 97722-09-3), if they contain more than 3% w/w DMSO extract.

847.

Hydrocarbons, C14-29, solvent-extd. light naphthenic (CAS No 97722-10-6), if they contain more than 3% w/w DMSO extract.

848.

Foots oil (petroleum), carbon-treated (CAS No 97862-76-5), if it contains more than 3% w/w DMSO extract.

849.

Foots oil (petroleum), silicic acid-treated (CAS No 97862-77-6), if it contains more than 3% w/w DMSO extract.

850.

Hydrocarbons, C27-42, dearomatised (CAS No 97862-81-2), if they contain more than 3% w/w DMSO extract.

851.

Hydrocarbons, C17-30, hydrotreated distillates, distn. Lights (CAS No 97862-82-3), if they contain more than 3% w/w DMSO extract.

852.

Hydrocarbons, C27-45, naphthenic vacuum distn. (CAS No 97862-83-4), if they contain more than 3% w/w DMSO extract.

853.

Hydrocarbons, C27-45, dearomatised (CAS No 97926-68-6), if they contain more than 3% w/w DMSO extract.

854.

Hydrocarbons, C20-58, hydrotreated (CAS No 97926-70-0), if they contain more than 3% w/w DMSO extract.

855.

Hydrocarbons, C27-42, naphthenic (CAS No 97926-71-1), if they contain more than 3% w/w DMSO extract.

856.

Extracts (petroleum), light paraffinic distillate solvent, carbon-treated (CAS No 100684-02-4), if they contain more than 3% w/w DMSO extract.

857.

Extracts (petroleum), light paraffinic distillate solvent, clay-treated (CAS No 100684-03-5), if they contain more than 3% w/w DMSO extract.

858.

Extracts (petroleum), light vacuum, gas oil solvent, carbon-treated (CAS No 100684-04-6), if they contain more than 3% w/w DMSO extract.

859.

Extracts (petroleum), light vacuum gas oil solvent, clay-treated (CAS No 100684-05-7), if they contain more than 3% w/w DMSO extract.

860.

Residual oils (petroleum), carbon-treated solvent-dewaxed (CAS No 100684-37-5), if they contain more than 3% w/w DMSO extract.

861.

Residual oils (petroleum), clay-treated solvent-dewaxed (CAS No 100684-38-6), if they contain more than 3% w/w DMSO extract.

862.

Lubricating oils (petroleum), C<25, solvent-extd., deasphalted, dewaxed, hydrogenated (CAS No 101316-69-2), if they contain more than 3% w/w DMSO extract.

863.

Lubricating oils (petroleum), C17-32, solvent-extd., dewaxed, hydrogenated (CAS No 101316-70-5), if they contain more than 3% w/w DMSO extract.

864.

Lubricating oils (petroleum), C20-35, solvent-extd., dewaxed, hydrogenated (CAS No 101316-71-6), if they contain more than 3% w/w DMSO extract.

865.

Lubricating oils (petroleum), C24-50, solvent-extd., dewaxed, hydrogenated (CAS No 101316-72-7), if they contain more than 3% w/w DMSO extract.

866.

Distillates (petroleum), sweetened middle (CAS No 64741-86-2), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen.

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.

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 substance from which it is produced is not a carcinogen.

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 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 substance from which it is produced is not a carcinogen.

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 substance from which it is produced is not a carcinogen.

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 substance from which it is produced is not a carcinogen.

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.

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 substance from which it is produced is not a carcinogen.

875.

Distillates (petroleum), hydrotreated middle (CAS No 64742-46-7), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen.

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 substance from which it is produced is not a carcinogen.

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 substance from which it is produced is not a carcinogen.

878.

Distillates (petroleum), catalytic reformer fractionator residue, high-boiling (CAS No 68477-29-2), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen.

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 substance from which it is produced is not a carcinogen.

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.

881.

Alkanes, C12-26 -branched and linear (CAS No 90622-53-0), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen.

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 substance from which it is produced is not a carcinogen.

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.

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.

885.

Naphtha (petroleum), solvent-refined hydrodesulfurised heavy (CAS No 97488-96-5), 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.

886.

Hydrocarbons, C16-20, hydrotreated middle distillate, distn. Lights (CAS No 97675-85-9), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen.

887.

Hydrocarbons, C12-20, 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.

888.

Hydrocarbons, C11-17, solvent-extd. light naphthenic (CAS No 97722-08-2), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen.

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.

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 substance from which it is produced is not a carcinogen.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

901.

Slack wax (petroleum), low-melting, clay-treated (CAS No 97863-05-3), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen.

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.

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 substance from which it is produced is not a carcinogen.

904.

Petrolatum (CAS No 8009-03-8), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen.

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.

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 substance from which it is produced is not a carcinogen.

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.

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 substance from which it is produced is not a carcinogen.

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 substance from which it is 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 substance from which it is produced is not a carcinogen.

911.

Distillates (petroleum), light catalytic cracked (CAS No 64741-59-9).

912.

Distillates (petroleum), intermediate catalytic cracked (CAS No 64741-60-2).

913.

Distillates (petroleum), light thermal cracked (CAS No 64741-82-8).

914.

Distillates (petroleum), hydrodesulfurised light catalytic cracked (CAS No 68333-25-5).

915.

Distillates (petroleum), light steam-cracked naphtha (CAS No 68475-80-9)

916.

Distillates (petroleum), cracked steam-cracked petroleum distillates (CAS No 68477-38-3).

917.

Gas oils (petroleum), steam-cracked (CAS No 68527-18-4).

918.

Distillates (petroleum), hydrodesulfurised thermal cracked middle (CAS No 85116-53-6).

919.

Gas oils (petroleum), thermal-cracked, hydrodesulfurised (CAS No 92045-29-9).

920.

Residues (petroleum), hydrogenated steam-cracked naphtha (CAS No 92062-00-5).

921.

Residues (petroleum), steam-cracked naphtha distn. (CAS No 92062-04-9).

922.

Distillates (petroleum), light catalytic cracked, thermally degraded (CAS No 92201-60-0).

923.

Residues (petroleum), steam-cracked heat-soaked naphtha (CAS No 93763-85-0).

924.

Gas oils (petroleum), light vacuum, thermal-cracked hydrodesulfurised (CAS No 97926-59-5).

925.

Distillates (petroleum), hydrodesulfurised middle coker (CAS No 101316-59-0).

926.

Distillates (petroleum), heavy steam-cracked (CAS No 101631-14-5).

927.

Residues (petroleum), atm. Tower (CAS No 64741-45-3).

928.

Gas oils (petroleum), heavy vacuum (CAS No 64741-57-7).

929.

Distillates (petroleum), heavy catalytic cracked (CAS No 64741-61-3).

930.

Clarified oils (petroleum), catalytic cracked (CAS No 64741-62-4).

931.

Residues (petroleum), catalytic reformer fractionator (CAS No 64741-67-9).

932.

Residues (petroleum), hydrocracked (CAS No 64741-75-9).

933.

Residues (petroleum), thermal cracked (CAS No 64741-80-6).

934.

Distillates (petroleum), heavy thermal cracked (CAS No 64741-81-7).

935.

Gas oils (petroleum), hydrotreated vacuum (CAS No 64742-59-2).

936.

Residues (petroleum), hydrodesulfurised atmospheric tower (CAS No 64742-78-5).

937.

Gas oils (petroleum), hydrodesulfurised heavy vacuum (CAS No 64742-86-5).

938.

Residues (petroleum), steam-cracked (CAS No 64742-90-1).

939.

Residues (petroleum), atmospheric (CAS No 68333-22-2).

940.

Clarified oils (petroleum), hydrodesulfurised catalytic cracked (CAS No 68333-26-6).

941.

Distillates (petroleum), hydrodesulfurised intermediate catalytic cracked (CAS No 68333-27-7).

942.

Distillates (petroleum), hydrodesulfurised heavy catalytic cracked (CAS No 68333-28-8).

943.

Fuel oil, residues-straight-run gas oils, high-sulfur (CAS No 68476-32-4).

944.

Fuel oil, residual (CAS No 68476-33-5).

945.

Residues (petroleum), catalytic reformer fractionator residue distn. (CAS No 68478-13-7).

946.

Residues (petroleum), heavy coker gas oil and vacuum gas oil (CAS No 68478-17-1).

947.

Residues (petroleum), heavy coker and light vacuum (CAS No 68512-61-8).

948.

Residues (petroleum), light vacuum (CAS No 68512-62-9).

949.

Residues (petroleum), steam-cracked light (CAS No 68513-69-9).

950.

Fuel oil, no. 6 (CAS No 68553-00-4).

951.

Residues (petroleum), topping plant, low-sulfur (CAS No 68607-30-7).

952.

Gas oils (petroleum), heavy atmospheric (CAS No 68783-08-4).

953.

Residues (petroleum), coker scrubber, condensed-ring-arom.-contg (CAS No 68783-13-1).

954.

Distillates (petroleum), petroleum residues vacuum (CAS No 68955-27-1).

955.

Residues (petroleum), steam-cracked, resinous (CAS No 68955-36-2).

956.

Distillates (petroleum), intermediate vacuum (CAS No 70592-76-6).

957.

Distillates (petroleum), light vacuum (CAS No 70592-77-7).

958.

Distillates (petroleum), vacuum (CAS No 70592-78-8).

959.

Gas oils (petroleum), hydrodesulfurised coker heavy vacuum (CAS No 85117-03-9).

960.

Residues (petroleum), steam-cracked, distillates (CAS No 90669-75-3).

961.

Residues (petroleum), vacuum, light (CAS No 90669-76-4).

962.

Fuel oil, heavy, high-sulfur (CAS No 92045-14-2).

963.

Residues (petroleum), catalytic cracking (CAS No 92061-97-7).

964.

Distillates (petroleum), intermediate catalytic cracked, thermally degraded (CAS No 92201-59-7).

965.

Residual oils (petroleum) (CAS No 93821-66-0).

966.

Residues, steam cracked, thermally treated (CAS No 98219-64-8).

967.

Distillates (petroleum), hydrodesulfurised full-range middle (CAS No 101316-57-8).

968.

Distillates (petroleum), light paraffinic (CAS No 64741-50-0).

969.

Distillates (petroleum), heavy paraffinic (CAS No 64741-51-1).

970.

Distillates (petroleum), light naphthenic (CAS No 64741-52-2).

971.

Distillates (petroleum), heavy naphthenic (CAS No 64741-53-3).

972.

Distillates (petroleum), acid-treated heavy naphthenic (CAS No 64742-18-3).

973.

Distillates (petroleum), acid-treated light naphthenic (CAS No 64742-19-4).

974.

Distillates (petroleum), acid-treated heavy paraffinic (CAS No 64742-20-7).

975.

Distillates (petroleum), acid-treated light paraffinic (CAS No 64742-21-8).

976.

Distillates (petroleum), chemically neutralised heavy paraffinic (CAS No 64742-27-4).

977.

Distillates (petroleum), chemically neutralised light paraffinic (CAS No 64742-28-5).

978.

Distillates (petroleum), chemically neutralised heavy naphthenic (CAS No 64742-34-3).

979.

Distillates (petroleum), chemically neutralised light naphthenic (CAS No 64742-35-4).

980.

Extracts (petroleum), light naphthenic distillate solvent (CAS No 64742-03-6).

981.

Extracts (petroleum), heavy paraffinic distillate solvent (CAS No 64742-04-7).

982.

Extracts (petroleum), light paraffinic distillate solvent (CAS No 64742-05-8).

983.

Extracts (petroleum), heavy naphthenic distillate solvent (CAS No 64742-11-6).

984.

Extracts (petroleum), light vacuum gas oil solvent (CAS No 91995-78-7).

985.

Hydrocarbons, C26-55, arom. Rich (CAS No 97722-04-8).

986.

Disodium 3,3'-[[1,1'-biphenyl]-4,4'-diylbis(azo)] bis(4-aminonaphthalene-1-sulphonate) (CAS No 573-58-0).

987.

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

989.

4-σ-Tolylazo-σ-toluidine (CAS No 97-56-3).

990.

4-Aminoazobenzene (CAS No 60-09-3).

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).

992.

Resorcinol diglycidyl ether (CAS No 101-90-6).

993.

1,3-Diphenylguanidine (CAS No 102-06-7).

994.

Heptachlor-epoxide (CAS No 1024-57-3).

995.

4-Nitrosophenol (CAS No 104-91-6).

996.

Carbendazim (CAS No 10605-21-7).

997.

Allyl glycidyl ether (CAS No 106-92-3).

998.

Chloroacetaldehyde (CAS No 107-20-0).

999.

Hexane (CAS No 110-54-3).

1000.

2-(2-Methoxyethoxy)ethanol (CAS No 111-77-3).

1001.

(+/-)-2-(2,4-Dichlorophenyl)-3-(1H-1,2,4-triazol-1-yl)propyl-1,1,2,2-tetrafluoroethylether (CAS No 112281-77-3).

1002.

4-[4-(1,3-Dihydroxyprop-2-yl)phenylamino]-1,8-dihydroxy-5-nitroanthraquinone (CAS No 114565-66-1).

1003.

5,6,12,13-Tetrachloroanthra(2,1,9-def:6,5,10-d'e'f')diisoquinoline-1,3,8,10(2H,9H)-tetrone (CAS No 115662-06-1).

1004.

tris(2-Chloroethyl) phosphate (CAS No 115-96-8).

1005.

4' -Ethoxy-2-benzimidazoleanilide (CAS No 120187-29-3)

1006.

Nickel dihydroxide (CAS No 12054-48-7).

1007.

N,N-Dimethylaniline (CAS No 121-69-7).

1008.

Simazine (CAS No 122-34-9).

1009.

Bis(cyclopentadienyl)-bis(2,6-difluoro-3-(pyrrol-1-yl)-phenyl)titanium (CAS No 125051-32-3).

1010.

N,N,N',N' -Tetraglycidyl-4,4'-diamino-3,3'-diethyldiphenylmethane (CAS No 130728-76-6).

1011.

Divanadium pentaoxide (CAS No 1314-62-1).

1012.

Alkali salts of pentachlorophenol (CAS Nos 131-52-2 and 7778-73-6).

1013.

Phosphamidon (CAS No 13171-21-6).

1014.

N-(Trichloromethylthio)phthalimide (CAS No 133-07-3).

1015.

N-2-Naphthylaniline (CAS No 135-88-6).

1016.

Ziram (CAS No 137-30-4).

1017.

1-Bromo-3,4,5-trifluorobenzene (CAS No 138526-69-9).

1018.

Propazine (CAS No 139-40-2).

1019.

3-(4-Chlorophenyl)-1,1-dimethyluronium trichloroacetate; monuron-TCA (CAS No 140-41-0).

1020.

Isoxaflutole (CAS No 141112-29-0).

1021.

Kresoxim-methyl (CAS No 143390-89-0).

1022.

Chlordecone (CAS No 143-50-0).

1023.

9-Vinylcarbazole (CAS No 1484-13-5).

1024.

2-Ethylhexanoic acid (CAS No 149-57-5).

1025.

Monuron (CAS No 150-68-5).

1026.

Morpholine-4-carbonyl chloride (CAS No 15159-40-7).

1027.

Daminozide (CAS No 1596-84-5).

1028.

Alachlor (CAS No 15972-60-8).

1029.

UVCB condensation product of: tetrakis-hydroxymethylphosphonium chloride, urea and distilled hydrogenated C16-18 tallow alkylamine (CAS No 166242-53-1).

1030.

Ioxynil (CAS No 1689-83-4).

1031.

3,5-Dibromo-4-hydroxybenzonitrile (CAS No 1689-84-5).

1032.

2,6-Dibromo-4-cyanophenyl octanoate (CAS No 1689-99-2).

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).

1034.

5-Chloro-1,3-dihydro-2H-indol-2-one (CAS No 17630-75-0).

1035.

Benomyl (CAS No 17804-35-2).

1036.

Chlorothalonil (CAS No 1897-45-6).

1037.

N'-(4-Chloro-σ-tolyl)-N,N-dimethylformamidine monohydrochloride (CAS No 19750-95-9).

1038.

4,4' -Methylenebis(2-ethylaniline) (CAS No 19900-65-3).

1039.

Valinamide (CAS No 20108-78-5).

1040.

[(p-Tolyloxy)methyl]oxirane (CAS No 2186-24-5).

1041.

[(m-Tolyloxy)methyl]oxirane (CAS No 2186-25-6).

1042.

2,3-Epoxypropyl σ-tolyl ether (CAS No 2210-79-9).

1043.

[(Tolyloxy)methyl]oxirane, cresyl glycidyl ether (CAS No 26447-14-3).

1044.

Di-allate (CAS No 2303-16-4).

1045.

Benzyl 2,4-dibromobutanoate (CAS No 23085-60-1).

1046.

Trifluoroiodomethane (CAS No 2314-97-8).

1047.

Thiophanate-methyl (CAS No 23564-05-8).

1048.

Dodecachloropentacyclo[5.2.1.02,6.03,9.05,8]decane (CAS No 2385-85-5).

1049.

Propyzamide (CAS No 23950-58-5).

1050.

Butyl glycidyl ether (CAS No 2426-08-6).

1051.

2,3,4-Trichlorobut-1-ene (CAS No 2431-50-7).

1052.

Chinomethionate (CAS No 2439-01-2).

1053.

(R)-α-Phenylethylammonium (-)-(1R,2S)-(1,2-epoxypropyl)phosphonate monohydrate (CAS No 25383-07-7).

1054.

5-Ethoxy-3-trichloromethyl-1,2,4-thiadiazole (CAS No 2593-15-9).

1055.

Disperse Yellow 3 (CAS No 2832-40-8).

1056.

1,2,4-Triazole (CAS No 288-88-0).

1057.

Aldrin (CAS No 309-00-2).

1058.

Diuron (CAS No 330-54-1).

1059.

Linuron (CAS No 330-55-2).

1060.

Nickel carbonate (CAS No 3333-67-3).

1061.

3-(4-Isopropylphenyl)-1,1-dimethylurea (CAS No 34123-59-6).

1062.

Iprodione (CAS No 36734-19-7).

1063.

4-Cyano-2,6-diiodophenyl octanoate (CAS No 3861-47-0).

1064.

5-(2,4-Dioxo-1,2,3,4-tetrahydropyrimidine)-3-fluro-2-hydroxymethylterahydrofuran (CAS No 41107-56-6).

1065.

Crotonaldehyde (CAS No 4170-30-3).

1066.

Hexahydrocyclopenta(c)pyrrole-1-(1H)-ammonium N-ethoxycarbonyl-N-(p-olylsulfonyl)azanide (EC No 418-350-1).

1067.

4,4' -Carbonimidoylbis[N,N-dimethylaniline] (CAS No 492-80-8).

1068.

DNOC (CAS No 534-52-1).

1069.

Toluidinium chloride (CAS No 540-23-8).

1070.

Toluidine sulphate (1:1) (CAS No 540-25-0).

1071.

2-(4-tert-Butylphenyl)ethanol (CAS No 5406-86-0).

1072.

Fenthion (CAS No 55-38-9).

1073.

Chlordane, pur (CAS No 57-74-9).

1074.

Hexan-2-one (CAS No 591-78-6).

1075.

Fenarimol (CAS No 60168-88-9).

1076.

Acetamide (CAS No 60-35-5).

1077.

N-cyclohexyl-N-methoxy-2,5-dimethyl-3-furamide (CAS No 60568-05-0).

1078.

Dieldrin (CAS No 60-57-1).

1079.

4,4' -Isobutylethylidenediphenol (CAS No 6807-17-6).

1080.

Chlordimeform (CAS No 6164-98-3).

1081.

Amitrole (CAS No 61-82-5).

1082.

Carbaryl (CAS No 63-25-2).

1083.

Distillates (petroleum), light hydrocracked . (CAS No 64741-77-1).

1084.

1-Ethyl-1-methylmorpholinium bromide (CAS No 65756-41-4).

1085.

(3-Chlorophenyl)-(4-methoxy-3-nitrophenyl)methanone (CAS No 66938-41-8).

1086.

Fuels, diesel (CAS No 68334-30-5), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen.

1087.

Fuel oil, no. 2 (CAS No 68476-30-2).

1088.

Fuel oil, no. 4 (CAS No 68476-31-3).

1089.

Fuels, diesel, no. 2 (CAS No 68476-34-6).

1090.

2,2-Dibromo-2-nitroethanol (CAS No 69094-18-4).

1091.

1-Ethyl-1-methylpyrrolidinium bromide (CAS No 69227-51-6).

1092.

Monocrotophos (CAS No 6923-22-4).

1093.

Nickel (CAS No 7440-02-0).

1094.

Bromomethane (CAS No 74-83-9).

1095.

Chloromethane (CAS No 74-87-3).

1096.

Iodomethane (CAS No 74-88-4).

1097.

Bromoethane (CAS No 74-96-4).

1098.

Heptachlor (CAS No 76-44-8).

1099.

Fentin hydroxide (CAS No 76-87-9).

1100.

Nickel sulphate (CAS No 7786-81-4).

1101.

3,5,5-Trimethylcyclohex-2-enone (CAS No 78-59-1).

1102.

2,3-Dichloropropene (CAS No 78-88-6).

1103.

Fluazifop-P-butyl (CAS No 79241-46-6).

1104.

(S)-2,3-Dihydro-1H-indole-carboxylic acid (CAS No 79815-20-6).

1105.

Toxaphene (CAS No 8001-35-2).

1106.

(4-Hydrazinophenyl)-N-methylmethanesulfonamide hydrochloride (CAS No 81880-96-8).

1107.

Solvent Yellow 14 (CAS No 842-07-9).

1108.

Chlozolinate (CAS No 84332-86-5).

1109.

Alkanes, C10-13, chloro (CAS No 85535-84-8).

1110.

Pentachlorophenol (CAS No 87-86-5).

1111.

2,4,6-Trichlorophenol (CAS No 88-06-2).

1112.

Diethylcarbamoyl-chloride (CAS No 88-10-8).

1113.

1-Vinyl-2-pyrrolidone (CAS No 88-12-0).

1114.

Myclobutanil; 2-(4-chlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)hexanenitrile (CAS No 88671-89-0).

1115.

Fentin acetate (CAS No 900-95-8).

1116.

Biphenyl-2-ylamine (CAS No 90-41-5).

1117.

Trans-4-cyclohexyl-L-proline monohydro-chloride (CAS No 90657-55-9).

1118.

2-Methyl-m-phenylene diisocyanate (CAS No 91-08-7).

1119.

4-Methyl-m-phenylene diisocyanate (CAS No 584-84-9).

1120.

m-Tolylidene diisocyanate (CAS No 26471-62-5).

1121.

Fuels, jet aircraft, coal solvent extn., hydrocracked hydrogenated (CAS No 94114-58-6).

1122.

Fuels, diesel, coal solvent extn., hydrocracked hydrogenated (CAS No 94114-59-7).

1123.

Pitch (CAS No 61789-60-4), if it contains more than 0.005 % w/w benzo[a]pyrene.

1124.

2-Butanone oxime (CAS No 96-29-7).

1125.

Hydrocarbons, C16-20, solvent-dewaxed hydrocracked paraffinic distn. Residue (CAS No 97675-88-2).

1126.

α,α-Dichlorotoluene (CAS No 98-87-3).

1127.

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

1128.

Reaction product of acetophenone, formaldehyde, cyclohexylamine, methanol and acetic acid (EC Nr. 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.

1131.

Trisodium bis(7-acetamido-2-(4-nitro-2-oxidophenylazo)-3-sulfonato-1-naphtholato)chromate(1-) (EC Nr.400-810-8).

1132.

A mixture of: 4-allyl-2,6-bis(2,3-epoxypropyl)phenol, 4-allyl-6-(3-(6-(3-(6-(3-(4-allyl-2,6-bis(2,3-epoxypropyl)phenoxy)2-hydroxypropyl)-4-allyl-2-(2,3-epoxypropyl)phenoxy)-2-hydroxypropyl)-4-allyl-2-(2,3-epoxypropyl)phenoxy-2-hydroxypropyl-2-(2,3-epoxypropyl)phenol, 4-allyl-6-(3-(4-allyl-2,6-bis(2,3-epoxypropyl)phenoxy)-2-hydroxypropyl)-2-(2,3-epoxypropyl)phenoxy)phenol and 4-allyl-6-(3-(6-(3-(4-allyl-2,6-bis(2,3-epoxypropyl)phenoxy)-2-hydroxypropyl)-4-allyl-2-(2,3-epoxypropyl)phenoxy)2-hydroxypropyl)-2-(2,3-epoxypropyl)phenol (EC Nr. 417-470-1).

Note

The designation (INN) indicates that the name is the recommended International Non-proprietary Name for the substance concerned as published by the World Health Organisation for pharmaceutical substances.

Schedule 3

( Regulation 8(1)(b) )

Part 1

List of substances which cosmetic products must not contain except subject to the restrictions and conditions laid down

 

 

RESTRICTIONS

 

Reference Number

Substance

Field of Application and/or use

Maximum authorised concentration in the finished cosmetic product

Other limitations and requirements

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

a

b

c

d

e

f

1a

Boric acid, borates and tetraborates

(a) Talc

(a) 5% (by mass/mass as boric acid)

(a)1  Not to be used in products for children under three years of age

(a)  1  Not to be used for children under three years of age

 

 

 

 

2. 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)

 

2. Not to be used on peeling or irritated skin

 

 

(b) Products for oral hygiene

(b) 0.1% (by mass/mass as boric acid)

(b)1 Not to be used in products for children under three years of age

(b) 1. Not to be swallowed

2. Not to be used for children under three years of age

 

 

(c) Other products (excluding bath products and hair waving products)

(c) 3% (by mass/mass as boric acid)

(c)1 Not to be used in products for children under three years of age

(c ) 1. Not to be used for children under three years of age

 

 

 

 

2. 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

2. Not to be used on peeling or irritated skin

1b

Tetraborates

(a)Bath products

(a) 18% (by mass/mass as boric acid)

(a) Not to be used in products for children under three years of age

(a)  Not to be used for bathing children under 3 years of age

 

 

(b) Hair waving products

(b) 8% (by mass/mass as boric acid)

 

(b)  Rinse well

2

Thioglycollic acid and its salts

(a) Hair waving or straightening products for:

 

(a)(b) and (c)

- Avoid contact with eyes.

- In the event of contact with eyes, rinse immediately with plenty of water and seek medical advice.

(a)(i)

- Contains thioglycolate.

- Follow the instructions.

- Keep out of reach of children.

(i) general use

(i) 8% ready for use pH 7 - 9.5

 

 

(ii) professional use

(ii) 11% ready for use pH 7 - 9.5

- Wear suitable gloves ((a) and (c) only)

(a)(ii)

- Contains thioglycolate.

- Follow the instructions.

- Keep out of reach of children

- For professional use only.

 

 

(b) Depilatories

(b) 9.5% ready for use pH 7 - 12.7

 

 

 

(c) Other hair care products which are removed after application

(c) 2% ready for use pH 7 - 9.5

(percentages calculated as thioglycollic acid).

 

(b) and (c)

- Contains thioglycolate.

- Follow the instructions.

- Keep out of reach of children

2b

Thioglycollic acid esters

(a) Hair waving or straightening products for -

(a)(i) and (ii)

The directions for use must incorporate the following :-

(a)(i)

(i) general use

- Contains thioglycolate.

(i) - 8% ready for use pH 6 - 9.5

- 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 medical advice.

- Wear suitable gloves.

- Follow the instructions.

- Keep out of reach of children

(ii) professional use

(ii) - 11% ready for use pH 6 - 9.5

(percentages calculated as thioglycollic acid).

(a)(ii)

- Contains thioglycolate.

- Follow the instructions.

- Keep out of reach of children

- For professional use only.

3

Oxalic acid, its esters and alkaline salts

Hair care products

5%

For professional use only.

4

Ammonia

6% calculated as NH3

Contains ammonia (not required when concentration is not more than 2%)

5

Tosylchloramide sodium (INN)

0.2%

6

Chlorates of alkali metals

(a) Toothpaste

(b) Other uses

(a) 5%

(b) 3%

7

Dichloromethane

35% (when mixed with 1,1,1-trichloroethane, total concentration must not exceed 35%

Purity of dichloromethane must be not less than 98%.

8

m- and p-Phenylenediamines, their N-substituted derivatives and their salts; N-substituted derivatives of o-Phenylenediamines1 , with the exception of those derivatives listed elsewhere in this Schedule

Oxidizing colouring agents for hair dyeing -

(a) general use

(b) professional use

6% calculated as free base

(a) - Contains phenylenediamines.

Can cause an allergic reaction.

Do not use to dye eyelases or eyebrows.

(b) - Contains phenylenediamines.

For professional use only.

Can cause an allergic reaction.

Wear suitable gloves.

9

Methylphenylenediamines (other than 4-methyl-m-phenylenediamine and its salts), their N-substituted derivatives and their salts (See Note (a) at end this Part of Schedule)

Oxidizing colouring agents for hair dyeing for - (a) general use (b) professional use

10% calculated as free base

(a) - Contains phenylenediamines.

Can cause an allergic reaction.

Do not use to dye eyelases or eyebrows.

(b) - Contains phenylenediamines.

For professional use only.

Can cause an allergic reaction.

Wear suitable gloves.

10

Diaminophenols (See Note (a) at end this Part of Schedule)

Oxidizing colouring agents for hair dyeing for: (a) general use (b) professional use

10% calculated as free base

(a) - Contains diaminophenols.

Can cause an allergic reaction.

Do not use to dye eyelashes or eyebrows.

(b) - Contains diaminophenols.

For professional use only.

Can cause an allergic reaction.

Wear suitable gloves.

11

Dichlorophen (INN)

 

0.5%

 

Contains dichlorophen

12

Hydrogen peroxide, and other compounds or mixtures that realease hydrogen peroxide, including carbamide peroxide and zinc peroxide

(a) Hair-care preparations

(b) Skin-care preparations

(c) Nail hardening preparations

(d) Oral hygiene products

(a) 12% H2O2 (40 volumes) present or released;

(b) 4% of H2O2 present or released;

(c) 2% of H2O2 present or released;

(d) 0.1% of H2O2 present or released

(a) (b) and (c)

- Contains hydrogen peroxide.

- Avoid contact with eyes.

- Rinse eyes immediately if product comes into contact with them.

(a) Wear suitable gloves.

13

Formaldehyde

Nail hardeners

5% calculated as formaldehyde

 

- Contains formaldehyde.

- Protect cuticles with grease or oil.

(Not required when concentration is not more than 0.05%)

14

Hydroquinone (See Note (b) at end this Part of Schedule)

(a) Oxidising colouring agent for hair-dyeing: -

0.3%

 

(a) (i) - Do not use to dye eyelashes or eyebrows

(i) General use

- Rinse the eyes immediately if the product comes into contact with them.

- Contains hydroquinone

(ii) Professional use

(ii) - For professional use only

- Contains hydroquinone.

- Rinse the eyes immediately if the product comes into contact with them

(b) artificial nail systems

0.02% (after mixing for use)

Professional use only

(b) -- For professional use only

- Avoid skin contact

- Read directions for use carefully

15a

Potassium or sodium hydroxide

(a) Nail cuticle solvent

(a) 5% by weight (See Note (c) at end this Part of Schedule)

 

(a) Contains alkali. Avoid contact with eyes. Can cause blindness. Keep out of reach of children.

(b) Hair straightener for -

(b)

(b)

(i) general use

(i) 2% by weight (See Note (c) at end this Part of Schedule)

(i). Contains alkali. Avoid contact with eyes. Can cause blindness.

(ii) professional use

(ii) 4.5% by weight (See Note (c) at end this Part of Schedule)

Keep out of reach of children.

(ii) For professional use only. Avoid contact with eyes. Can cause blindness.

(c) pH adjuster for depilatories

(c) pH not to exceed 12.7

(c) Keep out of reach of children.

Avoid contact with eyes.

(d) Other uses as pH adjuster

(d) pH not to exceed 11.0

15b

Lithium hydroxide

(a) Hair straighteners

(a)

(a)

1. General use

1.  2%2 by weight

1. Contains alkali

Avoid contact with eyes

Can cause blindness Keep out of reach of children

2. Professional use

2.  4.5%3 by weight

2. For professional use only

Avoid contact with eyes

Can cause blindness

(b) pH adjuster - for depilatories

(b) pH value not to exceed pH 12.7

(b) Contains alkali

Keep out of reach of children

Avoid contact with eyes

c) Other uses - as pH adjuster (for rinse-off products only)

c) pH value not to exceed pH 11

15C

Calcium hydroxide

(a) Hair straighteners containing two components : Calcium hydroxide and a guanidine salt

(a)7% by weight of Calcium hydroxide

(a) Contains alkali

Avoid contact with eyes

Keep out of reach of children

Can cause blindness

(b) pH adjuster - for depilatories

(b) pH value not to exceed pH 12.7

(b) Contains alkali

Keep out of reach of children

Avoid contact with eyes

 

 

(c) Other uses (e.g. pH adjuster, processing aid)

 

(c) pH value not to exceed pH 11

 

16

1-Naphthol (CAS No 90-15-3) and its salts

Oxidising colouring agents for hair dyeing

2.0%

In combination with hydrogen peroxide the maximum use concentration upon application is 1.0%

Can cause allergic reaction.

17

Sodium nitrite

Rust Inhibitor

0.2%

Do not use with secondary and/or tertiary amines or other substances forming nitrosamines

18

Nitromethane

Rush inhibitor

0.3%

 

 

19

Phenol and its alkali salts

Soaps and shampoos

1% calculated as phenol

 

Contains phenol

20

Entry deleted

 

 

 

 

21

Quinine and its salts

(a) Shampoos

(a) 0.5% calculated as quinine base

(b) Hair lotions

(b) 0.2% calculated as quinine base

22

Resorcinol (See Note (b) at end this Part of Schedule)

(a) Oxidizing colouring agent for hair dyeing for -

(a) 5%

(a)(i) Contains resorcinol. Rinse hair well after application.

(i) general use

Do not use to dye eyelashes or eyebrows. Rinse eyes immediately if product comes into contact with them.

(ii) professional use

(a)(ii) Contains resorcinol. For professional use only. Rinse eyes immediately if product comes into contact with them.

(b) Hair lotions and shampoos

(b) 0.5%

(b) Contains resorcinol

23

(a) Alkali sulphides

(a) Depilatories

(a) 2% calculated as sulphur;

- pH not to exceed 12.7.

(a) Keep out of reach of children.

Avoid contact with eyes.

(b) Alkaline earth sulphides

(b) Depilatories

(b) 6% calculated as suphur;

- pH not to exceed 12.7.

(b) Keep out of reach of children.

Avoid contact with eyes.

24

Water-soluble zinc salts with the exception of zinc 4-hydroxy-benzenesulphonate and zinc pyrithione

1% calculated as zinc

25

Zinc 4-hydroxybenzene sulphonate

Deodorants, anti-perspirants and astringent lotions

6% calculated as % of anhydrous substance

Avoid contact with eyes

26

Ammonium monofluorophosphate

Oral hygiene products

0.15% calculated as F. When mixed with other fluorine compounds specified in this Schedule, the total F concentration must not exceed 0.15%

Contains ammonium monofluorophosphate

27

Sodium monofluorophosphate

Oral hygiene products

As for ammonium monofluorophosphate

Contains sodium monofluorophosphate

28

Potassium monofluorophosphate

Oral hygiene products

As for ammonium monofluorophosphate

Contains potassium monofluoroophosphate

29

Calcium monofluorophosophate

Oral hygiene products

As for ammonium monofluorophosphate

Contains calcium monofluorophosphate

30

Calcium fluoride

Oral hygiene products

As for ammonium monofluorophosphate

Contains calcium fluoride

31

Sodium fluoride

Oral hygiene products

As for ammonium monofluorophosphate

Contains sodium fluroide

32

Potassium flouride

Oral hygiene products

As for ammonium monofluorophosphate

Contains potassium flouride

33

Ammonium flouride

Oral hygiene products

As for ammonium monofluorophosphate

Contains ammonium flouride

34

Aluminium flouide

Oral hygiene products

As for ammonium monofluorophosphate

Contains aluminium flouride

35

Stannous flouride

Oral hygiene products

As for ammonium monofluorophosphate

Contains stannous flouide

36

Hexadecylammonium flouride

Oral hygiene products

As for ammonium monofluorophosphate

Contains hexadecylammonium flouride

37

3-(n-Hexadecyl-N-2-hydroxyethylammonio) propylbis(2-hydroxyethyl) ammonium difluoride

Oral hygiene products

As for ammonium monofluorophosphate

Contains 3-(n-Hexadecyl-N-2-hydroxyethylammoni) propylbis (2-hydroxyethyl) ammonium difluoride

38

N,N'N'-Tris(polyoxyethylene)-n-hexadecylpropylenediamine dihydrofluoride

Oral hygiene products

As for ammonium monofluorophosphate

Contains N,N'N'-tris(polyoxyethylene)-n-hexadecylpropylenediamine dihydrofluoride

39

Octadecenylammonium fluoride

Oral hygiene products

As for ammonium monofluorophosphate

Contains octadecenylammonium fluoride

40

Sodium fluorosilicate

Oral hygiene products

As for ammonium monofluorophosphate

Contains sodium fluorosilicate

41

Potassium fluorosilicate

Oral hygiene products

As for ammonium monofluorophosphate

Contains potassium fluorosilicate

42

Ammonium fluorosilicate

Oral hygiene products

As for ammonium monofluorophosphate

Contains ammonium fluorosilicate

43

Magnesium fluorosilicate

Oral hygiene products

As for ammonium monofluorophosphate

Contains magnesium fluorosilicate

44

1,3-Bis(hydroxymethyl)imid-azolidine-2-thione

(a) Hair care preparations

(a) 2%

(a) Not to be used in aerosol dispensers (sprays)

(a) Contains 1,3-bis(hydroxy-methyl) imidazolidine-2-thione

(b) Nail care preparations

(b) 2%

(b) The pH of the product as applied must be less than 4

(b) Contains 1,3-bis(hydroxymethyl) imidazolidine-2-thione

45

Benzyl alcohol

Solvent, perfumes and flavourings

46

6-Methylcoumarin

Oral hygiene products

0.003%

47

Nicomethanol hydrofluoride

Oral hygiene products

As for ammonium monofluorophosphate

Contains nicomethanol hydrofluoride

48

Silver nitrate

Products intended for colouring eyelashes and eyebrows

4%

- Contains sliver nitrate

- Rinse the eyes immediately if product comes into contact with them

49

Selenium disulphide

Anti-dandruff shampoos

1%

- Contains selenium disulphide

- Avoid contact with eyes or damaged skin

50

Aluminium zirconium chloride hydroxide complexes AlxZr(OH)yClz and the aluminium zirconium chloride hydroxide glycine complexes

Anti-perspirants

20% as anhydrous aluminium zirconium chloride hydroxide;

5.4% as zirconium

1. The ratio of the number of aluminium atoms to that of zirconium atoms must be between 2 and 10

2. The ratio of the number of (Al+Zr) atoms to that of the chlorine atoms must be between 0.9 and 2.1.

3. Not to be used in aerosol dispensers (sprays)

Do not apply to irritated or damaged skin

51

Quinolin-8-ol and bis(8-hydroxy-quinolinium) sulphate

(a) Stabiliser for hydrogen peroxide in rinse-off hair-care preparations

(b) 0.03% calculated as base

(a) 0.3% calculated as base

(b) Stabilizer for hydrogen peroxide in non-rinse-off hair-care preparations

52

Methanol

Denaturant for ethanol and isopropyl alcohol

5% calculated as a percentage of ethanol and isopropyl alcohol

53

Etidronic acid and its salts (1-Hydroxyethylidene diphosphonic acid and its salts)

(a) Hair-care

(b) Soap

(a) 1.5% expressed as etidronic acid

(b) 0.2% expressed as etidronic acid

Contains etidronic acid

54

1-Phenoxypropan-2-ol

Products rinsed-off after use

2%

Prohibited in oral hygiene products

55

Entry deleted

56

Magnesium fluoride

Dental hygiene products

As for ammonium monofluorophosphate

Contains magnesium fluoride

57

Strontium chloride hexahydrate

(a) Toothpaste

(a) 3.5% calculated as strontium. When mixed with other permitted strontium compounds the total strontium content must not exceed 3.5%

(a) - Contains strontium chloride

- Frequent use by children is not advisable

(b) Shampoo and face care products

(b) 2.1% calculated as strontium. When mixed with other permitted strontium compounds the total strontium content must not exceed 2.1%

58

Strontium acetate hemihydrate

Toothpaste

3.5% calculated as strontium. When mixed with other permitted strontium products the total strontium content must not exceed 3.5%

- Contains strontium acetate

- Frequent use by children is not advisable

59

Talc: Hydrated magnesium silicate

(a) Powdery products intended to be used for children under three years of age

(b) Other products

(a) Keep powder away from children's nose and mouth

60

Fatty acid dialkylamides and dialkanolamides

Maximum secondary amine content: 0.5%

- Do not use with nitrosating systems;

- Maximum secondary amine content: 0.5% (applies to raw materials);

- Maximum nitrosamine content: 50mcg/kg;

- Keep in nitrite-free containers.

61

Monoalkanolamines, monoalkanolamines and their salts

Maximum secondary amine content: 0.5%

- Do not use with nitrosating systems;

- Minimum purity: 99%;

- Maximum secondary amine content: 0.5% (applies to raw materials);

- Maximum nitrosamine content: 50mcg/kg;

- Keep in nitrite-free containers.

62

Trialkylamines, trialkanolamines and their salts

(a) Non-rinse-off products

(a) 2.5%

(a) (b)

- Do not use with nitrosating systems;

(b) Other products

- Minimum purity: 99%;

- Maximum secondary amine content: 0.5% (applies to raw materials);

- Maximum N-nitrosoamine content: 50mcg/Kg;

- Keep in nitrite free containers.

63

Strontium hydroxide

pH-regulator in depilatory products

- 3.5% calculated as strontium;

- pH not to exceed 12.7

- Keep out of reach of children

- Avoid contact with the eyes

64

Strontium peroxide

Rinse-off hair care preparations for professional use

4.5% calculated as strontium in the ready-for-use preparation

All products must meet the hydrogen peroxide release requirements

- Avoid contact with eyes.

- Rinse eyes immediately if product comes into contact with them.

- For professional use only.

- Wear suitable gloves.

65

Benzalkonium chloride, bromide and saccharinate

(a) Rinse-off hair (head) care products

(a)   3% (as benzalkonium chloride)

(a) In the final products, the concentrations of benzalkonium chloride, bromide and saccharinate with an alkyl chain of C14, or less must not exceed 0.1% (as benzalkonium chloride)

(a) Avoid contact with the eyes

(b) Other products

(b)   0.1% (as benzalkonium chloride

(b) Avoid contact with the eyes

66

Polyacrylamides

(a) Body-care leave-on products

(a) Maximum residual Acrylamide content 0.1 mg/kg

(b) Other cosmetic products

(b) Maximum residual Acrylamide content 0.5 mg/kg.

67

Amyl cinnamal (CAS No 122-40-7)

The presence of the substance must be indicated when its concentration exceeds:

- 0,001% in leave-on products

- 0,01% in rinse-off products

68

Benzyl alcohol (CAS No 100-51-6)

The presence of the substance must be indicated when its concentration exceeds:

- 0,001% in leave-on products

- 0,01% in rinse-off products

69

Cinnamyl alcohol (CAS No 104-54-1)

The presence of the substance must be indicated when its concentration exceeds:

- 0,001% in leave-on products

- 0,01% in rinse-off products

70

Citral (CAS No 5392-40-5)

The presence of the substance must be indicated when its concentration exceeds:

- 0,001% in leave-on products

- 0,01% in rinse-off products

71

Eugenol (CAS No 97-53-0)

The presence of the substance must be indicated when its concentration exceeds:

- 0,001% in leave-on products

- 0,01% in rinse-off products

72

Hydroxycitronellal (CAS No 107-75-5)

The presence of the substance must be indicated when its concentration exceeds:

- 0,001% in leave-on products

- 0,01% in rinse-off products

73

Isoeugenol (CAS No 97-54-1)

The presence of the substance must be indicated when its concentration exceeds:

- 0,001% in leave-on products

- 0,01% in rinse-off products

74

Amylcinnamyl alcohol (CAS No 101-85-9)

The presence of the substance must be indicated when its concentration exceeds:

- 0,001% in leave-on products

- 0,01% in rinse-off products

75

Benzyl salicylate (CAS No 118-58-1)

The presence of the substance must be indicated when its concentration exceeds:

- 0,001% in leave-on products

- 0,01% in rinse-off products

76

Cinnamal (CAS No 104-55-2)

The presence of the substance must be indicated when its concentration exceeds:

- 0,001% in leave-on products

- 0,01% in rinse-off products

77

Coumarin (CAS No 91-64-5)

The presence of the substance must be indicated when its concentration exceeds:

- 0,001% in leave-on products

- 0,01% in rinse-off products

78

Geraniol (CAS No 106-24-1)

The presence of the substance must be indicated when its concentration exceeds:

- 0,001% in leave-on products

- 0,01% in rinse-off products

79

Hydroxymethylpentylcyclohexenec arboxaldehyde (CAS No 31906-04-4)

The presence of the substance must be indicated when its concentration exceeds:

- 0,001% in leave-on products

- 0,01% in rinse-off products

80

Anisyl alcohol (CAS No 105-13-5)

The presence of the substance must be indicated when its concentration exceeds:

- 0,001% in leave-on products

- 0,01% in rinse-off products

81

Benzyl cinnamate (CAS No 103-41-3)

The presence of the substance must be indicated when its concentration exceeds:

- 0,001% in leave-on products

- 0,01% in rinse-off products

82

Farnesol (CAS No 4602-84-0)

The presence of the substance must be indicated when its concentration exceeds:

- 0,001% in leave-on products

- 0,01% in rinse-off products

83

2-(4-tert-Butylbenzyl) propionaldehyde (CAS No 80-54-6)

The presence of the substance must be indicated when its concentration exceeds:

- 0,001% in leave-on products

- 0,01% in rinse-off products

84

Linalool (CAS No 78-70-6)

The presence of the substance must be indicated when its concentration exceeds:

- 0,001% in leave-on products

- 0,01% in rinse-off products

85

Benzyl benzoate (CAS No 120-51-4)

The presence of the substance must be indicated when its concentration exceeds:

- 0,001% in leave-on products

- 0,01% in rinse-off products

86

Citronellol (CAS No 106-22-9)

The presence of the substance must be indicated when its concentration exceeds:

- 0,001% in leave-on products

- 0,01% in rinse-off products

87

Hexyl cinnamaldehyde (CAS No 101-86-0)

The presence of the substance must be indicated when its concentration exceeds:

- 0,001% in leave-on products

- 0,01% in rinse-off products

88

d-Limonene (CAS No 5989-27-5)

The presence of the substance must be indicated when its concentration exceeds:

- 0,001% in leave-on products

- 0,01% in rinse-off products

89

Methyl heptin carbonate (CAS No 111-12-6)

The presence of the substance must be indicated when its concentration exceeds:

- 0,001% in leave-on products

- 0,01% in rinse-off products

90

3-Methyl-4-(2,6,6-tri-methyl-2-cyclohexen-1-yl)-3-buten-2-one (CAS No 127-51-5)

The presence of the substance must be indicated when its concentration exceeds:

- 0,001% in leave-on products

- 0,01% in rinse-off products

91

Oak moss extract (CAS No 90028-68-5)

The presence of the substance must be indicated when its concentration exceeds:

- 0,001% in leave-on products

- 0,01% in rinse-off products

92

Treemoss extract (CAS No 90028-67-4)

The presence of the substance must be indicated when its concentration exceeds:

- 0,001% in leave-on products

- 0,01% in rinse-off products

93

2,4-Diaminopyrimidine-3-oxide (CAS No 74638-76-9)

Hair care formulations

1.5%

94

Benzoyl peroxide

Artificial nail systems

0.7% (after mixing)

Professional use only

-For professional use only;

-Avoid skin contact;

-Read directions for use carefully.

95

Hydroquinone methylether

Artificial nail systems

0.02% (after mixing for use)

Professional use only

-For professional use only;

-Avoid skin contact;

-Read directions for use carefully.

96.

Musk xylene (CAS No. 81-15-2)

All cosmetic products, with the exception of oral care products

(a) 1.0% in fine fragrance

(b) 0.4% in eau de toilette

(c) 0.03% in other products

97.

Musk ketone (CAS No. 81-14-1)

All cosmetic products, with the exception of oral care products

(a) 1.4% in fine fragrance

(b) 0.56% in eau de toilette

(c) 0.042% in other products

 

Notes:

(a).         These substances may be used singly or in combination provided that the sum of the ratios of the levels of each of them in the cosmetic product expressed with reference to the maximum level authorised for each of them does not exceed 1.

(b).         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 uct expressed with reference to the maximum level authorised for each of them does not exceed 2.

(c).         The quantity of sodium, potassium or lithium hydroxide is expressed as weight of sodium hydroxide. In the case of mixtures the sum must not exceed the limits specified.

Schedule 3 - Part 2

List of Substances Provisionally Allowed in Cosmetic Products Subject to the Restrictions and Conditions Laid Down

 

 

RESTRICTIONS

 

 

Reference Number

Substance

Field of Application and/or use

Maximum authorised concentration in the finished cosmetic product

Other limitations and requirements

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

Allowed until

A

b

c

D

e

f

g

1.

Basic Blue 7 (CAS No. 2390-60-5)

Non-oxidising colouring agents for hair dyeing

0.2%

Can cause allergic reaction

31.12.2005

2.

2-Amino-3-nitrophenol (CAS No. 603-85-0) and its salts

(a) Oxidising colouring agents for hair dyeing

(a) 3.0%

In combination with hydrogen peroxide the maximum use concentration upon application is 1.5%

(a) Can cause allergic reaction

31.12.2005

(b) Non-oxidising colouring agent for hair dyeing

(b) 3.0%

(b) Can cause allergic reaction

 

3.

4-Amino-3-nitrophenol (CAS No. 610-81-1) and its salts

(a) Oxidising colouring agents for hair dyeing

(a) 3.0%

In combination with hydrogen peroxide the maximum use concentration upon application is 1.5%

(a) Can cause allergic reaction

31.12.2005

(b) Non-oxidising colouring agents for hair dyeing

(b) 3.0%

(b) Can cause allergic reaction

 

4.

2,7-Naphthalene-diol (CAS No. 582-17-2) and its salts

Oxidising colouring agents for hair dyeing

1.0%

In combination with hydrogen peroxide the maximum use concentration upon application is 0.5%

31.12.2005

5.

m-Aminophenol (CAS No. 591-27-5) and its salts

Oxidising colouring agents for hair dyeing

2.0%

In combination with hydrogen peroxide the maximum use concentration upon application is 1.0%

Can cause allergic reaction

31.12.2005

6.

2,6-Dihydroxy-3,4-di-methylpyridine (CAS No. 84540-47-6) and its salts

Oxidising colouring agents for hair dyeing

2.0%

In combination with hydrogen peroxide the maximum use concentration upon application is 1.0%

Can cause allergic reaction

31.12.2005

7.

4-Hydroxypropylamin o-3-nitrophenol (CAS No. 92952-81-3) and its salts

(a) Oxidising colouring agents for hair dyeing

(a)5.2%

In combination with hydrogen peroxide the maximum use concentration upon application is 2.6%

(a) Can cause allergic reaction

31.12.2005

(b) Non-oxidising colouring agents for hair dyeing

(b)2.6%

(b) Can cause allergic reaction

8.

6-Nitro-2,5-pyridinediamine (CAS No. 69825-83-8) and its salts

Non-oxidising colouring agents for hair dyeing

3.0%

Can cause allergic reaction

31.12.2005

9.

HC Blue No. 11 (CAS No. 23920-15-2) and its salts

(a) Oxidising colouring agents for hair dyeing

(a) 3.0%

In combination with hydrogen peroxide the maximum use concentration upon application is 1.5%

(a) Can cause allergic reaction

31.12.2005

(b) Non-oxidising colouring agents for hair dyeing

(b) 2.0%

(b) Can cause allergic reaction

10.

Hydroxyethyl-2-nitro-p-toluidine (CAS No. 100418-33-5) and its salts

(a) Oxidising colouring agents for hair dyeing

(a) 2.0%

In combination with hydrogen peroxide the maximum use concentration upon application is 1.0%

(a) Can cause allergic reaction

31.12.2005

(b) Non-oxidising colouring agents for hair dyeing

(b) 1.0%

(b) Can cause allergic reaction

11.

2-Hydroxyethyl-picramic acid (CAS No. 99610-72-7) and its salts

(a) Oxidising colouring agents for hair dyeing

(a) 3.0%

In combination with hydrogen peroxide the maximum use concentration upon application is 1.5%

(a) Can cause allergic reaction

31.12.2005

(b) Non-oxidising colouring agents for hair dyeing

(b) 2.0%

(b) Can cause allergic reaction

12.

p-Methylamino-phenol (CAS No. 150-75-4) and its salts

Oxidising colouring agents for hair dyeing

3.0%

In combination with hydrogen peroxide the maximum use concentration upon application is 1.5%

Can cause allergic reaction

31.12.2005

13.

2,4-Diamino-5-methyl-phenoxy-ethanol (CAS No. 141614-05-3) and its salts

Oxidising colouring agents for hair dyeing

3.0%

In combination with hydrogen peroxide the maximum use concentration upon application is 1.5%

Can cause allergic reaction

31.12.2005

14.

HC Violet No. 2 (CAS No. 104226-19-9) and its salts

Non-oxidising colouring agents for hair dyeing

2.0%

31.12.2005

15.

Hydroxyethyl-2,6-dinitro-p-anisidine (CAS No. 122252-11-3) and its salts

Non-oxidising colouring agents for hair dyeing

3.0%

Can cause allergic reaction

31.12.2005

16.

HC Blue No. 12 (CAS No. 104516-93-0) and its salts

(a) Oxidising colouring agents for hair dyeing

(a) 1.5%

In combination with hydrogen peroxide the maximum use concentration upon application is 0.75%

(a) Can cause allergic reaction

31.12.2005

(b) Non-oxidising colouring agents for hair dyeing

(b) 1.5%

(b) Can cause allergic reaction

17.

2,4-Diamino-5 methyphenetol (CAS No 113715-25-6) and its salts

Oxidising colouring agents for hair dyeing

2.0%

In combination with hydrogen peroxide the maximum use concentration upon application is 1.0%

Can cause allergic reaction

31.12.2005

18.

1,3-Bis-(2,4-diamino-phenoxy)propane (CAS No.81892-72-0) and its salts

Oxidising colouring agents for hair dyeing

2.0%

In combination with hydrogen peroxide the maximum use concentration upon application is 1.0%

Can cause allergic reaction

31.12.2005

19.

3-Amino-2,4-dichlorophenol (CAS No 61693-43-4) and its salts

Oxidising colouring agents for hair dyeing

2.0%

In combination with hydrogen peroxide the maximum use concentration upon application is 1.0%

Can cause allergic reaction

31.12.2005

20.

Phenyl methylpyrazolone (CAS No.89-25-8) and its salts

Oxidising colouring agents for hair dyeing

0.5%

In combination with hydrogen peroxide the maximum use concentration upon application is 0.25%

31.12.2005

21.

2-Methyl-5-hydroxy-ethylaminophenol (CAS No.55302-96-0) and its salts

Oxidising colouring agents for hair dyeing

2.0%

In combination with hydrogen peroxide the maximum use concentration upon application is 1.0%

Can cause allergic reaction

31.12.2005

22.

Hydroxybenzomorp holine (CAS No. 26021-57-8) and its salts

Oxidising colouring agents for hair dyeing

2.0%

In combination with hydrogen peroxide the maximum use concentration upon application is 1.0%

Can cause allergic reaction

31.12.2005

23.

1,7-Naphthalenediol (CAS No. 575-38-2) and its salts

Oxidising colouring agents for hair dyeing

1.0%

In combination with hydrogen peroxide the maximum use concentration upon application is 0.5%

Can cause allergic reaction

31.12.2005

24.

HC Yellow No. 10 (CAS No. 109023-83-8) and its salts

Non-oxidising colouring agents for hair dyeing

0.2%

31.12.2005

25.

2, 6-Dimethoxy-3,5-pyridinediamine (CAS No. 85679-78-3) and its salts

Oxidising colouring agents for hair dyeing

0.5%

In combination with hydrogen peroxide the maximum use concentration upon application is 0.25%

Can cause allergic reaction

31.12.2005

26.

HC Orange No. 2 (CAS No. 85765-48-6) and its salts

Non-oxidising colouring agents for hair dyeing

1.0%

31.12.2005

27.

HC Violet No. 1 (CAS No. 82576-75-8) and its salts

(a) Oxidising colouring agents for hair dyeing

(a) 0.5%

In combination with hydrogen peroxide the maximum use concentration upon application is 0.25%

31.12.2005

(b) Non-oxidising colouring agents for hair dyeing

(b) 0.5%

28.

3-Methylamino-4-nitro-phenoxyethanol (CAS No. 59820-63-2) and its salts

Non-oxidising colouring agents for hair dyeing

1.0%

31.12.2005

29.

2-Hydroxyethylamino -5-nitroanisole (CAS No. 66095-81-6) and its salts

Non-oxidising colouring agents for hair dyeing

1.0%

31.12.2005

30.

2-Chloro-5-nitro-N-hydroxyethyl-p-phenylenediamine (CAS No. 50610-28-1) and its salts

(a) Oxidising colouring agents for hair dyeing

(a) 2.0%

In combination with hydrogen peroxide the maximum use concentration upon application is 1.0%

31.12.2005

(b) Non-oxidising colouring agents for hair dyeing

(b) 1.0%

31.

HC Red No 13 (CAS No 94158-13-1) and its salts

(a) Oxidising colouring agents for hair dyeing

(a) 2.5%

In combination with hydrogen peroxide the maximum use concentration upon application is 1.25%

31.12.2005

(b) Non-oxidising colouring agents for hair dyeing

(b) 2.5%

32.

1, 5-Naphthalenediol (CAS No. 83-56-7) and its salts

Oxidising colouring agents for hair dyeing

1.0%

In combination with hydrogen peroxide the maximum use concentration upon application is 0.5%

31.12.2005

33.

Hydroxypropyl bis (N-hydroxyethyl-p-phenylene-diamine)(CAS No.128729-30-6) and its salts

Oxidising colouring agents for hair dyeing

3.0%

In combination with hydrogen peroxide the maximum use concentration upon application is 1.5%

Can cause allergic reaction

31.12.2005

34.

o-Aminophenol (CAS No.95-55-6) and its salts

Oxidising colouring agents for hair dyeing

2.0%

In combination with hydrogen peroxide the maximum use concentration upon application is 1.0%

31.12.2005

35.

4-Amino-2-hydroxy-toluene (CAS No.2835-95-2) and its salts

Oxidising colouring agents for hair dyeing

3.0%

In combination with hydrogen peroxide the maximum use concentration upon application is 1.5%

31.12.2005

36.

2,4-Diaminophenoxy-ethanol (CAS No 66422-95-5) and its salts

Oxidising colouring agents for hair dyeing

4.0%

In combination with hydrogen peroxide the maximum use concentration upon application is 2.0%

31.12.2005

37.

2-Methylresorcinol (CAS No.608-25-3) and its salts

Oxidising colouring agents for hair dyeing

2.0%

In combination with hydrogen peroxide the maximum use concentration upon application is 1.0%

31.12.2005

38.

4-Amino-m-cresol (CAS No.2835-99-6) and its salts

Oxidising colouring agents for hair dyeing

3.0%

In combination with hydrogen peroxide the maximum use concentration upon application is 1.5%

31.12.2005

39.

2-Amino-4-hydroxyethyl-aminoanisole (CAS No.83763-47-7) and its salts

Oxidising colouring agents for hair dyeing

3.0%

In combination with hydrogen peroxide the maximum use concentration upon application is 1.5%

31.12.2005

40.

3,4-Diaminobenzoic acid (CAS No.619-05-6) and its salts

Oxidising colouring agents for hair dyeing

2.0%

In combination with hydrogen peroxide the maximum use concentration upon application is 1.0%

31.12.2005

41.

6-Amino-o-cresol (CAS No.17672-22-9) and its salts

Oxidising colouring agents for hair dyeing

3.0%

In combination with hydrogen peroxide the maximum use concentration upon application is 1.5%

31.12.2005

42.

2-Aminomethyl-p-amino-phenol (CAS No.79352-72-0) and its salts

Oxidising colouring agents for hair dyeing

3.0%

In combination with hydrogen peroxide the maximum use concentration upon application is 1.5%

31.12.2005

43.

Hydroxyethylamino methyl-p-amino-phenol (CAS No. 110952-46-0) and its salts

Oxidising colouring agents for hair dyeing

3.0%

In combination with hydrogen peroxide the maximum use concentration upon application is 1.5%

31.12.2005

44.

Hydroxyethyl-3,4-methyl-enedioxyaniline (CAS No. 81329-90-0) and its salts

Oxidising colouring agents for hair dyeing

3.0%

In combination with hydrogen peroxide the maximum use concentration upon application is 1.5%

31.12.2005

45.

Acid Black 52 (CAS No 3618-58-4) and its salts

Oxidising colouring agents for hair dyeing

2.0%

In combination with hydrogen peroxide the maximum use concentration upon application is 1.0%

31.12.2005

46.

2-Nitro-p-phenylene-diamine (CAS No.5307-14-2) and its salts

(a) Oxidising colouring agents for hair dyeing

(a) 0.3%

In combination with hydrogen peroxide the maximum use concentration upon application is 0.15%

31.12.2005

(b) Non-oxidising colouring agents for hair dyeing

(b) 0.3%

47.

HC Blue No. 2 (CAS No.33229-34-4) and its salts

Non-oxidising colouring agents for hair dyeing

2.8%

31.12.2005

48.

3-Nitro-p-hydroxyethyl-aminophenol (CAS No.65235-31-6) and its salts

(a) Oxidising colouring agents for hair dyeing

(a) 6.0%

In combination with hydrogen peroxide the maximum use concentration upon application is 3.0%

31.12.2005

(b) Non-oxidising colouring agents for hair dyeing

(b) 6.0%

49.

4-Nitrophenylamino-ethylurea (CAS No.27080-42-8) and its salts

(a) Oxidising colouring agents for hair dyeing

(a) 0.5%

In combination with hydrogen peroxide the maximum use concentration upon application is 0.25%

31.12.2005

(b) Non-oxidising colouring agents for hair dyeing

(b) 0.5%

50.

HC Red No. 10+ HC Red No. 11 (CAS No.95576-89-9 + 95576-92-4) and its salts

(a) Oxidising colouring agents for hair dyeing

(a) 2.0%

In combination with hydrogen peroxide the maximum use concentration upon application is 1.0%

31.12.2005

(b) Non-oxidising colouring agents for hair dyeing

(b) 1.0%

51.

Yellow No. 6 (CAS No. 104333-00-8) and its salts

(a) Oxidising colouring agents for hair dyeing

(a) 2.0%

In combination with hydrogen peroxide the maximum use concentration upon application is 1.0%

31.12.2005

(b) Non-oxidising colouring agents for hair dyeing

(b) 1.0%

52.

HC Yellow No. 12 (CAS No.59320-13-7) and its salts

(a) Oxidising colouring agents for hair dyeing

(a) 1.0%

In combination with hydrogen peroxide the maximum use concentration upon application is 0.5%

31.12.2005

(b) Non-oxidising colouring agents for hair dyeing

(b) 0.5%

53.

HC Blue No 10 (CAS No 102767-27-1) and its salts

Oxidising colouring agents for hair dyeing

2.0%

In combination with hydrogen peroxide the maximum use concentration upon application is 1.0%

31.12.2005

54.

HC Blue No. 9 (CAS No.114087-47-1) and its salts

(a) Oxidising colouring agents for hair dyeing

(a) 2.0%

In combination with hydrogen peroxide the maximum use concentration upon application is 1.0%

31.12.2005

(b) Non-oxidising colouring agents for hair dyeing

(b) 1.0%

55.

2-Chloro-6-ethylamino-4-nitrophenol (CAS No. 131657-78-8) and its salts

(a) Oxidising colouring agents for hair dyeing

(a) 3.0%

In combination with hydrogen peroxide the maximum use concentration upon application is 1.5%

31.12.2005

(b) Non-oxidising colouring agents for hair dyeing

(b) 3.0%

56.

2-Amino-6-chloro-4-nitrophenol (CAS No. 6358-09-4) and its salts

(a) Oxidising colouring agents for hair dyeing

(a) 2.0%

In combination with hydrogen peroxide the maximum use concentration upon application is 1.0%

31.12.2005

(b) Non-oxidising colouring agents for hair dyeing

(b) 2.0%

57.

Basic Blue 26 (CAS No.2580-56-5) (CI 44045) and its salts

(a) Oxidising colouring agents for hair dyeing

(a) 0.5%

In combination with hydrogen peroxide the maximum use concentration upon application is 0.25%

31.12.2005

(b) Non-oxidising colouring agents for hair dyeing

(b) 0.5%

58.

Acid Red 33 (CAS No.3567-66-6) (CI 17200) and its salts

Non-oxidising colouring agents for hair dyeing

2.0%

31.12.2005

59.

Ponceau SX (CAS No. 4548-53-2) (CI 14700) and its salts

Non-oxidising colouring agents for hair dyeing

2.0%

31.12.2005

60.

Basic Violet 14 (CAS No.632-99-5) (CI 42510) and its salts

(a) Oxidising colouring agents for hair dyeing

(a) 0.3%

In combination with hydrogen peroxide the maximum use concentration upon application is 0.15%

31.12.2005

(b) Non-oxidising colouring agents for hair dyeing

(b) 0.3%

 

Schedule 4

Colouring agents

( Regulation 8(1)(c) )

In this Schedule, the following are the fields of application as set out in respect of each substance under the heading “Field of Application”:-

Field 1 = Colouring agents allowed in all cosmetic products;

Field 2 = Colouring agents allowed in all cosmetic products except those intended to be applied in the vicinity of the eyes, in particular eye in make-up and eye-make-up remover;

Field 3 = Colouring agents allowed exclusively in cosmetic products intended not to come into contact with the mucous membranes;

Field 4 = Colouring agents allowed exclusively in cosmetic products intended to come into contact only briefly with the skin.

Part 1

List of colouring agents allowed for use in cosmetic products(1)

Colour Index Number or Denomination

Colour

Field of Application

Other limitations and requirements(2)

 

 

1

2

3

4

 

10006

Green

 

 

 

X

 

10020

Green

 

 

X

 

 

10316(3)

Yellow

 

X

 

 

 

11680

Yellow

 

 

X

 

 

11710

Yellow

 

 

X

 

 

11725

Orange

 

 

 

X

 

11920

Orange

X

 

 

 

 

12010

Red

 

 

X

 

 

12085(3)

Red

X

 

 

 

3% max. concentration in the finished product

12120

Red

 

 

 

X

 

12150

Red

X

 

 

 

 

12370

Red

 

 

 

X

 

12420

Red

 

 

 

X

 

12480

Brown

 

 

 

X

 

12490

Red

X

 

 

 

 

12700

Yellow

 

 

 

X

 

13015

Yellow

X

 

 

 

E 105

14270

Orange

X

 

 

 

E 103

14700

Red

X

 

 

 

 

14720

Red

X

 

 

 

E 122

14815

Red

X

 

 

 

E 125

15510(3)

Orange

 

X

 

 

 

15525

Red

X

 

 

 

 

15580

Red

X

 

 

 

 

15620

Red

 

 

 

X

 

15630(3)

Red

X

 

 

 

3% max. concentration in the finished product

15800

Red

 

X

 

 

 

15850(3)

Red

X

 

 

 

 

15865(3)

Red

X

 

 

 

 

15880

Red

X

 

 

 

 

15980

Orange

X

 

 

 

E 111

15985(3)

Yellow

X

 

 

 

E 110

16035

Red

X

 

 

 

 

16185

Red

X

 

 

 

E 123

16230

Orange

 

 

X

 

 

16255(3)

Red

X

 

 

 

E 124

16290

Red

X

 

 

 

E 126

17200(3)

Red

X

 

 

 

 

18050

Red

 

 

X

 

 

18130

Red

 

 

 

X

 

18690

Yellow

 

 

 

X

 

18736

Red

 

 

 

X

 

18820

Yellow

 

 

 

X

 

18965

Yellow

X

 

 

 

 

19140(3)

Yellow

X

 

 

 

E 102

20040

Yellow

 

 

 

X

Maximum 3,3’-dimethylbenzidine concentration in the colouring agent: 5mg/Kg

20170

Orange

 

 

X

 

 

20470

Black

 

 

 

X

 

21100

Yellow

 

 

 

X

Maximum 3,3’-dimethylbenzidine concentration in the colouring agent: 5mg/Kg.

21108

Yellow

 

 

 

X

Maximum 3,3’-dimethylbenzidine concentration in the colouring agent: 5mg/Kg

21230

Yellow

 

 

X

 

 

24790

Red

 

 

 

X

 

26100

Red

 

 

X

 

Purity criteria:

Aniline ≤ 0.2%;

2-Naphtol ≤ 0.2%;

4-Aminoazobenzene ≤ 0.1%;

1-(Phenylazo)-2-napthol ≤ 3%;

1-[2-(Phenylazo)phenylazo]-2-naphthol ≤ 2.0%.

27290(3)

Red

 

 

 

X

 

27755

Black

X

 

 

 

E 152

28440

Black

X

 

 

 

E 151

40215

Orange

 

 

 

X

 

40800

Orange

X

 

 

 

 

40820

Orange

X

 

 

 

E 160 e

40825

Orange

X

 

 

 

E 160 f

40850

Orange

X

 

 

 

E 161 g

42045

Blue

 

 

X

 

 

42051(3)

Blue

X

 

 

 

E 131

42053

Green

X

 

 

 

 

42080

Blue

 

 

 

X

 

42090

Blue

X

 

 

 

 

42100

Green

 

 

 

X

 

42170

Green

 

 

 

X

 

42510

Violet

 

 

X

 

 

42520

Violet

 

 

 

X

Maximum concentration in the finished product: 5mg/Kg.

42735

Blue

 

 

X

 

 

44045

Blue

 

 

X

 

 

44090

Green

X

 

 

 

E 142

45100

Red

 

 

 

X

 

45190

Violet

 

 

 

X

 

45220

Red

 

 

 

X

 

45350

Yellow

X

 

 

 

Maximum concentration in the finished product: 6%

45370(3)

Orange

X

 

 

 

Not more than 1% of 2-(6-hydroxy-3-oxo-3H-xanthen-9-yl)benzoic acid, and Not more than 2% of 2-(bromo-6-hydroxy-3-oxo-3H-xanthen-9-yl) benzoic acid

45380(3)

Red

X

 

 

 

Not more than 1% of 2-(6-hydroxy-3-oxo-3H-xanthen-9-yl)benzoic acid, and Not more than 2% of 2-(bromo-6-hydroxy-3-oxo-3H-xanthen-9-yl) benzoic acid

45396

Orange

X

 

 

 

When used in lipstick, the colouring agent is allowed only in free acid form and in a maximum concentration of 1%

45405

Red

 

X

 

 

Not more than 1% of 2-(6-Hydroxy-3-oxo-3H-xanthen-9-yl)benzoic acid, and Not more that 2% of 2-(Bromo-6-hydroxy-3-oxo-3H-xanthen-9-yl) benzoic acid

45410(3)

Red

X

 

 

 

Not more than 1% of 2-(6-Hydroxy-3-oxo-3H-xanthen-9-yl)benzoic acid, and Not more that 2% of 2-(Bromo-6-hydroxy-3-oxo-3H-xanthen-9-yl) benzoic acid

45425

Red

X

 

 

 

Not more than 1% of 2-(6-Hydroxy-3-oxo-3H-xanthen-9-yl)benzoic acid, and Not more that 3% of 2-(Iodo-6-hydroxyl-3-oxo-3H-xanthen-9-yl) benzoic acid

45430(3)

Red

X

 

 

 

Not more than 1% of 2-(6-Hydroxy-3-oxo-3H-xanthen-9-yl)benzoic acid, and Not more that 3% of 2-(Iodo-6-hydroxyl-3-oxo-3H-xanthen-9-yl) benzoic acid.

E 127

47000

Yellow

 

 

X

 

 

47005

Yellow

X

 

 

 

E 104

50325

Violet

 

 

 

X

 

50420

Black

 

 

X

 

 

51319

Violet

 

 

 

X

 

58000

Red

X

 

 

 

 

59040

Green

 

 

X

 

 

60724

Violet

 

 

 

X

 

60725

Violet

X

 

 

 

 

60730

Violet

 

 

X

 

 

61565

Green

X

 

 

 

 

61570

Green

X

 

 

 

 

61585

Blue

 

 

 

X

 

62045

Blue

 

 

 

X

 

69800

Blue

X

 

 

 

E 130

69825

Blue

X

 

 

 

 

71105

Orange

 

 

X

 

 

73000

Blue

X

 

 

 

 

73015

Blue

X

 

 

 

E 132

73360

Red

X

 

 

 

 

73385

Violet

X

 

 

 

 

73900

Violet

 

 

 

X

 

73915

Red

 

 

 

X

 

74100

Blue

 

 

 

X

 

74160

Blue

X

 

 

 

 

74180

Blue

 

 

 

X

 

74260

Green

 

X

 

 

 

75100

Yellow

X

 

 

 

 

75120

Orange

X

 

 

 

E 160 b

75125

Yellow

X

 

 

 

E 160 d

75130

Orange

X

 

 

 

E 160 a

75135

Yellow

X

 

 

 

E 161 d

75170

White

X

 

 

 

 

75300

Yellow

X

 

 

 

E 100

75470

Red

X

 

 

 

E 120

75810

Green

X

 

 

 

E 140 and E 141

77000

White

X

 

 

 

E 173

77002

White

X

 

 

 

 

77004

White

X

 

 

 

 

77007

Blue

X

 

 

 

 

77015

Red

X

 

 

 

 

77120

White

X

 

 

 

 

77163

White

X

 

 

 

 

77220

White

X

 

 

 

E 170

77231

White

X

 

 

 

 

77266

Black

X

 

 

 

 

77267

Black

X

 

 

 

 

77268:1

Black

X

 

 

 

E 153

77288

Green

X

 

 

 

Free from chromate ions

77289

Green

X

 

 

 

Free from chromate ions

77346

Green

X

 

 

 

 

77400

Brown

X

 

 

 

 

77480

Brown

X

 

 

 

E 175

77489

Orange

X

 

 

 

E 172

77491

Red

X

 

 

 

E 172

77492

Yellow

X

 

 

 

E 172

77499

Black

X

 

 

 

E 172

77510

Blue

X

 

 

 

Free from cyanide ions

77713

White

X

 

 

 

 

77742

Violet

X

 

 

 

 

77745

Red

X

 

 

 

 

77820

White

X

 

 

 

E 174

77891

White

X

 

 

 

E 171

77947

White

X

 

 

 

 

Acid Red 195

Red

 

 

X

 

 

Aluminium, zinc, magnesium and calcium stearates

White

X

 

 

 

 

Anthocyanins

Red

X

 

 

 

E 163

Beetroot red

Red

X

 

 

 

E 162

Bromocresol green

Green

 

 

 

X

 

Bromothymol blue

Blue

 

 

 

X

 

Capsanthin, capsorubin

Orange

X

 

 

 

E 160 c

Caramel

Brown

X

 

 

 

E 150

Lactoflavin

Yellow

X

 

 

 

E 101

 

Schedule 4 - Part 2

List of colouring agents provisionally allowed for use in cosmetic products(1)

Colour Index number or Denomination

Colour

Field of Application

Other limitations and requirements(2)

Allowed until:

 

 

 

 

 

 

 

 

(See note below)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Note: No colorant is listed in this Part 2 at the time of making these Regulations

Notes:

(1)         Lakes or salts of these colouring agents using substances not prohibited under Schedule 2 are equally allowed.

(2)         Colouring agents whose number is preceded by the letter ‘E’, in accordance with the 1962 EEC Directive concerning colouring matters in foodstuffs, must fulfil the purity requirements laid down in that Directive. They also continue to be subject to the general criteria of purity set out in Annex III to the said 1962 Directive notwithstanding the fact that the letter ‘E’ may have been deleted therefrom.

(3)         The insoluble barium, strontium and zirconium lakes, salts and pigments of these colouring agents shall also be permitted. They must pass the test for insolubility which will be determined by the procedure laid down in Article 8 of the Directive.

Schedule 5

List of substances excluded from the scope of the Regulations

( Regulation 6 )

Strontium and its compounds, with the exception of strontium lactate, strontium nitrate and strontium polycarboxylate listed in Schedule 2, strontium sulphide, strontium chloride, strontium acetate, strontium hydroxide, strontium peroxide, under the conditions laid down in Schedule 3, Part 1, and of strontium lakes, pigments and salts of the colouring agents listed with the reference(3) in Schedule 4.

Schedule 6

Preservatives

( Regulation 8(1)(d) )

In this Schedule :-

1.   The substances marked with the symbol (O) may also be added to cosmetic products in concentration other than those laid down in this Schedule for specific purposes, other than for use as preservatives, as are apparent from the presentation of the products concerned, e.g. as deodorants in soaps or as anti -dandruff agents in shampoos;

2.   Other substances used in the formulation of cosmetic products may also have anti-microbial properties and thus help in the preservation of the products, as, for instance, many essential oils and some alcohols. These substances are not included in this Schedule;

3.   ‘salts’ are taken to mean: salts of the cations sodium, potassium, calcium, magnesium, ammonium and ethanolamines; salts of the anions chloride, bromide, sulphate, acetate; and ‘esters’ are taken to mean: esters of methyl, ethyl, propyl, isopropyl, butyl, isobutyl, phenyl;

4.   All finished cosmetic products containing formaldehyde or substances in this Schedule and which release formaldehyde must be labelled with the warning “contains formaldehyde” where the concentration of formaldehyde in the finished product exceeds 0.05%.

Schedule 6 - Part 1

List of preservatives allowed in cosmetic products

Reference number

Substance

Maximum authorised concentration

Limitations and requirements

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

a

b

c

d

e

1

Benzoic acid, its salts and esters (O)

0.5% (acid)

 

 

2

Propionic acid and its salts (O)

2% (acid)

 

 

3

Salicylic acid and its salts (O)

0.5% (acid)

Not to be used in preparations for children under 3 years of age, except for shampoos

Not to be used for children under 3 years of age (Solely for products which might be used for children under three years of age and which remain in prolonged contact with the skin).

4

Sorbic acid (Hexa-2,4-dienoic acid) and its salts (O)

0.6% (acid)

 

 

5

Formaldehyde and paraformaldehyde

(a) Products other than for oral hygiene - 0.2% (expressed as free formaldehyde);

Prohibited in aerosol dispensers (sprays)

 

 

 

(b) Products for oral hygiene - 0.1% (expressed as free formaldehyde).

 

 

6

Entry deleted

 

 

 

7

Biphenyl-2-ol (o-Phenylphenol) and its salts (O)

0.2% expressed as the phenol

 

 

8

Pyrithione zinc (INN) (O)

0.5%

- Permitted only in products rinsed-off after use;

- Prohibited in products for oral hygiene.

 

9

Inorganic sulphites and hydrogen sulphites (O)

0.2% (expressed as free SO2)

 

 

10

Sodium iodate

0.1%

Rinse-off products only

 

11

Chlorobutanol (INN)

0.5%

Prohibited in aerosol dispensers (sprays)

Contains chlorobutanol

12

4-Hydroxybenzoic acid and its salts and esters (O)

0.4% (acid) for 1 ester, 0.8% (acid) for mixtures of esters

 

 

13

3-Acetyl-6-methylpyran-2,4 (3H)-dione (Dehydroacetic acid) and its salts

0.6% (acid)

Prohibited in aerosol dispensers (sprays)

 

14

Formic acid and its sodium salt (O)

0.5% (expressed as acid)

 

 

15

3,3’-Dibromo-4,4’-hexamethylenedioxydi-benzamidine (Dibromohexamidine) and its salts (including isethionate)

0.1%

 

 

16

Thiomersal (INN)

0.007% calculated as mercury. When mixed with other mercury compounds authorized under these Regulations, the total mercury concentration must not exceed 0.007%.

For eye make-up and eye make-up remover products only.

Contains thiomersal

17

Phenylmercuric salts (including borate)

0.007% calculated as mercury. When mixed with other mercury compounds authorized under these Regulations, the total mercury concentration must not exceed 0.007%.

For eye make-up and eye make-up remover products only.

Contains phenylmercuric compounds

18

Undec-10-enoic acid and salts (O)

0.2% (acid)

 

 

19

Hexetidine (INN) (O)

0.1%

 

 

20

5-Bromo-5-nitro-1,3-dioxane

0.1%

- Rinse-off products only

- Avoid formation of nitrosamines

 

21

Bronopol (INN) (O)

0.1%

Avoid formation of nitrosamines

 

22

2,4-Dichlorobenzyl alcohol (O)

0.15%

 

 

23

Triclocarban (INN) (O)

0.2%

Purity criteria:

3,3’,4,4’-Tetrachloroazoybenzene - less than 1 mg/Kg; 3,3’,4,4’-

Tetrachloroazoxybenzene - less than 1 mg/Kg.

 

24

4-Chloro-m-cresol (O)

0.2%

Prohibited in products intended to come into contact with mucous membrane

 

25

Triclosan (INN) (O)

0.3%

 

 

26

4-Chloro-3,5-xylenol (O)

0.5%

 

 

27

3,3’-Bis(1-hydroxymethyl-2,5 dioxoimidazolidin-4-yl)-1,1’ methylenediurea (“Imidazolidinyl urea”) (O)

0.6%

 

 

28

Poly(1-hexamethylenebiguanide hydrochloride) (O)

0.3%

 

 

29

2-Phenoxyethanol (O)

1.0%

 

 

30

Hexamethylenetetramine (Methenamine (INN)) (O)

0.15%

 

 

31

Methenamine 3-chloroallylochloride (INN)

0.2%

 

 

32

1-(4-Chlorophenoxy)-1-(imidazol-1-yl)-3,3-di-methylbutan-2-one (O)

0.5%

 

 

33

1,3-Bis(hydroxymethyl)-5,5-dimethylimidaz-olidine-2,4-dione (O)

0.6%

 

 

34

Benzyl alcohol (O)

1.0%

 

 

35

1-Hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)- 2- pyridone and its monoethanolamine salt (O)

(a) 1.0%

(b) 0.5%

(a) Products rinsed off after use

(b) Other products

 

36

1,2-Dibromo-2,4-dicyanobutane (Methyldibromo glutaronitrile)

0.1%

Rinse-off products only

 

37

6,6-Dibromo-4,4-dichloro-2,2’-methylenedi-phenol (Bromochlorophen) (O)

0.1%

 

 

38

4-Isopropyl-m-cresol

0.1%

 

 

39

Mixture of 5-Chloro-2-methylisothiazol- 3(2H)-one and 2-methylisothiazol-3(2H)-one with magnesium chloride and magnesium nitrate

0.0015% of a mixture in a 3:1 ratio of 5-chloro-2-methylisothiazol-3(2H)-one to 2-methylisothiazol-3(2H)-one.

 

 

40□

2-Benzyl-4-chlorophenol (Chlorophene)

0.2%

 

 

41

2-Chloroacetamide

0.3%

 

Contains chloroacetamide

42

Chlorhexidine (INN) and its digluconate, diacetate and dihydrochloride (O)

0.3% expressed as chlorhexidine.

 

 

43

1-Phenoxypropan-2-ol

1.0%

Only for rinse-off products

 

44

Alkyl (C12-C22) trimethyl ammonium, bromide and chloride (O)

0.1%

 

 

45

4,4-Dimethyl-1,3-oxazolidine

0.1%

The pH of the finished product must not be lower than 6

 

46

N-(Hydroxymethyl)-N-(dihydroxymethyl-1,3-dioxo-2,5-imidazolidinyl-4)-N’-(hydroxymethyl)urea (Diazolidinyl urea).

0.5%

 

 

47

Hexamidine (INN) (4,4’-(Hexamethylenedi-oxy) dibenzamidine) and its salts (including isethionate and p-hydroxybenzoate) (O)

0.1%

 

 

48

Glutaraldehyde (Pentane-1,5-dial)

0.1%

Prohibited in aerosols (sprays)

Contains glutaraldehyde (not required when the glutaraldehyde concentration in the finished product is not greater than 0.05%).

49

5-Ethyl-3,7-dioxa-1-azabicyclo[3.3.0] octane

0.3%

Prohibited in oral hygiene products and in products intended to come into contact with mucous membranes

 

50

3-(p-Chlorophenoxy)propane-1,2-diol (Chlorphenesin)

0.3%

 

 

51

Sodium hydroxymethylaminoacetate (Sodium hydroxymethylglycinate)

0.5%

 

 

52

Silver chloride deposited on titanium dioxide

0.004% calculated as silver chloride.

(a) 20% silver chloride on titanium dioxide;

(b) Prohibited in products for children under three years of age, in oral hygiene products and in products for application around the eyes and on the lips.

 

53

Benzethonium chloride

0.1%

Rinse-off products only

 

54

Benzalkonium chloride, bromide and saccharate (O)

0.1% calculated as benzalkonium chloride

 

Avoid contact with the eyes

55

Benzylhemiformal

0.15%

Only for products to be removed by rinsing

 

56

3-Iodo-2-propynylbutylcarbamate

0.05%

1.Not to be used for oral hygiene and lipcare products

 

 

 

 

2.   If the concentration in products intended to remain on the skin exceeds 0.02%, add the phrase “Contains Iodine”.

2. Contains Iodine

 

Schedule 6 - Part 2

List of preservatives provisionally allowed

Reference Number

Substance

Maximum authorised concentration

Limitations and Requirements

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

Allowed until

a

b

c

d

e

f

1 to 15

Entries deleted

 

 

 

 

16

Entry deleted

 

 

 

 

17 to 20

Entries deleted

 

 

 

 

21

Entry deleted

 

 

 

 

22 to 28

Entries deleted

 

 

 

 

29

Entry deleted

 

 

 

 

30

Entry deleted

 

 

 

 

 

Schedule 7

UV Filters

( Regulation 8(1)(e) )

PART 1

List of permitted UV filters which cosmetic products may contain

Reference number

Substance

Maximum authorized concentration

Other limitations and requirements

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

a

b

c

d

e

1

4 -Aminobenzoic acid

5%

 

 

2

N,N,N-Trimethyl-4-(2-oxoborn-3-ylidenemethyl)anilinium methyl sulphate

6%

 

 

3

Homosalate (INN)

10%

 

 

4

Oxybenzone (INN)

10%

 

Contains oxybenzone (Not required when the concentration is not more than 0.5%, and when the substance is only intended to protect the product).

5

Entry deleted

 

 

 

6

2-Phenylbenzimidazole-5-sulphonic acid and its potassium, sodium and triethanolamine salts

8% (expressed as acid)

 

 

7

3,3’-(1,4-Phenylenedimethylene)bis(7,7-dimethyl-2-oxobicyclo-[2,2,1]hept-1-ylmethanesulphonic acid) and its salts

10% (expressed as acid)

 

 

8

1-(4-tert-Butylphenyl)-3-(4-methoxyphenyl)propane-1,3-dione

5%

 

 

9

alpha-(2-Oxoborn-3-ylidene) toluene-4-sulphonic acid and its salts

6% (expressed as acid)

 

 

10

2-Ethylhexyl 2-cyano-3,3-diphenylacrylate (Octocrylene)

10%(expressed as acid)

 

 

11

Polymer of N-{(2 and 4)-[(2-oxoborn-3-ylidene)methyl]benzyl} acrylamide

6%

 

 

12

Octyl methoxycinnamate

10%

 

 

13

Ethoxylated Ethyl 4-aminobenzoate (PEG-25 PABA)

10%

 

 

14

Isopentyl 4-methoxycinnamate (Isoamyl p-methoxycinnamate)

10%

 

 

15

2,4,6-Trianilino-(p-carbo-2’-ethylhexyl-1’-oxy)-1,3,5-triazine (Octyl triazone)

5%

 

 

16

Phenol,2-(2H-benzotriazol-2-yl)-4-methyl-6-(2-methyl-3-(1,3,3,3-tetramethyl-1-(trimethylsilyl)oxy)-disiloxanyl)propyl) (Drometrizole trisiloxane)

15%

 

 

17

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)

10%

 

 

18

3-(4’-Methylbenzylidene) dl-camphor (4-Methylbenzylidene camphor)

4%

 

 

19

3-Benzylidene camphor

2%

 

 

20

2-Ethylhexyl salicylate (Octyl salicylate)

5%

 

 

21

Ethy-2-hexyl 4-dimethylaminobenzoate (Octyl dimethyl PABA)

8%

 

 

22

2-Hydroxy-4-methoxybenzophenone-5-sulphonic acid (Benzophenone-5) and its sodium salt

5% (of acid)

 

 

23

2,2’-Methylene-bis-6-(2H-benzotriazol-2yl)-4-(tetramethylbutyl)-1,1,3,3-phenol

10%

 

 

24

Monosodium salt of 2,2’-bis-(1,4-phenylene)1H-benzimidazole-4,6-disulphonic acid)

10% (of acid)

 

 

25

(1,3,5)-Triazine-2,4-bis((4-(2-ethylhexyloxy)-2-hydroxy)phenyl)-6-(4-methoxyphenyl)

10%

 

 

26

Dimethicodiethylbenzalmalonate (CAS No. 207574-74-1)

10%

 

 

27

Titanium dioxide

25%

 

 

 

Schedule 7 - Part 2

List of UV filters which cosmetic products may provisionally contain

Reference Number

Substance

Maximum authorised concentration

Other limitations and requirements

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

Allowed until

a

b

c

d

e

f

 

 

 

 

 

 

1

Entry deleted

 

 

 

 

2

Entry deleted

 

 

 

 

3-4

Entries deleted

 

 

 

 

5

Entry deleted

 

 

 

 

6

Entry deleted

 

 

 

 

7-11

Entries deleted

 

 

 

 

12

Entry deleted

 

 

 

 

13

Entry deleted

 

 

 

 

14-16

Entries deleted

 

 

 

 

17

Entry deleted

 

 

 

 

18-24

Entries deleted

 

 

 

 

25

Entry deleted

 

 

 

 

26

Entry deleted

 

 

 

 

27-28

Entries deleted

 

 

 

 

29

Entry deleted

 

 

 

 

30-31

Entries deleted

 

 

 

 

32

Entry deleted

 

 

 

 

 

Schedule 8

Part 1

Open jar symbol required for the purposes of regulation 10(1)(d) showing the period after opening during which the product can be used without harm to the consumer

../images/en.si.2004.0870.0001.jpg

Part 2

Symbol required for the purposes of regulations 10(1)(c) and 10(5) showing where the particular precautions in use and the list of ingredients used may be found

../images/en.si.2004.0870.0002.jpg

Schedule 9

LIST OF ALTERNATIVE METHODS TO ANIMAL TESTING

( Regulation 9 )

PART 1

This Part lists the alternative methods validated by the European Centre on Validation of Alternative Methods (ACVAM) of the Joint Research Centre available to meet the requirements of this Directive which are listed in Annex V to the Dangerous Substances Directive.

 

Reference Number

Nature of Test (toxicological endpoint)

Alternative Method

Date after which test must be used

1

B40

Skin corrosion

Rat skin TER assay

31/12/2004

2

B40

Skin corrosion

Human skin model assay

31/12/2004

3

B41

Phototoxicity

In-vitro ST3 NRU phototoxicity test

31/12/2004

PART 2

This Part lists the alternative methods validated by the European Centre on Validation of Alternative Methods (ACVAM) of the Joint Research Centre available to meet the requirements of this Directive and which are not listed in Annex V to the Dangerous Substances Directive. As animal testing may not be replaced completely by an alternative method, it should be mentioned in this Schedule whether the alternative method fully or partially replaces animal testing.

Reference number

Validated Alternative Methods

Nature of Replacement (Full or Partial)

Date after which test must be used

A

B

C

D

(Note: No validated alternative methods for inclusion in this Part 2 had been adopted by the date these Regulations were made)

SCHEDULE 10

( Regulation 15(2) )

PART 1

Particulars to be included with a request to permit the non-disclosure of the identity of an ingredient for reasons of trade secrecy

1.         The name or trading style and address or registered office of the applicant.

2.         Precise identification of the ingredient for which confidentiality is requested, namely -

(a)  the CAS, EINECS and Colors Index numbers, the chemical name, the IUPAC name, the INCI name(a), the European Pharmacopoeia name, the international non-proprietary name as recommended by the World Health Organisation and the common name as provided for in the common ingredients nomenclature where such name(s) exist;

(b)  the European List of Notified Chemical Substances (ELINCS) name, the official number allocated to it if it has been notified pursuant to Dangerous Substances Directive and an indication of the decision to approve or refuse any request for confidentiality made under Article 19 of that Directive;

(c)  where the names or numbers referred to in sub-paragraphs (a) and (b) above do not exist, as in the case of certain ingredients of natural origin, the name of the base material, the name of the part of the plant or animal used, and the names of the ingredient's components, such as solvents.

3.         The evaluation of the safety for human health of the ingredient as used in the finished cosmetic product or products, taking into account the ingredient's toxicological profile, chemical structure and the level of exposure as specified in Regulation 12(2) and carried out in accordance with the requirements specified therein by a person holding a diploma referred to in Regulation 12(5).

4.         The envisaged use of the ingredient and in particular the different categories of cosmetic products in which it will be used.

5.         A detailed justification of why, by way of exception, confidentiality is sought addressing, for example :

(a)  the fact that the identity of the ingredient, or its function in the cosmetic product to be marketed, has not been described in the literature and is unknown to other manufacturers or suppliers of cosmetic products;

(b)  the fact that the information is not yet in the public domain even though a patent application has been lodged for the ingredient or its use;

(c)  the fact that if the information were known it would be easily reproducible, to the detriment of the applicant.

6.                     (a)  If known, the name of each cosmetic product which is to contain the ingredient and if different names are to be used in other Member States, precise details of each one of them;

(b)  If the name of a cosmetic product is not yet known, it may be communicated at a later date, but at least 15 days before the cosmetic product is placed on the market;

(c)  If the ingredient is used in several products, one request shall suffice, provided that the cosmetic products are clearly indicated to the competent authority.

7.         A statement setting out whether a request has been submitted to the competent authority of any other Member State in respect of the ingredient for which confidentiality is sought and particulars on the outcome of any such request.

PART 2

Registration number

( Regulation 15(4) )

1.         The registration number referred to in Regulation 15(4) shall consist of seven digits, the first two corresponding to the year of approval of confidentiality, the second two to the code assigned to Ireland, as indicated to in paragraph 2 below, and the final three digits being assigned by the Minister.

2.         The code allocated to Ireland is 07.

NOTES

(a)          The INCI name was formerly the CTFA name.

Schedule 11

Form of Certificate to be given by analyst stating results of test, examination or analysis

( Regulation 23 )

European Communities (Cosmetic Products) Regulations 2004

( S.I. No 870 of 2004 )

CERTIFICATE STATING RESULTS OF TEST, EXAMINATION OR ANALYSIS

This Certificate is issued by me, the undersigned, for the purpose of Regulation 23 of the European Communities (Cosmetic Products) Regulations 2004 being(1) _______________________________

I hereby certify that I received, on the _____ day of __________20____ , from(2) ____________________ of ______________________________, a sample of (3) ____________________________________ for test, examination or analysis; which was undamaged, duly sealed and marked(4) ____________________.

I further certify that the said sample has been tested, examined or analysed by me or under my direction and that the results are as follows:-

(5)

Signature__________________________________

Date _______________________________

Address __________________________________

__________________________________

__________________________________

(1) Here insert official title of analyst.

(2) Here insert the name of the sampling officer who submitted the sample for analysis.

(3) Here insert the name or description of the product.

(4) Here insert the distinguishing mark on the sample and the date of sampling shown thereon.

(5) Here insert the relevant results as appropriate.

 

Schedule 12

Commencement of Regulations in the case of cosmetic products containing certain substances

(Regulations 2 and 3)

 

Name of Substance and/or its identification in relevant Schedule and/or Part thereof

Date relevant to placing on the market

Date relevant to sale or supply to consumers

1

4-Benzyloxyphenol and 4-ethoxyphenol, -being substance No 178 in Schedule 2.

24 March 2005

24 September 2005

2

Lead and its compounds, - being substance No 289 in Schedule 2.

1 January 2005

1 April 2005

3

Substance No 382 in Schedule 2.

24 March 2005

24 September 2005

4

Secondary alkyl- and alkanolamines and their salts - being substance No 411 in Schedule 2.

24 March 2005

24 September 2005

5

Substance Nos 452 to 1132 (inclusive) in Schedule 2.

1 January 2005

1 April 2005

6

Hydroquinone, - being substance No 14 in Schedule 3 Part I.

24 March 2005

24 September 2005

7

Substance No 55 in Schedule 3 Part I.

1 January 2005

1 April 2005

8

Fatty acid dialkylamides and dialkanolamides, - being substance No 60 in Schedule 3 Part I.

24 March 2005

24 September 2005

9

Monoalkanolamines, monoalkanolamines and their salts - being substance No 61 in Schedule 3 Part I.

24 March 2005

24 September 2005

10

Trialkylamines, trialkanolamines and their salts - being substance No 62 in Schedule 3 Part I.

24 March 2005

24 September 2005

11

2,4-Diaminopyrimidine-3-oxide (CAS No 74638-76-9) - being substance No 93 in Schedule 3 Part I.

24 March 2005

24 September 2005

12

Benzoyl peroxide - being substance No 94 in Schedule 3 Part I.

24 March 2005

24 September 2005

13

Hydroquinone methylether - being substance No 95 in Schedule 3 Part I.

24 March 2005

24 September 2005

14

1,2-Dibromo-2,4-dicyanobutane (Methyldibromo glutaronitrile) - being substance No 36 in Schedule 6 Part I.

24 March 2005

24 September 2005

../images/seal.jpg

GIVEN under the Official Seal of the Minister for Health and Children this 20th day of December 2004

Mary Harney

____________________________

Minister for Health and Children

EXPLANATORY NOTE

(This note is not part of the Instrument and does not purport to be a legal interpretation.)

The purpose of the Regulations is to up-date the law in relation to the manufacture, marketing and sale of cosmetic products and to consolidate in one set of Regulations the laws in relation to cosmetic products.

The effect of the Regulations is to prohibit the placing on the market of cosmetic products that, under normal conditions of use, are liable to cause damage to human health. The presence in cosmetic products of certain listed substances is either prohibited absolutely or permitted subject to certain restrictions. Positive lists of colouring agents, anti-microbial preservatives and ultraviolet sun-screen filters are established which, subject to compliance with any prescribed restrictions, are permitted to be used. Substances that have been classified as carcinogenic, mutagenic or toxic to reproduction under the Dangerous Substances Directive have also been prohibited.

Certain requirements in regard to labelling are also laid down and the use of words, names, trade marks, images or other signs either in the labelling, presentation for sale or advertising of cosmetic products is prohibited, where such suggests a characteristic which the product in question does not possess. Full ingredient labelling is also required for all cosmetic products placed on the market and the presence of certain ingredients which may be present in certain perfume and aromatic compositions and which are a potential cause of contact-allergy reactions is also to be disclosed.

The testing of finished cosmetic products on animals for the purposes of the regulations is prohibited as is the testing of any ingredients or combination of ingredients whenever there is a validated alternative method available via Annex V of the Dangerous Substances Directive or in Schedule 9 of these Regulations. The same prohibitions apply to the marketing of cosmetic products that may contain ingredients tested on animals. Furthermore, the circumstances in which a claim, that a cosmetic product or any of its ingredients has not been tested on animals, may be made have been clearly set out.

The Regulations also lay down the information, which must be kept available to the control authorities by the manufacturers and initial EU importers of cosmetic products. This information must include all the necessary particulars relating to the composition, quality and safety of the products, including information on the claimed effects and undesirable effects. An assessment, prepared by an appropriate qualified person, on safety for human health, must also be available on each product.

1 OJ L.262, 27.9.1976

2 OJ No.L140, 23/6/95, p.26.

3 96/335/EC - Official Journal of the European Communities, No. L132, 1/6/96 (pages 1-684). (Inventory and common nomenclature of ingredients).

4 OJ 196, 16.8.1967, p. 1

1 OJ L.262, 27.9.1976

5 OJ No. L192, 31/7/79

6 OJ No.L167,15/6/82

7 OJ No. L332, 28/11/83

8 OJ No. L382, 31/12/88

9 OJ No. L398, 30/12/89

10 OJ No. L151, 23/6/93

11OJ No. L66, 11/3/03

12 OJ No. L63, 6/3/82

13 OJ No. L109, 26/4/83

14 OJ No. L188, 13/7/83

15 OJ No. L275, 8/10/83

16 OJ No. L228, 25/8/84

17 OJ No. L224, 22/8/85

18 OJ No. L138, 24/5/86

19 OJ No. L149, 3/6/86

20 OJ No L56, 26/2/87

21 OJ No L105, 26/4/88

22 OJ No. L64, 8/3/89

23 OJ No. L71, 17/3/90

24 OJ No. L91, 12/4/91

25 OJ No. L70, 17/3/92

26 OJ No. L325, 11/11/92

27 OJ No. L203, 13/8/93

28 OJ No. L181, 15/7/94

29 OJ No. L167, 18/7/95

30 OJ No. L198, 8/8/96

31 OJ No. L16, 18/1/97

32 OJ No. L196, 24/7/97

33 OJ No. L77, 14/3/98

34 OJ No. L253, 15/9/98

35 OJ No. L56, 1/3/2000

36 OJ No. L65, 14/3/2000

37 OJ No. L102, 18/4/2002

38 OJ No. L5, 10/1/2003

39 OJ No. L46, 20/2/2003

40 OJ No. L224, 6/9/2003

41 OJ No. L83, 25/9/2003

42 OJ No. L287, 8/9/2004

43 OJ No. L287, 8/9/2004

44 OJ No. L300, 25/9/2004

45 OJ No. L294, 17/9/2004

46 The cosmetic products Directives fall within the scope of the EEA Agreement by virtue of Chapter XVI of Annex II to that Agreement.

2 OJ No.L140, 23/6/95, p.26.

47 95/17/EEC - Official Journal of the European Communities, No. L140, 23/6/95 (pages 26-29). (Non-disclosure for reasons of trade secrecy).

48 OJ No.L.50, 20/2/2004, p44

49 OJ No. L383, 31/12/80

50 OJ No. L185, 30/6/82

51 OJ No. L291, 24/10/83

52 OJ No. L295, 7/11/85

53 OJ No. L57, 27/2/87

54 OJ No. L108, 28/4/90

55 OJ No. L231, 14/9/93

56 OJ No. L178, 28/7/95

57 OJ No. L213, 22/8/96

1 OJ No L. 159, 29.6. 1996, p.1.

2 OJ No. L 147 of 31.05.2001, p.1.

1 These substances may be used singly or in combination provided that the sum of the ratios of the levels of each of them in the cosmetic product expressed with reference to the maximum level authorized for each of them does not exceed 1

2 The concentration of Sodium, Potassium or Lithium hydroxide is expressed as weight of Sodium hydroxide. In case of mixtures, the sum should not exceed the limits given in column d

3 Idem


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