S.I. No. 87/1997:

EUROPEAN COMMUNITIES (COSMETIC PRODUCTS) REGULATIONS, 1997.

EUROPEAN COMMUNITIES (COSMETIC PRODUCTS) REGULATIONS, 1997.

ARRANGEMENT OF ARTICLES

ARTICLE

1. Citation

2. Revocation.

3. Commencement.

4. Interpretation.

5. Exemptions.

6. Prohibition, if likely to cause damage to public health.

7. Prohibitions and restrictions on use of certain ingredients.

8-10. Labelling.

11. Information to be retained by manufacturers.

12. Notification of place of manufacture or importation.

13. Authorisations for the use of ingredients not otherwise permitted.

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

15. Prohibition of sales to consumers.

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

17. Offences and penalties.

18-19. Enforcement.

20. Prescribed methods for official testing.

21. Evidential value of Certificate given by analyst.

SCHEDULES

SCHEDULE 1

Illustrative list by category of cosmetic products.

SCHEDULE 2

List of substances which cosmetic products must not contain.

SCHEDULE 3 -- PART I

List of substances which Comestic 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 I

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 I

List of preservatives allowed for use in cosmetic products.

SCHEDULE 6 -- PART 2

List of preservatives provisionally allowed.

SCHEDULE 7 -- PART I

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

Symbol required for the purposes of Articles 8 (1) (d) and 8 (4) (a) of the Regulations.

SCHEDULE 9 -- PART I

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

SCHEDULE 9 -- PART 2

Registration number.

SCHEDULE 10

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

REFERENCES

S.I. No. 87 of 1997.

EUROPEAN COMMUNITIES (COSMETIC PRODUCTS) REGULATIONS, 1997

The Minister for Health in exercise of the powers conferred on him by section 3 of the European Communities Act, 1972 (No. 27 of 1972), hereby makes the following Regulations:--

1. These Regulations may be cited as the European Communities (Cosmetic Products) Regulations, 1997.

2. The provisions of the European Communities (Cosmetic Products) Regulations, 1990 to 1996 are hereby revoked, provided that the said Regulations shall continue to apply to cosmetic products placed on the market before 1st day of March, 1997.

3. (1) Subject to the provisions of this article, these Regulations shall come into operation on the 1st day of March, 1997.

(2) The following provisions of these Regulations shall not come into force until the 1st July, 1997, in respect of cosmetic products which are sold by retail or otherwise supplied to a consumer--

( a ) article 7 (1) (a) and Schedule 2, but only insofar as they relate to entry numbers 358, 414, 415, 416 and 417 of the said Schedule; and

( b ) articles 7 (1) (e) and Part 1 of Schedule 7, but only insofar as they relate to entry number 10 of the said Part 1.

(3) The following provisions of these Regulations shall not come into force until the 1st July, 1997, in respect of cosmetic products which are placed on the market--

( a ) article 7 (1) (a) and Schedule 2, but only insofar as they relate to entry numbers 418 and 419 of the said Schedule;

( b ) article 7 (1) (b) and Part 1 of Schedule 3, but only insofar as they relate to entry numbers 15a, 15b and 15c of the said Part 1;

( c ) article 7 (1) (d) and Part 1 of Schedule 6, but only insofar as they relate to entry numbers 50, 51 and 52 of the said Part 1;

( d ) articles 7 (1) (d) and 7 (l) (g) and Part 2 of Schedule 6, but only insofar as they relate to entry numbers 2 and 30 of the said Part 2; and

( e ) article 7 (1) (c) and Part 1 of Schedule 7, but only insofar as they relate to entry number 11 of the said Part 1.

(4) The provisions specified in sub-article (3), in respect of the entry numbers specified therein, shall not come into force until the 1st July, 1998 in respect of cosmetic products which are sold by retail or otherwise supplied to a consumer.

(5) The provisions of article 7 (1) ( f ) shall not come into force until the 1st day of January, 1998.

4. (1) In these Regulations:--

"the 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 Principal Directive and contained in Commission Decision 96/335/EC⁽¹⁾;

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

"cosmetic 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;

"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;

"date of minimum durability" in relation to a cosmetic product means the date until which the product, when stored under appropriate conditions, continues to fulfil its initial function and in particular remains in conformity with article 6 of these Regulations;

"decorative cosmetic products" includes cosmetic products of one of the following categories, namely, lipstick, eye shadow, blusher, eye pencil, liquid foundation, powder, mascara and nail polish:

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

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

the "Minister" means the Minister for Health;

"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;

"the Principal Directive" means Council Directive 76/768/EEC⁽³⁾, as amended by Council Directives 79/661/EEC⁽⁴⁾, 82/368/EEC⁽⁵⁾, 83/574/EEC⁽⁶⁾, 88/667/EEC⁽⁷⁾, 89/679/EEC⁽⁸⁾ and 93/35/EEC⁽⁹⁾ and by Commission Directives 82/147/EEC⁽¹⁰⁾, 83/191/EEC⁽¹¹⁾, 83/341/EEC⁽¹²⁾, 8¾96/EEC⁽¹³⁾, 84/415/EEC⁽¹⁴⁾, 85/391/EEC⁽¹⁵⁾, 86/179/EEC⁽¹⁶⁾, 86/199/EEC⁽¹⁷⁾, 87/137/EEC⁽¹⁸⁾, 88/233/EEC⁽¹⁹⁾, 89/174/EEC⁽²⁰⁾, 90/121/EEC⁽²¹⁾, 91/184/EEC⁽²²⁾, 92/8/EEC⁽²³⁾, 92/86/EEC⁽²⁴⁾, 9¾7/EEC⁽²⁵⁾, 94/32/EC⁽²⁶⁾, 95/34/EC⁽²⁷⁾, 96/41/EC⁽²⁸⁾ and 97/1/EC⁽²⁹⁾;

"sale" includes offering or keeping for sale;

"supply by mail order" means any supply made, after solicitation of custom by the supplier, without the supplier and the customer being simultaneously present and using a means of communication at a distance, whether written or electronic, to convey the custom solicitation and the order for 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) In these Regulations, unless the context otherwise indicates, any reference to an article or Schedule shall be construed as a reference to an article contained in these Regulations or, as the case may be, to a Schedule thereto, and likewise any reference in an article to a sub-article shall be construed as a reference to a sub-article of that article.

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

6. A person shall not place a cosmetic product on the market 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 placing the cosmetic product on the market in the Community.

7. (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 in 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 ingredient or combination of ingredients which have been tested on animals where such testing has taken place after 1st January, 1998 and which has been undertaken in order that the cosmetic product may satisfy any requirement of these Regulations;

( g ) 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 article 6, the provisions of sub-article (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 sub-article (1) (c) shall not apply to cosmetic products containing colouring agents intended solely to colour hair.

8. (1) Subject to the provisions of these Regulations, a person shall not place a cosmetic product on the market 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 or of the person responsible for placing the cosmetic product on the market. Such manufacturer or person shall be established in a Member State of the Community. This information may be abbreviated provided that any such abbreviation makes it generally possible to identify the manufacturer or person concerned;

( 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 grammes or five milliliters, 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 which shall be indicated by the words "Best used before the end of. . . . ." and which shall incorporate either the date itself, clearly expressed in terms of month and year, in that order, or details of where the said date appears on the packaging. Such information shall, where necessary, be supplemented by an indication of the conditions which must be satisfied to guarantee the stated durability;

( d ) 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 Schedule 8. Any such reference shall appear on the container and on the packaging;

( e ) 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;

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

( g ) a list of cosmetic ingredients (preceded by the word "ingredients") in descending order of weight as determined at the time at which the said ingredients were added to the product.

(2) ( a ) The particulars referred to in paragraphs (b), (c), ( d ) and ( f ) of sub-article (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 paragraph (c) of sub-article (1) shall not be required when the minimum durability of the cosmetic product exceeds thirty months.

( c ) The particulars referred to in paragraph (g) of sub-article (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 paragraph (g) of sub-article (1)--

( a ) the following shall not be regarded as cosmetic 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 words "perfume" or "flavour";

( c ) ingredients in concentrations of less than 1% may be listed in any order after those in concentrations of 1% 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" are added;

( f ) a cosmetic 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 article 10 of Commission Directive 95/17/EC⁽³⁰⁾ in the grant of a request made in accordance with the provisions of the said Directive, shall be used to identify the cosmetic ingredient in respect of which such request was granted.

(4) ( a ) Where, in the case of the particular precautions to be observed in use (as referred to in paragraph (d) of sub-article (1)) and in the case of the list of ingredients (referred to in paragraph (g) of the said sub-article), its is impractical, for reasons of size or shape, for the required particulars to appear in an enclosed leaflet, such particulars shall appear on a label, tape or card which is enclosed or attached to the cosmetic product and to which the consumer is referred either by abbreviated information or by use of the symbol given in Schedule 8, which must appear on the packaging.

( b ) Where, in the case of soap, bath-balls and other small products, it is impracticable for reasons of size of shape, for the list of ingredients referred to in paragraph (g) of sub-article (1) to appear on a label, tag, tape or card or in a leaflet enclosed with the product, the list shall appear on a notice in the immediate proximity to the container in which the cosmetic product is exposed for sale.

9. 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.

10. Any reference to testing on animals which is included with or appears on the container or packaging of a cosmetic product or which appears in any advertising or promotional material relating to a cosmetic product must state clearly whether or not such tests have been carried out and, if they have, whether they relate to the cosmetic product itself, to any of its ingredients or to both.

11. (1) Subject to the provisions of this article, the manufacturer of a cosmetic product 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 article 8 (1) (a), the following information--

( a ) (i) in the case of perfume compositions and perfumes, the name and code number of the composition and the identity of the supplier; and

(ii) in all other cases the qualitative and quantitative composition of the product;

( 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 ) assessment of the safety for human health off the finished product taking into consideration the general toxicological profile of each ingredient used, its chemical structure and its level of exposure;

( e ) the name and address of the qualified person or persons responsible for the assessment referred to in sub-paragraph (d) above;

(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.

(2) The assessment referred to in paragraph (d ) of sub-article (1) shall be carried out in accordance with the principles of good laboratory practice referred to in article 1 of Council Directive 87/18/EEC⁽³¹⁾ on the application of the principles of good laboratory practice and the verification of their application for tests on chemical substances.

(3) The person referred to in paragraph (e) of sub-article (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.

(4) The person responsible for manufacture or first importation into the Community must possess appropriate experience or an appropriate level of professional qualification in accordance with the legislation and practice of the Member State which is the place of manufacture or first importation.

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

(6) Where the manufacturer of a cosmetic product is not established in the Community, the information referred to in subarticle (1) shall be kept, in the manner provided for in the said subarticle, by the manufacturer's agent established in the Community.

(7) Where the manufacturer of a cosmetic product is established outside the Community and has no agent established within the Community, the information referred to in subarticle (1) shall be kept in the manner provided in the said subarticle by the person who supplies the cosmetic product on the first occasion that it is supplied in the Community.

(8) Where the manufacturer of a cosmetic product manufactures to the order of a person who intends to supply it in the Community, that person shall keep the information referred to in subarticle (1) in the manner provided for in the said subarticle.

(9) The information referred to in subarticle (1) shall be available in the English language or in a language readily understood by the enforcement authority.

(10) For the purposes of this article and article 12, the term "enforcement authority" means the Minister for Health or any person duly authorised in writing by him.

12. (1) Subject to the provisions of this article, the manufacturer of a cosmetic product shall notify the enforcement authority of the place of manufacture of the cosmetic product before its supply in the Community.

(2) Where the manufacturer of a cosmetic product is not established in the Community, his agent established in the Community shall notify the enforcement authority of the point of importation of the cosmetic product into the Community (where that point of importation is within the State) before its first supply in the Community.

(3) Where the manufacturer of a cosmetic product is established outside the Community and has no agent established within the Community, the person who intends to supply the cosmetic product on the first occasion that it is supplied in the Community shall notify the enforcement authority of the point of importation of the cosmetic product into the Community (where that point of importation is within the State) before its first supply in the Community.

(4) Where the manufacturer of a cosmetic product manufactures to the order of a person who intends to supply it in the Community, that person shall notify the enforcement authority of the place of manufacture of the cosmetic product (where this is within the State) or of the point of importation of the cosmetic product into the Community (where that point of importation is within the State) before the cosmetic product is first supplied in the Community.

13. (1) Notwithstanding the provisions of article 7 and subject to sub-articles (2), (3) and (4), the Minister 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 sub-article (1), shall be limited in duration to a maximum period of three years and shall be subject to such conditions as the Minister 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 sub-article (2) shall be extended until a decision is made following a request, pursuant to paragraph 3 of article 8 (a) of the Principal 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 Minister a fee of £600.00 in respect of each application for an authorisation under sub-article (1).

14. (1) Subject to the provisions of this article and without prejudice to article 6, the Minister may grant a request made by a person (hereinafter in this article referred to as the applicant), who for reasons of trade secrecy, wishes not to include one or more ingredient of a cosmetic product on the list referred to in article 8 (1) (g).

(2) A request made under this article shall include the particulars set out in Part 1 of Schedule 9.

(3) Within four months of the receipt of a request in respect of which the requirements of sub-article (2) are satisfied, the Minister shall examine the request and inform the applicant in writing of his decision. In exceptional cases, the Minister 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 Minister grants a request made under this article, he 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 article 8 (1) (g). The said registration number shall be allocated to the product in the manner specified in Part 2 of the Schedule 9.

(5) ( a ) Subject to paragraph (b) of this article, a request granted under sub-article (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 may submit a reasoned request for such extension to the Minister. In those circumstances the Minister may grant the request which shall extend the period by not more than three years.

(6) All amendments to the information provided under sub-article (2) shall be communicated forthwith to the Minister. All changes to the names of the cosmetic products containing the ingredient shall be communicated to the Minister 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 sub-article (6) and any new information which may become available, the Minister may, particularly if there are compelling reasons of public health, withdraw his approval of a request granted under this article.

(8) Any refusal to grant a request made under this article shall include a statement of the reasons for refusal with a clear explanation of the appeal procedures and their time limits.

(9) There shall be paid to the Minister a fee of £600.00 in respect of each request made under this article.

15. With effect from the 1st day of January, 1998, 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.

16. (1) A person responsible for placing a cosmetic product on the market shall, on request made by the Minister or by a person authorised in writing by him or by a competent authority designated for the purpose by the Minister, make available forthwith in response to that request, for the purpose of prompt and appropriate medical treatment, adequate information on the substances used in the cosmetic product or class(es) of cosmetic products concerned.

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

17. A person who contravenes any provision of these Regulations, or any condition attached to an authorisation granted under article 13, shall be guilty of an offence and shall be liable on summary conviction to a fine not exceeding £1,000 and, in the case of a continuing offence, to a further fine not exceeding £100 for each day on which the offence is continued.

18. (1) These Regulations may be enforced by officers of the Minister and by health boards and their officers.

(2) The provisions of article 8 (1) (b) and article 9 may also be enforced by officers of the Minister for Enterprise and Employment.

19. (1) For the purpose of ascertaining whether or not there is or has been a contravention of these Regulations, an officer specified in article 18 (with, in the case of an officer of the Minister, a written authorisation of the Minister, in the case of an officer of the Minister for Enterprise and Employment, a written authorisation of the Minister for Enterprise and Employment and in the case of an officer of a health board, a written authorisation of the board) may, at all reasonable times--

( a ) enter any premises of any class or description, not being a premises used only as a private dwelling;

( b ) inspect and take (without payment) samples of any cosmetic product which is manufactured, stored, sold or offered or kept for sale or supply at such premises, for test, examination or analysis;

( c ) require the production of and, if he thinks fit, take copies of any order, invoice or other document at such premises; and

( d ) seize and detain any cosmetic product, substance or article which he has reasonable cause to believe to be a product, substance or article, in relation to which, or by means of which, an offence under article 17 is being committed, and any document which he has reasonable cause to believe to be a document which may be required as evidence in proceedings for an offence under the said article 17.

(2) Where a person seizes any cosmetic product, substance, article or document in the exercise of such a power as is specified in sub-article (1), he shall inform the person from whom it is seized of the said seizure.

(3) Notwithstanding anything contained in this article, where a person claiming to exercise a power by virtue of this article, is required to produce his credentials, the power shall not be exercisable except on production of those credentials.

(4) A person who is the provider of services, such as post office boxes, telephone or electronic mail facilities, to a person offering the supply by mail order of cosmetic products, and in respect of whom the name and address of the said person is not otherwise available, shall, on demand by a person holding an authorisation referred to in sub-article (1), furnish such particulars as may be requested in order to positively identify the person concerned.

(5) A person shall not wilfully obstruct or interfere with the exercise of a power by a person duly exercising such power as is specified in sub-article (1).

20. The official testing of cosmetic products by, or under the direction of any of the persons specified in article 21 (1) shall be carried out in accordance with the methods described in Commission Directives 80/1335/EEC⁽³²⁾, 82/434/EEC⁽³³⁾, 83/514/EEC⁽³⁴⁾, 85/490/EEC⁽³⁵⁾, 87/143/EEC⁽³⁶⁾ and 90/207/EEC⁽³⁷⁾ 93/73/EEC⁽³⁸⁾ and 95/32/EEC⁽³⁹⁾, insofar as such methods are applicable.

21. (1) In any proceedings for an offence under article 17 a certificate signed by--

( a ) the State Chemist, or

( b ) a public analyst appointed under section 10 of the Sale of Food and Drugs Act, 1875, or

( c ) a chemist or analyst appointed by the Minister for that purpose

-- stating the results of any test, examination or analysis of a sample shall, with regard to that sample, be evidence for all purposes of such result.

(2) The certificate referred to in sub-article (1) shall be in the form set out in Schedule 10 to these Regulations.

SCHEDULE 1

Illustrative list by category of cosmetic products

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

-- face masks (with the exception of peeling products).

-- tinted bases (liquids, pastes, powders).

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

-- toilet soaps, deodorant soaps, etc.

-- perfumes, toilet waters and eau de cologne.

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

-- depilatories,

-- deodorants and anti-perspirants.

-- hair care products.

-- hair tints and bleaches,

-- products for waving, straigthening 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

(Article 7 (1) (a))

List of substances which cosmetic products must not contain

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. Alloclaimide (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), it 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 (R5,6,6a,7 Tetrahydro-6-methyl-4H-dibenzo[de,g] quinoline-10, 11-diol) 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 I and in Schedule 4, Part 2.

47. Benzene.

48. Benzimidazo-2(3H)-one.

49. Benzazepines and benzodiazepines.

50. l-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-l, 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) methylaimine N-oxide and its salts.

87. Chlormethine (INN) and it 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. 2-[2-(4-Chlorophenyl)-2-phenylacetyl]indan-1,3-dione; (Chlorophacinone -- ISO).

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 cyanaide 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(ethyldimethyl-ammonium) 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[(o-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. Monobenzone (INN).

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. (IR,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. (IR,4S,5R,8S)-1,2,3,4,10,10-Hexachloro-1,4,4a,5,8,8a-hexahydro-1,4:5,8dimethanonaphthalene; (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- trimethylnaphtol[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,-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]-[l]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. l-and 2-Naphthylamines and their salts.

243. 3(l-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 nitrates.

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-ylbenzyl 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 with the exception of lead acetate under the conditions laid down for that substance in Schedule 3, Part I (No. 55).

290. Coniine.

291. Prunus laurocerasus L. ("Cherry laurel water").

292. Metyrapone (INN).

293. Radioactive substances (except substances which are radioactive naturally or by reason of contamination from the environment, which have not been enriched for manufacturing purposes, and in respect of which the concentration complies with Council Directive No. 76/579/Euratom^(a)).

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. Trichloronitromethane (Chloropicrine).

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 seed 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',6',8',8'-tetramethyl-2'-acetonaphthalene; (Acetylethyltetramethyltetralin, AETT),

363. o-Phenylenediamine and its salts.

364. 4-Methyl-m-phenylenediamine and its salts.

365. Aristolochic acid and its salts.

366. Chloroform.

367. 2,3,7,8-Tetrachlorodibenzo-p-dioxin.

368. 2,6-Dimethyl-1,3-dioxan-4-yl acetate; (Dimethicone).

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), its salts and derivatives.

373. 3,4',5-Tribromosalicylanilide; (Tribromsalan).

374. Phytolacca species, and their preparations.

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

376. l-Methoxy-2,4-diaminobenzene (2,4-Diaminoanisole – CI 76050) and its salts.

377. l-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. Benzoyl peroxide.

383. 2-Amino-4-nitrophenol.

384. 2-Amino-5-nitrophenol,

385. 11-apha-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 steroid structure.

391. Zirconium and its compounds, with the exception of those zirconium complexes specified in Schedule 3, Part 1 (No. 50), and of those zirconium lakes, salts and pigments of colouring agents identified with the reference (3) in Schedule 4, Part 1.

392. Thyrothricine.

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 agent 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 dialkanolamines.

412. 4-Amino-2-nitrophenol.

413. 2-Methyl-m-phenylenediamine.

414. 4-tert-Butyl-3-methoxy-2,6-dinitrotoluene; (Musk Ambrette).

415. Diisobutylphenoxyethoxyethyldimethylbenzylammonium chloride; (Benzethonium chloride).

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, Bovine, ovine and caprine tissues and fluids from the encephalon, the spinol chord and the eyes, and ingredients derived therefrom.

Notes:( a ) Official Journal of the European Communities, No. L187, 12/7/76, pl.

( b ) The designation (INN) indicates that the name is the International Nonproprietary Name for the substance concerned as published by the World Health Organisation for pharmaceutical substances.

SCHEDULE 3

PART I

List of Substances which Cosmetic Products must not Contain Except Subject to the Restrictions and Conditions Laid Down

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 product 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.

PART 2

List of Substances Provisionally Allowed in Cosmetic Products Subject to the Restrictions and Conditions Laid Down

Note: There are no entries in this Part 2 at present.

SCHEDULE 4

Colouring Agents

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⁾

PART 2

List of Colouring Agents Provisionally Allowed for use in Cosmetic Products⁽¹⁾

Note: No colorant is listed in this Part 2 at the present time.

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 Principal Directive.

SCHEDULE 5

List of Substances Excluded from the Scope of the Regulations

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

(Article 6 (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%.

PART 1

List of Preservatives Allowed in Cosmetic Products

PART 2

List of Preservatives Provisionally Allowed

SCHEDULE 7

UV Filters

PART I

List of Permitted UV Filters which Cosmetic Products may Contain

PART 2

List of UV Filters which Cosmetic Products may Provisionally Contain

SCHEDULE 8

Symbol Required for the Purposes of Articles 8 (1) (d) and 8 (4) (a) of the Regulations

SCHEDULE 9

(Article 14 (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 cosmetic 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 ELINCS name, the official number allocated to it if it has been notified pursuant to Council Directive 67/548EEC^(b) 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 cosmetic ingredient's components, such as solvents.

3. The evaluation of the safety for human health of the cosmetic ingredient as used in the finished cosmetic product or products, taking into account the cosmetic ingredient's toxicological profile, chemical structure and the level of exposure as specified in Article 11 (1) (d) and carried out in accordance with the requirements of sub-article (2) and (3) of Article 11.

4. The envisaged use of the cosmetic 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 cosmetic 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 cosmetic 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 cosmetic 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 cosmetic 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 cosmetic ingredient for which confidentiality is sought and particulars on the outcome of any such request.

PART 2

Registration Number

1. The registration number referred to in Article 14 (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 0.7.

Notes

( a ) The INCI name was formerly the CTFA name.

( b ) Official Journal of the European Communities, No. L196, 16.8.1967, p.1.

SCHEDULE 10

European Communities (Cosmetic Products) Regulations, 1997

( S.I. No. 87 of 1997 )

CERTIFICATE STATING RESULTS OF TEST, EXAMINATION OR ANALYSIS

⁽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.

References

1. 96/335/EC -- Official Journal of the European Communities, No. L132, 1/6/96 (pages 1-684). (Inventory and common nomenclature of ingredients).

2. The cosmetic products Directives fall within the scope of the EEA Agreement by virtue of Chapter XVI of Annex II to that Agreement.

3. 76/768/EEC-- Official Journal of the European Communities, No. L262, 27/9/76 (pages 169-200). (First Council Directive).

4. 79/661/EEC -- Official Journal of the European Communities, No. L192, 31/7/79 (page 35). (First Amending Council Directive).

5. 82/368/EEC -- Official Journal of the European Communities, No. L167, 15/6/82 (pages 1-32). (Second Amending Council Directive).

6. 83/574/EEC -- Official Journal of the European Communities, No. L332, 28/11/83 (pages 38-42). (Third Amending Council Directive).

7. 88/667/EEC -- Official Journal of the European Communities, No. L382, 31/12/88 (pages 46-48). (Fourth Amending Council Directive).

8. 89/679/EEC -- Official Journal of the European Communities, No. L398, 30/12/89 (page 25). (Fifth Amending Council Directive).

9. 93/35/EEC -- Official Journal of the European Communities, No. L151, 23/6/93 (pages 32-37). (Sixth Amending Council Directive).

10. 82/47/EEC -- Official Journal of the European Communities, No. L63, 6/3/82 (page 26). (First Commission Directive).

11. 83/191/EEC -- Official Journal of the European Communities, No. L109, 26/4/83 (pages 25-27). (Second Commission Directive).

12. 83/341/EEC -- Official Journal of the European Communities, No. L188, 13/7/83 (page 15). (Third Commission Directive).

13. 8¾96/EEC -- Official Journal of the European Communities, No. L275, 8/10/83 (pages 20-21). (Fourth Commission Directive).

14. 84/415/EEC -- Official Journal of the European Communities, No. L228, 25/8/84 (pages 31-33). (Fifth Commission Directive).

15. 85/391/EEC -- Official Journal of the European Communities, No. L224, 22/8/85 (pages 40-41). (Sixth Commission Directive).

16. 86/]79/EEC -- Official Journal of the European Communities, No. L138, 24/5/86 (pages 40-48). (Seventh Commission Directive).

17. 86/199/EEC -- Official Journal of the European Communities, No. L149, 3/6/86 (pages 38-45). (Eight Commission Directive).

18. 87/137/EEC -- Official Journal of the European Communities, No. L56, 26/2/87 (pages 20-21). (Ninth Commission Directive).

19. 88/233/EEC -- Official Journal of the European Communities, No. L105, 26/4/88 (pages 11-14) and corrigendum published on 24/6/88 in No. L157 (page 38) (Tenth Commission Directive).

20. 89/174/EEC -- Official Journal of the European Communities, No. L64, 8/3/89 (pages 10-13) and corrigendum published on 13/7/89 in No. L199 (page 23) (Eleventh Commission Directive).

21. 90/121/EEC -- Official Journal of the European Communities, No. L71, 17/3/90 (pages 40-42). (Twelfth Commission Directive).

22. 91/184/EEC -- Official Journal of the European Communities, No. L91, 12/4/91 (pages 56-62). (Thirteenth Commission Directive).

23. 92/8/EEC -- Official Journal of the European Communities, No. L70, 17/3/92 (pages 23-24). (Fourteenth Commission Directive).

24. 92/86/EEC -- Official Journal of the European Communities, No. L325, 11/11/92 (pages 18-22). (Fifteenth Commission Directive).

25. 9¾7/EEC -- Official Journal of the European Communities, No. L203, 13/8/93 (pages 24-26). (Sixteenth Commission Directive).

26. 94/32/EC -- Official Journal of the European Communities, No. L181, 15/7/94 (pages 31-34). (Seventeenth Commission Directive).

27. 95/34/EEC -- Official Journal of the European Communities, No. L167, 18/7/95 (pages 19-21). (Eighteenth Commission Directive).

28. 96/41/EC -- Official Journal of the European Communities, No. L198, 8/8/96 (pages 36-39). (Nineteenth Commission Directive).

29. 97/1/EC -- Official Journal of the European Communities, No. L16, 18/1/97 (pages 85-86). (Twentieth Commission Directive).

30. 9S/17/EEC -- Official Journal of the European Communities, No. L140, 23/6/95 (pages 26-29). (Non-disclosure for reasons of trade secrecy).

31. 87/18/EEC -- Official Journal of the European Communities, No. L15, 17/1/87 (pages 29-30). (Principles of Good Laboratory Practice).

32. 80/1335/EEC -- Official Journal of the European Communities, No. L383, 31/12/80 (pages 27-46). (Methods of analysis).

33. 82/434/EEC -- Official Journal of the European Communities, No. L185, 30/6/82 (pages 1-28), (Methods of analysis).

34. 83/514/EEC -- Official Journal of the European Communities, No. L291, 24/10/83 (pages 9-46). (Methods of analysis).

35. 85/490/EEC -- Official Journal of the European Communities, No. L295, 7/11/85 (pages 30-45). (Methods of analysis).

36. 87/143/EEC -- Official Journal of the European Communities, No. L57, 27/2/87 (pages 56). (Methods of analysis).

37. 90/207/EEC -- Official Journal of the European Communities, No. L108, 28/4/90 (pages 92-101). (Methods of analysis).

38. 93/73/EEC -- Official Journal of the European Communities, No. L231, 14/9/93 (pages 34-53). (Methods of analysis).

39. 95/32/EC -- Official Journal of the European Communities, No. L178, 28/7/95 (pages 20-35). (Methods of analysis).

GIVEN under the Official Seal of the Minister for Health, this 20th day of February, 1997.

MICHAEL NOONAN,

Minister for Health.

EXPLANATORY NOTE.

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 which, 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.

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.

With effect from 1st March, 1997, full ingredient labelling will be required for all cosmetic products placed on the market. Furthermore, any reference to testing on animals must clearly indicate whether or not such testing was carried out and if so whether it was carried out on the cosmetic product itself, on any of its ingredients or to both.