The Cosmetic Products (Safety) Regulations 1996

• Citation: S.I. 1996/2925
• Sections: 29

Section 1 Citation, commencement and revocation

(1) These Regulations may be cited as the Cosmetic Products (Safety) Regulations 1996 and except as provided by paragraphs (2) to (8) below shall come into force on 16th December 1996.

(2) Regulations 3(1)(b), 3(3), 4(4), 4(5), 6(1), 6(2)(h), 6(5)(a) (in so far as it relates only to regulation 6(2)(h)), 6(5)(b), 6(6), 6(7) and 6(9) to (12) shall come into force—

(a) on 1st January 1997 in relation to the supply of cosmetic products by the manufacturer in or importer into the United Kingdom or, in the case of cosmetic products manufactured or imported into the United Kingdom on behalf of another person, by that other person, except where the cosmetic products are supplied by retail in which case they shall come into force on 1st January 1998; and

(b) in all other cases on 1st January 1998.

(3) The following provisions shall come into force in accordance with paragraph (4) below—

(a) regulation 4(2)(a) and Schedule 1, in so far as they relate only to entry numbers 81, 92, 98, 113, 132, 154, 356, 462, 489, 557, 620 and 743 in that Schedule;

(b) regulations 4(2)(e)(ii), 4(2)(f) and 4(2)(g) and Part II of Schedule 4, in so far as they relate only to the deletion of entry number 15 in that Part; and

(c) regulations 4(2)(h)(i) and 4(2)(i) and Part I of Schedule 5, in so far as they relate only to entry number 10 in that Part.

(4) The provisions referred to in paragraph (3) above shall come into force—

(a) on 16th December 1996 in relation to the supply of cosmetic products by the manufacturer in or importer into the United Kingdom or, in the case of cosmetic products manufactured or imported into the United Kingdom on behalf of another person, by that other person, except where the cosmetic products are supplied by retail in which case they shall come into force on 1st July 1997; and

(b) in all other cases on 1st July 1997.

(5) The following provisions shall come into force in accordance with paragraph (6) below—

(a) regulation 4(2)(a) and Schedule 1, in so far as they relate only to entry numbers 342, 405 and 751 in that Schedule;

(b) regulation 4(2)(b) and Part I of Schedule 2, in so far as they relate only to entry numbers 15a, 15b and 15c in that Part;

(c) regulations 4(2)(e)(i) and 4(2)(f) and Part I of Schedule 4, in so far as they relate only to entry numbers 50, 51 and 52 in that Part;

(d) regulations 4(2)(e)(ii) and 4(2)(g) and Part II of Schedule 4, in so far as they relate only to the deletion of entry numbers 2 and 30 in that Part;

(e) regulations 4(2)(h)(i) and 4(2)(i) and Part I of Schedule 5, in so far as they relate only to entry number 11 in that Part; and

(f) regulations 4(2)(h)(ii) and 4(2)(i) and Part II of Schedule 5, in so far as they relate only to the deletion of entry numbers 33 and 34 in that Part.

(6) The provisions referred to in paragraph (5) above shall come into force—

(a) on 1st July 1997 in relation to the supply of cosmetic products by the manufacturer in or importer into the United Kingdom or, in the case of cosmetic products manufactured or imported into the United Kingdom on behalf of another person, by that other person, except where the cosmetic products are supplied by retail in which case they shall come into force on 1st July 1998; and

(b) in all other cases on 1st July 1998.

(7) Paragraph 6(41) of Schedule 8 shall come into force on 30th September 1997.

(8) Regulation 4(3) shall come into force on 1st January 1998.

(9) Subject to paragraph (10) below, the Regulations specified in Schedule 9 hereto are revoked with effect from 16th December 1996 provided that the Cosmetic Products (Safety) Regulations 1989 shall continue to apply to cosmetic products which are supplied before 16th December 1996.

(10) The notes in Part I of Schedule 2, Part II of Schedule 4 and Part II of Schedule 5 shall apply.

Section 2 Interpretation

(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;

“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 , as amended or substituted from time to time;

“the Community” means the European Economic Community and other States in the European Economic Area;

“the Confidentiality Directive” means Commission Directive 95/17/EC ;

“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 any part of the external surfaces of the human body (that is to say, the 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, protecting them, keeping them in good condition or correcting body odours except where such cleaning, perfuming, protecting, changing, keeping or correcting is wholly for the purpose of treating or preventing disease;

“cosmetic product intended to come into contact with the mucous membranes” means a cosmetic product intended to be applied in the vicinity of the eyes, on the lips, in the oral cavity or to the external genital organs, and does not include any cosmetic product which is intended to come into only brief contact with the skin;

“the Directive” means Council Directive 76/768/ EEC , as amended by Council Directive 82/368/EEC , Commission Directive 82/147/EEC , Commission Directive 83/191/EEC , Commission Directive 83/341/EEC , Council Directive 83/574/EEC , Commission Directive 83/496/EEC , Commission Directive 84/415/EEC , Commission Directive 85/391/EEC , Commission Directive 86/179/EEC , Commission Directive 86/199/EEC , Commission Directive 87/137/EEC , Commission Directive 88/233/EEC , Council Directive 88/667/EEC , Commission Directive 89/174/EEC , Council Directive 89/679/EEC , Commission Directive 90/121/EEC , Commission Directive 91/184/EEC , Commission Directive 92/8/EEC , Commission Directive 92/86/EEC , Commission Directive 93/47/EEC , Council Directive 93/35/EEC , Commission Directive 94/32/EC , Commission Directive 95/34/EC , and Commission Directive 96/41/EC ;

“ EEA Agreement” means the Agreement on the European Economic Area signed at Oporto on 2 May 1992 as adjusted by the Protocol signed at Brussels on 17 March 1993 ;

“market research experiment” means any activities conducted for the purpose of ascertaining the opinion of persons of—

any cosmetic product; or

anything in, on or with which the cosmetic product is supplied; or

the appearance or any other characteristic of the cosmetic product or any such thing; or

the name or description under which the cosmetic product is supplied;

but a cosmetic product is not the subject of a market research experiment unless—

any person to whom a cosmetic product is supplied in the course of the experiment is informed, at or before the time at which it is supplied to him, that it is supplied for the purpose of a market research experiment and

no consideration in money or money’s worth is given by such a person for the cosmetic product or any other cosmetic product supplied to him for comparison;

“member State” means a State which is a Contracting Party to the EEA Agreement;

“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;

“supply” includes offering to supply, agreeing to supply, exposing for supply and possessing for supply, and cognate expressions shall be construed accordingly; and

“ UV filter” means a substance which is added to a sunscreen cosmetic product for the primary purpose of filtering ultra violet rays for the purpose of protecting the epidermis of the user from harmful effects of such ultra violet rays.

(2) Unless the contrary intention appears, references in these Regulations to a numbered regulation or Schedule are references to the regulation or Schedule so numbered in these Regulations.

Section 3 General Requirements

(1) Subject to paragraph (2) below, no person shall supply 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 cosmetic product’s presentation, labelling, any instructions for its use and disposal and any other information or indication provided by the manufacturer, his agent or the person who supplies the cosmetic product on the first occasion that it is supplied in the Community.

(2) Paragraph (1) above shall apply only to the supply by the manufacturer in or importer into the United Kingdom or, in the case of cosmetic products manufactured or imported into the United Kingdom on behalf of another person, by that other person.

(3) The provision of any instructions, information or indication referred to in sub-paragraph (b) of paragraph (1) above shall not exempt any person from the obligation to comply with any other provisions of these Regulations which are applicable to him.

Section 4 Particular requirements

(1) The following provisions of this regulation are without prejudice to regulation 3 and are subject to regulation 5.

(2) No person shall supply a cosmetic product which contains—

(a) any substance listed in column 2 of Schedule 1, provided that no account shall be taken of any such substance which is present only as a trace which could not reasonably have been removed during or after manufacture;

(b) any substance listed in column 2 of Schedule 2, unless the requirements in columns 3, 4, 5 and (in the case of Part II) 7 of that Schedule in relation to that substance are satisfied;

(c) any colouring agent listed in columns 1 and 2 of Schedule 3 with the exception of cosmetic products containing colouring agents intended solely to colour hair unless—

(i) the requirements in columns 3 and 4 of Part I of that Schedule in relation to that colouring agent are satisfied; or

(ii) the requirements in columns 3 and 4 of Part II of that Schedule in relation to that colouring agent are satisfied and the cosmetic product in question was supplied on or before the date specified in column 5 of that Part;

(d) any colouring agent which is not listed in Schedule 3 with the exception of cosmetic products containing colouring agents intended solely to colour hair;

(e) any preservative listed in column 2 of Schedule 4 unless—

(i) the requirements in columns 3, 4 and 5 of Part I of that Schedule in relation to that preservative are satisfied; or

(ii) the requirements in columns 3, 4 and 5 of Part II of that Schedule in relation to that preservative are satisfied and the preservative in question is supplied on or before the date specified in column 7 of that Part;

(f) any preservative which is not listed in Schedule 4;

(g) any preservative listed in column 2 of Part II of Schedule 4 after the date specified in column 7 of that Part;

(h) any UV filter listed in column 2 of Schedule 5 unless—

(i) the requirements in columns 3 and 4 of Part I of that Schedule in relation to that UV filter are satisfied; or

(ii) the requirements in columns 3 and 4 of Part II of that Schedule in relation to that UV filter are satisfied and the UV filter in question is supplied on or before the date specified in column 6 of that Part;

(i) any UV filter which is not listed in Schedule 5.

(3) No person shall supply a cosmetic product which contains any ingredients or combinations of ingredients which are tested on animals where such testing takes place after 1st January 1998 and is undertaken in order that the cosmetic product may satisfy any requirements of these Regulations.

(4) Any reference to testing on animals in the labelling, putting up for sale or advertising of a cosmetic product must state clearly whether the tests carried out involved the cosmetic product itself or its ingredients.

(5) No person shall supply any cosmetic product in respect of which the requirements of paragraph (4) above are not satisfied.

Section 5 Authorisation by the Secretary of State

(1) The Secretary of State may authorise the use in a cosmetic product for a maximum period of three years of a particular substance, not being a substance listed in Schedule 1 or 2.

(2) In giving an authorisation the Secretary of State may impose conditions relating to the use of a particular substance in a cosmetic product, and such conditions may relate to any matter which the Secretary of State considers appropriate including—

(a) the purpose of the substance;

(b) the type of cosmetic product;

(c) the maximum concentration of the substance in any cosmetic product; and

(d) information and marking requirements.

(3) The Secretary of State may on reasonable notice vary or revoke any authorisation given under paragraph (1) above.

(4) On giving, varying or revoking an authorisation, the Secretary of State shall arrange for the authorisation, variation or revocation, as the case may be, to be published in such manner as he considers appropriate for bringing it to the attention of persons who, in his opinion, would be likely to have an interest in it.

(5) No person shall be convicted of an offence under section 12 of the Consumer Protection Act 1987 by reason of a cosmetic product’s containing a particular substance provided that at the time when but for this regulation an offence would have been committed—

(a) the use of that particular substance in that cosmetic product was duly authorised; and

(b) all of the conditions imposed by the authorisation were complied with.

Section 6 Marking

(1) Subject to paragraphs (5)(b) and (9) to (12) below, no person shall supply a cosmetic product unless the packaging in which it is supplied bears, in lettering which is visible, indelible and easily legible, a list of its cosmetic ingredients (preceded by the word “ingredients”) in descending order of weight, the weight to be determined at the time the ingredients are added to the product.

(2) Subject to paragraphs (3), (4), (5)(a), (6) to (8) and (13) to (16) below, no person shall supply a cosmetic product unless the container and packaging in which it is supplied bear the following particulars in lettering which is visible, indelible and easily legible—

(a) the name or trade name and the address or registered office of the manufacturer of the product or of the supplier thereof, being a manufacturer or supplier established within a member State of the Community;

(b) in the case of a cosmetic product likely within 30 months from the manufacture thereof to cease either to comply with the requirements of regulation 3 or to fulfil the purpose for which it was intended, the words “Best before . . .” immediately followed by

(i) the earliest date on which it is likely to so cease; or

(ii) an indication of where that date appears on the labelling

and any particular precautions to be observed to ensure that the product does not so cease before that date;

(c) in the case of a cosmetic product containing a substance listed in column 2 of Schedule 2, the information specified in column 6 of that Schedule in relation to that substance;

(d) in the case of a cosmetic product containing a preservative listed in column 2 of Schedule 4, the information specified in column 6 of that Schedule in relation to that preservative;

(e) in the case of a cosmetic product containing a UV filter listed in column 2 of Schedule 5, the information specified in column 5 of that Schedule in relation to that UV filter;

(f) any particular precautions to be observed in use and any special precautionary information on a cosmetic product for professional use, in particular in hairdressing (not being precautions included in the information referred to in sub-paragraphs (b), (c), (d) and (e) above);

(g) a means of identifying the batch in which the product was manufactured (or, if the product was not manufactured in a batch, a reference from which the date and place of manufacture can be identified); and

(h) the function of the product unless this is clear from its presentation:

Provided that the requirements specified in sub-paragraphs (b) and (g) above need not be complied with in relation to a cosmetic product which is the subject of a market research experiment.

(3) The particulars referred to in sub-paragraph (a) of paragraph (2) above may be abbreviated if such abbreviation does not prevent the person concerned from being identified.

(4) The date referred to in sub-paragraph (b) of paragraph (2) above shall include the month and the year, and the month shall precede the year.

(5) The particulars referred to—

(a) in sub-paragraphs (b) to (f) and (h) of paragraph (2) above shall be in English, but this shall not prohibit the additional use of other languages;

(b) in paragraph (1) above shall be in a language easily understood by the consumer.

(6) Where it is impossible for practical reasons for the particulars referred to in sub-paragraphs (c) to (f) of paragraph (2) above to appear on the container and packaging, they shall appear on a leaflet, label, tag, tape or card enclosed with the cosmetic product, to which the consumer is referred either by abbreviated information or by the symbol given in Schedule 6, which must appear on the container and packaging; and where it is impracticable for reasons of size or shape for the particulars so to appear, they shall appear on a label, tag, tape or card attached to the product.

(7) Where it is impossible, for reasons of size, for the particulars referred to in sub-paragraph (g) of paragraph (2) above to appear on the container and packaging, the said particulars shall appear on the packaging.

(8) In the case of a supply of soap which is not in a container, either the soap itself or the packaging in which it is exposed for supply or the container in which it was last contained before the supply shall bear the particulars referred to in sub-paragraphs (a) and (g) of paragraph (2) above, and in so far as any of the particulars referred to in sub-paragraphs (b) to (f) and (h) of paragraph (2) above are required they shall appear on a leaflet which shall be delivered to the buyer with the soap; and where either of the particulars referred to in sub-paragraphs (a) and (g) of paragraph (2) above appears on the soap itself the requirement of indelibility shall apply only until it has been put into use.

(9) In relation to the compilation of the list of ingredients referred to in paragraph (1) above—

(a) the following shall not be regarded as cosmetic ingredients—

(i) impurities in the raw materials used;

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

(iii) materials used in strictly necessary quantities as solvents or as carriers for perfumes 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 the colour index number or denomination found in Schedule 3;

(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; and

(f) an ingredient shall be identified by its common name as provided for in the common ingredients nomenclature or, in the absence of the nomenclature or of a common name, by its chemical name, its CTFA name, its European Pharmacopoeia name, its International Non-proprietary Name as recommended by the World Health Organisation, its EINECS , IUPAC or CAS identification reference or its colour index number .

(10) Subject to paragraph (11) below, where a cosmetic product has no packaging or it is impossible for practical reasons for the list of ingredients referred to in paragraph (1) above 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 supply or a notice displayed in immediate proximity to that container.

(11) Subject to paragraph (12) below, where it is impossible for practical reasons for the list of ingredients referred to in paragraph (1) above 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 Schedule 6, which must appear on the packaging; and where it is impracticable for reasons of size or shape for the list so to appear, it shall appear on a label, tag, tape or card attached to the cosmetic product.

(12) In the case of soap, bathballs 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.

(13) Where two or more cosmetic products are 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 sub-paragraphs (c) to (f) of paragraph (2) above shall appear on an enclosed leaflet and an indication shall appear on both the containers and on the packaging referring the consumer to the information in the leaflet.

(14) Where a cosmetic product other than soap is supplied or delivered pursuant to a supply in neither a container nor packaging, the particulars referred to in paragraph (2) above shall appear on the container in which the product is exposed for supply or a notice displayed in immediate proximity to that container.

(15) In the case of a cosmetic product supplied before paragraph (6) above has come into force, where it is impracticable by reason of the size or shape of the container or packaging (if any) for the particulars referred to in sub-paragraphs (c) to (f) of paragraph (2) above to appear on the container and packaging, or on one of them, the said particulars shall appear on an enclosed leaflet and an indication shall appear on both the container and the packaging (if any) referring the consumer to the information in that leaflet.

(16) Where, before paragraph (7) above has come into force, a cosmetic product is supplied or delivered pursuant to any supply in a container and packaging and it is impracticable, for reasons of size, for the particulars referred to in sub-paragraph (g) of paragraph (2) above to appear on the container, the said particulars shall appear on the packaging.

Section 7 Responsible Persons and Competent Authorities

(1) For the purposes of regulations 8, 9, 10 and 11—

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

(i) the manufacturer of that product;

(ii) the manufacturer’s agent;

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

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

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

(bb) the manufacturer’s agent is not the supplier of that cosmetic product,

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

(b) “competent authority” means a body responsible for requiring and receiving the information provided for in Articles 7.3, 7a.1 and 7a.4 of the Directive and granting and refusing requests for confidentiality pursuant to Article 4 of the Confidentiality Directive, and which is—

(i) a United Kingdom competent authority pursuant to paragraph (2) below; or

(ii) for the time being a competent authority of a member State other than the United Kingdom, having been notified as a competent authority by the member State concerned to the Commission pursuant to Articles 7.3 and 7a.5 of the Directive and Article 10 of the Confidentiality Directive.

(2) The United Kingdom competent authority shall be the Secretary of State provided that he may from time to time appoint such persons as he thinks fit to be a United Kingdom competent authority in addition to or in substitution for himself.

Section 8 Product Information

(1) Subject to paragraph (5) below, where a cosmetic product is manufactured or supplied in the United Kingdom a responsible person shall for control purposes keep readily accessible to a United Kingdom competent authority at the address or registered office specified on the container or packaging of the cosmetic product in accordance with regulation 6(2)(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 and reasonably foreseeable conditions of use it shall not endanger human health or safety;

(d) assessment of the safety for human health of 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 person or persons, qualified in accordance with paragraph (3) below, 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; and

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

(3) The person referred to in sub-paragraph (e) of paragraph (1) above must be a registered pharmacist within the meaning of the Pharmacy Act 1954 or a registered medical practitioner within the meaning of the Medical Act 1983 .

(4) Where the responsible person is the manufacturer or the person who first imports the cosmetic product into the Community he must possess appropriate experience or an appropriate level of professional qualification in accordance with the legislation and practice of the United Kingdom if it is the place of manufacture or first importation.

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

(6) Where the information referred to in paragraph (1) above is to be kept accessible to a United Kingdom competent authority it must be in English or a language readily understood by the said authority.

Section 9 Product Information

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

Section 10 Product Information

(1) A United Kingdom competent authority may, where difficulties are encountered in providing prompt and appropriate medical treatment, require that any holder of appropriate and adequate information on substances used in cosmetic products make such information available to it, where the difficulties referred to may be overcome or eased by the provision of the said information.

(2) Where the information referred to in paragraph (1) above is made available the United Kingdom competent authority shall ensure that it is used solely for the purposes of the treatment referred to in paragraph (1) above.

Section 11 Product Information

(1) Without prejudice to the provisions of regulations 3, 4, 8 and 10, a responsible person who for reasons of trade secrecy wishes not to include one or more cosmetic ingredients in the list of cosmetic ingredients referred to in regulation 6(1) above shall submit a request to that effect to the competent authority.

(2) In this regulation, “applicant” means a responsible person who submits a request for confidentiality.

(3) The applicant shall ensure that—

(a) the request for confidentiality includes the particulars laid down in Part I of Schedule 7; and

(b) any amendments to the particulars provided for in sub-paragraph (a) above are communicated as quickly as possible to the competent authority and, in particular, that all changes to the names of cosmetic products containing the cosmetic ingredient in respect of which confidentiality is or has been sought, are communicated to the competent authority at least 15 days before those cosmetic products are supplied under their new name.

(4) Within four months of the receipt of a request for confidentiality in respect of which the requirements of paragraph (3)(a) above are satisfied the competent authority shall examine the request and inform the applicant in writing of its decision.

(5) If the competent authority decides to grant its approval to the applicant’s request it shall, in notifying the applicant of its decision, in accordance with paragraph (4) above, also notify him of the registration number which will replace the cosmetic ingredient in question in the list referred to in regulation 6(1), the said number to be allocated to the product in accordance with the procedure provided for in Part II of Schedule 7.

(6) If the competent authority decides to refuse to grant its approval to the applicant’s request it shall, in its notification of this refusal, include a statement of the reasons for refusal and a clear explanation of appeals procedures and their time limits.

(7) In exceptional cases the competent authority may inform the applicant in writing that a period of two months in addition to the four month period referred to in paragraph (4) above is required for the examination of the request.

(8) Subject to paragraphs (9), (10), (11) and (12) below, a decision granting confidentiality shall be valid for a period of five years.

(9) An applicant may, by submitting a reasoned request to the competent authority, request that the period of confidentiality referred to in paragraph (8) above be extended.

(10) In the event of a reasoned request being submitted in accordance with paragraph (9) above, the competent authority shall deal with the request in accordance with paragraphs (4), (5) and (6) above.

(11) Any extension of the period of confidentiality shall not exceed three years.

(12) The competent authority may withdraw its approval to an applicant’s request for confidentiality if it considers this appropriate taking into account—

(a) any amendments to the particulars provided for in paragraph (3)(a) above which are communicated to it in accordance with paragraph (3)(b) above; and

(b) any new information which comes to its attention which makes it imperative, particularly for compelling reasons of public health, for it to so act,

and in withdrawing its approval the competent authority shall comply with the provisions of paragraphs (4), (6), and (7) above.

Section 12 Contravention of regulations 8, 9 and 10

(1) Subject to paragraph (2) below, any contravention of a requirement of regulation 8, 9 or 10 shall be treated for all purposes as though it were a contravention of a requirement of safety regulations made under section 11 of the Consumer Protection Act 1987 .

(2) The term of imprisonment to which a person guilty of an offence of contravening any requirement of regulation 8, 9 or 10 shall be liable on summary conviction shall not exceed three months.

Section 13 Enforcement

(1) No proceedings shall be brought and no enforcement action taken in respect of—

(a) any failure to comply with regulations 3, 4, 6, 7, 8, 9, 10 and 11 in any case in which the cosmetic product is supplied for the purposes of exporting that product to any country which is not a member State; or

(b) any failure to comply with regulation 6(5)(a) in any case in which the enforcement authority is satisfied that the person supplying the cosmetic product reasonably believes that it will not be used in the United Kingdom.

(2) No proceedings shall be brought and no enforcement action taken in respect of any failure to comply with regulations 4(4), 4(5), 6(1), 6(2)(h), 6(5)(a) (in so far as it relates only to regulation 6(2)(h)), 6(5)(b), 6(6), 6(7) or 6(9) to (12) in the case of—

(a) any supply of a cosmetic product before 31st December 1997 by the manufacturer in or importer into the United Kingdom or, in relation to a cosmetic product manufactured or imported into the United Kingdom on behalf of another person, by that other person, except for a supply by retail in which case no proceedings shall be brought and no enforcement action taken in respect of a supply before 31st December 1998; or

(b) any other supply of a cosmetic product before 31st December 1998, provided that, in the case of a failure to comply with regulation 6(6), the cosmetic product complies with the requirements of regulation 6(15) and, in the case of a failure to comply with regulation 6(7), the product complies with the requirements of regulation 6(16).

(3) For the purposes of this regulation, “enforcement action” means any action taken pursuant to or in connection with sections 13, 14, 16, 17, 28, 29, 30 or 31 of the Consumer Protection Act 1987.

Section 14 Enforcement

Any test of goods purchased under section 28 or seized under section 29 of the Consumer Protection Act 1987 (which relate to enforcement) by or on behalf of an enforcement authority for the purpose of ascertaining whether the provisions of these Regulations have been contravened shall in all cases be carried out in accordance with the provisions of paragraphs 2 to 5 of Schedule 8 and any test for which a method is specified in paragraph 6 of Schedule 8 shall be carried out in accordance with that method.

Section 1

The name or trade name and address or registered office of the applicant.

Section 1

The registration number referred to in regulation 11(5) shall consist of seven digits, the first two corresponding to the year of approval of confidentiality, the second two to the code assigned to each member State, as referred to in paragraph 2 below, and the final three digits assigned by the competent authority.

Section 2

Precise identification of the cosmetic ingredient for which confidentiality is requested, namely—

(a) where they exist, the CAS, EINECS and colour index numbers, the chemical name, the IUPAC name, the INCI name, the European Pharmacopoeia name, the International Non-proprietary Name as recommended by the World Health Organization and the common name as provided for in the common ingredients nomenclature;

(b) the Elincs name and the official number allocated to it if it has been notified pursuant to Council Directive 67/548/EEC 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, for example 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 compounds, such as solvents.

Section 2

The code allocated to the United Kingdom is 06.

Section 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 regulation 8(1)(d) and carried out in accordance with the requirements of regulations 8(2) and (3).

Section 4

The envisaged use of the cosmetic ingredient and in particular the different categories of cosmetic products in which it will be used.

Section 5

A detailed justification of why 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 supplied has not been described in the literature accompanying the cosmetic product 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.

Section 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 supplied.

(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.

Section 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.

Section 1

In this Schedule—

“Annex A” means the Annex to Commission Directive No. 80/1335/EEC as amended by Commission Directive No. 87/143/EEC ;

“Annex B” means the Annex to Commission Directive No. 82/434/EEC as amended by Commission Directive No. 90/207/EEC ;

“Annex C” means the Annex to Commission Directive No. 83/514/EEC ;

“Annex D” means the Annex to Commission Directive No. 85/490/EEC ;

“Annex E” means the Annex to Commission Directive No. 93/73/EEC ;

“Annex F” means the Annex to Commission Directive No. 95/32/EC ;

“Annex G” means the Annex to Commission Directive No. 96/45/EC ;

“purchase” means purchase for the purpose of carrying out a test.

Section 2

An enforcement authority intending to purchase a cosmetic product shall purchase a sufficient laboratory sample, as defined in paragraph 2.3 of Part I of Annex A, for the purpose of Annex A; and, for the purposes of the definition of “total sample” in paragraph 2.2 of Part I of Annex A, samples shall be regarded as having the same batch number if—

(a) the means of identifying the batch referred to in regulation 6(2)(g) above shows that they were manufactured in the same batch; or

(b) in the case of a product not manufactured in a batch, the reference referred to in regulation 6(2)(g) above shows that they are derived from the same unit of production; or

(c) in the case of a product which does not comply with the requirements of regulation 6(2)(g) above, the officer effecting the purchase has reasonable cause to believe that they were manufactured in the same batch or are derived from the same unit of production, as the case may be.

Section 3

The immediate container, if any, of a cosmetic product purchased by an enforcement authority shall not have been opened by, on behalf of or at the request of the enforcement authority before the purchase takes place and the container shall not thereafter be opened except in accordance with paragraph 5.3 of Part I of Annex A and paragraph 1.2 of Part II of Annex A.

Section 4

As soon as an enforcement authority has purchased a cosmetic product, the officer effecting the purchase shall—

(a) either—

(i) place a seal on the product’s container or outer packaging, or

(ii) place the product in a container and forthwith place a seal on that container, in such a way that the product’s immediate container cannot be opened or (in the case of a product which was not in a container when it was purchased) the product cannot be touched without (in either case) the seal being broken in such a manner that it would be apparent thereafter that it had been broken, and

(b) attach to the product a label indicating—

(i) the name of the product,

(ii) the date, time and place at which the product was purchased,

(iii) his own name, and

(iv) the name of the enforcement authority making the purchase.

Section 5

(1) Subject to sub-paragraph (2) below, the provisions of Part I of Annex A, other than paragraphs 3.1, 3.2 and 4, and of Part II of Annex A, other than paragraph 1.4, shall be complied with in the sampling of cosmetic products and the laboratory preparation of test portions.

(2) Where, because of the way in which a cosmetic product is put up for sale, it is not practicable for Part II of Annex A to be complied with, it shall be prepared for testing in accordance with good analytical practice, and the person so preparing it shall record in writing the method of preparation which he has used.

Section 6

(1) Any test to determine whether a cosmetic product contains a significant amount of free sodium hydroxide or free potassium hydroxide shall be carried out in accordance with paragraphs 1 to 4 of Part III of Annex A.

(2) Any test to determine the amount of free sodium hydroxide or free potassium hydroxide in a hair straightener product or a nail cuticle solvent product shall be carried out in accordance with paragraphs 1, 2, 3 and 5 of Part III of Annex A.

(3) Any test to determine whether a hair-care product contains oxalic acid or any alkaline salt of oxalic acid or to determine the amount of such a substance in a hair-care product shall, subject to the limitation specified in the second sentence of paragraph 1 of Part IV of Annex A, be carried out in accordance with the said Part IV.

(4) Any test to determine the amount of chloroform in toothpaste shall, subject to the limitation specified in the second sentence of paragraph 1 of Part V of Annex A, be carried out in accordance with the said Part V.

(5) Any test to determine the amount of zinc chloride, zinc sulphate or zinc 4-hydroxybenzenesulphonate by virtue of their zinc contents in a cosmetic product shall be carried out in accordance with Part VI of Annex A and Commission Directive 87/143/EEC , and shall take into account paragraph 11 of Part VII of Annex A.

(6) Any test to determine whether a cosmetic product contained in an aerosol dispenser or a cream, emulsion, lotion, gel or oil intended to be applied to the skin contains 4-hydroxybenzenesulphonic acid, or to determine the amount of that acid in such a product, shall be carried out in accordance with Part VII of Annex A.

(7) Any test to determine whether a hair-care product contains persulphate, bromate or hydrogen peroxide shall be carried out in accordance with Part A of Part I of Annex B.

(8) Any test to determine whether a hair-care product contains barium peroxide shall be carried out in accordance with Part B of Part I of Annex B.

(9) Any test to determine the amount of hydrogen peroxide in a hair-care product shall be carried out in accordance with Part C of Part I of Annex B.

(10) Any test to determine whether a hair-dye contains any of the oxidation colourants specified in paragraph 1 of Part II of Annex B, or to determine the amount of such a substance in a hair-dye, shall be carried out in accordance with the said Part II.

(11) Any test to determine whether a cosmetic product contains nitrite, or to determine the amount of that substance in a cosmetic product, shall be carried out in accordance with Part III of Annex B.

(12) Any test to determine whether a cosmetic product contains free formaldehyde, or to determine the amount of that substance in a cosmetic product, shall be carried out in accordance with Part IV of Annex B.

(13) Any test to determine the amount of resorcinol in a shampoo or hair lotion shall, subject to the limitation specified in the second sentence of paragraph 1 of Part V of Annex B, be carried out in accordance with the said Part V.

(14) Any test to determine the amount of methanol in relation to ethanol or propan-2-ol in a cosmetic product shall be carried out in accordance with Part VI of Annex B.

(15) Any test to determine the amount of dichloromethane or 1,1,1-trichloroethane in a cosmetic product shall be carried out in accordance with paragraphs 1 to 10 of that part of Annex C which is headed “Determination of dichloromethane and 1,1,1-trichloroethane”.

(16) Any test to determine whether a cosmetic product contains quinolin-8-ol or bis(8-hydroxyquinolinium) sulphate, or to determine the amount of such a substance in a cosmetic product, shall be carried out in accordance with paragraphs 1 to 9 of that part of Annex C which is headed “Identification and determination of quinolin-8-ol and bis(8-hydroxyquinolinium) sulphate”.

(17) Any test to determine the amount of ammonia in a cosmetic product shall be carried out in accordance with paragraphs 1 to 8 of that part of Annex C which is headed “Determination of ammonia”.

(18) Any test to determine whether a cosmetic product contains nitromethane, or to determine the amount of that substance in a cosmetic product, shall be carried out in accordance with paragraphs 1 to 7 of that part of Annex C which is headed “Identification and determination of nitromethane”.

(19) Any test to determine whether a hair waving, hair straightening or depilatory product contains mercaptoacetic acid (thioglycolic acid), or to determine the amount of that substance in such a product, shall be carried out in accordance with paragraphs 1 to 6 of that part of Annex C which is headed “Identification and determination of mercaptoacetic acid in hair-waving, hair-straightening and depilatory products”.

(20) Any test to determine whether a cosmetic product contains hexachlorophene (INN) shall be carried out in accordance with paragraphs 1 to 7 of Part A of that part of Annex C which is headed “Identification and determination of hexachlorophene”.

(21) Any test to determine the amount of hexachlorophene (INN) in a cosmetic product shall be carried out in accordance with paragraphs 1 to 9 of Part B of that part of Annex C which is headed “Identification and determination of hexachlorophene”.

(22) Any test to determine the amount of tosylchloramide sodium (INN) in a cosmetic product shall be carried out in accordance with paragraphs 1 to 9 of that part of Annex C which is headed “Quantitative determination of tosylchloramide sodium (INN) (chloramine-T)”.

(23) Any test to determine the total amount of fluorine in dental creams shall be carried out in accordance with paragraphs 1 to 8 of that part of Annex C which is headed “Determination of total fluorine in dental creams”.

(24) Any test to determine whether a cosmetic product contains organomercury compounds shall be carried out in accordance with paragraphs 1 to 4 of Part A of that part of Annex C which is headed “Identification and determination of organomercury compounds”.

(25) Any test to determine the amount of organomercury compounds in a cosmetic product shall be carried out in accordance with paragraphs 1 to 7 of Part B of that part of Annex C which is headed “Identification and determination of organomercury compounds”.

(26) Any test to determine the amount of alkali sulphides or alkaline earth sulphides in a cosmetic product shall be carried out in accordance with paragraphs 1 to 8 of that part of Annex C which is headed “Determination of alkali and alkaline earth sulphides”.

(27) Any test for the identification and determination of the amount of glycerol 1-(4-aminobenzoate) in a cosmetic product shall be carried out in accordance with that part of Annex D which is headed “Identification and determination of glycerol 1-(4-aminobenzoate)”.

(28) Any test to determine the amount of chlorobutanol (INN) in a cosmetic product shall be carried out in accordance with that part of Annex D which is headed “Determination of chlorobutanol”.

(29) Any test for the identification and determination of the amount of quinine in a cosmetic product shall be carried out in accordance with that part of Annex D which is headed “Identification and determination of quinine”.

(30) Any test for the identification and determination of inorganic sulphites and hydrogen sulphites in a cosmetic product shall be carried out in accordance with that part of Annex D which is headed “Identification and determination of inorganic sulphites and hydrogen sulphites”.

(31) Any test for the identification and determination of chlorates of the alkali metals in a cosmetic product shall be carried out in accordance with that part of Annex D which is headed “Identification and determination of chlorates of the alkali metals”.

(32) Any test for the identification and determination of sodium iodate in a cosmetic product shall be carried out in accordance with that part of Annex D which is headed “Identification and determination of sodium iodate”.

(33) Any test for the identification and determination of silver nitrate in a cosmetic product shall be carried out in accordance with that part of Annex E which is headed “Identification and determination of silver nitrate in cosmetic products”.

(34) Any test for the identification and determination of selenium disulphide in anti-dandruff shampoos shall be carried out in accordance with that part of Annex E which is headed “Identification and determination of selenium disulphide in anti-dandruff shampoos”.

(35) Any test for the determination of soluble barium and soluble strontium in pigments in the form of salts or lakes shall be carried out in accordance with that part of Annex E which is headed “Determination of soluble barium and strontium in pigments in the form of salts or lakes”.

(36) Any test for the identification and determination of benzyl alcohol in a cosmetic product shall be carried out in accordance with that part of Annex E which is headed “Identification and determination of benzyl alcohol in cosmetic products”.

(37) Any test for the identification of zirconium and the determination of zirconium, aluminium and chlorine in non-aerosol anti-perspirants shall be carried out in accordance with that part of Annex E which is headed “Identification of zirconium, and determination of zirconium, aluminium and chlorine in non-aerosol anti-perspirants”.

(38) Any test for the identification and determination of hexamidine, dibromohexamidine, dibromopropamidine and chlorhexidine in a cosmetic product shall be carried out in accordance with that part of Annex E which is headed “Identification and determination of hexamidine, dibromohexamidine, dibromopropamidine and chlorhexidine”.

(39) Any test for the identification and determination of benzoic acid, 4-hydroxybenzoic acid, sorbic acid, salicylic acid and propionic acid in a cosmetic product shall be carried out in accordance with that part of Annex F which is headed “Identification and determination of benzoic acid, 4-hydroxybenzoic acid, sorbic acid, salicylic acid and propionic acid in cosmetic products”.

(40) Any test for the identification and determination of hydroquinone, hydroquinone monomethylether, hydroquinone monoethylether and hydroquinone monobenzylether (monobenzone) in a cosmetic product shall be carried out in accordance with that part of Annex F which is headed “Identification and determination of hydroquinone, hydroquinone monomethylether, hydroquinone monoethylether and hydroquinone monobenzylether in cosmetic products”.

(41) Any test for the identification and determination of 2-phenoxyethanol, 1-phenoxypropan-2-ol, and methyl, ethyl, propyl, butyl and benzyl 4-hydroxybenzoate in a cosmetic product shall be carried out in accordance with Annex G.