European Union (Cosmetic Products) Regulations 2013.
Statutory Instruments
Source: Statutory Instruments

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paragraphs: These Regulations may be cited as the European Union (Cosmetic Products) Regulations 2013.
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paragraphs: (1) In these Regulations—
(a) a Deputy Public Analyst located at a Public Analyst’s Laboratory,
(b) an Executive Analytical Chemist located at a Public Analyst’s Laboratory,
(c) a Public Analyst located at a Public Analyst’s Laboratory,
(d) a chemist or analyst appointed by the Board;
(a) a person appointed under Regulation 9,
(b) a person who was appointed under Regulation 19(1) of the European Communities (Cosmetic Products) Regulations 2004 ( S.I. No. 870 of 2004 ), until such time as the said appointment is revoked by a relevant person, or
(c) an officer of Customs and Excise;
(a) Public Analyst’s Laboratory, Cork,
(b) Public Analyst’s Laboratory, Dublin,
(c) Public Analyst’s Laboratory, Galway, or
(d) a laboratory designated by the Board;
(a) a disc, tape, sound-track or other device in which information, sounds or signals are embodied so as to be capable, with or without the aid or some other instrument, of being reproduced in legible or audible form,
(b) a film, tape or other device in which visual images are embodied so as to be capable, with or without the aid or some other instrument, of being reproduced in visual form, and
(c) a photograph,
(i) in the case of a record to which paragraph (a) of this definition applies, a transcript of the sounds or signals embodied therein,
(ii) in the case of a record to which paragraph (b) of this definition applies, a still reproduction of the images embodied therein, and
(iii) in the case of a record to which paragraphs (a) and (b) of this definition apply, such a transcript together with such a still reproduction;
(a) the chief executive of the Board, or
(b) the director general of the Health Service Executive;
(a) any cosmetic product, or
(b) any article or substance used in the manufacture, processing, packaging, labelling, preparation, storage or distribution of any cosmetic product;
(2) A word or expression which is used in these Regulations and which is also used in the EU Regulation has, unless the context otherwise requires, the same meaning in these Regulations as it has in the EU Regulation.
PART 2
GENERAL PROVISIONS
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paragraphs: (1) The national competent authority for the purposes of the EU Regulation shall be the Board.
(2) The functions of the national competent authority specified in Article 5(2), Article 5(3), Article 6(3), Article 6(5), Article 7, Article 11(3), Article 13(5), Article 23(5), the second paragraph of Article 24, Article 25(1), the first paragraph of Article 25(5), Article 26, Article 27(1) and Article 38 of the EU Regulation may also be performed by the Health Service Executive in accordance with these Regulations.
(3) The Board and the Health Service Executive shall perform market surveillance functions for the purposes of Article 22 of the EU Regulation.
(4) The functions of the State referred to in Article 10(2), Article 20(2), the first, second and fourth paragraphs of Article 22, and Article 35 of the EU Regulation shall be performed by the Board.
(5) The functions of the State referred to in the first paragraph of Article 22 of the EU Regulation may also be performed by the Health Service Executive.
(6) The Board may charge fees for its functions under the EU Regulation in accordance with regulations made under section 13(1) of the Act, read in conjunction with section 4(1)(v) of the Act.
(7) The Board and the Health Service Executive shall agree and submit to the Minister a memorandum of understanding regarding the implementation of the EU Regulation and shall update that memorandum of understanding from time to time.
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paragraphs: (1) For the purposes of compliance with the fourth paragraph of Article 22 of the EU Regulation, the Board shall, with the cooperation of the Health Service Executive, carry out a review and assessment of the functioning of market surveillance activities at least every four years.
(2) The Board shall provide a copy of the results of the review and assessment referred to in paragraph (1) to—
(a) the Commission,
(b) the other Member States of the European Economic Area,
(c) the Minister, and
(d) the Health Service Executive.
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paragraphs: For the purposes of the EU Regulation, Beaumont Hospital, Dublin, is the poisons centre in the State.
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paragraphs: In carrying out its function, under Article 10(2) of the EU Regulation, of assessing whether persons carrying out a cosmetic product safety assessment, are in possession of evidence of formal qualifications awarded on completion of a course equivalent to one of the courses referred to in that provision, the Board shall assess the evidence on a case by case basis, having regard to the course content and the experience of the person concerned.
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paragraphs: (1) Subject to paragraphs (2) and (3), in the case of cosmetic products that are not pre-packaged, are packaged at the point of sale at the purchaser’s request, or are pre-packaged for immediate sale, the information set out in Article 19(1) of the EU Regulation shall appear on the container in which the product is exposed for sale or supply.
(2) In the case of cosmetic products to which paragraph (1) applies, where it is impractical to display the information set out in Article 19(1) of the EU Regulation in the manner provided for in paragraph (1), the information shall—
(a) be mentioned on an enclosed or attached leaflet, label, tape, tag or card, and
(b) unless impracticable, be referred to by abbreviated information, or the symbol given in point 1 of Annex VII to the EU Regulation, on the container in which the product is exposed for sale or supply.
(3) In the case of cosmetic products to which paragraph (1) applies, where it is impractical to display the information set out in Article 19(1) of the EU Regulation in the manner provided for in paragraph (1) or (2), the information shall appear on a notice in immediate proximity to the container in which the cosmetic product is exposed for sale.
(4) Subject to Article 19(6) of the EU Regulation, any information required to be displayed in connection with a cosmetic product, whether under this Regulation or under Article 19 of the EU Regulation, shall be in the English language or in both the English language and the Irish language.
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paragraphs: For the purposes of Articles 5(3), 6(5) and 11(3), the language which can be easily understood by the Board or the Health Service Executive shall be the English language or both the Irish language and the English language.
PART 3
COMPLIANCE AND ENFORCEMENT
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paragraphs: (1) For the purposes of ensuring compliance with the EU Regulation and these Regulations, a relevant person—
(a) may appoint such and so many persons as he or she thinks fit to be authorised officers for the purposes of these Regulations, and
(b) shall furnish each authorised officer appointed by him or her with a warrant of the authorised officer’s appointment.
(2) An authorised officer, other than an authorised officer who is an officer of Customs and Excise, shall, when performing a function imposed under these Regulations on an authorised officer, produce his or her warrant for inspection if requested to do so by a person affected by the performance of that function.
(3) For the purposes of ensuring compliance with the EU Regulation, an authorised officer may—
(a) subject to paragraph (5), enter (if necessary by the use of reasonable force), at all reasonable times, any premises at which he or she has reasonable grounds for believing that—
(i) any trade, business or activity connected with the manufacture, processing, disposal, export, import, distribution, sale, supply, storage, packaging, labelling or preparation of any relevant thing is or has been carried on, or
(ii) books, records or other documents (including documents stored in non-legible form) relating to such trade, business or activity are kept,
(b) at such premises inspect and take copies of, any books, records, other documents (including documents stored in non-legible form) or extracts therefrom, which he or she finds in the course of his or her inspection,
(c) remove any such books, records or other documents from such premises and detain them for such period as he or she reasonably considers to be necessary for the purposes of his or her functions under these Regulations,
(d) carry out, or have carried out, such tests, examinations, analyses, inspections and checks of—
(i) the premises,
(ii) any relevant thing at the premises, or
(iii) any equipment, machinery or plant at the premises,
(e) require any person at the premises or the owner or person in charge of the premises and any person employed there to give to him or her such assistance and information and to produce to him or her such books, records or other documents (and in the case of documents or records stored in non-legible form, produce to him or her a legible reproduction thereof) that are in that person’s power or procurement, as he or she may reasonably require for the purposes of his or her functions under these Regulations,
(f) purchase or take without payment a sample of any relevant thing found at the premises for the purposes of any test, examination or analysis,
(g) direct that such relevant thing found at the premises as he or she, upon reasonable grounds, believes contravenes a provision of these Regulations not be sold or distributed or moved from the premises, without his or her consent,
(h) secure for later inspection any premises or part of any premises in which a relevant thing is found or ordinarily kept, or books, records or other documents are found or ordinarily kept, for such period as may reasonably be necessary for the purposes of his or her functions under these Regulations,
(i) without payment, take possession of and remove from the premises for any test, examination or analysis any relevant thing found there, and detain it for such period as he or she considers reasonably necessary for the purposes of his or her functions under these Regulations,
(j) without payment, take samples of any relevant thing, detained pursuant to subparagraph (i), for the purposes of any test, examination, or analysis,
(k) where the taking of samples of any relevant thing pursuant to subparagraph (f) or (j) is, for whatever reason, not practicable, purchase or take without payment the relevant thing concerned for the purposes of any test, examination or analysis,
(l) stop any person, vehicle, vessel or container at the premises,
(m) board and search any such vehicle, vessel or container,
(n) require the name and address of any person at the premises, including the person to whom a relevant thing is being delivered or who is causing it to be delivered,
(o) make a record whether in writing, by photography or otherwise,
(p) inspect and copy or extract information from any data within the meaning of the Data Protection Acts 1988 and 2003,
(q) require a person, having authority to do so, to break open any container, receptacle or package, or to open any vending machine, or to permit him or her to do so, as he or she may reasonably require for the purposes of his or her functions under these Regulations, or
(r) require a person, who makes available facilities such as post office boxes, telecommunications or electronic mail addresses or other like facilities, to give him or her such assistance and information as he or she may reasonably require for the purposes of his or her functions under these Regulations in any case where the officer has reasonable grounds for believing that any relevant thing is being supplied by mail.
(4) When performing a function under these Regulations, an authorised officer may, subject to any warrant under paragraph (6), be accompanied by such number of—
(a) other authorised officers,
(b) members of An Garda SÃ­ochÃ¡na, or
(c) persons with expertise relating to any relevant thing,
(5) An authorised officer shall not enter a dwelling, other than—
(a) with the consent of the occupier, or
(b) in accordance with a warrant issued under paragraph (6).
(6) Upon the application of an authorised officer, a judge of the District Court, if satisfied that there are reasonable grounds for believing that—
(a) a relevant thing is to be found in any dwelling, or is being or has been subjected to any process or stored in any dwelling,
(b) a dwelling is occupied in whole or in part by an undertaking engaged in any trade, business or activity referred to in paragraph (3)(a)(i), or
(c) books, records or other documents (including documents stored in non-legible form) referred to in paragraph (3)(a)(ii) are being stored or kept in any dwelling,
(7) Where an authorised officer, upon reasonable grounds, believes that a person has committed an offence under these Regulations, he or she may require that person to provide him or her with his or her name, date of birth, and the address at which he or she ordinarily resides, and to produce corroborative evidence of same.
(8) Where an authorised officer has reasonable cause to suspect that—
(a) an offence is being or has been committed under these Regulations, or
(b) evidence of an offence or contravention may be, is or has been on or in any premises,
(i) search a person, where the authorised officer considers it necessary,
(ii) seize and detain a vessel, vehicle, container, equipment, machinery or relevant thing, or
(iii) dispose of a relevant thing, or require the owner or person in charge of or in possession of a relevant thing to deal with or dispose of it (or any other thing used in connection with, or that may have been in contact with, the relevant thing) in a manner that the authorised officer thinks fit.
(9) An authorised officer may dispose of, or cause to be disposed, a relevant thing, or a sample of a relevant thing, taken under this Regulation, in such manner and at such place as the authorised officer considers appropriate in the circumstances of the case.
(10) The costs (including ancillary costs) of any seizure, detention or disposal carried out by the Board or by the Health Service Executive under paragraph (8) or (9) shall be recoverable as a simple contract debt in any court of competent jurisdiction from the manufacturer, responsible person or distributor.
(11) A statement or admission made by a person pursuant to a requirement under paragraph (3) shall not be admissible as evidence in proceedings brought against that person for an offence (other than an offence under Regulation 18(3)(p), (q) or (r)).
(12) Nothing in this Regulation shall be taken to compel the production by any person of a document which he or she would be exempt from producing in proceedings in a court on the ground of legal professional privilege.
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paragraphs: (1) Subject to paragraph (3), where an authorised officer purchases or takes without payment a sample of a relevant thing pursuant to Regulation 9(3)(f) or (j), he or she may—
(a) divide the sample into 3 approximately equal parts,
(b) place each part into separate containers, and
(c) forthwith seal and mark each such container in such a manner as to identify it as part of the sample taken by that authorised officer.
(2) Where an authorised officer has divided, sealed and marked a sample of a relevant thing in accordance with paragraph (1), he or she shall—
(a) offer one of the sealed containers to the owner or person for the time being in charge or possession of the relevant thing from which the sample concerned was taken,
(b) retain one of the sealed containers, and
(c) forward, or cause to be forwarded, one of the sealed containers for test, examination or analysis of the sample concerned by an approved examiner in an official laboratory or where appropriate for examination by the Board.
(3) Where a relevant thing is contained in a container and its division into parts pursuant to paragraph (1) is, for whatever reason, not practicable, an authorised officer, who wishes to take samples of such relevant things for the purposes of any tests, examination or analysis may take possession of 3 such containers belonging to the same batch, and each such container shall be deemed to be part of a sample for the purposes of paragraph (1), and the provisions of paragraphs (1) and (2) shall apply thereto accordingly.
(4) Where an authorised officer purchases or takes without payment a relevant thing pursuant to Regulation 9(3)(k), he or she may—
(a) place the relevant thing in a container,
(b) forthwith seal and mark the container in such a manner as to identify it as a relevant thing taken pursuant to that subparagraph, and
(c) forward, or cause to be forwarded, the sealed container for test, examination or analysis of the relevant thing by an approved examiner.
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paragraphs: (1) The official testing of cosmetic products by, or under the direction of, an approved examiner shall be carried out in accordance with Article 12 of the EU Regulation insofar as the methods referred to in that Article are applicable.