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I, Heather Humphreys, Minister for Business, Enterprise and Innovation, in the exercise of the powers co
nferred on me by section 3 of the European Communities Act, 1972 , (No. 27 of 1972), and for the purpose of giving effect to Directive 2004/9/EC1 and Directive 2004/10/EC2 , both of the European Parliament and of the Council of 11 February 2004, hereby make the following Regulations:
1. These Regulations may be cited as the European Communities (Good Laboratory Practice) Regulations, 2020.
2. In these Regulations
Accreditation Board means the Irish Natio
nal Accreditation Board, a committee of the Authority under section 56A (1) of the Act of 2005, (inserted by section 32 of the Industrial Development (Forfs Dissolution) Act 2014 (Number 13 of 2014));Act of 2005 means the Safety, Health and Welfare at Work Act 2005 (No. 10 of 2005);authorised person means an officer of the Accreditation Board or other person authorised in writing by the Manager of the Accreditation Board on behalf of the Authority to exercise for the purpose of these Regulations, Directive 2004/10/EC and Directive 2004/9/EC, the powers co
nferred on an authorised person by these Regulations;Authority means the Health and Safety Authority;Directive 2004/9/EC means Directive 2004/9/EC of the European Parliament and of the Council of 11 February 2004 on the inspection and verification of good laboratory practice (GLP) (codified version);Directive 2004/10/EC means Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmo
nisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances (codified version);Manager of the Accreditation Board shall be co
nstrued in accordance with section 56A (6) of the Act of 2005;The Minister means the Minister for Business, Enterprise and Innovation;the principles of good laboratory practice means the principles of good laboratory practice laid down in Annex I to Directive 2004/10/EC.
3. (1) Laboratories carrying out tests and/or studies on chemical products in accordance with Regulation (EC) No 1272/20083 or any other Community provision shall comply with the principles of good laboratory practice.
(2) In paragraph (1) of this Regulation any other Community provision means any other Community provision providing for the application of the principles of good laboratory practice in respect of tests and/or studies on chemical products to e
valuate their safety for humans or the enviro
nment or both.
(3) If the Accreditation Board has reaso
nable grounds for believing that there is a co
ntravention of this Regulation by a laboratory it may serve a notice on the owner and/or person in charge of the laboratory (referred to in these Regulations as a Regulation 3 warning notice):
(i) identifying the alleged contravention;(ii) specifying the measures required to correct the alleged contravention; and(iii) requiring the owner and/or person in charge of the laboratory to take those measures or measures which are at least equivalent to them, within such period as may be specified in the warning notice.
(4) Service of a Regulation 3 warning notice shall be effected in accordance with section 3 of the Act of 2005.
(5) Any owner and/or person in charge of a laboratory who fails to comply with a Regulation 3 warning notice shall be guilty of an offence.
4. (1) Wher
e a laboratory has carried out a test and/or study in accordance with Regulation 3 of these Regulations, it shall give co
nfirmation in writing to the person who commissio
ned the test and/or study and to the Accreditation Board stating that the test and/or study has been carried out in co
nformity with the principles of good laboratory practice.
(2) Wher
e a laboratory fails to give the co
nfirmation referred to in paragraph (1) of this Regulation, the Accreditation Board may serve upon the owner and/or person in charge of the laboratory a notice (referred to in these Regulations as a Regulation 4 warning notice) requiring the laboratory to give such co
nfirmation within such period as may be specified within the notice.
(3) Service of a Regulation 4 warning notice shall be effected in accordance with section 3 of the Act of 2005.
(4) Wher
e a laboratory fails to comply with a Regulation 4 warning notice, the owner and/or person in charge of the laboratory shall be guilty of an offence.
(5) Wher
e a laboratory gives co
nfirmation in purported compliance with paragraph 1 of this Regulation that is false or misleading in a material particular, the owner and/or the person in charge of the laboratory shall be guilty of an offence.
(6) Wher
e a laboratory gives co
nfirmation in purported compliance with paragraph (1) of this Regulation that is false or misleading with the intention that it shall be used to induce the regulatory authority of any EU member state charged with the oversight and enforcement of good laboratory practice to accept the co
nfirmation as evidence of compliance with good laboratory practice by the laboratory the owner and/or the person in charge of the laboratory shall be guilty of an offence.
5. (1) For the purpose of assessing compliance with Regulations 3 and 4 of these Regulations, the Accreditation Board shall have the right to and shall inspect laboratories and audit tests and/or studies carried out by laboratories.
(2) The inspections and audits shall be carried out in accordance with the provisions of Annex I to Directive 2004/9/EC and shall be directed to the inspection and verification of the organisatio
nal processes and the co
nditions under which laboratory tests and/or studies are planned, performed, recorded and reported for the non-clinical testing and/or studying, carried out in accordance with the rules and regulations, of all chemicals (e.g. cosmetics, industrial chemicals, medicinal products, food and animal feed additives, pesticides) in order to assess the effect of such products on humans, animals and the environment.
(3) The Accreditation Board may, for the purposes of its functions under these Regulations, request a laboratory to furnish it with a copy of any report, docu
ment, data or recor
d (in whatever form held) of the laboratory of, or in co
nnection with, any test and/or study made by the laboratory in relation to a chemical substance, and the laboratory shall furnish the requested report, docu
ment, data or record within such time f
rame as the Accreditation Board may specify or, in the absence of a specified time f
rame, within a reaso
nable period of time from the making of the request.
(4) The Accreditation Board shall communicate to the laboratory co
ncerned the results of any inspection or audits of tests and/or studies referred to in paragraph (1) of this Regulation and, in making any decision co
nsequent upon those results, the Accreditation Board shall take into account any representations made to it by the laboratory in relation to the results not later than 28 days after the day on which they were communicated to the laboratory.
(5) (a) The Authority, acting on behalf of the Accreditation Board may, in respect of an inspection of a laboratory or of an audit of a test and/or study carried out by a laboratory, charge the laboratory, and the laboratory shall pay to the Authority, a fee of such amount as the Accreditation Board co
nsiders to be equal to the amount of the costs incurred by it in relation to the inspection(b) The fee shall be so charged in accordance with the provisions of section 47 of the Act of 2005 (amended by section 33 of the Industrial Development (Forfs Dissolution) Act 2014), and is payable to the Authority in accordance with the terms and co
nditions of the invoice issued by the Authority.
(c) Fees referred to in subparagraph (a) and (b) are payable in accordance with any terms or co
nditions stated on the invoice issued by the Authority.
(d) A fee payable to the Authority, acting on behalf of the Accreditation Board, under this Regulation may be recovered by it from the laboratory co
ncerned as a simple co
ntract debt in any court of competent jurisdiction.
(6) If a laboratory:
(a) obstructs, impedes or fails to co-operate with the Accreditation Board in the exercise by the Accreditation Board of any right co
nferred upon the Accreditation Board by this Regulation;(b) fails or refuses to comply with a request under paragraph (3) of this Regulation; and/or(c) knowingly or recklessly furnishes the Accreditation Board with information which is false or misleading in a material particular,the owner and/or the person in charge of the laboratory shall be guilty of an offence.
6. (1) An authorised person may, for the purposes of these Regulations, on production, if so requested by any person affected, of his/her authorisation(a) enter any premises which s/he reaso
nably believes to be a laboratory in which tests and/or studies referred to in Regulation 3 of these Regulations are carried out;(b) carry out on the premises or elsewher
e such inspections, examinations, tests and analyses (including the inspections and study checks referred to in Articles I and III of Directive 2004/10/EC) as s/he co
nsiders necessary;(c) request the production of, inspect and take copies of, or of extracts from, any docu
mentation or records, either electro
nic or hard copy, found on the premises;(d) take, without payment, samples of any substances found on the premises; and/or(e) request any person found on the premises to furnish them with such information as they may reaso
nably require for the purposes of these Regulations.
(2) A person who obstructs or impedes an authorised person in the exercise of a power or, without reaso
nable excuse, does not comply with a request under this Regulation or who, in purported compliance with such a request, gives information to an authorised person that he knows to be false or misleading in a material particular, shall be guilty of an offence.
7. (1) A person who has gained access to commercially sensitive or other co
nfidential information by virtue of these Regulations shall not disclose the information to a person (other than the Commission of the European Communities or the Accreditation Board) unless it is necessary to do so for the purpose of the enforcement of these Regulations.
(2) A person who co
ntravenes this Regulation shall be guilty of an offence.
8. It shall be a defence for a person charged with an offence under any of the preceding provisions of these Regulations to prove that s/he took all reaso
nable precautions and exercised all due diligence to avoid the commission of an offence.
9. (1) A person guilty of an offence under these Regulations shall be liable on summary co
nviction to a Class A fine or impriso
nment for a term not exceeding 6 mo
nths or both.
(2) An offence under these Regulations may be brought and prosecuted by the Authority.
(3) Wher
e an offence under these Regulations is committed by a body corporate and is proved to have been so committed with the co
nsent or co
nnivance of or to be attributable to any neglect on the part of any person, being a director, manager, secretary or other officer of the body corporate, or a person who was purporting to act in such capacity, that person shall, as well as the body corporate, be guilty of an offence and shall be liable to be proceeded against and punished as if he were guilty of the first-mentio
ned offence.
(4) For the purpose of this Regulation, a company within the meaning of the Companies Acts shall be deemed to be ordinarily resident at its registered office, and every other body corporate and every unincorporated body of persons shall be deemed to be ordinarily resident at its principal office or place of business.
(5) Wher
e a person is co
nvicted of an offence under these Regulations in proceedings brought by the Authority, the court shall, unless it is satisfied that there are special and substantial reasons for not so doing, order the person to pay to the Authority the costs and expenses, measured by the court, incurred by the Authority in relation to the investigation, detection and prosecution of the offence including(a) the costs and expenses incurred in taking samples;(b) the carrying out of examinations, tests, inspections, analyses or checks; and(c) the remuneration and expenses of co
nsultants and advisors engaged by the Authority.
10. The European Communities (Good Laboratory Practice) Regulations 1991 ( S.I. No. 4 of 1991 ) and the European Communities (Good Laboratory Practice) (Amendment) Regulations, 1999 ( S.I. No. 294 of 1999 ) are hereby revoked.
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