European Communities (Good Laboratory Practice) Regulations, 2020

• Jurisdiction: Ireland
• Citation: IR SI 18/2020

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of 28th January, 2020.

I, Heather Humphreys, Minister for Business, Enterprise and Innovation, in the exercise of the powers conferred 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 National Accreditation Board, a committee of the Authority under section 56A (1) of the Act of 2005, (inserted by section 32 of the Industrial Development (Forfás 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 conferred 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 harmonisation 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 construed 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 evaluate their safety for humans or the environment or both.

(3) If the Accreditation Board has reasonable grounds for believing that there is a contravention 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) Where a laboratory has carried out a test and/or study in accordance with Regulation 3 of these Regulations, it shall give confirmation in writing to the person who commissioned the test and/or study and to the Accreditation Board stating that the test and/or study has been carried out in conformity with the principles of good laboratory practice.

(2) Where a laboratory fails to give the confirmation 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 confirmation 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) Where 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) Where a laboratory gives confirmation 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) Where a laboratory gives confirmation 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...