xmlns:atom="http://www.w3.org/2005/Atom" xmlns:atom="http://www.w3.org/2005/Atom"
Regulation 12
1. The General Product Safety Regulations 2005 are amended in accordance with paragraphs 2 to 10.
Commencement Information
I1Sch. 9 para. 1 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
2. In regulation 2—
(a)omit the definition of “EU law”;
(b)omit the definition of “the GPS Directive”;
(c)after the definition of “magistrates' court” insert—
““the market” means the [F1market of Great Britain];”;
(d)omit the definition of “Member State”;
(e)in the definition of “producer”—
(i)for “a Member State”, in the first, second and third place it occurs, substitute “ the United Kingdom ”; and
(ii)in paragraph (b)(ii), for the words “importer of the product from a state that is not a Member State into a Member State” substitute “ person established in the United Kingdom that places a product from a country outside the United Kingdom on the market ”;
(f)after the definition of “record” insert—
““relevant enactment” means any retained EU law [F2 (as it applies in Great Britain)] derived from an EU instrument harmonising the conditions for the marketing of products in the EU but does not include Regulation (EC) No 765/2008 of the European Parliament and the Council setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93;”.
Textual Amendments
F1Words in Sch. 9 para. 2(c) substituted (31.12.2020 immediately before IP completion day) by The Product Safety and Metrology etc. (Amendment to Extent and Meaning of Market) (EU Exit) Regulations 2020 (S.I. 2020/676), regs. 1(1), 4(2)
F2Words in Sch. 9 para. 2(f) inserted (31.12.2020 immediately before IP completion day) by The Product Safety and Metrology etc. (Amendment etc.) (UK(NI) Indication) (EU Exit) Regulations 2020 (S.I. 2020/1460), reg. 1(4), Sch. 3 para. 6
Commencement Information
I2Sch. 9 para. 2 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
3. In regulation 3—
(a)for “rules of EU law” substitute “ any relevant enactment ”, in both places it occurs;
(b)omit “other than the GPS Directive”, in both places it occurs; and
(c)in paragraph (2)(a) for “rules” substitute “ provisions of the enactment ”.
Commencement Information
I3Sch. 9 para. 3 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
4.—(1) Regulation 6 is amended as follows.
(2) In paragraph (1)—
(a)for “rules of EU law” substitute “ any relevant enactment ”; and
(b)for “the law” substitute “ any other law ”.
(3) In paragraph (2)—
(a)for the words from “giving” to “Directive”, substitute “ (“S”) which meets the conditions in paragraph (2A) ”;
(b)for “that national standard” substitute “ S ”; and
(c)omit the final sentence.
(4) After paragraph (2) insert—
“(2A) The conditions referred to in paragraph (2) are that—
(a)the Secretary of State considers S appropriate for the purposes of giving rise to the presumption of conformity; and
(b)the Secretary of State has published the reference to S in a manner the Secretary of State considers appropriate.”
(5) In paragraph (3)—
(a)omit sub-paragraph (a);
(b)in sub-paragraph (b) omit “other”; and
(c)in sub-paragraph (c), for “European Commission” substitute “ Secretary of State ”.
Commencement Information
I4Sch. 9 para. 4 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
5. In regulation 9—
(a)in paragraph (1)(a), omit “and”; and
(b)omit paragraph (1)(b).
Commencement Information
I5Sch. 9 para. 5 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
6.—(1) Regulation 33 is amended as follows.
(2) In the heading, omit “and Commission”.
(3) At the beginning insert—
“(A1) The Secretary of State must establish and operate a database containing information relating to market surveillance and product safety.”.
(4) Before paragraph (1) insert—
“(B1) The database referred to in paragraph (A1) must be designed so as to enable notifications required under paragraph (1), (2) or (4), or under Article 22 of Regulation (EC) 765/2008 of the European Parliament and of the Council setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93, to be made to the Secretary of State through the database.”.
(5) For paragraph (1), substitute—
“(1) An enforcement authority which has received a notification of a risk under regulation 9(1) shall immediately notify the Secretary of State of the risk through the database referred to in paragraph (A1).”.
(6) In paragraph (2), after “Secretary of State”, in the first place it occurs, insert “ of the action taken through the database referred to in paragraph (A1) ”;
(7) Omit paragraph (3).
(8) In paragraph (4)—
(a)for “pharmaceutical” substitute “ medicinal ”;
(b)after “Secretary of State”, in the first place it occurs, insert “ of the measure or action taken through the database referred to in paragraph (A1) ”; and
(c)after “withdrawal of any such measure or action” insert “through the database referred to in paragraph (A1).
(9) Omit paragraphs (5) to (9).
(10) For paragraph (10)(b), substitute—
“(b)“medicinal product” has the meaning given to it in regulation 2 of the Human Medicines Regulations 2012 M1.”.
Commencement Information
I6Sch. 9 para. 6 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
Marginal Citations
M1S.I. 2012/1916, to which there are amendments not relevant to these Regulations.
7. In regulation 34—
(a)in paragraph (1)—
(i)for “to (6), (8) or 27(9)”, substitute “ or (4) ”;
(ii)omit “or the Commission”; and
(iii)omit “be in writing and shall”; and
(b)omit paragraphs (2) and (3).
Commencement Information
I7Sch. 9 para. 7 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
8. Omit regulation 35.
Commencement Information
I8Sch. 9 para. 8 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
9. In regulation 36, omit “and competent authorities of other Member States”.
Commencement Information
I9Sch. 9 para. 9 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
10. In regulation 38, omit paragraph (2).
Commencement Information
I10Sch. 9 para. 10 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1