The REACH etc. (Amendment etc.) (EU Exit) Regulations 2019

PART 1 Amendment of Title 1: General issues

Chapter 1 of Title 1

1.  In Article 1(1), omit “on the internal market”.

2.—(1) Article 2 is amended as follows.

(2) In paragraph 1(a), for “Council Directive 96/29/Euratom” to the end of the point substitute “retained EU law that transposed Council Directive 2013/59/Euratom(1) laying down basic safety standards for protection against the dangers arising from exposure to ionising radiation(2);”.

(3) In paragraph 2, for “Directive 2006/12/EC” substitute “Article 3(1) of Directive 2008/98/EC(3)”.

(4) After paragraph 2, insert—

“2A.   For the purposes of this Regulation, Directive 2008/98/EC means that Directive as last amended by Council Regulation (EU) 2017/997, and read in accordance with paragraphs 2B and 2C.

2B.   Article 5 is to be read as if paragraph 2 were omitted.

2C.   Article 6 is to be read as if—

(a) paragraphs 1 to 3 were omitted;

(b) in paragraph 4—

(i) in the first sentence, for the words “Where criteria” to “paragraphs 1 and 2” there were substituted “Except where Council Regulation (EU) No 333/2011, Commission Regulation (EU) No 1179/2012 or Commission Regulation (EU) No 715/2013 applies”;

(ii) the second sentence were omitted.”.

(5) In paragraph 3, for “Member States” substitute “The Secretary of State”.

(6) Omit paragraph 4.

(7) In paragraph 5—

(a) for point (a) substitute—

“(a) in medicinal products for human or veterinary use within the scope of the Veterinary Medicines Regulations 2013(4), or the Human Medicines Regulations 2012(5);”;

(b) for point (b)(i) substitute—

“(i) as a food additive in foodstuffs as defined by Article 3(2)(a) of Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives;”;

(c) for point (b)(ii) substitute—

“(ii) as a flavouring in foodstuffs within the scope of Regulation (EC) No 1334/2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods or Commission Implementing Regulation (EU) No 872/2012 adopting the list of flavouring substances provided for by Regulation (EC) No 2232/96 of the European Parliament and of the Council, introducing it in Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council;”;

(d) for point (b)(iv) substitute—

“(iv) in animal nutrition within the scope of Article 2(1) of Regulation (EC) No 767/2009.”.

(8) In paragraph 6—

(a) for point (a) substitute—

“(a) medicinal products for human or veterinary use within the scope of the Veterinary Medicines Regulations 2013, or the Human Medicines Regulations 2012;”;

(b) for point (b) substitute—

“(b) cosmetic products as defined in Regulation (EC) No 1223/2009 on cosmetic products;”;

(c) for point (c) substitute—

“(c) medical devices which are invasive or used in direct physical contact with the human body in so far as legislation relating to the classification and labelling of dangerous substances and mixtures applies to them which ensures the same level of information provision and protection as Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures;”;

(d) for point (d)(i) and (ii) substitute—

“(i) as a food additive in foodstuffs as defined by Article 3(2)(a) of Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives;

(ii) as a flavouring in foodstuffs within the scope of Regulation (EC) No 1334/2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods or Commission Implementing Regulation (EU) No 872/2012 adopting the list of flavouring substances provided for by Regulation (EC) No 2232/96 of the European Parliament and of the Council, introducing it in Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council;”;

(e) for point (d)(iv) substitute—

“(iv) in animal nutrition within the scope of Article 2(1) of Regulation (EC) No 767/2009.”.

(9) In paragraph 7(c)—

(a) for “from the Community” substitute “from the United Kingdom”;

(b) for “into the Community” substitute “into the United Kingdom”.

(10) In paragraph 7(d), for “Community” substitute “United Kingdom”.

Chapter 2 of Title 1

3.  In Chapter 2 of Title 1, before Article 3 insert—

“Article 2A The Agency

1.   The functions and powers of the Agency under the REACH legislation are to be functions and powers of the HSE.

Accordingly, any reference to the Agency in the REACH legislation must be read as meaning the HSE.

2.   The general incidental powers of the HSE are to be exercisable for the purpose of carrying out the functions of the Agency under the REACH legislation.

But that does not limit the powers which the HSE has under the REACH legislation.

3.   The non-REACH functions of the HSE are not limited by the functions of the Agency under the REACH legislation.

Accordingly, the HSE is not prevented from carrying out non-REACH functions in relation to a matter just because any of the functions of the Agency under the REACH legislation is also exercisable, or has been exercised, in relation to that matter.

4.   The power of the Secretary of State under section 12(2)(a) of HASWA 1974 to give directions (as read with section 12(4) of HASWA 1974) is to be exercisable with respect to the functions of the Agency under the REACH legislation.

The Secretary of State may not give any such directions with regard to the enforcement of the REACH legislation in any particular case.

The Secretary of State must consider any request made by any of the other appropriate authorities for the Secretary of State to give a direction by virtue of this paragraph.

The function of giving directions by virtue of this section is subject to the consent requirement in Article 4A (whether or not there has been a request under the previous subparagraph).

5.   In this Article—

“general incidental powers” means the powers which the HSE has under—

(a) section 13 of HASWA 1974, and

(b) Schedule 2 to HASWA 1974;

“HASWA 1974” means the Health and Safety at Work etc. Act 1974(6);

“HSE” means the Health and Safety Executive;

“non-REACH function” means any function which arises otherwise than under the REACH legislation;

“REACH legislation” means—

(a) this Regulation,

(b) any instrument made under this Regulation, and

(c) any retained direct EU legislation that was originally made under EU REACH.

Article 2B Advice from Environment Agency or other environmental regulators to Agency

1.   The Agency must comply with paragraph 2 when exercising—

(a) its functions under—

(i) Article 7(5),

(ii) Article 9(4), (7) and (8),

(iii) Article 21,

(iv) Articles 40(1) and (3), 41(1), (3) and (5), 42(1), 43, 44, 45, 46(1) and (3), 48, 49, 51 and 52,

(v) Articles 58(3) and (4) and 59(1), (2), (3), (6) and (7),

(vi) Article 64(1), (3), (4), (5) and (6),

(vii) Articles 69, 70 and 71, and

(b) any of its other functions under this Regulation,

if, and to the extent that, the exercise of the function involves consideration of any relevant environmental issues.

2.   The Agency must—

(a) obtain the advice of the Environment Agency before exercising the function concerned, and

(b) use the advice obtained when exercising the function concerned.

3.   Whenever the advice of the Environment Agency is sought by the Agency under this Article, the Environment Agency must collaborate with the other environmental regulators when formulating the advice.

4.   If, as part of a collaboration under paragraph 3, one of the other environmental regulators gives advice to the Environment Agency, the Environment Agency must pass that advice on to the Agency if that other environmental regulator requires it to do so.

5.   In this Article—

“other environmental regulator” means—

(a) in relation to Wales, the Natural Resources Body for Wales;

(b) in relation to Scotland, the Scottish Environment Protection Agency;

(c) in relation to Northern Ireland, the Department of Agriculture, Environment and Rural Affairs.

“relevant environmental issue” means—

(a) exposure of the environment to chemicals;

(b) exposure of humans to chemicals in the environment;

(c) assessment of the potential effect of chemicals on the environment;

(d) measures aimed at controlling the release of chemicals into the environment.”.

4.—(1) Article 3 is amended as follows.

(2) Before paragraph 1 insert—

“A1.   EU REACH: means Regulation (EC) No 1907/2006 of the European Parliament and of the Council(7) as it has effect in EU law;

A2.   appropriate authority: means—

(a) the Secretary of State, in relation to England;

(b) the Scottish Ministers, in relation to Scotland;

(c) the Welsh Ministers, in relation to Wales;

(d) the Department of Agriculture, Environment and Rural Affairs and the Department for the Economy, in relation to Northern Ireland (and those Departments’ exercise of their functions under this Regulation is subject to the following provision of this paragraph).

When—

(a) the function of giving consent under Article 4A is exercisable by the Department of Agriculture, Environment and Rural Affairs and the Department for the Economy, or

(b) a function under Article 129 is exercisable by the Department of Agriculture, Environment and Rural Affairs and the Department for the Economy as the appropriate authority,

that function is to be exercised by those Departments acting jointly.

When any other function under this Regulation is exercisable by the Department of Agriculture, Environment and Rural Affairs and the Department for the Economy as the appropriate authority, that function is to be exercised either—

(a) by one of those Departments acting alone, or

(b) by both of those Departments acting jointly.”.

(3) In paragraph 4, for “Community” substitute “United Kingdom”.

(4) In paragraph 9, for “Community”, in both places it occurs, substitute “United Kingdom”.

(5) In paragraph 10, for “customs territory of the Community” substitute “United Kingdom”.

(6) In paragraphs 11, 13 and 14, for “Community” substitute “United Kingdom”.

(7) For paragraph 18 substitute—

“18.   Agency: see Article 2A;

18A.   ECHA: means the European Chemicals Agency established under EU REACH;”.

(8) Omit paragraph 19.

(9) In paragraph 20, in points (b) and (c)—

(a) for “Community” substitute “European Community”;

(b) for “the entry into force of this Regulation” substitute “1 June 2007”.

(10) In paragraph 21, for “has been” substitute “was”.

(11) In paragraph 36, at the end insert—

“and, in its application for the purposes of this paragraph, the Annex to that Recommendation has effect with the following modifications—

(a) in Article 2(1)—

(i) the reference to EUR 50 million has effect as a reference to £43.650 million;

(ii) the reference to EUR 43 million has effect as a reference to £37.539 million;

(b) in Article 2(2) the reference to EUR 10 million has effect as a reference to £8.730 million;

(c) in Article 2(3) the reference to EUR 2 million has effect as a reference to £1.746 million;

(d) in Article 3(2)—

(i) in point (a), the reference to EUR 1,250,000 has effect as a reference to £1,091,250;

(ii) in point (d), the reference to EUR 10 million has effect as a reference to £8.730 million.”.

5.  After Article 4 insert—

“Article 4A The consent requirement

1.   Where any provision of this Regulation states that a function is subject to the consent requirement in this Article, the function may be exercised in a particular instance only if the person exercising it has obtained the consent or consents (if any) required by paragraphs 2 to 4.

2.   The consent of the Scottish Ministers is required if, or to the extent that, the exercise of the function is within devolved competence (within the meaning of section 54 of the Scotland Act 1998(8)), whether or not the exercise of the function also relates to a part of the United Kingdom other than Scotland.

3.   The consent of the Welsh Ministers is required if, or to the extent that, the exercise of the function is within devolved competence (within the meaning of section 58A(7) and (8) of the Government of Wales Act 2006(9)) whether or not the exercise of the function also relates to a part of the United Kingdom other than Wales.

4.   The consent of the Department of Agriculture, Environment and Rural Affairs and the Department for the Economy is required if, or to the extent that, the exercise of the function is within devolved competence, whether or not the exercise of the function also relates to a part of the United Kingdom other than Northern Ireland.

The exercise of the function is within devolved competence for the purposes of this paragraph unless it is outside competence by virtue of paragraphs 5 or 6.

5.   It is outside devolved competence—

(a) to make any provision by subordinate legislation which would be outside the legislative competence of the Northern Ireland Assembly if it were included in an Act of the Assembly, or

(b) to confirm or approve subordinate legislation containing such provision.

6.   In the case of any function other than a function of making, confirming or approving subordinate legislation, it is outside devolved competence to exercise the function (or exercise it in any way) so far as a provision of an Act of the Northern Ireland Assembly conferring the function (or, as the case may be, conferring it so as to be exercisable in that way) would be outside the legislative competence of the Assembly.

7.   References in paragraphs 5 and 6 to provision being outside the legislative competence of the Northern Ireland Assembly are to be read in accordance with section 6 of the Northern Ireland Act 1998(10).

Any provision that would be outside the legislative competence of the Northern Ireland Assembly unless the Secretary of State consented to it is to be regarded, for the purposes of paragraphs 5 and 6, as outside legislative competence.

8.   Article 3(A2) includes provision about the exercise by the Department of Agriculture, Environment and Rural Affairs and the Department for the Economy of the function of giving consent under this Article.”.

(1)

Different aspects of Council Directive 2013/59/Euratom have been transposed by various pieces of legislation, including the Ionising Radiations Regulations 2017 (S.I. 2017/1075) in Great Britain and the Ionising Radiations Regulations (Northern Ireland) 2017 (S.R. 2017/229) in Northern Ireland.

(2)

OJ No. L 13, 17.1.2014, p. 1.

(3)

OJ No. L 312, 22.11.2008, p. 3, as last corrected by Corrigendum (OJ No. L 042, 18.2.2017, p. 43).

(4)

S.I. 2013/2033, amended by S.I. 2014/599, 2018/761.

(5)

S.I. 2012/1916, amended by S.I. 2013/235, 1855, 2593, 2014/490, 1878, 2015/323, 570, 903, 1503, 1862, 1879, 2016/186, 190, 696, 2017/715, 1322, 2018/199, 378.

(6)

1974 c. 37. Section 12 was substituted by S.I. 2008/960. Section 13 was substituted by S.I. 2008/960 and amended by section 116 of the Energy Act 2013 (c. 32).

(7)

OJ No. L 396, 30.12.2006, p. 1, as last amended by Regulation (EU) 2018/1513 (OJ No. L 256, 12.10.2018, p. 1).

(8)

1998 c. 46.

(9)

2006 c. 32. Section 58A was inserted by section 19(1) of the Wales Act 2017 (c. 4) and amended by paragraph 33 of Schedule 3 to the European Union (Withdrawal) Act 2018.

(10)

1998 c. 47. Section 6 was amended by section 12(5) of the European Union (Withdrawal) Act 2018 and S.I. 2011/1043.