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

Type Statutory-Instrument

Publication 2019-03-29

Last updated 2020-12-31

State In force

Department King's Printer of Acts of Parliament

Source legislation.gov.uk

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(1) An existing EU registration under Articles 6, 7(1), 7(5) or 24(1) of EU REACH has effect on and after IP completion day as a GB registration (the “transferred GB registration”) if the registration— (a) has a current connection with Great Britain, or (b) has a relevant past connection with Great Britain (but does not have a current connection with Great Britain). (2) A registration has a current connection with Great Britain if— (a) the registrant immediately before IP completion day is a person established in Great Britain (a “current GB registrant”), and (b) a registration of the substance concerned by the current GB registrant is a registration of a kind that could be submitted on IP completion day under Article 6 or 7(1) or (5) of this Regulation. (3) A registration has a relevant past connection with Great Britain if— (a) the registrant at any time in the period beginning with 29 March 2017 and ending immediately before IP completion day was a person established in Great Britain (a “former GB registrant”), and (b) a registration of the substance concerned by the former GB registrant is a registration of a kind that could be submitted on IP completion day under Article 6 or 7(1) or (5) of this Regulation. (4) Where an existing EU registration has effect by virtue of this Article as a transferred GB registration, it has effect— (a) if it is an existing EU registration under Article 6 of EU REACH, as a transferred GB registration under Article 6 of this Regulation; (b) if it is an existing EU registration under Article 7(1) of EU REACH, as a transferred GB registration under Article 7(1) of this Regulation; (c) if it is an existing EU registration under Article 7(5) of EU REACH, as a transferred GB registration under Article 7(5) of this Regulation; (d) if it is an existing EU registration that existed by virtue of Article 24(1) of EU REACH, as a transferred GB registration that exists by virtue of Article 6 of this Regulation. (5) Where a registration that has a current connection with Great Britain has effect as a transferred GB registration by virtue of this Article, the current GB registrant becomes the registrant in relation to the transferred GB registration on IP completion day. (6) Where a registration that has a relevant past connection with Great Britain has effect as a transferred GB registration by virtue of this Article, the former GB registrant becomes the registrant in relation to the transferred GB registration on IP completion day. If two or more persons have been former GB registrants at different times in the period beginning with 29 March 2017 and ending immediately before IP completion day, only the person who was the former GB registrant most recently before IP completion day is to become registrant in relation to the transferred GB registration by virtue of this paragraph. (1) The other Titles of this Regulation apply to a transferred GB registration as they would apply to the registration— (a) if it had been submitted on IP completion day to the Agency under Article 6 or 7(1) or (5) (as the case may be); (b) in a case where the existing EU registration came into existence by virtue of Article 24(1) of EU REACH, if it had been submitted on IP completion day to the Agency under Article 6. Accordingly, no registration under that Article needs to be submitted. (2) But, in their application to the transferred GB registration, the other Titles of this Regulation have effect with the modifications set out in the following provisions of this Article. (3) In the case of— (a) a transferred GB registration under Article 6, no fee is payable under Article 6(4); (b) a transferred GB registration under Article 7, no fee is payable under Article 7(1) or (5). (4) The registrant must submit— (a) the Article 10 information referred to in Article 10(a)(i), (ii), and (iii), and any relevant indication under Article 10(a)(viii), to the Agency within the 120 day post-IP completion period; (b) the other Article 10 information to the Agency within the relevant post-IP completion period. Where the existing EU registration existed by virtue of Article 24(1) of EU REACH, the duty under this paragraph does not apply in relation to a transferred GB registration unless Article 24(2) applied in relation to the notified substance concerned before IP completion day. (5) The technical dossier that is submitted in accordance with point (a) in Article 10 does not need to include the proposals for testing mentioned in paragraph (ix) if, before IP completion day, ECHA has made a decision under Article 40(3) of EU REACH in relation to the testing proposals included in the technical dossier that was included in the existing EU registration. For further provision about certain cases where there is an existing EU decision on a testing proposal, see Article 127I. (6) The registrant must submit the registration number and registration date assigned to the existing EU registration by ECHA in accordance with Article 20(3) of EU REACH, and such other evidence as the Agency may require of the existing EU registration, to the Agency within the 120 day post-IP completion period. (7) Article 20 has effect with the following provision substituted for paragraphs 1 to 3— (1) The Agency must assign a submission date to each transferred GB registration, which must be the date on which the registrant complies with paragraph 4(a) or (b) of Article 127B. (2) The Agency may undertake a completeness check of each registration in order to ascertain that all the elements required under Articles 10 and 12 have been provided. The completeness check must not include an assessment of the quality or the adequacy of any data or justifications submitted. If a registration is incomplete, the Agency must inform the registrant as to what further information is required in order for the registration to be complete, while setting a reasonable deadline for this. The registrant must complete his registration and submit it to the Agency within the deadline set. The Agency must confirm the submission date of the further information to the registrant. The Agency must perform a further completeness check, considering the further information submitted. (3) Once the registrant has complied with paragraph 4(a) of Article 127B, the Agency must assign a registration number to the substance concerned and a registration date, which must be the same as the registration date for the existing EU registration. (8) Article 21 has effect with the following provision substituted for the first subparagraph of paragraph 1— (1) A registrant of a transferred GB registration may continue the manufacture or import of a substance or production or import of an article from IP completion day, subject to any indication to the contrary from the Agency in accordance with Article 20(2). (9) The Agency is not required by Article 41(5) to carry out compliance checking of dossiers relating to transferred GB registrations in the tonnage bands of over 100 to 1,000 tonnes or over 1,000 tonnes. (10) The reference in Article 43(1) to the preparation of a draft decision within 180 days of receiving a registration has effect as a reference to the preparation of a draft decision within 180 days of receipt of the information required by Article 10(a)(ix) under paragraph 4. (1) This Article applies in relation to an existing EU registration which has effect as a transferred GB registration under Article 127A. (2) Any existing ECHA decision which relates to the registration has effect on and after IP completion day as a decision of the Agency which relates to the transferred GB registration. (3) The registrant must— (a) notify the Agency, within the 120 day post-IP completion period, of any existing ECHA decision which relates to the registration, and (b) if required to do so by the Agency, supply the Agency, within the period specified by the Agency, with copies of any existing ECHA decision which relates to the registration. (4) The Agency may extend any period of time specified in an existing ECHA decision. (5) The other Titles of this Regulation apply to the decision as they would apply to it if it had been made by the Agency on IP completion day. (6) In this Article “existing ECHA decision” means a decision which has been made by ECHA under any provision of EU REACH and which is valid immediately before IP completion day. (1) In Articles 127A to 127C— - “Article 10 information” means the information which a registration is required to include by virtue of Article 10; - “existing EU registration” means a registration of a substance with ECHA which is subsisting immediately before IP completion day; - “transferred GB registration” has the meaning given in Article 127A(1); - “GB registration” means a registration of a substance with the Agency. (1) This Article applies in a case where— (a) a person is— (i) an existing GB downstream user under EU REACH, or (ii) an existing GB distributor under EU REACH, in relation to a substance (the “GB user or distributor”), and (b) there is a protected transitional import of the substance by the GB user or distributor. (2) There is a protected transitional import of the substance by the GB user or distributor if— (a) the substance is imported to Great Britain on its own, in a mixture or in an article, (b) the GB user or distributor is the importer in relation to the import, (c) the import occurs during the relevant post-IP completion period, and (d) either— (i) the person who supplies the substance, mixture or article to the GB user or distributor for the import is a registrant or a downstream user under EU REACH as respects the substance as it is imported (the “relevant supplier”), or (ii) an only representative appointed under Article 8(1) of EU REACH by the manufacturer, formulator or producer of the substance, mixture or article is a registrant under EU REACH as respects the substance as it is imported. (3) The GB user or distributor is to be treated for the purposes of this Regulation— (a) as a downstream user as respects any protected transitional imports of the substance by them (if they are an existing GB downstream user under EU REACH), or (b) as a distributor as respects any protected transitional imports of the substance by them (if they are an existing GB distributor under EU REACH). (4) For the purposes of deciding whether the requirement in paragraph 2(d)(i) is met in relation to a particular import, it does not matter whether the relevant supplier is— (a) the person from which the GB user or distributor obtained supplies of the substance, mixture or article before IP completion day (and therefore the person in relation to which the GB user was a downstream user or distributor under EU REACH), or (b) a different person. (5) For the purposes of deciding whether the requirement in paragraph 2(d)(ii) is met in relation to a particular import, it does not matter whether the manufacturer, formulator or producer who has appointed the only representative is— (a) the person who was the manufacturer, formulator or producer of supplies of the substance, mixture or article which the GB user or distributor obtained before IP completion day, or (b) a different person. (6) The provisions of this Regulation that apply to importers , including in respect of protected NI imports, do not apply to the GB user or distributor in relation to the protected transitional import of the substance by the GB user or distributor. (7) If the GB user or distributor imports the substance into Great Britain in quantities of 1 to 10 tonnes per year, they must within the 300 day post-IP completion period— (a) supply the Agency with the information referred to in point (a)(i) of Article 10; (b) supply the Agency with the information referred to in points (a)(ii) and (iv) of Article 10 to the extent that information is available to the GB user or distributor; (c) supply the Agency with the information referred to in points (a) to (d) of Article 32(1) and otherwise comply with Article 32; (d) supply the Agency with the relevant registration number for the substance under EU REACH to the extent that information is available to the GB user or distributor; (e) supply the Agency with such other evidence as the Agency may require demonstrating that the information supplied in accordance with subparagraph (c) complies with the requirements of Articles 10, 12 and 14 (as they apply to the tonnage of the substance which the GB user or distributor imports into Great Britain by protected transitional imports); (f) if any part of the import is a protected NI import, notify the Agency of the quantity of the import that is a protected NI import. (8) If the GB user or distributor imports the substance into Great Britain in quantities of 10 tonnes or more per year, they must within the 300 day post-IP completion period— (a) supply the Agency with the information referred to in point (a)(i) of Article 10; (b) supply the Agency with the information referred to in points (a)(ii) and (iv) of Article 10 to the extent that information is available to the GB user or distributor; (c) supply the Agency with the information referred to in— (i) Article 14(6) to the extent that information is available to the GB user or distributor, (ii) Article 31, and (iii) Article 32(1)(a) to (d); (d) otherwise comply with Articles 14(6), 31 and 32; (e) supply the Agency with the relevant registration number for the substance under EU REACH to the extent that information is available to the GB user or distributor; (f) supply the Agency with such other evidence as the Agency may require demonstrating that the information supplied in accordance with subparagraph (c) complies with the requirements of Articles 10, 12 and 14 (as they apply to the tonnage of the substance which the GB user or distributor imports into Great Britain by protected transitional imports); (g) if any part of the import is a protected NI import, notify the Agency of the quantity of the import that is a protected NI import. (9) The GB user or distributor must provide the Agency with updated information of the kind required by paragraph 7 or 8, in particular where the GB user or distributor begins to import the substance— (a) from a different relevant supplier, or (b) from a different manufacturer, formulator or producer who (as described in paragraph 2(d)(ii)) has appointed an only representative that is a registrant under EU REACH. (10) This Article ceases to apply to the GB user or distributor as respects a protected transitional import of the substance by them if they become a registrant or downstream user under this Regulation , or a notification is made under Article 139A, in relation to the substance as so imported by them. For that purpose, a person is not to be treated as having become a downstream user because they are treated as one in accordance with paragraph 3(a). (11) Paragraphs 7, 8 and 9 are subject to paragraph 3 of Article 127EA and paragraph 6 of Article 127EB. (12) In this Article— - “existing GB distributor under EU REACH” means a person who was, at any time in the 2 year period before IP completion day, a distributor under EU REACH established in Great Britain in relation to a substance on its own, in a mixture or in an article; - “existing GB downstream user under EU REACH” means a person who was, at any time in the 2 year period before IP completion day, a downstream user under EU REACH established in Great Britain in relation to a substance on its own, in a mixture or in an article; - “relevant supplier” has the meaning given in paragraph 2(d)(i); - “GB user or distributor” has the meaning given in paragraph 1(a). (1) This Article applies in relation to a protected transitional import of a substance by a GB user or distributor (within the meaning of Article 127E) that is not a protected NI import. (2) If, or to the extent that, the appointment of an only representative by the manufacturer, formulator or producer relates to the substance as imported, Article 8 has effect as if the following provision were substituted for paragraphs 1 to 3 of that Article— (1) A person established outside Great Britain who manufactures a substance on its own, in mixtures or in articles, formulates a mixture or produces an article that is imported into Great Britain may by mutual agreement appoint a person established in Great Britain to fulfil, as his only representative, the obligations on the GB user or distributor under Article 127E. (1A) Article 36 applies to the representative. (2) The representative must have a sufficient background in the practical handling of substances and the information related to them and, without prejudice to Article 36, must keep available and up-to-date information on quantities imported and customers sold to, as well as information on the supply of the latest update of the safety data sheet referred to in Article 31. (3) If a representative is appointed in accordance with paragraphs 1 and 2, the non-Great British manufacturer shall inform the GB user or distributor of the appointment. (3) If the GB user or distributor is informed of the appointment of the only representative in accordance with paragraph 3 of Article 8 (as set out above), paragraphs 7, 8 and 9 of Article 127E cease to apply to the GB user or distributor as respects any protected transitional import where the manufacturer, formulator or producer is the person who appointed the representative. (1) This Article applies in relation to a protected transitional import of a substance by a GB user or distributor (within the meaning of Article 127E) that is also a protected NI import. (2) A person established in Northern Ireland who manufactures a substance on its own, in mixtures or in articles, formulates a mixture, or produces an article that is imported into Great Britain may fulfil the obligations on the GB user or distributor under Article 127E (the “NI notifier”). (3) Article 36 applies to the NI notifier. (4) The NI notifier must, without prejudice to Article 36, keep available and up-to-date information on quantities imported and customers sold to, as well as information on the supply of the latest update of the safety data sheet referred to in Article 31. (5) A person who intends to act in accordance with paragraph 2 must inform the GB user or distributor that they intend to do so. (6) If the GB user or distributor is informed of the intention in accordance with paragraph 5, paragraphs 7 to 9 of Article 127E apply to the NI notifier instead of the GB user or distributor as respects any protected transitional import from the NI notifier. (1) The holder of an existing EU authorisation which has the relevant connection with Great Britain must, before the end of the 60 day post-IP completion period, supply the Agency with the required technical information relating to the authorisation. (2) An existing EU authorisation which does not have the relevant connection with Great Britain ceases to have effect (as retained EU law) on IP completion day. (3) An existing EU authorisation has the relevant connection with Great Britain if the holder of the authorisation is established in Great Britain. (4) In this Article— - “existing EU authorisation” means an authorisation granted in accordance with Articles 60 to 64 of EU REACH which is subsisting immediately before IP completion day; - “holder”, in relation to an existing EU authorisation, means the person to whom the authorisation has been granted; - “required technical information”, in relation to an existing EU authorisation, means— (a) the information included in the application for the authorisation in accordance with Article 62(4) and (5) of EU REACH, (b) any other information provided to ECHA by the applicant for the authorisation which was material to the formation of ECHA's opinion in relation to the application for the authorisation, and (c) any information required to be submitted or recorded before IP completion day under any condition under which the authorisation is granted. (1) The Secretary of State must decide an existing application for an EU authorisation (as mentioned in Article 64(8)) if— (a) the application— (i) is at the final decision stage on IP completion day, (ii) has the relevant connection with Great Britain; and (b) the person who made the application— (i) notifies the Secretary of State of the existence of the application, (ii) provides the Secretary of State with copies of the application, the information included in it under Article 62(4) and (5) of EU REACH, and any other information provided to ECHA by the applicant for the authorisation which was material to the formation of ECHA's opinion in relation to the application for the authorisation, and (iii) provides the Secretary of State with copies of the final opinions of ECHA referred to in Article 64(5) of EU REACH. (2) An application for an EU authorisation is at the final decision stage if— (a) ECHA has adopted the final opinions referred to in Article 64(5) of EU REACH, but (b) the Commission has not made a final decision granting or refusing the application. (3) An application for an EU authorisation has the relevant connection with Great Britain if the person making the application is established in Great Britain. (4) The period of six months for the Secretary of State to make an authorisation decision in accordance with Article 64(8) of this Regulation begins with the day on which paragraph 1(b) is complied with. (5) Where, immediately before IP completion day, a person may place a substance on the market for a use or use it himself in reliance on Article 56(1)(d) of EU REACH, the person may continue to do so on and after IP completion day in reliance on Article 56(1)(d) of this Regulation. But this paragraph ceases to apply at the end of the 180 day post-IP completion period if the person does not comply with paragraph 1(b) of this Article before the end of that period. (6) In this Article “existing application for an EU authorisation” means an application made before IP completion day for the grant of an authorisation in accordance with Articles 60 to 64 of EU REACH. (1) Paragraphs 2 and 3 apply where— (a) immediately before IP completion day, a substance is included in Annex 14 to EU REACH; (b) the EU latest application date fell before or during the relevant pre-IP completion period; (c) the EU sunset date fell during the relevant pre-IP completion period; (d) before the EU latest application date, an application had been made for the grant of an authorisation in accordance with Articles 60 to 64 of EU REACH in relation to the substance (the “authorisation application”); and (e) immediately before IP completion day, the authorisation application was still under consideration (see paragraph 11). (2) Where, immediately before IP completion day, a person established in Great Britain may place the substance on the market or use it himself in reliance on Article 56(1)(d) of EU REACH by virtue of the authorisation application having been made, this Regulation has effect subject to the modifications set out in paragraph 3. (3) As respects that person placing the substance on the market or using it himself on and after IP completion day— (a) the GB latest application date, and (b) the GB sunset date, both fall on the transitional cut-off date (rather than on the dates specified in Annex 14 for that substance). (4) Paragraphs 5 and 6 apply where— (a) immediately before IP completion day, a substance is included in Annex 14 to EU REACH; (b) the EU latest application date fell during the relevant pre-IP completion period; (c) the EU sunset date falls after the end of that period; (d) before the EU latest application date, an application had been made for the grant of an authorisation in accordance with Articles 60 to 64 of EU REACH in relation to the substance (the “authorisation application”); and (e) immediately before IP completion day, the authorisation application was still under consideration (see paragraph 11). (5) Where, on and after the GB sunset date, a person established in Great Britain would be able to place the substance on the market or use it himself in reliance on Article 56(1)(d) of this Regulation had the authorisation application been made under this Regulation, this Regulation has effect subject to the modifications set out in paragraph 6. (6) As respects that person placing the substance on the market or using it himself on and after IP completion day— (a) the GB latest application date, and (b) the GB sunset date, both fall on the transitional cut-off date (rather than on the dates specified in Annex 14 for that substance). The effect of this paragraph is to be ignored in reading the reference to the GB sunset date in paragraph 5. (7) Paragraph 8 applies where— (a) immediately before IP completion day, a substance is included in Annex 14 to EU REACH; and (b) the GB latest application date falls during the 18 month post-IP completion period. (8) As respects a person established in Great Britain placing the substance on the market or using it himself on and after IP completion day, the GB latest application date falls on the transitional cut-off date (rather than on the date specified in Annex 14 for that substance). (9) Where paragraph 3, 6 or 8 modifies this Regulation, Article 56(1) has effect with the following provision substituted for point (d)— (d) the GB sunset date (within the meaning of Article 127GA) has been reached and he made an application before the GB latest application date (within the meaning of Article 127GA) but a decision on the application for authorisation has not yet been taken; or (10) Where paragraph 3 or 6 modifies the date that is the GB sunset date, any reference in this Regulation to the date of the kind referred to in Article 58(1)(c)(i) has effect subject to the modification made by paragraph 3 or 6. (11) For the purposes of paragraph 1(e) or 4(e), the authorisation application is “still under consideration” unless— (a) the Commission has made a final decision granting or refusing the authorisation application, or (b) the authorisation application— (i) has the relevant connection with Great Britain (within the meaning of Article 127G), and (ii) is at the final decision stage (within the meaning of Article 127G). (12) In this Article— - “EU latest application date”, in relation to a substance, means the date of the kind referred to in Article 58(1)(c)(ii) of EU REACH that is specified in Annex 14 to EU REACH in relation to the substance; - “EU sunset date”, in relation to a substance, means the date of the kind referred to in Article 58(1)(c)(i) of EU REACH that is specified in Annex 14 to EU REACH in relation to the substance; - “relevant pre-IP completion period” means the period that— (a) begins with 29 March 2017, and (b) ends immediately before IP completion day; “transitional cut-off date” means the last day of the 18 month post-IP completion period; - “GB latest application date”, in relation to a substance, means the date of the kind referred to in Article 58(1)(c)(ii) of this Regulation that is specified in Annex 14 to this Regulation in relation to the substance; - “GB sunset date”, in relation to a substance, means the date of the kind referred to in Article 58(1)(c)(i) of this Regulation that is specified in Annex 14 to this Regulation in relation to the substance; - “18 month post-IP completion period” means the period of 18 months beginning with the day after that on which IP completion day falls. (1) On and after IP completion day, a person who— (a) is established in Great Britain, and (b) is an existing authorised downstream user under EU law in relation to a substance, is authorised to use that substance in accordance with Article 56(2). (2) Where Article 56(2) applies to the use of a substance by virtue of paragraph 1, a reference in Article 56(2) to an authorisation granted to a person up a supply chain is a reference to an existing EU authorisation relating to that use of the substance. (3) Accordingly, paragraph 1 ceases to apply to a person if the existing EU authorisation relating to that use of the substance ceases to have effect. (4) A person to whom paragraph 1 applies must, before the end of the 60 day post-IP completion period— (a) confirm to the Agency that they are an existing authorised downstream user under EU law in relation to the substance, and (b) notify the Agency of— (i) the existing EU authorisation; (ii) any conditions set out in the existing EU authorisation (as referred to in Article 56(2) of EU REACH); (iii) the identity of the supplier of the substance to the person. (5) Article 66(1) does not apply to the use of a substance in accordance with Article 56(2) by virtue of this Article. (6) In this Article— - “existing authorised downstream user under EU law” means a person who, immediately before IP completion day, is authorised to use a substance in accordance with Article 56(2) of EU REACH; - “existing EU authorisation” means an authorisation granted to a person up a supply chain (as referred to in Article 56(2) of EU REACH) which is subsisting immediately before IP completion day, as it has effect in EU law; (1) On and after IP completion day, an existing EU decision on a testing proposal which has the relevant connection with Great Britain has effect as a decision by the Agency under Article 40(3) of this Regulation. (2) An existing EU decision on a testing proposal has the relevant connection with Great Britain if the registrant, or downstream user, concerned is established in Great Britain. (3) The Agency may extend any deadline specified in an existing EU decision on a testing proposal. (4) In this Article, “existing EU decision on a testing proposal” means a decision taken by ECHA— (a) in accordance with Article 40(3)(a), (b), (c) or (e) of EU REACH, if the requirements of the decision have not been fulfilled, or (b) in accordance with Article 40(3)(d) of EU REACH. (1) This Article applies if— (a) before IP completion day, a producer of articles established in Great Britain, or an importer of articles established in Great Britain, has given ECHA a notification under Article 7(2) of EU REACH in relation to a substance, and (b) immediately before IP completion day, that person is not a registrant in relation to the substance concerned. (2) The person that gave the notification to ECHA must submit to the Agency, within the 60 day post-IP completion period, the information notified to ECHA in accordance with Article 7(2) and (4) of EU REACH. (1) This Article applies if— (a) a five year exemption under Article 9(1) of EU REACH, or (b) an extended exemption under Article 9(7) of EU REACH, applies in relation to a substance immediately before IP completion day where the research and development concerned takes place in Great Britain. (2) On and after IP completion day— (a) a five year exemption under Article 9(1) of this Regulation, or, (b) an extended exemption under Article 9(7) of this Regulation, (as the case may be) applies in relation to the substance, subject to the same conditions (if any) imposed by ECHA under Article 9(4) in relation to the corresponding exemption under EU REACH. (3) That exemption under Article 9(1) or (7) of this Regulation is to end on the same date that the corresponding exemption under EU REACH would have ended. (4) Where an exemption under Article 9(1) or (7) of this Regulation applies to a substance by virtue of this Article, the following duties must be complied with in relation to the exemption of the substance within the 120 day post-IP completion period— (a) Article 9(2) must be complied with by the manufacturer or importer or producer, as the case may be (the “notifier”); (b) the notifier must also notify the Agency of the number and notification date assigned by ECHA under Article 9(3) of EU REACH; (c) the notifier must give the Agency copies of any additional necessary information given to ECHA under Article 9(4) of EU REACH. Where the notifier complies with Article 9(2) in accordance with this paragraph, no fee is payable under Article 9(2). (1) This Article applies if a registration with ECHA under Article 17 of EU REACH which relates to an on-site isolated intermediate that is manufactured in Great Britain is— (a) subsisting immediately before IP completion day, and (b) either— (i) has a current connection with Great Britain, or (ii) has a relevant past connection with Great Britain (but does not have a current connection with Great Britain). (2) On and after IP completion day, the registration has effect as a registration with the Agency under Article 17 of this Regulation. (3) Where paragraph 2 operates on a registration the manufacturer concerned must give the Agency— (a) the information referred to in Article 17(2)(a), (b), (e) and (f) and the confirmation referred to in Article 17(3), within the 120 day post-IP completion period, and (b) the information referred to in Article 17(2)(c) and (d) within the relevant post-IP completion period. (4) Article 19(1) does not apply to the giving of information in accordance with paragraph 3 of this Article. (5) The manufacturer concerned must submit the registration number and registration date assigned to the existing EU registration by ECHA in accordance with Article 20(3) of EU REACH, and such other evidence as the Agency may require of the existing EU registration, to the Agency within the 120 day post-IP completion period. (6) Where paragraph 2 operates on a registration, the other Titles of this Regulation apply to that registration as they would apply to the registration if it had been submitted to the Agency under Article 17 on IP completion day, but with the modifications set out in the following provisions of this Article. (7) No fee is payable under Article 17(2). (8) Article 20 has effect with the following provision substituted for paragraphs 1 to 3— (1) The Agency must assign a submission date to each registration which has effect under Article 127L, which must be the date on which the registrant complies with paragraph 3(a) or (b) of Article 127L. (2) The Agency may undertake a completeness check of each registration in order to ascertain that all the elements required under Article 17 have been provided. The completeness check must not include an assessment of the quality or the adequacy of any data or justifications submitted. If a registration is incomplete, the Agency must inform the registrant as to what further information is required in order for the registration to be complete, while setting a reasonable deadline for this. The registrant must complete his registration and submit it to the Agency within the deadline set. The Agency must confirm the submission date of the further information to the registrant. The Agency must perform a further completeness check, considering the further information submitted. (3) Once the registrant has complied with paragraph 3(a) of Article 127L, the Agency must assign a registration number to the substance concerned and a registration date, which must be the same as the registration date for the existing EU registration. (9) Article 21 has effect with the following provision substituted for the first subparagraph of paragraph 1— (1) A registrant may continue the manufacture of a substance from IP completion day, subject to any indication to the contrary from the Agency in accordance with Article 20(2). (1) This Article applies if a registration with ECHA under Article 18 of EU REACH which relates to a transported isolated intermediate that is manufactured in or imported into Great Britain is— (a) subsisting immediately before IP completion day, and (b) either— (i) has a current connection with Great Britain, or (ii) has a relevant past connection with Great Britain (but does not have a current connection with Great Britain). (2) On and after IP completion day, the registration has effect as a registration with the Agency under Article 18 of this Regulation. (3) Where paragraph 2 operates on a registration, the manufacturer or importer concerned must give the Agency— (a) the information referred to in Article 18(2)(a), (b), (e) and (f) and the confirmation referred to in Article 18(4), within the 120 day post-IP completion period, and (b) the information referred to in Article 18(2)(c) and (d) and 18(3) within the relevant post-IP completion period. (4) Article 19(1) does not apply to the giving of information in accordance with paragraph 3 of this Article. (5) The manufacturer or importer concerned must submit the registration number and registration date assigned to the existing EU registration by ECHA in accordance with Article 20(3) of EU REACH, and such other evidence as the Agency may require of the existing EU registration, to the Agency within the 120 day post-IP completion period. (6) Where paragraph 2 operates on a registration, the other Titles of this Regulation apply to that registration as they would apply to the registration if it had been submitted to the Agency under Article 18 on IP completion day, but with the modifications set out in the following provisions of this Article. (7) No fee is payable under Article 18(2). (8) Article 20 has effect with the following provision substituted for paragraphs 1 to 3— (1) The Agency must assign a submission date to each registration which has effect under Article 127M, which must be the date on which the registrant complies with paragraph 3(a) or (b) of Article 127M. (2) The Agency may undertake a completeness check of each registration in order to ascertain that all the elements required under Article 18 have been provided. The completeness check must not include an assessment of the quality or the adequacy of any data or justifications submitted. If a registration is incomplete, the Agency must inform the registrant as to what further information is required in order for the registration to be complete, while setting a reasonable deadline for this. The registrant must complete his registration and submit it to the Agency within the deadline set. The Agency must confirm the submission date of the further information to the registrant. The Agency must perform a further completeness check, considering the further information submitted. (3) Once the registrant has complied with paragraph 3(a) of Article 127M, the Agency must assign a registration number to the substance concerned and a registration date, which must be the same as the registration date for the existing EU registration. (9) Article 21 has effect with the following provision substituted for the first subparagraph of paragraph 1— (1) A registrant may continue the manufacture or import of a substance from IP completion day, subject to any indication to the contrary from the Agency in accordance with Article 20(2). (1) Articles 127L and 127M are to be read in accordance with paragraphs 2 to 5. (2) A registration under Article 17 or 18 of EU REACH (as the case may be) has a current connection with Great Britain if— (a) the registrant immediately before IP completion day is a person established in Great Britain (a “current GB registrant”), and (b) a registration of the substance concerned by the current GB registrant is a registration of a kind that could be submitted on IP completion day under Article 17 or 18 (as the case may be) of this Regulation. (3) A registration under Article 17 or 18 of EU REACH (as the case may be) has a relevant past connection with Great Britain if— (a) the registrant at any time in the period beginning with 29 March 2017 and ending immediately before IP completion day was a person established in Great Britain (a “former GB registrant”), and (b) a registration of the substance concerned by the former GB registrant is a registration of a kind that could be submitted on IP completion day— (i) under Article 17 of this Regulation if the former GB registrant was the manufacturer of the on-site intermediate concerned on IP completion day, or (ii) under Article 18 of this Regulation if the former GB registrant was the manufacturer or importer of the transported isolated intermediate concerned on IP completion day. (4) Where a registration that has a current connection with Great Britain has effect as a registration with the Agency by virtue of Article 127L or 127M, the current GB registrant becomes the registrant in relation to the registration with the Agency on IP completion day. (5) Where a registration that has a relevant past connection with Great Britain has effect as a registration with the Agency by virtue of Article 127L or 127M, the former GB registrant becomes the registrant in relation to the registration with the Agency on IP completion day. If two or more persons have been former GB registrants at different times in the period beginning with 29 March 2017 and ending immediately before IP completion day, only the person who was the former GB registrant most recently before IP completion day is to become the registrant in relation to the registration with the Agency by virtue of this paragraph. (1) This Article applies to a person established in Great Britain who, immediately before IP completion day, is, as respects any information, bound by the obligation imposed by Article 36(1) of EU REACH. (2) On and after IP completion day, the person is, as respects the information concerned, bound by the obligation imposed by Article 36(1) of this Regulation. (3) Where paragraph 2 applies to a person, the person is not bound by the obligation imposed by Article 36(1) of this Regulation after the end of a 10 year period under Article 36(1) of EU REACH that was running at IP completion day (and the reference to the 10 year period in Article 36(1) of this Regulation is accordingly to be read as a reference to the remainder of the 10 year period under EU REACH that falls after IP completion day). In this Title— (1) “60 day post-IP completion period” means the period of 60 days beginning with the day after that on which IP completion day falls; (2) “90 day post-IP completion period” means the period of 90 days beginning with the day after that on which IP completion day falls; (3) “120 day post-IP completion period” means the period of 120 days beginning with the day after that on which IP completion day falls; (4) “180 day post-IP completion period” means the period of 180 days beginning with the day after that on which IP completion day falls; (4A) “300 day post-IP completion period” means the period of 300 days beginning with the day after that on which IP completion day falls; (4B) “relevant post-IP completion period” means the period beginning with the day after that on which IP completion day falls and ending— (a) two years after the end of the 300 day post-IP completion period in respect of— (i) substances included on the candidate list by virtue of Article 59(1A), (ii) substances classified as carcinogenic, mutagenic or toxic to reproduction, category 1A or 1B, in accordance with Regulation (EC) No 1272/2008 and manufactured in Great Britain or imported, in quantities reaching one tonne or more per year per manufacturer or importer, at least once after IP completion day, (iii) substances classified as aquatic chronic category 1 (very toxic to aquatic life with long lasting effects) or aquatic acute category 1 (very toxic to aquatic life) in accordance with Regulation (EC) No 1272/2008 and manufactured in Great Britain or imported, in quantities reaching 100 tonnes or more per year per manufacturer or importer, at least once after IP completion day, (iv) substances manufactured in Great Britain or imported, in quantities reaching 1,000 tonnes or more per year per manufacturer or importer, at least once after IP completion day, (b) four years after the end of the 300 day post-IP completion period in respect of— (i) substances added to the candidate list referred to in Article 59(1), other than by virtue of Article 59(1A), before the end of the period referred to in subparagraph (a), (ii) substances manufactured in Great Britain or imported, in quantities reaching 100 tonnes or more per year per manufacturer or importer, at least once after IP completion day, (c) six years after the end of the 300 day post-IP completion period in respect of substances manufactured in Great Britain or imported, in quantities reaching 1 tonne or more per year per manufacturer or importer, at least once after IP completion day. (5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

SCHEDULE 3 — Amendment of the Annexes and Appendices to the REACH Regulation

PART 1 — The Annexes

Annex 1

1

(1) Annex 1 (general provisions for assessing substances and preparing chemical safety reports) is amended as follows.

(2) In point 0.5, in the first paragraph, for “Community” substitute “domestic or European Union”.

(3) In point 1.1.2, for the words from “test methods laid down” to “Article 13(3)” substitute “Council Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to REACH”.

(4) In point 1.3.1, in the first paragraph, omit “and Articles 4 to 7 of Directive 1999/45/EC”.

(5) In point 5.1.1, in the second paragraph, for “the Community” substitute “Great Britain”.

Annex 2

2

(1) Annex 2 (requirements for the compilation of safety data sheets) is amended as follows.

(2) In point 0.2.2, after “set out in” insert “ retained EU law that transposed ”.

(3) In point 1.1—

(a) in the first paragraph, for the words from “the official language(s)” to the end of the paragraph substitute “ English ”;

(b) in the third paragraph, in point (b), omit the words “Member State”.

(4) In point 1.3—

(a) omit the second paragraph;

(b) in the fourth paragraph, for “non-Union” substitute “non-Great British”.

(5) In point 1.4, omit from “in the Member State” to “on the market”.

(6) In point 2.1, in the first paragraph, omit “to the classification and labelling inventory”.

(7) In point 3.2.2(a)(ii), omit “Union”.

(8) In point 3.2.3, omit “Union”.

(9) In point 3.2.4, in point (b), omit the words “Member State”.

(10) In point 7, in the second paragraph, after “measures according to” insert “ retained EU law that transposed ”.

(11) In point 8.1.1, omit “in the Member State in which the safety data sheet is being provided”.

(12) For points 8.1.1.1 to 8.1.1.5 substitute—

(8.1.1.1) the workplace exposure limit within the meaning of the Control of Substances Hazardous to Health Regulations 2002 (S.I. 2002/2677); (8.1.1.2) the occupational exposure limit within the meaning of the Control of Lead at Work Regulations 2002 (S.I. 2002/2676).

(13) In point 8.2.1, after “in accordance with” insert “ the retained EU law that transposed ”.

(14) In point 8.2.2.2, for “Council Directive 89/686/EEC” substitute “ Regulation (EU) 2016/425 ”.

(15) In point 8.2.3, omit “Union”.

(16) In point 13, in the first paragraph—

(a) after “the requirements of” insert “ the retained EU law that transposed ”;

(b) omit “by the Member State in which the safety data sheet is being supplied”.

(17) In point 13.1, in the second paragraph, for the words from “Union” to “force” substitute “ legislation relating to waste ”.

(18) In point 14, omit from “, all three” to “of the Council”.

(19) In point 15.1, in the first paragraph—

(a) omit “Union”;

(b) for “for example,” substitute “ including relevant EU provisions transposed through retained EU law, such as the ”;

(d) omit the second sentence.

Annex 5

3

In Annex 5 (exemptions from the obligation to register in accordance with Article 2(7)(b)), in paragraph 8, for “dangerous” substitute “ hazardous ”.

Annex 7

4

In Annex 7 (standard information requirements for substances manufactured or imported in quantities of one tonne or more), in footnote (2), for the words from “the appropriate” to “specified in” substitute “ regulations under ”.

Annex 8

5

In Annex 8 (standard information requirements for substances manufactured or imported in quantities of 10 tonnes or more), in footnote (2), for the words from “the appropriate” to “specified in” substitute “ regulations under ”.

Annex 9

6

(1) Annex 9 (standard information requirements for substances manufactured or imported in quantities of 100 tonnes or more) is amended as follows.

(2) In footnote (2), for the words from “the appropriate” to “specified in” substitute “ regulations under ”.

(3) In point 8.7.2, in the first column, for “as specified in” substitute “ made under ”.

(4) In point 8.7.3, in the first column, for “as specified in” substitute “ made under ”.

Annex 10

7

(1) Annex 10 (standard information requirements for substances manufactured or imported in quantities of 1,000 tonnes or more) is amended as follows.

(2) In footnote (2), for the words from “the appropriate” to “specified in” substitute “ regulations under ”.

(3) In point 8.7.3, in the first column, for “as specified in” substitute “ made under ”.

Annex 11

8

(1) Annex 11 (general rules for adaptation of the standard testing regime set out in Annexes 7 to 10) is amended as follows.

(2) In point 1.2, in the second paragraph, omit “the Commission or”.

(3) In point 1.3, in the second paragraph, omit “the Commission, Member States and”.

(4) In point 1.4, in the first paragraph—

(a) omit “(e.g. the European Centre for the Validation of Alternative Methods (ECVAM)) criteria”;

(b) for “process)” substitute “ process ”.

(5) In point 1.5, in the first paragraph, omit “sufficiently in advance of the first registration deadline for phase-in substances”.

Annex 12

9

In Annex 12 (general provisions for downstream users to assess substances and prepare chemical safety reports), in the introduction, in the second paragraph, for “Community” substitute “ other ”.

Annex 14

10

In Annex 14 (list of substances subject to authorisation), in entry Nr 4, in the entry for the column headed “exempted (categories of) uses”, for “Directive 2001/82/EC, and/or Directive 2001/83/EC” substitute “ the Veterinary Medicines Regulations 2013 or the Human Medicines Regulations 2012 ”.

Annex 15

11

(1) Annex 15 (dossiers) is amended as follows.

(2) In Part 1 (introduction and general provisions), in the first paragraph, in the second indent, omit “within the Community”.

(3) In Part 2 (content of dossiers), in section 3 (Dossiers for restrictions proposal)—

(a) in the heading “Justification for Restrictions at Community Level”, omit “at Community level”;

(b) in the paragraph that follows that heading—

(i) in the first indent omit “on a Community-wide basis”;

(ii) in the second indent omit “Community wide”.

Annex 17

12

Annex 17 (restrictions on the manufacture, placing on the market and use of certain dangerous substances, mixtures and articles) is amended as follows.

13

Immediately before the Table insert—

(1) In this Annex “competent appropriate authority”, in relation to the exercise of a function under this Annex, means— (a) the Secretary of State if, or to the extent that, the exercise of the function— (i) relates to England; (ii) relates to Scotland and is not within devolved competence (within the meaning of section 54 of the Scotland Act 1998); (iii) relates to Wales and is not within devolved competence (within the meaning of section 58A(7) and (8) of the Government of Wales Act 2006); (iv) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (b) the Scottish Ministers 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); (c) the Welsh Ministers 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); (d) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

14

(1) In entry 3 in the table (liquid substances or mixtures regarded as dangerous or fulfilling the criteria for certain hazard classes or categories), the second column is amended as follows.

(2) In paragraph 4, for the words from “European Standard” to “(CEN)” substitute “ British Standard Specification on Decorative oil lamps (BS EN 14059) adopted by the British Standards Institute ”.

(3) In paragraph 5, for “Community provisions” substitute “ legislation ”.

(4) Omit paragraph 6.

(5) In paragraph 7, for the words from “competent” to “Commission” substitute “ Agency ”.

15

In entry 5 in the table (benzene), in the second column, in paragraph (4), in point (a), for “Directive 98/70/EC” substitute “ the Motor Fuel (Composition and Content) Regulations 1999 ”.

16

(1) In entry 6 in the table (asbestos fibres), the second column is amended as follows.

(2) In paragraph 1, omit the second, third and fourth subparagraphs.

(3) In paragraph 2—

(a) in the first subparagraph, for “Member States may” substitute “ the competent appropriate authority may, after having consulted the other appropriate authorities ”;

(b) in the second subparagraph—

(i) for “Member States may” substitute “ The competent appropriate authority may, after having consulted the other appropriate authorities, ”;

(ii) omit the second and third sentences.

(4) In paragraph 3, for “Community provisions” substitute “ legislation ”.

17

In entries 16 (lead carbonates) and 17 (lead sulphates) in the table, in the second column—

(a) for “Member States may” substitute “ the competent appropriate authority may, after having consulted the other appropriate authorities ”;

(b) omit “on their territory”;

18

In entry 18a in the table (mercury), in the second column, in paragraph 2, for “Member States may” substitute “ the competent appropriate authority may, after having consulted the other appropriate authorities, ”.

19

(1) In entry 19 in the table (arsenic compounds), the second column is amended as follows.

(2) In paragraph 4—

(a) in point (a), for “Article 5(1) of Directive 98/8/EC” substitute “ Articles 19 or 26 of Regulation (EU) No 528/2012 ”;

(b) in point (c), for “Community provisions” substitute “ legislation ”.

(3) In paragraph 7, for “Member States may” substitute “ The competent appropriate authority may, after having consulted the other appropriate authorities, ”.

20

In entry 23 in the table (cadmium), in the second column—

(a) in the first paragraph, after “2658/87” insert “ , as it has effect in EU law immediately before IP completion day. For the purposes of this entry that Regulation has effect as if the references to Euratom were omitted ”;

(b) in paragraph 1—

(i) omit the penultimate subparagraph (which begins “The first and second subparagraphs”);

(ii) omit the final subparagraph (which begins “By 19 November 2012,”);

21

In entry 24 in the table (monomethyl – tetrachlorodiphenyl methane), in the second column, in paragraph 2, in the second subparagraph, for “Member States may” substitute “ the competent appropriate authority may, after having consulted the other appropriate authorities ”.

22

(1) In entries 28 to 30 of the table (certain substances that are carcinogens, cell mutagens or toxic to reproduction) the second column is amended as follows.

(2) In paragraph 1, in the second subparagraph, for “Community provisions” substitute “ legislation ”.

(3) In paragraph 2—

(a) for point (a) substitute—

(a) medicinal or veterinary medicinal products as defined by the Veterinary Medicines Regulations 2013 and the Human Medicines Regulations 2012;

(b) in point (b), for “Directive 76/768/EEC” substitute “ Regulation 1223/2009 ”;

(c) in point (c), in the first indent, for “Directive 98/70/EC” substitute “ the Motor Fuel (Composition and Content) Regulations 1999 ”.

23

In entry 31 of the table (creosotes etc.), in the second column, in paragraph 2(a)—

(a) in the first subparagraph omit “Community”;

(b) in the third subparagraph, for “Community provisions” substitute “ legislation ”.

24

In entries 32 to 38 of the table (chloroform etc.), in the second column, in paragraph 2—

(a) for “Community provisions” substitute “ legislation ”;

(b) for point (a) substitute—

(a) medicinal or veterinary medicinal products as defined by the Veterinary Medicines Regulations 2013 and the Human Medicines Regulations 2012;

25

In entry 40 of the table (certain flammable substances etc.), in the second column, in paragraph 2, for “Community provisions” substitute “ legislation ”.

26

In entry 45 of the table (diphenylether, octabromo derivative), in the second column, in paragraph 3, for “Directive 2002/95/EC” substitute “ the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 2012 ”.

27

In entry 47 of the table (chromium VI compounds), in the second column, in paragraph 2, for “Community provisions” substitute “ legislation ”.

28

(1) In entry 50 of the table (polycyclic-aromatic hydrocarbons), the second column is amended as follows.

(2) In paragraph 1, in the second subparagraph, for “EN” substitute “ BS EN ”.

(3) For paragraph 4 substitute—

(4) For the purpose of this entry ‘tyres’ shall mean tyres for vehicles covered by: - — Regulation (EU) 2018/858 of the European Parliament and of the Council of 30 May 2018 on the approval and market surveillance of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles; - — Regulation (EU) No 167/2013 of the European Parliament and of the Council on the approval and market surveillance of agricultural and forestry vehicles ; - — Regulation (EU) No 168/2013 of the European Parliament and of the Council on the approval and market surveillance of two- or three-wheel vehicles and quadricycles .

29

In entry 55 of the table (2-(2-butoxyethoxy)ethanol), in the second column, in paragraph 3, omit “Community”.

30

(1) In entry 56 of the table (methylenediphenyl diisocyanate), the second column is amended as follows.

(2) In paragraph 1(a), for “Council Directive 89/686/EEC” substitute “ Regulation (EU) 2016/425 ”.

(3) In paragraph 1(b)—

(a) omit “Community”;

(b) in the third indent, for “EN” substitute “ BS EN ”.

31

In entry 57 of the table (cyclohexane), in the second column, in paragraph 3, omit “Community”.

32

(1) In entry 58 of the table (ammonium nitrate), the second column is amended as follows.

(2) In paragraph 2(a), for “Council Directive 93/15/EEC” substitute “ the retained EU law that transposed Directive 2014/28/EU ”.

(3) In paragraph 2(b)—

(a) in the definition of “farmer”—

(i) omit “by national law”;

(ii) for the words from “Community” to “Treaty” substitute “Great Britain”;

(b) in the definition of “agricultural activity”, omit from “as established” to the end of the definition.

(4) Omit paragraph 3.

33

(1) In entry 59 of the table (dichloromethane), the second column is amended as follows.

(2) In paragraph 2—

(a) in the first subparagraph—

(i) for “Member States may” substitute “ the competent appropriate authority may, after having consulted the other appropriate authorities, ”;

(ii) omit “on their territories and”.

(b) in the second subparagraph—

(i) for “Member States making use of this” substitute “ A ”;

(ii) omit “and shall inform the Commission thereof”;

(i) omit “that is accepted by the Member State in which that professional operates”;

(ii) omit “or be otherwise approved by that Member State,”;

(d) omit the fourth subparagraph.

(3) In paragraph 3, in the first subparagraph—

(a) omit the first sentence;

(b) in point (c), for “Directive 89/686/EEC” substitute “ Regulation (EU) 2016/425 ”.

(4) In paragraph 4—

(a) omit “Community”;

(b) in point (d), for “Directive 89/686/EEC” substitute “ Regulation (EU) 2016/425 ”.

(5) In paragraph 5—

(a) for “Community provisions” substitute “ legislation ”;

(b) in the text in quotation marks—

(i) after “industrial use and to” insert “ approved ”;

(ii) omit “approved in certain EU Member States”.

34

(1) In entry 63 of the table (lead), the second column is amended as follows.

(2) In paragraph 4(a), for the words from “Annex I” to “69/493/EEC” substitute “ the Crystal Glass (Descriptions) Regulations 1973 ”.

(3) In paragraph 4(c), after “2658/87” insert “ as it has effect in EU law immediately before IP completion day ”.

(4) Omit paragraph 6.

(5) In paragraph 8(b), for the words from “Annex I” to “69/493/EEC” substitute “ the Crystal Glass (Descriptions) Regulations 1973 ”.

(6) In paragraph 8(c), after “2658/87” insert “ as it has effect in EU law immediately before IP completion day ”.

(7) In paragraph 8(k)—

(a) in point (i), before “Directive” insert “ the retained EU law that transposed ”;

(b) for point (iii) substitute—

(iii) the Toys (Safety) Regulations 2011 ;

(iv) the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 2012.

(8) In paragraph 9—

(a) for “Commission” substitute “ Agency ”;

(b) for “modify this entry accordingly” substitute “ make recommendations to the Secretary of State ”.

35

In entry 65 of the table (inorganic ammonium salts), in the second column—

(a) omit paragraph 3;

(b) in paragraph 4, for “CEN/TS 16516” substitute “ BS EN 16516: 2017 ”.

36

(1) In entry 67 (Bis(pentabromophenyl)ether), the second column is amended as follows.

(2) In paragraph 3(b)(ii)—

(a) for “Directive 2007/46/EC” substitute “Regulation (EU) 2018/858 of the European Parliament and of the Council”;

(b) for “Directive 2006/42/EC of the European Parliament and of the Council” substitute “ the Supply of Machinery (Safety) Regulations 2008 ”.

(3) In paragraph 4(d), for “Directive 2011/65/EU” substitute “ the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 2012 ”.

(4) In paragraph 5, for “Regulation (EU) No 216/2008 of the European Parliament and of the Council” substitute “ Regulation (EU) 2018/1139 of the European Parliament and of the Council ”.

37

In entry 68 (Perfluorooctanoic acid), in the second column, in paragraphs 3(c) and 4(d)(i), for “Directive 93/42/EEC” substitute “ the Medical Devices Regulations 2002 ”.

PART 2 — The Appendices

38

In Appendix 7 (special provisions on the labelling of articles containing asbestos)—

(a) in paragraph 1(c), omit the second subparagraph;

(b) in paragraph 5, for “Community provisions” substitute “ legislation ”;

(c) in paragraph 7, for the words from “the official” to the end substitute “ English, and may also be done in other languages ”.

39

In Appendix 10 (entry 43 – Azocolourants – list of testing methods)—

(a) in the heading of the first column of the table, omit “European”;

(b) in the first column of each entry in the table, for “CEN” substitute “ BSI ”;

SCHEDULE 4 — Amendment of the Test Methods Regulation

1

Commission Regulation (EC) No 440/2008 laying down test methods pursuant to the REACH Regulation is amended in accordance with this Schedule.

2

In Article 2, for “Commission” substitute “ Secretary of State ”.

3

For Article 4 substitute—

In this Regulation, “Agency” has the meaning given in Article 3(18) of Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency.

4

(1) Part B of the Annex (methods for the determination of toxicity and other health effects) is amended as follows.

(2) In the General Introduction, in section C (alternative testing), for “The European Union” substitute “Great Britain”.

(3) In section B.36 (toxicokinetics), in paragraphs 37 and 38, for “a competent authority” substitute “ the Agency ”.

(4) In section B.54 (uterotrophic bioassay in rodents: a short-term screening test for oestrogenic properties), in paragraphs 11 and 19, for the words from “local regulations” to “scientific purposes” substitute “ , for example, the Animals (Scientific Procedures) Act 1986 ”.

(5) In section B.55 (Hershberger bioassay in rats: a short-term screening assay for (anti)androgenic properties), in paragraphs 10 and 19, for the words from “local regulations” to “scientific purposes” substitute “ , for example, the Animals (Scientific Procedures) Act 1986 ”.

5

(1) Part C of the Annex (methods for the determination of ecotoxicity) is amended as follows.

(2) In section C.11 (activated sludge, respiration inhibition test (carbon and ammonium oxidation)), in paragraph 3, for the text after the semi-colon substitute “ lower limits for the concentration of nitrogen in treated effluents discharged to receiving waters are now in force. ”.

(3) In section C.41 (fish sexual development test), in paragraph 39, for the words from “Directive 2010/63/EU” to “scientific purposes” substitute “ the Animals (Scientific Procedures) Act 1986 ”.

1

Commission Implementing Regulation (EU) 2016/9 on joint submission of data and data-sharing in accordance with Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) is amended in accordance with this Schedule.

2

(1) Article 2 is amended as follows.

(2) In paragraph 1, omit “or participants in a Substance Information Exchange Forum (SIEF)”.

(3) In paragraph 2—

(a) in the first subparagraph—

(i) for “already exists on the date of entry into force of this Regulation” substitute “ existed before 25 January 2016 ”;

(ii) after “paragraph 1.” insert “ A waiver under Article 2(2) of the EU Implementing Regulation which is in effect immediately before IP completion day has effect on and after IP completion day as a waiver under this Article of this Regulation (and here “EU Implementing Regulation” means Commission Implementing Regulation (EU) 2016/9 as it has effect in EU law). ”;

(b) in the second subparagraph, for “Articles 27 and 30” substitute “ Article 27 ”;

(i) in point (a), for “after the date of entry into force of this Regulation” substitute “ on or after 25 January 2016 ”;

(ii) in point (b), for the words from “the date” to the end substitute “ 25 January 2016, that is requested ”.

(4) In paragraph 3—

(a) in the third subparagraph, for “the entry into force of this Regulation” substitute “ 25 January 2016 ”;

(b) in the fourth subparagraph, after “of a study” insert “ (whether to ECHA or the Agency) ”;

In this paragraph the term “ECHA” has the same meaning as in Regulation (EC) No 1907/2006.

3

In Article 3—

(a) in paragraph 2, for “Articles 27(6) and 30(3)” substitute “ Article 27(6) ”;

(b) in paragraph 3, for “Articles 26 or 29” substitute “ Article 26 ”.

4

In Article 4—

(a) in paragraph 1, for “Articles 27(3) and 30(1)” substitute “ Article 27(3) ”;

(b) in paragraph 3, for “Articles 27 and 30” substitute “ Article 27 ”;

(i) for “already exists on the date of entry into force of this Regulation” substitute “ existed before 25 January 2016 ”;

(ii) after “model.” insert—

A waiver under Article 4(5) of the EU Implementing Regulation which is in effect immediately before IP completion day has effect on and after IP completion day as a waiver under this Article of this Regulation (and here “EU Implementing Regulation” means Commission Implementing Regulation (EU) 2016/9 as it has effect in EU law).

5

In Article 5—

(a) in paragraph 1, for “Articles 27(5) and 30(3)” substitute “ Article 27(5) ”;

(b) omit paragraph 2.

6

Omit Article 6.

SCHEDULE 6 — Amendment of the Fees and Charges Regulation

1

Commission Regulation (EC) No 340/2008 on the fees and charges payable to the European Chemicals Agency is amended in accordance with this Schedule.

2

In Article 1, for “European Chemicals Agency, hereinafter the ‘Agency’, as provided for in” substitute “ Agency, within the meaning of ”.

3

In Article 2, at the end insert—

In the application of Recommendation 2003/361/EC for the purposes of this Regulation, 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.

4

In Article 3(5), omit the second subparagraph.

5

In Article 4(5), omit the second subparagraph.

6

Omit Article 10.

7

(1) Article 11 is amended as follows.

(2) In paragraph 1—

(a) in the second subparagraph, omit the words from “and for” to “1907/2006”;

(b) in the third subparagraph, omit “Executive Director of the”.

(3) In paragraph 5—

(a) omit “the Management Board of”;

(b) for “Commission” substitute “ Secretary of State ”;

The function of the Secretary of State under this paragraph is subject to the consent requirement in Article 4A of Regulation (EC) No 1907/2006.

8

In Article 12, for “non-Community”, in both places it occurs, substitute “non-Great British”.

9

(1) Article 13 is amended as follows.

(2) In paragraph 1, for “3 to 10” substitute “ 3 to 9 ”.

(3) In paragraph 3, in the second subparagraph—

(a) for “one of the official languages of the Union” substitute “ English ”;

(b) for “any of those official languages” substitute “ English ”.

10

Omit Articles 14 and 15.

11

(1) Article 16 is amended as follows.

(2) In paragraph 1, for “euro” substitute “ sterling ”.

(3) In paragraph 2, omit “, with the exception of payments due under Article 10”.

12

In Article 17(1)—

(a) in the first subparagraph, for the words from “invoice” to “Article 10.” substitute “ submission number assigned by the Agency under Article 20 of Regulation (EC) No 1907/2006. ”;

(b) omit the second subparagraph.

13

In Article 19(2), omit “the Management Board of”.

14

In Article 20(1)—

(a) in the first subparagraph, omit “the Executive Director of”;

(b) in the second subparagraph, for “EUR 100” substitute “ £87 ”.

15

Omit Article 21.

16

For Article 22 substitute—

(1) The Secretary of State may, by regulations, amend this Regulation so as to alter the fees and charges provided for in it if the Secretary of State considers that the alterations are appropriate having regard to— (a) the change in the relevant prices index, and (b) the costs of the Agency (taking one year with another). (2) Regulations under this Article are to be made by statutory instrument. A statutory instrument containing regulations under this Article is subject to annulment in pursuance of a resolution of either House of Parliament. The Secretary of State must consult the other appropriate authorities before making regulations under this Article. (3) In this Article— (a) “appropriate authority” has the same meaning as in Article 3 of Regulation (EC) No 1907/2006; (b) “relevant prices index” means— (i) the all items consumer prices index published by the Statistics Board, or (ii) if that index ceases to be available, such other similar general index of prices which the Secretary of State considers appropriate to use for the purposes of this Article.

17

Omit Article 23.

18

(1) Annex 1 is amended as follows.

(2) In Table 1, for the entries which set out the fees substitute—

£1,518	£1,138
£4,080	£3,061
£10,913	£8,185
£29,419	£22,064

(3) In Table 2, for the entries which set out the fees substitute—

£987	£740	£532	£399	£76	£57
£2,652	£1,990	£1,428	£1,071	£204	£153
£7,094	£5,320	£3,819	£2,865	£546	£409
£19,122	£14,342	£10,297	£7,723	£1,471	£1,103

19

(1) Annex 2 is amended as follows.

(2) In Table 1, for the entries which set out the fees substitute—

£1,518	£1,138

(3) In Table 2, for the entries which set out the fees substitute—

£987	£740	£532	£399	£76	£57

20

(1) Annex 3 is amended as follows.

(2) In Table 1, for the entries which set out the fees substitute—

£2,562	£1,921
£9,395	£7,046
£27,901	£20,926
£6,833	£5,125
£25,339	£19,003
£18,506	£13,879

(3) In Table 2, for the entries which set out the fees substitute—

*£1,666*	*£1,249*	*£897*	*£672*	*£128*	*£96*
£6,107	£4,580	£3,289	£2,466	£470	£353
£18,136	£13,601	£9,765	£7,324	£1,395	£1,046
£4,441	£3,331	£2,391	£1,794	£341	£257
£16,470	£12,353	£8,869	£6,651	£1,267	£950
£12,029	£9,022	£6,477	£4,857	£925	£694

(4) In Table 3—

(a) for “EUR 1 631” in the first place (the fee for a change in the identity of the registrant involving a change in legal personality) substitute “ £1,424 ”;

(b) for the entries which set out the other fees substitute—

£4,271	£3,203
£1,424	£1,068
£4,271	£3,203
£2,847	£2,135
£1,424	£1,068
£1,424	£1,068
£1,424	£1,068

(5) In Table 4—

(a) for the first three entries which set out fees (fees for changes of identity of the registrant involving a change in legal personality) substitute—

£925	£498	£72

(b) for the other entries which set out fees substitute—

£2,776	£2,082	£1,495	£1,121	£214	£160
£925	£694	£498	£374	£72	£53
£2,776	£2,082	£1,495	£1,121	£214	£160
£1,851	£1,388	£996	£747	£142	£107
£925	£694	£498	£374	£72	£53
£925	£694	£498	£374	£72	£53
£925	£694	£498	£374	£72	£53

21

(1) Annex 4 is amended as follows.

(2) In Table 1, for the entries which set out the fees substitute—

£4,271	£3,203
£1,424	£1,068
£4,271	£3,203
£2,847	£2,135
£1,424	£1,068
£1,424	£1,068
£1,424	£1,068

(3) In Table 2, for the entries which set out the fees substitute—

£2,776	£2,082	£1,495	£1,121	£214	£160
£925	£694	£498	£374	£72	£53
£2,776	£2,082	£1,495	£1,121	£214	£160
£1,851	£1,388	£996	£747	£142	£107
£925	£694	£498	£374	£72	£53
£925	£694	£498	£374	£72	£53
£925	£694	£498	£374	£72	£53

22

(1) Annex 5 is amended as follows.

(2) In Table 1, for the entries which set out the fees substitute—

£475
£308
£166
£24

(3) In Table 2, for the entries which set out the charges substitute—

£949
£617
£332
£47

23

(1) Annex 6 is amended as follows.

(2) In Table 1, for the entries which set out the fees substitute—

£47,229
£9,446
£42,506

(3) In Table 2, for the entries which set out the fees substitute—

£35,422
£7,084
£31,880

(4) In Table 3, for the entries which set out the fees substitute—

£21,253
£4,251
£19,128

(5) In Table 4, for the entries which set out the fees substitute—

£4,723
£945
£4,251

24

(1) Annex 7 is amended as follows.

(2) In Table 1, for the entries which set out the charges substitute—

£47,229
£9,446
£42,506

(3) In Table 2, for the entries which set out the charges substitute—

£35,422
£7,084
£31,880

(4) In Table 3, for the entries which set out the charges substitute—

£21,253
£4,251
£19,128

(5) In Table 4, for the entries which set out the charges substitute—

£4,723
£945
£4,251

25

Omit Annex 8.

SCHEDULE 7 — Amendment of an authorisation under Article 60(4) of the REACH Regulation

1

Commission Implementing Decision C(2017) 3439 granting an authorisation for a use of chromium trioxide under REACH (Rimex Metals (UK) Ltd) is amended in accordance with this Schedule.

2

In Article 3(d), for “competent authority of the Member State where the authorised use takes place” substitute “ Agency (as defined in that Regulation) ”.

SCHEDULE 8 — Revocation of retained direct EU legislation

1

The following retained direct EU legislation is revoked—

(a) Commission Regulation (EC) No 506/2007 imposing testing and information requirements on the importers or manufacturers of certain priority substances in accordance with Council Regulation (EEC) No 793/93 on the evaluation and control of the risks of existing substances;

(b) Commission Regulation (EC) No 1238/2007 on laying down rules on the qualifications of the members of the Board of Appeal of the European Chemicals Agency;

(c) Commission Regulation (EC) No 465/2008 imposing, pursuant to Council Regulation (EEC) No 793/93, testing and information requirements on importers and manufacturers of certain substances that may be persistent, bioaccumulating and toxic and are listed in the European Inventory of Existing Commercial Chemical Substances;

(d) Commission Regulation (EC) No 466/2008 imposing testing and information requirements on the importers and manufacturers of certain priority substances in accordance with Council Regulation (EEC) No 793/93 on the evaluation and control of the risks of existing substances;

(e) Commission Regulation (EC) No 771/2008 laying down the rules of organisation and procedure of the Board of Appeal of the European Chemicals Agency;

(f) Commission Decision 2010/226/EU on the re-examination of the restriction concerning short-chain chlorinated paraffins (SCCPs) listed in Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council.

SCHEDULE 9 — Amendment of the EEA agreement

1

In Annex 2 to the EEA agreement (Technical Regulations, Standards, Testing and Certification), in Chapter 15 (dangerous substances)—

(a) in point 12zc, omit—

(i) from “The Provisions” to “following adaptations:”;

(ii) paragraphs (a) to (p);

(b) omit points 12zca, 12zf, 12zl, 12zm, 12zn, 12zs, 12zx, 12zza.

SCHEDULE 10 — Amendment of the REACH Enforcement Regulations 2008

PART 1 — Enforcement of requirements under transitional provisions relating to EU exit

Enforcement of requirements under transitional provisions relating to EU exit

1

(1) In regulation 2(1)—

(a) in the definition of “a listed REACH provision”, for “the REACH table” substitute “ a REACH table ”;

(b) for the definition of “the REACH table” substitute—

“a REACH table” means— (a) the table in Schedule 1 to these Regulations, ... (b) the table in Schedule 1A to these Regulations, or (c) the table in Schedule 1B to these Regulations; “the relevant REACH table” means— (a) in relation to a listed REACH provision, the REACH table in which that REACH provision is listed; (b) in relation to an enforcement duty, the REACH table under which that enforcement duty arises.

(2) In regulation 3—

(a) for “REACH table”, in each place it occurs, substitute “relevant REACH table”.

(i) in subparagraph (a), for “adjacent to Northern Ireland” substitute “within the seaward limits of the territorial sea adjacent to Northern Ireland”;

(ii) omit subparagraph (b).

(3) In regulation 3A(1), for “in any column” to the end substitute “ against any listed REACH provision in any column of the relevant REACH table ”.

(4) In the title of Schedule 1, after “of” insert “ General ”.

(5) After Schedule 1 insert—

SCHEDULE 1A

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