- Draft legislation
This is a draft item of legislation and has not yet been made as a UK Statutory Instrument. This draft has been replaced by a new draft, The REACH etc. (Amendment etc.) (EU Exit) Regulations 2019 ISBN 978-0-11-118035-8
Regulation 4
1. After Article 127 of the REACH Regulation insert—
1. An existing EU registration under Articles 6, 7(1), 7(5) or 24(1) of EU REACH has effect on and after exit day as a UK registration (the “transferred UK registration”) if the registration—
(a)has a current connection with the UK, or
(b)has a relevant past connection with the UK (but does not have a current connection with the UK).
2. A registration has a current connection with the UK if—
(a)the registrant immediately before exit day is a person established in the United Kingdom (a “current UK registrant”), and
(b)a registration of the substance concerned by the current UK registrant is a registration of a kind that could be submitted on exit day under Articles 6, 7(1) or 7(5) of this Regulation.
3. A registration has a relevant past connection with the UK if—
(a)the registrant at any time during the 2 year period before exit day was a person established in the United Kingdom (a “former UK registrant”), and
(b)a registration of the substance concerned by the former UK registrant is a registration of a kind that could be submitted on exit day—
(i)under Article 6 of this Regulation if the former UK registrant was the manufacturer or importer of the substance concerned on exit day, or
(ii)under Article 7(1) or (5) of this Regulation if the former UK registrant was the producer or importer of the article containing the substance concerned on exit day.
4. Where an existing EU registration has effect by virtue of this Article as a transferred UK registration, it has effect—
(a)if it is an existing EU registration under Article 6 of EU REACH, as a transferred UK 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 UK 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 UK 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 UK registration that exists by virtue of Article 6 of this Regulation.
5. Where a registration that has a current connection with the UK has effect as a transferred UK registration by virtue of this Article, the current UK registrant becomes the registrant in relation to the transferred UK registration on exit day.
6. Where a registration that has a former connection with the UK has effect as a transferred UK registration by virtue of this Article, the former UK registrant becomes the registrant in relation to the transferred UK registration on exit day.
If two or more persons have been former UK registrants at different times during the 2 year period before exit, only the person who was the former UK registrant most recently before exit day is to become registrant in relation to the transferred UK registration by virtue of this paragraph.
1. The other Titles of this Regulation apply to a transferred UK registration as they would apply to the registration—
(a)if it had been submitted on exit day to the Agency under Articles 6, 7(1) or 7(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 exit 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 UK 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 UK registration under Article 6, no fee is payable under Article 6(4);
(b)a transferred UK 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 60 day post-exit period;
(b)the other Article 10 information to the Agency within the 2 year post-exit 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 UK registration unless Article 24(2) applied in relation to the notified substance concerned before exit 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 exit 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 60 day post-exit 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 UK 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 shall 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 UK registration may continue the manufacture or import of a substance or production or import of an article from exit 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 UK 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 UK registration under Article 127A.
2. Any existing ECHA decision which relates to the registration has effect on and after exit day as a decision of the Agency which relates to the transferred UK registration.
3. The registrant must—
(a)notify the Agency, within the 60 day post-exit 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 exit 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 exit 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 exit day;
“transferred UK registration” has the meaning given in Article 127A(1);
“UK registration” means a registration of a substance with the Agency.
1. This Article applies to a person that is—
(a)an existing UK downstream user under EU REACH, or
(b)an existing UK distributor under EU REACH,
in relation to a substance (the “UK user or distributor”).
2. In any case where the transitional protection conditions are met, the UK user or distributor is to be treated for the purposes of this Regulation—
(a)as a downstream user as respects the substance concerned (if they are an existing UK downstream user), or
(b)as a distributor as respects the substance concerned (if they are an existing UK distributor).
3. The transitional protection conditions are met in any case where—
(a)the substance is imported to the United Kingdom from an EEA state,
(b)the existing UK user or distributor is the importer in relation to the import,
(c)the import occurs during the 2 year post-exit period, and
(d)the person who supplies the substance to the UK user or distributor for the import (the “relevant supplier”) is either a registrant or a downstream user under EU REACH as respects the substance concerned.
4. If the relevant supplier meets the requirement in paragraph 3(d), it does not matter whether they are—
(a)the person from which the UK user or distributor obtained supplies of the substance before exit day (and therefore the person in relation to which the UK user was a downstream user or distributor under EU REACH), or
(b)a different person.
5. Where paragraph 3 applies in the case of an import of the substance concerned, the provisions of this Regulation that apply to importers do not apply to the UK user or distributor in relation to that import.
6. If the UK user or distributor imports the substance into the United Kingdom in quantities of 1 to 10 tonnes per year, they must within the 180 day post-exit 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 (ii) and (iv) of Article 10 to the extent that information is available to the UK 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, and such other evidence as the Agency may require demonstrating that the information supplied in accordance with paragraph (c) above complies with the requirements of Articles 10, 12 and 14 (as they apply to the tonnage of the substance which the UK user or distributor imports into the United Kingdom).
7. If the UK user or distributor imports the substance into the United Kingdom in quantities of 10 tonnes or more per year, they must within the 180 day post-exit 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 (ii) and (iv) of Article 10 to the extent that information is available to the UK user or distributor;
(c)supply the Agency with the information referred to in—
(i)Article 14(6),
(ii)Article 31,
(iii)points (a) to (d) of Article 32(1), and
(iv)otherwise comply with Articles 14(6), 31 and 32;
(d)supply the Agency with the relevant registration number for the substance under EU REACH, and such other evidence that the Agency may require demonstrating that the information supplied in accordance with paragraph (c) above complies with the requirements of Articles 10, 12 and 14 (as they apply to the tonnage of the substance which the UK user or distributor imports into the United Kingdom).
8. The UK user or distributor must provide the Agency with updated information of the kind required by paragraph 6 or 7, in particular where the UK user or distributor begins to import the substance concerned from a different relevant supplier.
9. In this Article—
“existing UK distributor under EU REACH” means a person who was, at any time in the 2 year period before exit day, a distributor under EU REACH established in the United Kingdom in relation to a substance;
“existing UK downstream user under EU REACH” means a person who was, at any time in the 2 year period before exit day, a downstream user under EU REACH established in the United Kingdom in relation to a substance;
“relevant supplier” has the meaning given in paragraph 3(d).
1. The holder of an existing EU authorisation which has the relevant connection with the United Kingdom must, before the end of the 60 day post-exit 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 the United Kingdom ceases to have effect (as retained EU law) on exit day.
3. An existing EU authorisation has the relevant connection with the United Kingdom if the holder of the authorisation is established in the United Kingdom.
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 exit 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 exit 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 exit day,
(ii)has the relevant connection with the United Kingdom; 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 the United Kingdom if the person making the application is established in the United Kingdom.
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 exit 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 exit 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-exit 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 exit day for the grant of an authorisation in accordance with Articles 60 to 64 of EU REACH.
1. On and after exit day, a person who—
(a)is established in the United Kingdom, 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-exit 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 exit 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 exit day, as it has effect in EU law;
1. On and after exit day, an existing EU decision on a testing proposal which has the relevant connection with the United Kingdom 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 the United Kingdom if the registrant, or downstream user, concerned is established in the United Kingdom.
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 exit day, a producer of articles established in the United Kingdom, or an importer of articles established in the United Kingdom, has given ECHA a notification under Article 7(2) of EU REACH in relation to a substance, and
(b)immediately before exit 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-exit 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 exit day where the research and development concerned takes place in the United Kingdom.
2. On and after exit 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 60 day post-exit 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 the United Kingdom is—
(a)subsisting immediately before exit day, and
(b)either—
(i)has a current connection with the UK, or
(ii)has a relevant past connection with the UK (but does not have a current connection with the UK).
2. On and after exit 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 60 day post-exit period, and
(b)the information referred to in Article 17(2)(c) and (d) within the 2 year post-exit 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 60 day post-exit 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 exit 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 exit 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 the United Kingdom is—
(a)subsisting immediately before exit day, and
(b)either—
(i)has a current connection with the UK, or
(ii)has a relevant past connection with the UK (but does not have a current connection with the UK).
2. On and after exit 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 60 day post-exit period, and
(b)the information referred to in Article 18(2)(c) and (d) and 18(3) within the 2 year post-exit 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 60 day post-exit 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 exit 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 exit 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 the UK if—
(a)the registrant immediately before exit day is a person established in the United Kingdom (a “current UK registrant”), and
(b)a registration of the substance concerned by the current UK registrant is a registration of a kind that could be submitted on exit 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 the UK if—
(a)the registrant at any time during the 2 year period before exit was a person established in the United Kingdom (a “former UK registrant”), and
(b)a registration of the substance concerned by the former UK registrant is a registration of a kind that could be submitted on exit day—
(i)under Article 17 of this Regulation if the former UK registrant was the manufacturer of the on-site intermediate concerned on exit day, or
(ii)under Article 18 of this Regulation if the former UK registrant was the manufacturer or importer of the transported isolated intermediate concerned on exit day.
4. Where a registration that has a current connection with the UK has effect as a registration with the Agency by virtue of Article 127L or 127M, the current UK registrant becomes the registrant in relation to the registration with the Agency on exit day.
5. Where a registration that has a former connection with the UK has effect as a registration with the Agency by virtue of Article 127L or 127M, the former UK registrant becomes the registrant in relation to the registration with the Agency on exit day.
If two or more persons have been former UK registrants at different times during the 2 year period before exit, only the person who was the former UK registrant most recently before exit day is to become registrant in relation to the registration with the Agency by virtue of this paragraph.
1. This Article applies to a person established in the United Kingdom who, immediately before exit day, is, as respects any information, bound by the obligation imposed by Article 36(1) of EU REACH.
2. On and after exit 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 exit 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 exit day).
In this Title—
(1) “60 day post-exit period” means the period of 60 days beginning with the day after that on which exit day falls;
(2) “90 day post-exit period” means the period of 90 days beginning with the day after that on which exit day falls;
(3) “180 day post-exit period” means the period of 180 days beginning with the day after that on which exit day falls;
(4) “2 year period before exit” means the period of two years ending with exit day;
(5) “2 year post-exit period” means the period of two years beginning with the day after that on which exit day falls.”.
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