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

“TITLE 14AEU withdrawal: transitional provision

Article 127AExisting EU registrations which have effect as F49GB registrations

1.

An existing EU registration under Articles 6, 7(1), 7(5) or 24(1) of EU REACH has effect on and after F50IP completion day as a F49GB registration (the “transferred F49GB registration”) if the registration—

(a)

has a current connection with F51Great Britain, or

(b)

has a relevant past connection with F51Great Britain (but does not have a current connection with F51Great Britain).

2.

A registration has a current connection with F51Great Britain if—

(a)

the registrant immediately before F50IP completion day is a person established in F51Great Britain (a “current F49GB registrant”), and

(b)

a registration of the substance concerned by the current F49GB registrant is a registration of a kind that could be submitted on F50IP completion day under Article 6 or 7(1) or (5) of this Regulation.

3.

A registration has a relevant past connection with F51Great Britain if—

(a)

the registrant at any time F52in the period beginning with 29 March 2017 and ending immediately before F50IP completion day was a person established in F51Great Britain (a “former F49GB registrant”), and

(b)

a registration of the substance concerned by the former F49GB registrant is a registration of a kind that could be submitted on F50IP 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 F49GB registration, it has effect—

(a)

if it is an existing EU registration under Article 6 of EU REACH, as a transferred F49GB 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 F49GB 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 F49GB 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 F49GB registration that exists by virtue of Article 6 of this Regulation.

5.

Where a registration that has a current connection with F51Great Britain has effect as a transferred F49GB registration by virtue of this Article, the current F49GB registrant becomes the registrant in relation to the transferred F49GB registration on F50IP completion day.

6.

Where a registration that has a relevant past connection with F51Great Britain has effect as a transferred F49GB registration by virtue of this Article, the former F49GB registrant becomes the registrant in relation to the transferred F49GB registration on F50IP completion day.

If two or more persons have been former F49GB registrants at different times F53in the period beginning with 29 March 2017 and ending immediately before F50IP completion day, only the person who was the former F49GB registrant most recently before F50IP completion day is to become registrant in relation to the transferred F49GB registration by virtue of this paragraph.

Article 127BApplication of this Regulation to transferred F49GB registrations

1.

The other Titles of this Regulation apply to a transferred F49GB registration as they would apply to the registration—

(a)

if it had been submitted on F50IP 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 F50IP 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 F49GB 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 F49GB registration under Article 6, no fee is payable under Article 6(4);

(b)

a transferred F49GB 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 F54post-IP completion period;

(b)

the other Article 10 information to the Agency within the F55relevant F54post-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 F49GB registration unless Article 24(2) applied in relation to the notified substance concerned before F50IP 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 F50IP 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 F54post-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 F49GB 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 F49GB registration may continue the manufacture or import of a substance or production or import of an article from F50IP 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 F49GB 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.

Article 127CDecisions of ECHA relating to existing EU registrations

1.

This Article applies in relation to an existing EU registration which has effect as a transferred F49GB registration under Article 127A.

2.

Any existing ECHA decision which relates to the registration has effect on and after F50IP completion day as a decision of the Agency which relates to the transferred F49GB registration.

3.

The registrant must—

(a)

notify the Agency, within the 120 day F54post-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 F50IP 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 F50IP completion day.

Article 127DInterpretation of Articles 127A to 127C

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 F50IP completion day;

“transferred F49GB registration” has the meaning given in Article 127A(1);

“F49GB registration” means a registration of a substance with the Agency.

F56Article 127E F57Pre-IP completion downstream users and distributors that are to continue to be regarded as downstream users

1.

This Article applies in a case where—

(a)

a person is—

(i)

an existing F49GB downstream user under EU REACH, or

(ii)

an existing F49GB distributor under EU REACH,

in relation to a substance (the “F49GB user or distributor”), and

(b)

there is a protected transitional import of the substance by the F49GB user or distributor.

2.

There is a protected transitional import of the substance by the F49GB user or distributor if—

(a)

the substance is imported to F51Great Britain on its own, in a mixture or in an article,

(b)

the F49GB user or distributor is the importer in relation to the import,

(c)

the import occurs during the F58relevant F54post-IP completion period, and

(d)

either—

(i)

the person who supplies the substance, mixture or article to the F49GB 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 F49GB 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 F49GB 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 F49GB 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 F49GB user or distributor obtained supplies of the substance, mixture or article before F50IP completion day (and therefore the person in relation to which the F49GB 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 F49GB user or distributor obtained before F50IP completion day, or

(b)

a different person.

6.

The provisions of this Regulation that apply to importers F59, including in respect of protected NI imports, do not apply to the F49GB user or distributor in relation to the protected transitional import of the substance by the F49GB user or distributor.

7.

If the F49GB user or distributor imports the substance into F51Great Britain in quantities of 1 to 10 tonnes per year, they must within the F60300 day F54post-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 F49GB 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 F49GB 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 F49GB user or distributor imports into F51Great Britain by protected transitional F61imports);

F62(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 F49GB user or distributor imports the substance into F51Great Britain in quantities of 10 tonnes or more per year, they must within the F63300 day F54post-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 F49GB 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 F49GB 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 F49GB 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 F49GB user or distributor imports into F51Great Britain by protected transitional F64imports);

F65(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 F49GB user or distributor must provide the Agency with updated information of the kind required by paragraph 7 or 8, in particular where the F49GB 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 F49GB 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 F66, 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 F67and paragraph 6 of Article 127EB.

12.

In this Article—

“existing F49GB distributor under EU REACH” means a person who was, at any time in the 2 year period before F50IP completion day, a distributor under EU REACH established in F51Great Britain in relation to a substance on its own, in a mixture or in an article;

“existing F49GB downstream user under EU REACH” means a person who was, at any time in the 2 year period before F50IP completion day, a downstream user under EU REACH established in F51Great 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);

“F49GB user or distributor” has the meaning given in paragraph 1(a).

F68Article 127EAAppointment of only representative where Article 127E applies

1.

This Article applies in relation to a protected transitional import of a substance by a F49GB user or distributor (within the meaning of Article 127E) F69that 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 F51Great Britain who manufactures a substance on its own, in mixtures or in articles, formulates a mixture or produces an article that is imported into F51Great Britain may by mutual agreement appoint a person established in F51Great Britain to fulfil, as his only representative, the obligations on the F49GB user or distributor under Article 127E.

F701A.

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 F71non-Great British manufacturer shall inform the F49GB user or distributor of the appointment.”.

3.

If the F49GB 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 F49GB user or distributor as respects any protected transitional import where the manufacturer, formulator or producer is the person who appointed the representative.

F72Article 127EBImport from Northern Ireland where Article 127E applies

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.

Article 127FExisting EU authorisations

1.

The holder of an existing EU authorisation which has the relevant connection with F51Great Britain must, before the end of the 60 day F54post-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 F51Great Britain ceases to have effect (as retained EU law) on F50IP completion day.

3.

An existing EU authorisation has the relevant connection with F51Great Britain if the holder of the authorisation is established in F51Great 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 F50IP 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 F50IP completion day under any condition under which the authorisation is granted.

Article 127GExisting applications for EU authorisations

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 F50IP completion day,

(ii)

has the relevant connection with F51Great 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 F51Great Britain if the person making the application is established in F51Great 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 F50IP 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 F50IP 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 F54post-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 F50IP completion day for the grant of an authorisation in accordance with Articles 60 to 64 of EU REACH.

F73Article 127GASubstances of very high concern: sunset dates and latest application dates

1.

Paragraphs 2 and 3 apply where—

(a)

immediately before F50IP completion day, a substance is included in Annex 14 to EU REACH;

(b)

the EU latest application date fell before or during the relevant F57pre-IP completion period;

(c)

the EU sunset date fell during the relevant F57pre-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 F50IP completion day, the authorisation application was still under consideration (see paragraph 11).

2.

Where, immediately before F50IP completion day, a person established in F51Great 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 F50IP completion day—

(a)

the F49GB latest application date, and

(b)

the F49GB 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 F50IP completion day, a substance is included in Annex 14 to EU REACH;

(b)

the EU latest application date fell during the relevant F57pre-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 F50IP completion day, the authorisation application was still under consideration (see paragraph 11).

5.

Where, on and after the F49GB sunset date, a person established in F51Great 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 F50IP completion day—

(a)

the F49GB latest application date, and

(b)

the F49GB 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 F49GB sunset date in paragraph 5.

7.

Paragraph 8 applies where—

(a)

immediately before F50IP completion day, a substance is included in Annex 14 to EU REACH; and

(b)

the F49GB latest application date falls during the 18 month F54post-IP completion period.

8.

As respects a person established in F51Great Britain placing the substance on the market or using it himself on and after F50IP completion day, the F49GB 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 F49GB sunset date (within the meaning of Article 127GA) has been reached and he made an application before the F49GB 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 F49GB 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 F51Great 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 F57pre-IP completion period” means the period that—

(a)

begins with 29 March 2017, and

(b)

ends immediately before F50IP completion day;

“transitional cut-off date” means the last day of the 18 month F54post-IP completion period;

“F49GB 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;

“F49GB 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 F54post-IP completion period” means the period of 18 months beginning with the day after that on which F50IP completion day falls.

Article 127HExisting authorised downstream users under EU law

1.

On and after F50IP completion day, a person who—

(a)

is established in F51Great 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 F54post-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 F50IP 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 F50IP completion day, as it has effect in EU law;

Article 127IExisting examinations of testing proposals

1.

On and after F50IP completion day, an existing EU decision on a testing proposal which has the relevant connection with F51Great 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 F51Great Britain if the registrant, or downstream user, concerned is established in F51Great 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.

Article 127JExisting Article 7(2) notifications

1.

This Article applies if—

(a)

before F50IP completion day, a producer of articles established in F51Great Britain, or an importer of articles established in F51Great Britain, has given ECHA a notification under Article 7(2) of EU REACH in relation to a substance, and

(b)

immediately before F50IP 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 F54post-IP completion period, the information notified to ECHA in accordance with Article 7(2) and (4) of EU REACH.

Article 127KExisting Article 9 exemptions

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 F50IP completion day where the research and development concerned takes place in F51Great Britain.

2.

On and after F50IP 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 F54post-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).

Article 127LExisting Article 17 registrations

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 F51Great Britain is—

(a)

subsisting immediately before F50IP completion day, and

(b)

either—

(i)

has a current connection with F51Great Britain, or

(ii)

has a relevant past connection with F51Great Britain (but does not have a current connection with F51Great Britain).

2.

On and after F50IP 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 F54post-IP completion period, and

(b)

the information referred to in Article 17(2)(c) and (d) within the F74relevant F54post-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 F54post-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 F50IP 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 F50IP completion day, subject to any indication to the contrary from the Agency in accordance with Article 20(2).”.

Article 127MExisting Article 18 registrations

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 F51Great Britain is—

(a)

subsisting immediately before F50IP completion day, and

(b)

either—

(i)

has a current connection with F51Great Britain, or

(ii)

has a relevant past connection with F51Great Britain (but does not have a current connection with F51Great Britain).

2.

On and after F50IP 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 F54post-IP completion period, and

(b)

the information referred to in Article 18(2)(c) and (d) and 18(3) within the F75relevant F54post-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 F54post-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 F50IP 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 F50IP completion day, subject to any indication to the contrary from the Agency in accordance with Article 20(2).”.

Article 127NRegistrations under Article 127L and Article 127M

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 F51Great Britain if—

(a)

the registrant immediately before F50IP completion day is a person established in F51Great Britain (a “current F49GB registrant”), and

(b)

a registration of the substance concerned by the current F49GB registrant is a registration of a kind that could be submitted on F50IP 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 F51Great Britain if—

(a)

the registrant at any time F76in the period beginning with 29 March 2017 and ending immediately before F50IP completion day was a person established in F51Great Britain (a “former F49GB registrant”), and

(b)

a registration of the substance concerned by the former F49GB registrant is a registration of a kind that could be submitted on F50IP completion day—

(i)

under Article 17 of this Regulation if the former F49GB registrant was the manufacturer of the on-site intermediate concerned on F50IP completion day, or

(ii)

under Article 18 of this Regulation if the former F49GB registrant was the manufacturer or importer of the transported isolated intermediate concerned on F50IP completion day.

4.

Where a registration that has a current connection with F51Great Britain has effect as a registration with the Agency by virtue of Article 127L or 127M, the current F49GB registrant becomes the registrant in relation to the registration with the Agency on F50IP completion day.

5.

Where a registration that has a relevant past connection with F51Great Britain has effect as a registration with the Agency by virtue of Article 127L or 127M, the former F49GB registrant becomes the registrant in relation to the registration with the Agency on F50IP completion day.

If two or more persons have been former F49GB registrants at different times F77in the period beginning with 29 March 2017 and ending immediately before F50IP completion day, only the person who was the former F49GB registrant most recently before F50IP completion day is to become the registrant in relation to the registration with the Agency by virtue of this paragraph.

Article 127OObligation to keep information

1.

This Article applies to a person established in F51Great Britain who, immediately before F50IP completion day, is, as respects any information, bound by the obligation imposed by Article 36(1) of EU REACH.

2.

On and after F50IP 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 F50IP 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 F50IP completion day).

Article 127P F78Post-IP completion periods used in this Title

In this Title—

(1)

“60 day F54post-IP completion period” means the period of 60 days beginning with the day after that on which F50IP completion day falls;

(2)

“90 day F54post-IP completion period” means the period of 90 days beginning with the day after that on which F50IP completion day falls;

(3)

“120 day F54post-IP completion period” means the period of 120 days beginning with the day after that on which F50IP completion day falls;

(4)

“180 day F54post-IP completion period” means the period of 180 days beginning with the day after that on which F50IP completion day falls;

F79(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.

F80(5)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F81(6)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .”.

“Title 15AImports from Northern Ireland

Article 139AProtected NI imports

1.

This Article applies in a case where there is a protected NI import of a substance.

2.

There is a protected NI import of a substance if—

(a)

a substance—

(i)

has a relevant connection to Northern Ireland, and

(ii)

is imported on its own, in a mixture or in an article,

(b)

the substance, mixture or article is a qualifying Northern Ireland good, and

(c)

the person who supplies the substance, mixture or article for the import is a registrant or a downstream user under EU REACH as respects the substance as it is imported.

3.

A substance has a relevant connection to Northern Ireland if—

(a)

it is—

(i)

manufactured in Northern Ireland,

(ii)

in a mixture that is manufactured or formulated in Northern Ireland, or

(iii)

in an article that is manufactured or produced in Northern Ireland, and

(b)

it is imported from a supplier established in Northern Ireland.

4.

The importer of the substance (the “GB importer”) is to be treated for the purposes of this Regulation as a downstream user as respects any protected NI imports of the substance by them.

5.

The provisions of this Regulation that apply to importers do not apply to the GB importer in relation to the protected NI import of the substance by the GB importer.

6.

If the GB importer imports the substance in quantities of 1 to 10 tonnes per year they must, before they make a protected NI import—

(a)

notify the Agency of their intention to make the protected NI import,

(b)

supply the Agency with the information referred to in point (a)(i) of Article 10,

(c)

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 importer,

(d)

supply the Agency with the information referred to in points (a) to (d) of Article 32(1) and otherwise comply with Article 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 importer,

(f)

supply the Agency with such other evidence as the Agency may require demonstrating that the information supplied in accordance with subparagraph (d) complies with the requirements of Articles 10, 12 and 14 (as they apply to the tonnage of the substance which the GB importer imports into Great Britain by protected NI imports).

7.

If the GB importer imports the substance in quantities of 10 tonnes or more per year they must, before they make a protected NI import—

(a)

notify the Agency of their intention to make the protected NI import,

(b)

supply the Agency with the information referred to in point (a)(i) of Article 10,

(c)

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 importer,

(d)

supply the Agency with the information referred to in—

(i)

Article 14(6) to the extent that information is available to the GB importer,

(ii)

Article 31, and

(iii)

Article 32(1)(a) to (d),

(e)

otherwise comply with Articles 14(6), 31 and 32,

(f)

supply the Agency with the relevant registration number for the substance under EU REACH to the extent that information is available to the GB importer,

(g)

supply the Agency with such other evidence as the Agency may require demonstrating that the information supplied in accordance with subparagraph (d) complies with the requirements of Articles 10, 12 and 14 (as they apply to the tonnage of the substance which the GB importer imports into Great Britain by protected NI imports).

8.

The GB importer must update the information provided to the Agency under paragraph 6 or 7 with any relevant new information and submit it to the Agency.

1.

9. Paragraphs 6, 7 and 8 are subject to paragraph 6 of Article 139B.

Article 139BNotification by Northern Irish supplier where Article 139A applies

1.

This Article applies in relation to a protected NI import of a substance.

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 importer under Article 139A (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 importer that they intend to do so.

6.

If the GB importer is informed of the intention in accordance with paragraph 5, then paragraphs 6 to 8 of Article 139A apply to the NI notifier instead of the GB importer as respects any protected NI import from the NI notifier.

Article 139CAuthorisations and imports from Northern Ireland

Subject to Articles 139D and 139E, Title 7 applies to and in respect of substances imported from Northern Ireland as it applies to and in respect of other substances.

Article 139DAuthorisations and qualifying Northern Ireland goods

1.

This Article applies to a person (“P”) that is established in Northern Ireland that is a manufacturer, importer or downstream user of a substance under EU REACH.

2.

P may apply for an authorisation in respect of that substance under Article 62 if the substance is a qualifying Northern Ireland good (“QNIG”).

3.

A substance is a QNIG if it is a QNIG on its own, or contained in a mixture or article that is a QNIG.

4.

This Regulation applies to P in respect of the application, and to the authorisation if it is granted, as if P was an only representative of P appointed in accordance with Article 8.

Article 139EApplication of Article 127G to qualifying Northern Ireland goods

1.

This Article applies to a person established in Northern Ireland that made an existing application for an EU authorisation within the meaning of Article 127G(6) (the “existing NI applicant”) that satisfies the condition in paragraph 2.

2.

The condition is that the substance in respect of which the application was made is a qualifying Northern Ireland good (“QNIG”).

3.

The condition in paragraph (2) is satisfied if the application was in respect of a substance that is a QNIG on its own, or a substance contained in a mixture or article that is a QNIG.

4.

Paragraphs 1 to 4 and 6 of Article 127G apply to the existing NI applicant as if the references to “Great Britain” were to “the United Kingdom”.

5.

If the authorisation is granted—

(a)

it has no effect in Northern Ireland,

(b)

this Regulation applies to the existing NI applicant in respect of the authorisation as if the existing NI applicant was an only representative of the existing NI applicant appointed in accordance with Article 8.”.