The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019

235.  After Article 22 insert— U.K.

“Article 22A U.K. Transitional measures for ongoing applications submitted before [F1 IP completion day]

1.   This Article applies where an application was made before [F1 IP completion day] to a Member State in accordance with Article 3 and accepted under Article 4 of Regulation (EU) No 1062/2014 or Article 9 of Regulation (EC) No 1451/2007 as they had effect immediately before [F1 IP completion day] and where a decision on approval has not been made before [F1 IP completion day].

2.   The application will be treated as having been received under Article 4 of this Regulation as it has effect in retained EU law if the participant resubmits their application and supporting dossier to the competent authority within:

(a) 90 days after [F2 IP completion day] where the United Kingdom [F3 competent authority] was the evaluating [F4 competent authority] prior to [F5 30 March 2019]; or

(b) 180 days after [F2 IP completion day] where the United Kingdom [F3 competent authority] was not the evaluating [F4 competent authority] prior to [F5 30 March 2019].

[F6 3.   Where the applicant does not meet the requirements of this Article, the application is to be treated as having been withdrawn under Article 11(1)(b).]

Article 22B U.K. Declaration of interest to notify

1.   This Article applies where a declaration of interest to notify was submitted before [F7 IP completion day] under Article 16 of Regulation (EU) No 1062/2014 as it had effect immediately before [F7 IP completion day].

2.   Where a declaration of interest to notify made pursuant to Article 16(1) was declared compliant under Article 16(3) or (4) it will be treated as being compliant under this Regulation as it has effect in retained EU law.

3.   If a declaration of interest to notify was made pursuant to Article 16(1) but no decision on whether the declaration is compliant has been made before [F7 IP completion day], the person with an interest to notify may submit their declaration of interest under Article 16 of this Regulation to the competent authority within 180 days of [F7 IP completion day].

4.   In circumstances where the time period for declarations of interest to notify as specified in Article 16(1)(a) of Regulation (EU) 1062/2014 has not expired before [F7 IP completion day], applications for declarations of interest to notify may be made to the competent authority under this Regulation at the latest 365 days after the publication of the decision or guidance referred to in point (a) of Article 15 of Regulation (EU) 1062/2014.

Where a declaration of interest is made in compliance with paragraph 3 or 4 the declaration shall be treated as having been made under Article 16 of this Regulation.

Article 22C U.K. Notification procedure pursuant to Articles 14(2) and 16(5)

1.   This Article applies in relation to notifications made under Article 14(2) or 16(5) of Regulation (EU) 1062/2014.

2.   Where a notification made under Article 14(2) or Article 16(5) was declared compliant under Article 17(5) before [F7 IP completion day], the notification will be treated as if it were compliant under this Regulation. The Secretary of State must update Annex II to this Regulation in accordance with Article 89(2) of Regulation 528/2012 if:

(a) a declaration of interest to notify is resubmitted to the competent authority; and

(b) the information as detailed within Annex I to this Regulation is resubmitted to the competent authority within a period of 180 days of [F7 IP completion day].

3.   The applications referred to in Article 3(1) must be submitted to the competent authority within two years of the notification of the declaration of compliance made under Article 17(5) of this Regulation.

4.   Where a notification made pursuant to either Article 14(2) or Article 16(5) was made in accordance with Regulation (EU) 1062/2014 before [F7 IP completion day] but for which no declaration of compliance pursuant to Article 17(5) was made before [F7 IP completion day], the person may within 180 days of [F7 IP completion day] resubmit their notification to the competent authority under Article 16 of this Regulation.

5.   Where the relevant notification deadline as specified within Article 14(2) or Article 16(5) of Regulation (EU) 1062/2014 has not passed before [F7 IP completion day], a person may submit their notification to the competent authority under Article 16 of this Regulation, provided the notification is submitted before that notification deadline has passed.

6.   A declaration of compliance made in accordance with paragraph 3 or 4 shall be considered as having been made under Article 17(5) of this Regulation.

Article 22D U.K. Dossiers submitted to Rapporteur Member States before [F8 IP completion day]

1.   This Article applies where a dossier was submitted before [F8 IP completion day] for evaluation by a Member State in accordance with Article 14 of Commission Regulation (EC) No 1451/2007.

2.   The application will be treated as having being made under this Regulation if the applicant resubmits their application and supporting dossier to the competent authority within:

[F9 (a) 90 days of IP completion day, where the United Kingdom competent authority was the evaluating competent authority before 30 March 2019, or

(b) 180 days of IP completion day, where the United Kingdom competent authority was not the evaluating competent authority before 30 March 2019].

[F10 3.   Where the applicant does not meet the requirements of this Article, the application will be treated as having been withdrawn under Article 11(1)(b).”]

Textual Amendments

F1 Words in Sch. 2 para. 235 substituted (31.12.2020 immediately before IP completion day) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1567), reg. 1(2), Sch. 2 para. 72(a)(i)

F2 Words in Sch. 2 para. 235 substituted (31.12.2020 immediately before IP completion day) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1567), reg. 1(2), Sch. 2 para. 72(a)(ii)(aa)

F3 Words in Sch. 2 para. 235 inserted (31.12.2020 immediately before IP completion day) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1567), reg. 1(2), Sch. 2 para. 72(a)(ii)(bb)

F4 Words in Sch. 2 para. 235 substituted (31.12.2020 immediately before IP completion day) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1567), reg. 1(2), Sch. 2 para. 72(a)(ii)(cc)

F5 Words in Sch. 2 para. 235 substituted (31.12.2020 immediately before IP completion day) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1567), reg. 1(2), Sch. 2 para. 72(a)(ii)(dd)

F6 Words in Sch. 2 para. 235 inserted (31.12.2020 immediately before IP completion day) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1567), reg. 1(2), Sch. 2 para. 72(a)(iii)

F7 Words in Sch. 2 para. 235 substituted (31.12.2020 immediately before IP completion day) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1567), reg. 1(2), Sch. 2 para. 72(b)

F8 Words in Sch. 2 para. 235 substituted (31.12.2020 immediately before IP completion day) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1567), reg. 1(2), Sch. 2 para. 72(c)(i)

F9 Words in Sch. 2 para. 235 substituted (31.12.2020 immediately before IP completion day) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1567), reg. 1(2), Sch. 2 para. 72(c)(ii)

F10 Words in Sch. 2 para. 235 inserted (31.12.2020 immediately before IP completion day) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1567), reg. 1(2), Sch. 2 para. 72(c)(iii)

Commencement Information

I1 Sch. 2 para. 235 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)