CHAPTER 2PROCESS FOR EVALUATION OF DOSSIERS
Article 3Application for approval or inclusion in F1the Simplified Active Substance List
1.
An application for approval or inclusion in F2the Simplified Active Substance List may be submitted only by a participant whose notification has been found compliant by the F3competent authority pursuant to Article 17(5) of this Regulation.
Where the application concerns inclusion in F2the Simplified Active Substance List, it may only concern F4categories A or B of that F5list.
2.
Applications referred to in paragraph 1 shall be submitted to the F3competent authority within two years of the declaration of compliance pursuant to Article 17(5).
F6Article 4Acceptance of applications
The competent authority shall inform the participant of the appropriate fee within 30 days after the competent authority has accepted the application. If the participant fails to pay the fee within 30 days of notification of the fee, the competent authority shall reject the application and inform the participant accordingly.
Article 5Validation of applications for approval or inclusion in F7category B of F8the Simplified Active Substance List
F91.
Where an application for approval or inclusion in F10category B of the Simplified Active Substance List containing the data required in accordance with Article 6(1) and (2) of Regulation (EU) No 528/2012 has been accepted by the competent authority and the appropriate fee has been paid pursuant to Article 4 the competent authority shall validate the application within 30 days of that payment.
F112.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.
4.
Where the F14... competent authority considers that the application is incomplete, it shall inform the participant as to what additional information is required for the validation of the application and shall set a reasonable time limit for the submission of that information. That time limit shall not normally exceed 90 days.
The F14... competent authority shall, within 30 days of receipt of the additional information, validate the application if it determines that the additional information submitted is sufficient to comply with the requirement laid down in paragraph F151.
The F14... competent authority shall reject the application if the participant fails to submit the requested information within the deadline and shall inform the participant F16... accordingly. In such cases, part of the F17appropriate fees paid shall be reimbursed.
On validating an application, the F14... competent authority shall without delay inform the participant, F18... indicating the date of the validation.
Article 6Evaluation of applications
1.
This Article shall apply where any of the following conditions applies:
(a)
where an application has been validated pursuant to Article 5;
F19(b)
where, before IP completion day, the evaluating competent authority in a Member State has accepted the dossier as complete pursuant to Article 13 of Regulation (EC) No 1451/2007 but not yet submitted the competent authority report to the Commission pursuant to Article 14(4) of that Regulation;
2.
The F24... competent authority shall evaluate the application in accordance with Articles 4 and 5 of Regulation (EU) No 528/2012, including, where relevant, any proposal to adapt data requirements submitted in accordance with Article 6(3) of that Regulation, and F25produce an assessment report and conclusions of its evaluation.
3.
Where several participants support the same substance/product-type combination, the F26... competent authority shall draft only one assessment report. The assessment report and the conclusions shall be F27produced within either of the following time-limits, whichever is the later:
(a)
365 days of the last validation referred to in paragraph 1(a), acceptance of completeness referred to in paragraph 1(b) or payment of the fee referred to in paragraph 1(c), for the substance/product-type combination in question;
(b)
the time limits F28specified by the Secretary of State and Devolved Authorities.
4.
Prior to F29producing its conclusions F30... the F31... competent authority shall give the participant the opportunity to provide written comments on the assessment report and on the conclusions of the evaluation within 30 days. The F31... competent authority shall take due account of those comments when finalising its evaluation.
5.
Where it appears that additional information is necessary to carry out the evaluation, the F32... competent authority shall ask the participant to submit such information within a specified time limitF33....
The 365-day period referred to in paragraph 3 shall be suspended from the date of issue of the request until the date the information is received. Unless it is justified by the nature of the data requested or by exceptional circumstances, the suspension shall not exceed the following time-limits:
(a)
365 days in cases where the additional information relates to concerns which were not addressed under Directive 98/8/EC or under the practice established for application of that Directive;
(b)
180 days in other cases.
6.
7.
Upon finalisation of its hazard evaluation, the F35... competent authority shall without undue delay and no later than at the time F36the assessment report is produced pursuant to paragraph 3, as appropriate:
(a)
submit a proposal to the F37relevant authority pursuant to F38Article 37A(2) of Regulation (EC) No 1272/2008, where it considers that one of the criteria referred to in Article 36(1) thereof is fulfilled and not properly addressed in F39the F40GB mandatory classification and labelling list defined in Article 2 of that Regulation;
(b)
consult the F41relevant authority appointed under Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC where it considers that one of the criteria of Article 5(1)(d) or (e) of Regulation (EU) No 528/2012, or the condition of Article 10(1)(d) of that Regulation, is fulfilled and not properly addressed in Annex XIV to Regulation (EC) No 1907/2006 or in the candidate list referred to in Article 59(1) of that Regulation.
F42Article 6aApplications for which the competent authority of the United Kingdom was the evaluating competent authority before 30 March 2019
1.
This Article is applicable to applications for which the competent authority of the United Kingdom was the evaluating competent authority before 30 March 2019 for the entries 79, 85, 113, 171, 187, 188, 321, 345, 346, 458, 531, 554, 571, 599, 609, 1045, 1046 and 1047 of Annex II.
2.
The evaluating competent authority of a Member State having replaced the competent authority of the United Kingdom in relation to an application that has been submitted before 30 March 2019 , shall inform the participant of the fees payable under Article 80(2) of Regulation (EU) No 528/2012 at the latest by 30 April 2019 , and shall reject the application if the participant fails to pay the fees within a period of time fixed by the evaluating competent authority. It shall inform the participant and the Agency accordingly.
3.
By derogation from the time limits laid down in Article 6(3), the assessment report and the conclusions shall be sent by the evaluating competent authority within either of the following time limits, whichever is the later:
(a)
31 December 2020 ;
(b)
the time limit for submitting the assessment report pursuant to Article 6(3)(b) set out in Annex III.
F44Article 7Opinion of F43the competent authority
1.
This Article shall apply where the competent authority has produced an assessment report pursuant to Article 6(2) and, where relevant, a proposal or a consultation pursuant to Article 6(7).
2.
The competent authority shall within 270 days of completion of the assessment report, prepare and submit an opinion to the Secretary of State and the Devolved Authorities on the approval of the substance/product-type combination or its inclusion in F45categories A or B of the Simplified Active Substance list or both.
The competent authority shall start the preparation of the opinion within 90 days of the completion of the assessment report and evaluation conclusions.
Article 8Active substances which are candidates for substitution
1.
When preparing its opinion pursuant to Article 7(2), F46the competent authority shall examine whether the active substance fulfils any of the criteria listed in Article 10(1) of Regulation (EU) No 528/2012 and address the matter in its opinion.
2.
Prior to submitting its opinion to F47the Secretary of State, F46the competent authority shall make publicly available, without prejudice to Articles 66 and 67 of Regulation (EU) No 528/2012, information on potential candidates for substitution during a period of no more than 60 days, during which time interested third parties may submit relevant information, including information on available substitutes. F46The competent authority shall take due account of the information received when finalising its opinion.
3.
Where the active substance is approved and fulfils one of the criteria laid down in Article 10(1) of Regulation (EU) No 528/2012, it shall be identified as a candidate for substitution in the F48decision made pursuant to Article 89(5) of that Regulation.
Article 9F49Decision
Upon receipt of the opinion of F50the competent authority pursuant to Article 7(2), F51the Secretary of State shall without undue delay F52issue a decision pursuant to Article 89(5) or, as appropriate, Article 28(1) of Regulation (EU) No 528/2012.
F53The Secretary of State's decision is subject to the consent requirement.