Commission Delegated Regulation (EU) No 1062/2014
of 4 August 2014
on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products(1), and in particular the first subparagraph of Article 89(1) thereof,
Whereas:
(1)Commission Regulation (EC) No 1451/2007(2) lays down the detailed rules for the programme of review of existing biocidal active substances (the ‘review programme’) commenced in accordance with Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council(3). Since that Directive has been repealed and replaced by Regulation (EU) No 528/2012, the detailed rules for the continuation of the review programme should be adapted to the provisions of that Regulation.
(2)It is important to identify the active substance/product-type combinations that may be made available on the market and used, subject to national rules, by virtue of the transitional provisions laid down in Article 89 of Regulation (EU) No 528/2012. Such should be the case for active substance/product-type combinations that are under evaluation in the review programme.
(3)Where a product has benefitted from the derogation for food and feed provided for by Article 6 of Regulation (EC) No 1451/2007, but is not covered by the exemption for food and feed laid down in Article 2(5)(a) of Regulation (EU) No 528/2012, the active substances it contains should be evaluated in the review programme for the relevant product-type. Subject to national rules, it should be allowed to be made available on the market and used until the end of that evaluation. A system of prior declaration should define which products benefit from this provision. The same should apply where the failure to notify an active substance/product-type combination is due to the new definition of product-types in Regulation (EU) No 528/2012 compared with that in Directive 98/8/EC, or is well justified based on a Commission decision taken in accordance with Article 3(3) of Regulation (EU) No 528/2012, on the case law, such as case C-420/10(4), or on authoritative guidance from the Commission or Member States' competent authorities, which is subsequently reviewed.
(4)Where a biocidal product contains, consists of or generates an active substance which is no longer included in the review programme but the use of that biocidal product is essential in a Member State, that use and the making available on the market for that use should be allowed in that Member State, under the responsibility of the Member State, subject to certain conditions and for a limited period of time.
(5)With a view to ensure consistency and simplification, the procedure for evaluation of active substances in the review programme should, in all relevant parts, be identical with that for applications submitted pursuant to Article 7 of Regulation (EU) No 528/2012 or pursuant to Commission Implementing Regulation (EU) No 88/2014(5).
(6)For substances meeting the exclusion or substitution criteria, the evaluating Competent Authority should submit to the Agency a proposal for harmonised classification and labelling pursuant to Article 37(1) of Regulation (EC) No 1272/2008 of the European Parliament and of the Council(6) for the endpoints of concern, while preserving the right of the Member State to submit a proposal on other or all endpoints. The evaluating Competent Authority should also consult the Agency on substances which would meet the criteria for being persistent, bioaccumulative or toxic, or on substances that would be considered as having endocrine disrupting properties.
(7)In order to ensure that the review programme is finalised by the target date indicated in Article 89(1) of Regulation (EU) No 528/2012, the evaluations should be limited to active substance/product-type combinations for which the relevant data has been submitted within the deadlines laid down in Regulation (EC) No 1451/2007 or this Regulation. Furthermore, appropriate time limits should be established for finalising the evaluations, taking into account the possibility that applications could be validated less than a year before those deadlines.
(8)No data requirements have yet been established for inclusion in category 7 of Annex I to Regulation (EU) No 528/2012. It is therefore appropriate at this time to limit applications for inclusion in that Annex to category 1, 2, 3, 4, 5 or 6.
(9)Notwithstanding Article 90(2) of Regulation (EU) No 528/2012, it follows from Article 91 of that Regulation that the criteria listed in Article 10 of that Regulation should be relevant for the subsequent authorisation of biocidal products in all cases. It is therefore appropriate to identify substances fulfilling those criteria in all active substance evaluations.
(10)A prospective participant in the review programme should be allowed to join or replace an existing participant by mutual agreement, provided that the evaluation is not thereby delayed by limited data access, as the prospective applicant would otherwise have to generate data again.
(11)Since participation in the review programme is voluntary, a participant should be allowed to withdraw from that programme. Where that occurs, prospective participants should be allowed to take over the support, unless that opportunity has already been granted once, thereby already causing delay to the review programme, and unless the Agency has already begun working on its opinion.
(12)Where the evaluation of an active substance demonstrates that the identity formally included in the review programme does not exactly match that of the substance actually being evaluated, and the evaluation does not allow conclusions to be drawn regarding the formally included substance identity, it should be possible to redefine the substance in the course of the evaluation and allow other persons to take over the support of the formally included substance.
(13)Certain substances included in the review programme are not supported by any participant at the time of adoption of this Regulation. The same applies to certain nanomaterials, although, pursuant to Article 4(4) of Regulation (EU) No 528/2012, such materials cannot be approved unless explicitly mentioned. Persons should be allowed to take over the participation for those substances and those nanomaterials, failing which those substances and nanomaterials should be excluded from the review programme.
(14)In order to ensure that no substance is unduly maintained or included in the review programme without subsequently being evaluated, maintenance or inclusion of a substance not yet under evaluation should be subject to a notification of essential data regarding the substance,
HAS ADOPTED THIS REGULATION:
CHAPTER 1SUBJECT MATTER AND DEFINITIONS
Article 1Subject matter
This Regulation lays down rules for the carrying out of the work programme for the systematic examination of all existing active substances referred to in Article 89 of Regulation (EU) No 528/2012.
Article 2Definitions
For the purposes of this Regulation, the following definitions shall apply:
‘non-approval decision’ means a decision—
pursuant to Article 9(1)(b) of Regulation (EU) No 528/2012 not to approve a substance/product-type combination;
made before IP completion day, pursuant to the third subparagraph of Article 89(1) of that Regulation as it had effect immediately before IP completion day, not to approve a substance/product-type combination;
made after IP completion day, pursuant to Article 89(5) of that Regulation, not to approve a substance/product-type combination; or
not to include it in Annex I or IA to Directive 98/8/EC.
‘substance/product-type combination included in the review programme’ means a substance/product-type combination listed in Annex II which complies with the following conditions:
it has not been the subject of either of the following:
a Directive on inclusion in Annex I or IA to Directive 98/8/EC,
a Regulation , made before IP completion day, providing that it is approved pursuant to the third subparagraph of Article 89(1) of Regulation (EU) No 528/2012;
a decision issued by the Secretary of State pursuant to Article 89(5) of Regulation (EU) No 528/2012 after IP completion day;
it has not been the subject of any non-approval decision or the latest non-approval decision concerning it has been repealed;
‘participant’ means a person who has submitted an application for a substance/product-type combination included in the review programme, or has submitted a notification found compliant pursuant to Article 17(5) of this Regulation, or on whose behalf such application or notification has been submitted.
“competent authority” means the authority appointed in accordance with regulation 5 of the Biocidal Products and Chemicals (Appointment of Authorities and Enforcement) Regulations 2013;
“the consent requirement” means the requirement for consent in accordance with Article 83B of Regulation (EU) No 528/2012;
“appropriate fee” means the fee payable for the activity concerned in regulations made under section 43 of the Health and Safety at Work etc. Act 1974 where the competent authority is appointed in accordance with regulation 5 of the Biocidal Products and Chemicals (Appointment of Authorities and Enforcement) Regulations 2013;
“Devolved Authority” means—
the Scottish Ministers, or
the Welsh Ministers.
CHAPTER 2PROCESS FOR EVALUATION OF DOSSIERS
Article 3Application for approval or inclusion in the Simplified Active Substance List
1.An application for approval or inclusion in the Simplified Active Substance List may be submitted only by a participant whose notification has been found compliant by the competent authority pursuant to Article 17(5) of this Regulation.
Where the application concerns inclusion in the Simplified Active Substance List , it may only concern categories A or B of that list .
2.Applications referred to in paragraph 1 shall be submitted to the competent authority within two years of the declaration of compliance pursuant to Article 17(5).
Article 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 category B of the Simplified Active Substance List
1.Where an application for approval or inclusion in category 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.
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3.In the cases referred to in paragraph 1 , the ... competent authority shall not make an assessment of the quality or the adequacy of the data or justifications submitted.
4.Where the ... 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 ... 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 1 .
The ... competent authority shall reject the application if the participant fails to submit the requested information within the deadline and shall inform the participant ... accordingly. In such cases, part of the appropriate fees paid shall be reimbursed.
On validating an application, the ... competent authority shall without delay inform the participant, ... 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;
(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;
(c)where an application for inclusion in category A of the Simplified Active Substance List has been accepted ... and the appropriate fee has been paid pursuant to Article 4(4).
2.The ... 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 produce an assessment report and conclusions of its evaluation .
3.Where several participants support the same substance/product-type combination, the ... competent authority shall draft only one assessment report. The assessment report and the conclusions shall be produced 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 specified by the Secretary of State and Devolved Authorities .
4.Prior to producing its conclusions ... the ... 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 ... 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 ... competent authority shall ask the participant to submit such information within a specified time limit....
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.Where the ... competent authority considers that there are concerns for human health, animal health or the environment as a result of the cumulative effects from the use of biocidal products containing the same or different active substances, it shall document its concerns in accordance with the requirements of the relevant parts of Section II.3 of Annex XV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council(7) and include this as part of its conclusions.
7.Upon finalisation of its hazard evaluation, the ... competent authority shall without undue delay and no later than at the time the assessment report is produced pursuant to paragraph 3, as appropriate:
(a)submit a proposal to the relevant authority pursuant to Article 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 the GB mandatory classification and labelling list defined in Article 2 of that Regulation ;
(b)consult the relevant 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.
Article 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.
Article 7Opinion of the 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 categories 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), the 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 the Secretary of State , the 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. The 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 decision made pursuant to Article 89(5) of that Regulation .
Article 9Decision
Upon receipt of the opinion of the competent authority pursuant to Article 7(2), the Secretary of State shall without undue delay issue a decision pursuant to Article 89(5) or, as appropriate, Article 28(1) of Regulation (EU) No 528/2012.
The Secretary of State's decision is subject to the consent requirement.
CHAPTER 3CHANGES OF ELEMENTS OF THE REVIEW PROGRAMME
Article 10Joining or replacing participants by mutual agreement
1.The role of participant may be taken over or shared by mutual agreement between an existing participant and a prospective participant, provided that the prospective participant has the right to refer to all the data submitted or referred to by the existing participant.
2.A notification for the purpose of this Article shall be submitted jointly to the competent authority by the prospective and the existing participant through the system for the exchange of information between the competent authority and applicants referred to in Article 71 of Regulation (EU) No 528/2012 ..., and shall include all relevant letters of access.
3.Upon receipt of a notification complying with paragraph 2, the competent authority shall update its records with respect to the identity of the participant.
4.A person established in the United Kingdom having taken over or joined the role of participant pursuant to this Article shall be considered as having submitted a dossier or a letter of access to a dossier for the purpose of Article 95 of Regulation (EU) No 528/2012.
Article 11Participants' withdrawal
1.A participant shall be considered to have withdrawn its support for a substance/product-type combination in the review programme in the following cases:
(a)where it has informed the ... competent authority ... of its intention to withdraw;
(b)where it has failed to submit an application within the time limits specified in Article 3(2);
(c)where its application has been rejected pursuant to ..., Article 4(4) or Article 5(4);
(d)where it has failed to provide the additional information within the time limits provided for by Article 6(5);
(e)where it has otherwise failed to pay the fees payable to the competent authority .
2.A withdrawal shall be considered as timely unless it occurs after the date when the ... competent authority submits its competent authority report to the applicant pursuant to Article 6(4) of this Regulation.
Article 12Consequences of a timely withdrawal
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2.Where a timely withdrawal is known to the competent authority , it shall update its records with respect to the identity of the participant.
3.Where all participants supporting the same substance/product-type combination have made a timely withdrawal from the review programme, and where the role of participant for that combination has previously been taken over, the competent authority shall inform the Secretary of State and the Devolved Authorities ...
Article 13Redefinition of active substances
1.Where the evaluation of an existing active substance does not allow for conclusions to be drawn relating to the substance as identified in Annex II, the ... competent authority shall, after consultation with the participant concerned, establish a new substance identity. ...
2.The competent authority shall update its records with respect to the identity of the substance.
Article 14Taking over the role of participant
1.The competent authority shall publish an open invitation to take over the role of participant for a substance/product-type combination where one of the following cases applies:
(a)where all participants supporting the same substance/product-type combination have made a timely withdrawal pursuant to Article 11, and the role of participant for that combination has not previously been taken over;
(b)following a redefinition pursuant to Article 13, in which case, the invitation shall only concern any substance covered by the existing identity in Annex II, but not by the new substance identity.
2.Within 12 months from the date of the publication referred to in paragraph 1, any person may submit a notification for the combination pursuant to Article 17.
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Article 15Substance/product-type combinations eligible for inclusion in the review programme
Where a biocidal product covered by the scope of Regulation (EU) No 528/2012 and being placed on the market consists of, contains or generates an existing active substance which is neither approved, nor included in the review programme, for the product-type, and is not included in the Simplified Active Substance List , that substance shall be eligible for inclusion in the review programme for the relevant product-type on any of the following grounds:
the product was placed on the market before IP completion day and the person placing the product on the market has relied on guidance published by, or written advice received from, the Commission or a competent authority designated in accordance with Article 26 of Directive 98/8/EC or Article 81 of Regulation (EU) No 528/2012, where that guidance or advice gave objectively justified reasons to believe that the product was excluded from the scope of Directive 98/8/EC or of Regulation (EU) No 528/2012, or that the relevant product-type was one for which the active substance had been notified and where that guidance or advice is subsequently reviewed in a decision adopted pursuant to Article 3(3) of Regulation (EU) No 528/2012 or in new, authoritative guidance published by the Commission before IP completion day or the competent authority after IP completion day ;
the product was placed on the market after IP completion day and the person placing the product on the market has relied on guidance published by, or written advice received from, the competent authority after IP completion day, where that guidance or advice gave objectively justified reasons to believe that the product was excluded from the scope of Regulation (EU) No 528/2012, or that the relevant product-type was one for which the active substance had been notified and where that guidance or advice is subsequently reviewed in a decision issued pursuant to Article 3(3) of Regulation (EU) No 528/2012 or in new, authoritative guidance published by the Competent Authority;
the substance has benefitted from the derogation for food and feed provided for by Article 6 of Regulation (EC) No 1451/2007and the person placing the product on the market has complied with the time limits provided for by Regulation (EU) No 528/2012 ;
...
Article 16Declaration of interest to notify
1.A declaration of interest to notify a substance which is eligible for inclusion in the review programme pursuant to Article 15 shall be submitted through the system for the exchange of information between the competent authority and applicants referred to in Article 71 of Regulation (EU) No 528/2012 by any person with an interest to notify a substance/product-type combination to the competent authority at the latest 12 months after the publication of the decision or guidance referred to in point (a) or (aa) of Article 15.
2.A declaration shall indicate the relevant substance/product-type combination. In cases referred to in point (a) or (aa) of Article 15, the declaration shall provide a substantiated justification showing that all the conditions listed therein are fulfilled.
3.Where a declaration has been made in a case referred to in point (a) or (aa) of Article 15, and the competent authority finds , that paragraph 6 is not applicable, and, where relevant, that the conditions for notification listed in point (a) or (aa) of Article 15 are fulfilled, it shall update its records accordingly .
4.Where the competent authority determines that a declaration made under paragraph 3 is valid, the competent authority shall make that information publicly available by electronic means, mentioning the relevant substance/product-type combination. For the purposes of this Regulation, a publication made pursuant to the third subparagraph of Article 3a(3) of Regulation (EC) No 1451/2007 shall be considered as a publication made pursuant to this paragraph.
5.Within 6 months from the date of a publication referred to in paragraph 4, any person with an interest to notify the substance/product-type combination may do so pursuant to Article 17.
6.In cases referred to in points (a) and (aa) of Article 15, a substance/product-type combination shall be considered as notified by a participant, and shall not be eligible for additional notification where the following conditions apply:
(a)the relevant active substance is already included in the review programme;
(b)one of the dossiers submitted to the competent authority for the relevant active substance already contains all the data required for the evaluation of the product-type;
(c)the participant which has submitted that dossier indicates an interest to support the substance/product-type combination.
Article 17Notification procedure
1.Notifications pursuant to Article 14(2) or Article 16(5) shall be made to the competent authority.
2.The notification shall be submitted in accordance with the format specified under Article 79 of Regulation 528/2012 . It shall contain the information referred to in Annex I.
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4.Upon receipt of a notification, the competent authority shall inform the notifier of the fee payable. If the notifier fails to pay the appropriate fee within 30 days from the receipt of that information, the competent authority shall reject the notification and inform the notifier.
5.Upon receipt of payment of the fees, the competent authority shall verify within 30 days whether the notification complies with the requirements of paragraph 2. If the notification does not comply with those requirements, the competent authority shall grant the notifier a period of 30 days in which to complete or correct the notification. After the expiry of that 30-day period, the competent authority shall, within 30 days, either declare that the notification complies with the requirements of paragraph 2 or reject the notification...
6.An appeal may be brought, in accordance with Article 77 of Regulation (EU) No 528/2012 against decisions of the competent authority taken pursuant to ... paragraph 5.
7.Where a notification has been found compliant pursuant to paragraph 5, the competent authority shall without delay:
(a)where the notification has been submitted pursuant to Article 14(2), update its records with respect to the identity of the participant and, where relevant, of the substance;
(b)where the notification has been submitted pursuant to Article 16(5), update its records .
Article 18Inclusion in the review programme
Where a substance/product-type combination is considered notified in accordance with Article 16(6) or 17(7)(b) the Secretary of State shall include the substance/product-type combination in the review programme.
The paragraph above is subject to the consent requirement.
Article 19Information on substances no longer supported under the review programme
Where no notification has been received within the time limit referred to in Article 16(5), or where a notification referred to in that Article has been received and subsequently rejected by the competent authority pursuant to Article 17(4) or (5), the competent authority shall ... publish that information electronically.
Article 20... Decisions on substances no longer supported under the review programme
The competent authority shall make a recommendation to the Secretary of State to issue a non-approval decision pursuant to ... Article 89(5) of Regulation (EU) No 528/2012 in the following cases:
where the competent authority informs the Secretary of State and the Devolved Authorities of all participants' timely withdrawal pursuant to Article 12(3) of this Regulation;
where no person has submitted a notification within the time limits provided for by Article 14(2) of this Regulation, or where such a notification has been submitted and rejected pursuant to Article 17(4) or Article 17(5) thereof;
where a notification has been submitted within the time limits provided for by Article 14(2) of this Regulation and has been found compliant pursuant to Article 17(5) thereof, but the substance identity in the notification only covers part of the existing identity in Annex II to this Regulation.
In case referred to in point (c) of first paragraph, the draft non-approval decision shall cover any substance covered by the existing identity in Annex II to this Regulation, but not by the notification or any approval decision.
CHAPTER 4TRANSITIONAL MEASURES
Article 21Transitional measures for substances referred to in Article 15
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2.The current system or practice of making available on the market and using a biocidal product consisting of, containing or generating an existing active substance referred to in point (a) or (aa) of Article 15 shall continue to apply . In such cases:
(a)The biocidal product shall no longer be made available on the market with effect from 24 months after the notification or publication of the decision or guidance referred to in point (a) or (aa) of Article 15.
(b)Use of existing stocks of the biocidal product may continue until 30 months after the notification or publication of the decision or guidance referred to in point (a) or (aa) of Article 15.
3.The current system or practice of making available on the market or using a biocidal product consisting of, containing or generating an existing active substance for which the competent authority has made a publication pursuant to Article 16(4) for the relevant product-type shall continue to apply . In such cases:
(a)The biocidal product shall no longer be made available on the market with effect from 12 months after the date when the competent authority has made the electronic publication referred to in Article 19; and
(b)Use of existing stocks of the biocidal product may continue until 18 months after the date of that publication.
Article 22Essential use
1.Without prejudice to Article 55(1) of Regulation No 528/2012, within 18 months of the date of a decision not to approve an existing active substance, where the competent authority considers this existing active substance to be essential for one of the reasons referred to in points (b) or (c) of the first subparagraph of Article 5(2) of Regulation (EU) No 528/2012, the competent authority may submit a reasoned application to the Secretary of State or a Devolved Authority for a derogation from Article 89(8) of that Regulation.
2.The competent authority shall make the application, or where relevant, the non-confidential version, publicly available by electronic means. Any person may submit comments within 60 days of publication.
3.Taking account of the comments received, the Secretary of State or a Devolved Authority may exercise a derogation from ... Article 89(8) of Regulation (EU) No 528/2012 allowing biocidal products consisting of, containing or generating the substance to be made available on the market and used in Great Britain subject to the conditions in paragraph 8 and any further conditions imposed by the Secretary of State or a Devolved Authority if they have competence to exercise the derogation within the meaning of paragraphs 4 to 6.
4.The Secretary of State has competence to exercise the derogation if, or to the extent that, the exercise of the function to take that measure—
(a)relates to England;
(b)relates to Scotland and is not within devolved competence (within the meaning of section 54 of the Scotland Act 1998);
(c)relates to Wales and is not within devolved competence (within the meaning of section 58A(7) and (8) of the Government of Wales Act 2006)
5.The Scottish Ministers have competence to exercise the derogation if, or to the extent that, the exercise of the function to take that measure is within devolved competence (within the meaning of section 54 of the Scotland Act 1998).
6.The Welsh Ministers have competence to exercise the derogation if, or to the extent that, the exercise of the function to take that measure is within devolved competence (within the meaning of section 58A(7) and (8) of the Government of Wales Act 2006).
7.Where the Secretary of State exercises the derogation under paragraph 3, the Secretary of State must immediately inform the Devolved Authorities giving reasons for the decision. Where a Devolved Authority exercises the derogation under paragraph 3, it must immediately inform the other Devolved Authority and the Secretary of State giving reasons for the decision.
8.The competent authority shall:
(a)ensure that continued use is limited to such cases where and such time during which the conditions of paragraph 1 are fulfilled;
(b)impose appropriate risk mitigation measures to ensure the exposure of humans, animals and the environment is minimised;
(c)ensure that alternatives are being sought, or that an application for approval of the active substance is being prepared for submission in accordance with Article 7 of Regulation (EU) No 528/2012 in due time before the expiry of the derogation.
Article 22ATransitional measures for ongoing applications submitted before IP completion day
1.This Article applies where an application was made before 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 IP completion day and where a decision on approval has not been made before 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 IP completion day where the United Kingdom competent authority was the evaluating competent authority prior to 30 March 2019; or
(b)180 days after IP completion day where the United Kingdom competent authority was not the evaluating competent authority prior to 30 March 2019.
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 22BDeclaration of interest to notify
1.This Article applies where a declaration of interest to notify was submitted before IP completion day under Article 16 of Regulation (EU) No 1062/2014 as it had effect immediately before 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 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 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 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 22CNotification 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 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 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 IP completion day but for which no declaration of compliance pursuant to Article 17(5) was made before IP completion day, the person may within 180 days of 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 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 22DDossiers submitted to Rapporteur Member States before IP completion day
1.This Article applies where a dossier was submitted before 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:
(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.
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).
CHAPTER 5FINAL PROVISIONS
Article 23Repeal
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Article 24Entry into force
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...
ANNEX IInformation requirements for notifications pursuant to Article 17
A notification pursuant to Article 17 shall contain the following information:
evidence that the substance is an existing active substance within the meaning of Article 3(1)(d) of Regulation (EU) No 528/2012;
an indication of the product-type(s) concerned by the notification;
information on any studies that have been commissioned for the purpose of application for approval or inclusion in the Simplified Active Substance list , as well as the expected date of completion;
the information referred to in Sections
1, 2 and 7.1 to 7.5 of the table in Title 1 of Annex II to Regulation (EU) No 528/2012 for chemical substances;
1, 2 and 6.1 to 6.4 of the table in Title 2 of Annex II to Regulation (EU) No 528/2012 for micro-organisms;
where the notification has been made in a case referred to in point (a) of Article 15, evidence that the substance was on the market as an active substance of a biocidal product falling under the relevant product-type on the date of notification or publication of the decision or guidance referred to in that point.
ANNEX II SUBSTANCE/PRODUCT-TYPE COMBINATIONS INCLUDED IN THE REVIEW PROGRAMME ON 6 NOVEMBER 2018
Active substance/product-type combinations supported on 6 November 2018 , excluding any other nanomaterial than those explicitly mentioned in entries 1017 and 1023, and excluding any generation in situ of the active substance except when explicitly mentioned with the reference to the supported precursor(s).
| Entry number | Substance name | ... | EC number | CAS number | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 17 | 18 | 19 | 21 | 22 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | Formaldehyde | . . . | 200-001-8 | 50-00-0 | x | x | x | |||||||||||||||
| 9 | Bronopol | . . . | 200-143-0 | 52-51-7 | x | x | x | x | x | x | ||||||||||||
| 36 | Ethanol | . . . | 200-578-6 | 64-17-5 | x | x | x | |||||||||||||||
| 37 | Formic acid | . . . | 200-579-1 | 64-18-6 | x | x | x | x | x | x | x | |||||||||||
| 1025 | Performic acid generated from formic acid and hydrogen peroxide | . . . | x | x | x | x | x | x | x | |||||||||||||
| 43 | Salicylic acid | . . . | 200-712-3 | 69-72-7 | x | x | x | |||||||||||||||
| 52 | Ethylene oxide | . . . | 200-849-9 | 75-21-8 | x | |||||||||||||||||
| 69 | Glycolic acid | . . . | 201-180-5 | 79-14-1 | x | x | x | |||||||||||||||
| 1026 | Peracetic acid generated from tetraacetylethylenediamine (TAED) and hydrogen peroxide | . . . | x | |||||||||||||||||||
| 1027 | Peracetic acid generated from 1,3-diacetyloxypropan-2-yl acetate and hydrogen peroxide | . . . | x | x | ||||||||||||||||||
| 1028 | Peracetic acid generated from tetraacetylethylenediamine (TAED) and sodium perborate monohydrate | . . . | x | |||||||||||||||||||
| 1029 | Peracetic acid generated by perhydrolysis of N-acetylcaprolactam by hydrogen peroxide in alkaline conditions | . . . | x | |||||||||||||||||||
| 71 | L-(+)-lactic acid | . . . | 201-196-2 | 79-33-4 | x | |||||||||||||||||
| 79 | (2R,6aS,12aS)-1,2,6,6a,12,12a-Hexahydro-2-isopropenyl-8,9-dimethoxychromeno[3,4-b]furo[2,3-h]chromen-6-one (Rotenone) | . . . | 201-501-9 | 83-79-4 | x | |||||||||||||||||
| 85 | Symclosene | . . . | 201-782-8 | 87-90-1 | x | x | x | x | x | x | ||||||||||||
| 92 | Biphenyl-2-ol | . . . | 201-993-5 | 90-43-7 | x | x | x | |||||||||||||||
| 113 | 3-Phenyl-propen-2-al (Cinnamaldehyde) | . . . | 203-213-9 | 104-55-2 | x | |||||||||||||||||
| 117 | Geraniol | . . . | 203-377-1 | 106-24-1 | x | x | ||||||||||||||||
| 122 | Glyoxal | . . . | 203-474-9 | 107-22-2 | x | x | x | |||||||||||||||
| 133 | Hexa-2,4-dienoic acid (Sorbic acid) | . . . | 203-768-7 | 110-44-1 | x | |||||||||||||||||
| 154 | Clorophene | . . . | 204-385-8 | 120-32-1 | x | |||||||||||||||||
| 171 | 2-Phenoxyethanol | . . . | 204-589-7 | 122-99-6 | x | x | x | x | x | |||||||||||||
| 1072 | Carbon dioxide | . . . | 204-696-9 | 124-38-9 | x | |||||||||||||||||
| 179 | Carbon dioxide generated from propane, butane or a mixture of both by combustion | . . . | x | |||||||||||||||||||
| 180 | Sodium dimethylarsinate (Sodium Cacodylate) | . . . | 204-708-2 | 124-65-2 | x | |||||||||||||||||
| 185 | Tosylchloramide sodium (Chloramin T) | . . . | 204-854-7 | 127-65-1 | x | x | x | x | ||||||||||||||
| 187 | Potassium dimethyldithiocarbamate | . . . | 204-875-1 | 128-03-0 | x | x | x | |||||||||||||||
| 188 | Sodium dimethyldithiocarbamate | . . . | 204-876-7 | 128-04-1 | x | x | x | |||||||||||||||
| 195 | Sodium 2-biphenylate | . . . | 205-055-6 | 132-27-4 | x | x | x | x | x | x | ||||||||||||
| 206 | Thiram | . . . | 205-286-2 | 137-26-8 | x | |||||||||||||||||
| 210 | Metam-sodium | . . . | 205-293-0 | 137-42-8 | x | x | ||||||||||||||||
| 227 | 2-Thiazol-4-yl-1H-benzoimidazole (Thiabendazole) | . . . | 205-725-8 | 148-79-8 | x | x | x | |||||||||||||||
| 235 | Diuron | . . . | 206-354-4 | 330-54-1 | x | x | ||||||||||||||||
| 239 | Cyanamide | . . . | 206-992-3 | 420-04-2 | x | x | ||||||||||||||||
| 253 | Tetrahydro-3,5-dimethyl-1,3,5-thiadiazine-2-thione (Dazomet) | . . . | 208-576-7 | 533-74-4 | x | x | ||||||||||||||||
| 283 | Terbutryn | . . . | 212-950-5 | 886-50-0 | x | x | x | |||||||||||||||
| 292 | (1,3,4,5,6,7-Hexahydro-1,3-dioxo-2H-isoindol-2-yl)methyl (1R-trans)-2,2-dimethyl-3-(2-methylprop-1-enyl)cyclopropanecarboxylate (d-Tetramethrin) | . . . | 214-619-0 | 1166-46-7 | x | |||||||||||||||||
| 321 | Monolinuron | . . . | 217-129-5 | 1746-81-2 | x | |||||||||||||||||
| 330 | N-(3-Aminopropyl)-N-dodecylpropane-1,3-diamine (Diamine) | . . . | 219-145-8 | 2372-82-9 | x | x | x | x | x | x | x | x | ||||||||||
| 336 | 2,2′-Dithiobis[N-methylbenzamide] (DTBMA) | . . . | 219-768-5 | 2527-58-4 | x | |||||||||||||||||
| 339 | 1,2-Benzisothiazol-3(2H)-one (BIT) | . . . | 220-120-9 | 2634-33-5 | x | x | x | x | x | x | ||||||||||||
| 341 | 2-Methyl-2H-isothiazol-3-one (MIT) | . . . | 220-239-6 | 2682-20-4 | x | |||||||||||||||||
| 346 | Sodium dichloroisocyanurate dihydrate | . . . | 220-767-7 | 51580-86-0 | x | x | x | x | x | x | ||||||||||||
| 345 | Troclosene sodium | . . . | 220-767-7 | 2893-78-9 | x | x | x | x | x | x | ||||||||||||
| 348 | Mecetronium ethylsulfate (MES) | . . . | 221-106-5 | 3006-10-8 | x | |||||||||||||||||
| 359 | Formaldehyde released from (Ethylenedioxy)dimethanol (Reaction products of ethylene glycol with paraformaldehyde (EGForm)) | . . . | 222-720-6 | 3586-55-8 | x | x | x | x | x | |||||||||||||
| 365 | Pyridine-2-thiol 1-oxide, sodium salt (Sodium pyrithione) | . . . | 223-296-5 | 3811-73-2 | x | x | x | x | x | x | ||||||||||||
| 368 | Methenamine 3-chloroallylochloride (CTAC) | . . . | 223-805-0 | 4080-31-3 | x | x | x | |||||||||||||||
| 377 | 2,2′,2″-(Hexahydro-1,3,5-triazine-1,3,5-triyl)triethanol (HHT) | . . . | 225-208-0 | 4719-04-4 | x | x | x | x | ||||||||||||||
| 382 | Tetrahydro-1,3,4,6-tetrakis(hydroxymethyl)imidazo[4,5-d]imidazole-2,5(1H,3H)-dione (TMAD) | . . . | 226-408-0 | 5395-50-6 | x | x | x | x | x | |||||||||||||
| 392 | Methylene dithiocyanate | . . . | 228-652-3 | 6317-18-6 | x | |||||||||||||||||
| 393 | 1,3-Bis(hydroxymethyl)-5,5-dimethylimidazolidine-2,4-dione (DMDMH) | . . . | 229-222-8 | 6440-58-0 | x | x | ||||||||||||||||
| 397 | Didecyldimethylammonium chloride (DDAC) | . . . | 230-525-2 | 7173-51-5 | x | x | x | x | x | x | x | x | ||||||||||
| 401 | Silver | . . . | 231-131-3 | 7440-22-4 | x | x | x | x | ||||||||||||||
| 1023 | Silver, as a nanomaterial | . . . | 231-131-3 | 7440-22-4 | x | x | x | |||||||||||||||
| 405 | Sulfur dioxide generated from sulfur by combustion | . . . | x | |||||||||||||||||||
| 424 | Active bromine generated from sodium bromide and sodium hypochlorite | . . . | x | x | x | |||||||||||||||||
| 1030 | Active bromine generated from sodium bromide and calcium hypochlorite | . . . | x | x | x | |||||||||||||||||
| 1031 | Active bromine generated from sodium bromide and chlorine | . . . | x | x | x | |||||||||||||||||
| 1032 | Active bromine generated from sodium bromide by electrolysis | . . . | x | x | x | |||||||||||||||||
| 1033 | Active bromine generated from hypobromous acid and urea and bromourea | . . . | x | x | ||||||||||||||||||
| 1034 | Active bromine generated from sodium hypobromite and N-bromosulfamate and sulfamic acid | . . . | x | |||||||||||||||||||
| 1035 | Active bromine generated from ozone and bromide of natural water and sodium bromide | . . . | x | |||||||||||||||||||
| 434 | Tetramethrin | . . . | 231-711-6 | 7696-12-0 | x | |||||||||||||||||
| 439 | Hydrogen peroxide | . . . | 231-765-0 | 7722-84-1 | x | x | ||||||||||||||||
| 1036 | Hydrogen peroxide released from sodium percarbonate | . . . | x | x | x | |||||||||||||||||
| 444 | 7a-Ethyldihydro-1H,3H,5H-oxazolo[3,4-c]oxazole (EDHO) | . . . | 231-810-4 | 7747-35-5 | x | x | ||||||||||||||||
| 450 | Silver nitrate | . . . | 231-853-9 | 7761-88-8 | x | |||||||||||||||||
| 453 | Disodium peroxodisulfate | . . . | 231-892-1 | 7775-27-1 | x | |||||||||||||||||
| 432 | Active chlorine released from sodium hypochlorite | . . . | x | x | ||||||||||||||||||
| 455 | Active chlorine released from calcium hypochlorite | . . . | x | |||||||||||||||||||
| 457 | Active chlorine released from chlorine | . . . | x | |||||||||||||||||||
| 458 | Monochloramine generated from ammonium sulfate and a chlorine source | . . . | x | x | ||||||||||||||||||
| 1016 | Silver chloride | . . . | 232-033-3 | 7783-90-6 | x | x | x | x | x | |||||||||||||
| 473 | Pyrethrins and Pyrethroids | . . . | 232-319-8 | 8003-34-7 | x | x | ||||||||||||||||
| 491 | Chlorine dioxide | . . . | 233-162-8 | 10049-04-4 | x | x | x | x | x | x | ||||||||||||
| 1037 | Chlorine dioxide generated from sodium chlorite by electrolysis | . . . | x | x | x | x | x | x | ||||||||||||||
| 1038 | Chlorine dioxide generated from sodium chlorite by acidification | . . . | x | x | x | x | x | x | ||||||||||||||
| 1039 | Chlorine dioxide generated from sodium chlorite by oxidation | . . . | x | x | x | x | x | x | ||||||||||||||
| 1040 | Chlorine dioxide generated from sodium chlorate and hydrogen peroxide in the presence of a strong acid | . . . | x | x | x | x | ||||||||||||||||
| 1041 | Chlorine dioxide generated from sodium chloride by electrolysis | . . . | x | x | x | x | x | x | ||||||||||||||
| 1042 | Chlorine dioxide generated from sodium chlorite and sodium bisulfate and hydrochloric acid | . . . | x | x | ||||||||||||||||||
| 1043 | Chlorine dioxide generated from sodium chlorite and sodium bisulfate | . . . | x | x | x | x | x | x | ||||||||||||||
| 1044 | Chlorine dioxide generated from sodium chlorite and sodium persulfate | . . . | x | x | x | x | x | x | ||||||||||||||
| 494 | 2,2-Dibromo-2-cyanoacetamide (DBNPA) | . . . | 233-539-7 | 10222-01-2 | x | x | x | x | x | x | ||||||||||||
| 501 | Carbendazim | . . . | 234-232-0 | 10605-21-7 | x | x | x | |||||||||||||||
| 1022 | Dialuminium chloride pentahydroxide | . . . | 234-933-1 | 12042-91-0 | x | |||||||||||||||||
| 515 | Bromide activated chloramine (BAC) generated from precursors ammonium bromide and sodium hypochlorite | . . . | x | x | ||||||||||||||||||
| 522 | Pyrithione zinc | . . . | 236-671-3 | 13463-41-7 | x | x | x | x | x | x | ||||||||||||
| 524 | Dodecylguanidine monohydrochloride | . . . | 237-030-0 | 13590-97-1 | x | x | ||||||||||||||||
| 529 | Active bromine generated from bromine chloride | . . . | x | |||||||||||||||||||
| 531 | (Benzyloxy)methanol | . . . | 238-588-8 | 14548-60-8 | x | x | ||||||||||||||||
| 550 | D-Gluconic acid, compound with N,N′-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediamidine (2:1) (CHDG) | . . . | 242-354-0 | 18472-51-0 | x | x | x | |||||||||||||||
| 554 | p-[(Diiodomethyl)sulphonyl]toluene | . . . | 243-468-3 | 20018-09-1 | x | x | x | x | ||||||||||||||
| 559 | (Benzothiazol-2-ylthio)methyl thiocyanate (TCMTB) | . . . | 244-445-0 | 21564-17-0 | x | x | ||||||||||||||||
| 562 | 2-Methyl-4-oxo-3-(prop-2-ynyl)cyclopent-2-en-1-yl 2,2-dimethyl-3-(2-methylprop-1-enyl)cyclopropanecarboxylate (Prallethrin) | . . . | 245-387-9 | 23031-36-9 | x | |||||||||||||||||
| 563 | Potassium (E,E)-hexa-2,4-dienoate (Potassium Sorbate) | . . . | 246-376-1 | 24634-61-5 | x | |||||||||||||||||
| 566 | Reaction products of paraformaldehyde and 2-hydroxypropylamine (ratio 1:1) (HPT) | . . . | x | x | x | x | ||||||||||||||||
| 571 | 2-Octyl-2H-isothiazol-3-one (OIT) | . . . | 247-761-7 | 26530-20-1 | x | x | x | x | x | x | ||||||||||||
| 577 | Dimethyloctadecyl[3-(trimethoxysilyl)propyl]ammonium chloride | . . . | 248-595-8 | 27668-52-6 | x | x | x | |||||||||||||||
| 588 | Bromochloro-5,5-dimethylimidazolidine-2,4-dione (BCDMH) | . . . | 251-171-5 | 32718-18-6 | x | x | x | |||||||||||||||
| 590 | 3-(4-Isopropylphenyl)-1,1-dimethylurea (Isoproturon) | . . . | 251-835-4 | 34123-59-6 | x | x | ||||||||||||||||
| 597 | 1-[2-(Allyloxy)-2-(2,4-dichlorophenyl)ethyl]-1H-imidazole (Imazalil) | . . . | 252-615-0 | 35554-44-0 | x | |||||||||||||||||
| 599 | S-[(6-Chloro-2-oxooxazolo[4,5-b]pyridin-3(2H)-yl)methyl] O,O-dimethyl thiophosphate (Azamethiphos) | . . . | 252-626-0 | 35575-96-3 | x | |||||||||||||||||
| 608 | Dimethyltetradecyl[3-(trimethoxysilyl)propyl]ammonium chloride | . . . | 255-451-8 | 41591-87-1 | x | |||||||||||||||||
| 1045 | Eucalyptus citriodora oil, hydrated, cyclized | . . . | 1245629-80-4 | x | ||||||||||||||||||
| 1046 | Cymbopogon winterianus oil, fractionated, hydrated, cyclized | . . . | Not available | Not available | x | |||||||||||||||||
| 1047 | Eucalyptus citriodora oil and citronellal, hydrated, cyclized | . . . | Not available | Not available | x | |||||||||||||||||
| 609 | 2-Hydroxy-α,α,4-trimethylcyclohexanemethanol | . . . | 255-953-7 | 42822-86-6 | x | |||||||||||||||||
| 619 | 3-Iodo-2-propynylbutylcarbamate (IPBC) | . . . | 259-627-5 | 55406-53-6 | x | x | x | |||||||||||||||
| 620 | Tetrakis(hydroxymethyl)phosphonium sulphate(2:1) (THPS) | . . . | 259-709-0 | 55566-30-8 | x | x | x | |||||||||||||||
| 648 | 4,5-Dichloro-2-octylisothiazol-3(2H)-one (4,5-Dichloro-2-octyl-2H-isothiazol-3-one (DCOIT)) | . . . | 264-843-8 | 64359-81-5 | x | x | x | x | ||||||||||||||
| 656 | Reaction products of paraformaldehyde and 2-hydroxypropylamine (ratio 3:2) (MBO) | . . . | x | x | x | x | x | |||||||||||||||
| 667 | Alkyl (C 12-18 ) dimethylbenzyl ammonium chloride (ADBAC (C 12-18 )) | . . . | 269-919-4 | 68391-01-5 | x | x | x | x | x | x | x | x | ||||||||||
| 671 | Alkyl (C 12-16 ) dimethylbenzyl ammonium chloride (ADBAC/BKC (C 12 -C 16 )) | . . . | 270-325-2 | 68424-85-1 | x | x | x | x | x | x | x | x | ||||||||||
| 673 | Didecyldimethylammonium chloride (DDAC (C 8-10 )) | . . . | 270-331-5 | 68424-95-3 | x | x | x | x | x | x | x | x | ||||||||||
| 690 | Quaternary ammonium compounds, benzyl-C 12-18 -alkyldimethyl, salts with 1,2-benzisothiazol-3(2H)-one 1,1-dioxide (1:1) (ADBAS) | . . . | 273-545-7 | 68989-01-5 | x | x | ||||||||||||||||
| 691 | Sodium N-(hydroxymethyl)glycinate | . . . | 274-357-8 | 70161-44-3 | x | |||||||||||||||||
| 692 | Amines, C 10-16 -alkyldimethyl, N-oxides | . . . | 274-687-2 | 70592-80-2 | x | |||||||||||||||||
| 693 | Pentapotassium bis(peroxymonosulfate)bis(sulfate) (KPMS) | . . . | 274-778-7 | 70693-62-8 | x | x | x | x | ||||||||||||||
| 939 | Active chlorine generated from sodium chloride by electrolysis | . . . | x | x | x | x | x | x | ||||||||||||||
| 1048 | Active chlorine released from hypochlorous acid | . . . | x | x | x | x | ||||||||||||||||
| 1049 | Active chlorine generated from sodium chloride and pentapotassium bis(peroxymonosulfate)bis(sulfate) | . . . | x | x | x | x | ||||||||||||||||
| 1050 | Active chlorine generated from seawater (sodium chloride) by electrolysis | . . . | x | |||||||||||||||||||
| 1051 | Active chlorine generated from magnesium chloride hexahydrate and potassium chloride by electrolysis | . . . | x | |||||||||||||||||||
| 1052 | Active chlorine generated from magnesium chloride hexahydrate by electrolysis | . . . | x | |||||||||||||||||||
| 1053 | Active chlorine generated from potassium chloride by electrolysis | . . . | x | x | ||||||||||||||||||
| 1054 | Active chlorine generated from sodium N-chlorosulfamate | . . . | x | x | x | |||||||||||||||||
| 1055 | Active chlorine generated from sodium chloride and pentapotassium bis(peroxymonosulfate)bis(sulfate) and sulfamic acid | . . . | x | x | ||||||||||||||||||
| 1056 | Active chlorine generated from hydrochloric acid by electrolysis | . . . | x | x | x | |||||||||||||||||
| 701 | Dihydrogen bis[monoperoxyphthalato(2-)-O1,OO1]magnesate(2-) (MMPP) | . . . | 279-013-0 | 84665-66-7 | x | |||||||||||||||||
| 1024 | Margosa extract from cold-pressed oil of the kernels of Azadirachta Indica extracted with super-critical carbon dioxide | . . . | x | |||||||||||||||||||
| 724 | Alkyl (C 12 -C 14 ) dimethylbenzylammonium chloride (ADBAC (C 12 -C 14 )) | . . . | 287-089-1 | 85409-22-9 | x | x | x | x | x | x | x | x | ||||||||||
| 725 | Alkyl (C 12 -C 14 ) dimethyl(ethylbenzyl)ammonium chloride (ADEBAC (C 12 -C 14 )) | . . . | 287-090-7 | 85409-23-0 | x | x | x | x | x | x | x | x | ||||||||||
| 731 | Chrysanthemum cinerariaefolium , ext. | . . . | 289-699-3 | 89997-63-7 | x | |||||||||||||||||
| 1057 | Chrysanthemum cinerariaefolium extract from open and mature flowers of Tanacetum cinerariifolium obtained with hydrocarbon solvent | . . . | x | x | ||||||||||||||||||
| 1058 | Chrysanthemum cinerariaefolium extract from open and mature flowers of Tanacetum cinerariifolium obtained with supercritical carbon dioxide | . . . | x | x | ||||||||||||||||||
| 744 | Lavender, Lavandula hybrida , ext./Lavandin oil | . . . | 294-470-6 | 91722-69-9 | x | |||||||||||||||||
| 779 | Reaction products of: glutamic acid and N-(C 12 -C 14 -alkyl)propylenediamine (Glucoprotamin) | . . . | 403-950-8 | 164907-72-6 | x | x | ||||||||||||||||
| 785 | 6-(Phthalimido)peroxyhexanoic acid (PAP) | . . . | 410-850-8 | 128275-31-0 | x | x | ||||||||||||||||
| 791 | 2-Butyl-benzo[d]isothiazol-3-one (BBIT) | . . . | 420-590-7 | 4299-07-4 | x | x | x | x | x | |||||||||||||
| 792 | Chlorine dioxide generated from tetrachlorodecaoxide complex (TCDO) by acidification | . . . | x | x | ||||||||||||||||||
| 811 | Silver sodium hydrogen zirconium phosphate | . . . | 422-570-3 | 265647-11-8 | x | x | x | x | x | |||||||||||||
| 794 | sec-Butyl 2-(2-hydroxyethyl)piperidine-1-carboxylate (Icaridine) | . . . | 423-210-8 | 119515-38-7 | x | |||||||||||||||||
| 797 | cis-1-(3-Chloroallyl)-3,5,7-triaza-1-azoniaadamantane chloride (cis CTAC) | . . . | 426-020-3 | 51229-78-8 | x | x | ||||||||||||||||
| 813 | Peroxyoctanoic acid | . . . | 33734-57-5 | x | x | x | ||||||||||||||||
| 1014 | Silver zeolite | . . . | Not available | Not available | x | x | x | x | x | |||||||||||||
| 152 | Reaction products of 5,5-dimethylhydantoin, 5-ethyl-5-methylhydantoin with bromine and chlorine (DCDMH) | . . . | Not available | Not available | x | |||||||||||||||||
| 459 | Reaction mass of titanium dioxide and silver chloride | . . . | Not available | Not available | x | x | x | x | x | x | x | |||||||||||
| 777 | Reaction products of 5,5-dimethylhydantoin, 5-ethyl-5-methylhydantoin with chlorine (DCEMH) | . . . | Not available | Not available | x | |||||||||||||||||
| 810 | Silver phosphate glass | . . . | Not available | 308069-39-8 | x | x | x | |||||||||||||||
| 824 | Silver zinc zeolite | . . . | Not available | 130328-20-0 | x | x | x | x | ||||||||||||||
| 1013 | Silver copper zeolite | . . . | Not available | 130328-19-7 | x | x | x | x | ||||||||||||||
| 1017 | Silver adsorbed on silicon dioxide (as a nanomaterial in the form of a stable aggregate with primary particles in the nanoscale) | . . . | Not available | Not available | x | |||||||||||||||||
| 854 | (RS)-3-Allyl-2-methyl-4-oxocyclopent-2-enyl-(1R,3R;1R,3S)-2,2-dimethyl-3-(2-methylprop-1-enyl)-cyclopropanecarboxylate (mixture of 4 isomers 1R trans, 1R: 1R trans, 1S: 1R cis, 1R: 1R cis, 1S 4:4:1:1) (d-Allethrin) | . . . | Plant protection product | 231937-89-6 | x | |||||||||||||||||
| 855 | (RS)-3-Allyl-2-methyl-4-oxocyclopent-2-enyl (1R,3R)-2,2-dimethyl-3-(2-methylprop-1-enyl)-cyclopropanecarboxylate (mixture of 2 isomers 1R trans: 1R/S only 1:3) (Esbiothrin) | . . . | Plant protection product | 260359-57-7 | x | |||||||||||||||||
| 843 | 4-Bromo-2-(4-chlorophenyl)-1-ethoxymethyl-5-trifluoromethylpyrrole-3-carbonitrile (Chlorfenapyr) | . . . | Plant protection product | 122453-73-0 | x | |||||||||||||||||
| 859 | Polymer of N-Methylmethanamine (Einecs 204-697-4 with (chloromethyl)oxirane (Einecs 203-439-8)/Polymeric quaternary ammonium chloride (PQ Polymer) | . . . | Polymer | 25988-97-0 | x | x | ||||||||||||||||
| 868 | Polyhexamethylene biguanide hydrochloride with a mean number-average molecular weight (Mn) of 1415 and a mean polydispersity (PDI) of 4,7 (PHMB(1415;4,7)) | . . . | Polymer | 32289-58-0 and 1802181-67-4 | x | x | x | |||||||||||||||
| 869 | Poly(oxy-1,2-ethanediyl),.alpha.-[2-(didecylmethylammonio)ethyl]-.omega.-hydroxy-, propanoate (salt) (Bardap 26) | . . . | Polymer | 94667-33-1 | x | x | x | |||||||||||||||
| 872 | N-Didecyl-N-dipolyethoxyammonium borate/Didecylpolyoxethylammonium borate (Polymeric betaine) | . . . | Polymer | 214710-34-6 | x | |||||||||||||||||
| 1059 | Capsicum oleoresin Extractives and their physically modified derivatives. It is a product which may contain resin acids and their esters, terpenes, and oxidation or polymerization products of these terpenes. ( Capsicum frutescens , Solanaceae ) | . . . | Not available | 8023-77-6 | x | |||||||||||||||||
| 1060 | Capsicum annuum , ext. Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Capsicum annuum , Solanaceae . | . . . | 283-403-6 | 84625-29-6 | x | |||||||||||||||||
| 1061 | Reaction mass of (6E)-N-(4-hydroxy-3-methoxy-2-methylphenyl)-8-methylnon-6-enamide and N-(4-hydroxy-3-methoxy-2-methylphenyl)-8-methylnonanamide | . . . | Not available | Not available | x | |||||||||||||||||
| 1062 | D-Fructose | . . . | 200-333-3 | 57-48-7 | x | |||||||||||||||||
| 1063 | Honey | . . . | 8028-66-8 | x | ||||||||||||||||||
| 1064 | Malt, ext. Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Hordeum , Gramineae . | . . . | 232-310-9 | 8002-48-0 | x | |||||||||||||||||
| 1065 | Vinegar (food grade containing a maximum of 10 % acetic acid) | . . . | Not available | 8028-52-2 | x | |||||||||||||||||
| 1066 | Cheese | . . . | Not available | Not available | x | |||||||||||||||||
| 1067 | Powdered egg | . . . | Not available | Not available | x | |||||||||||||||||
| 1068 | Saccharomyces cerevisiae | . . . | Not available | 68876-77-7 | x | |||||||||||||||||
| 1069 | Concentrated apple juice | . . . | Not available | Not available | x | |||||||||||||||||
| 1070 | Orange, sweet, ext. Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Citrus sinensis , Rutaceae . | . . . | 232-433-8 | 8028-48-6 | x | |||||||||||||||||
| 1071 | Garlic, ext. Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Allium sativum , Liliaceae . | . . . | 232-371-1 | 8008-99-9 | x |
ANNEX IIITime limits
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (OJ L 325, 11.12.2007, p. 3).
Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ L 123, 24.4.1998, p. 1).
Case C-420/10: Judgment of the Court (Third Chamber) of 1 March 2012 (reference for a preliminary ruling from the Landgericht Hamburg — Germany) — Söll GmbH v Tetra GmbH (Placing on the market of biocidal products — Directive 98/8/EC — Article 2(1)(a) — Concept of ‘biocidal products’ — Product causing flocculation of harmful organisms without destroying or deterring them or rendering them harmless).
Commission Implementing Regulation (EU) No 88/2014 of 31 January 2014 specifying a procedure for the amendment of Annex I to Regulation (EU) No 528/2012 of the European Parliament and of the Council concerning the making available on the market and use of biocidal products (OJ L 32, 1.2.2014, p. 3).
Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).
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 (OJ L 396, 30.12.2006, p. 1).
Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (OJ L 325, 11.12.2007, p. 3).
Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ L 123, 24.4.1998, p. 1).
Case C-420/10: Judgment of the Court (Third Chamber) of 1 March 2012 (reference for a preliminary ruling from the Landgericht Hamburg — Germany) — Söll GmbH v Tetra GmbH (Placing on the market of biocidal products — Directive 98/8/EC — Article 2(1)(a) — Concept of ‘biocidal products’ — Product causing flocculation of harmful organisms without destroying or deterring them or rendering them harmless).
Commission Implementing Regulation (EU) No 88/2014 of 31 January 2014 specifying a procedure for the amendment of Annex I to Regulation (EU) No 528/2012 of the European Parliament and of the Council concerning the making available on the market and use of biocidal products (OJ L 32, 1.2.2014, p. 3).
Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).
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 (OJ L 396, 30.12.2006, p. 1).