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
(Text with EEA relevance)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to 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 (1), and in particular Article 16(2) thereof,
Whereas:
(1)
Pursuant to Directive 98/8/EC, Member States may only authorise the placing on the market of biocidal products containing active substances included in Annex I, IA or IB to that Directive. However, under the transitional measures provided for in Article 16(1) of Directive 98/8/EC Member States may allow the placing on the market of biocidal products containing active substances not listed in Annex I, IA or IB to Directive 98/8/EC which were already on the market on 14 May 2000, hereinafter ‘existing active substances’. Pursuant to paragraph 2 of that same Article, a 10-year programme of work is to be carried out for the review of all existing active substances. This programme of work was intended to identify the existing active substances and determine those to be evaluated under the review programme with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC.
(2)
The initial phase of the programme was laid down in Commission Regulation (EC) No 1896/2000 of 7 September 2000 on the first phase of the programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council on biocidal products (2).
(3)
Under Regulation (EC) No 1896/2000, existing active substances for use in biocidal products had to be identified, and those to be evaluated with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC in one or more product types had to be notified no later than 28 March 2002.
(4)
Commission Regulation (EC) No 2032/2003 of 4 November 2003 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, and amending Regulation (EC) No 1896/2000 (3) established a list of existing active substances. That list covered active substances that had been identified in accordance with Article 3(1) or Article 5(2) of Regulation (EC) No 1896/2000 or in respect of which equivalent information had been submitted in a notification in accordance with Article 4(1) of that Regulation.
(5)
Regulation (EC) No 2032/2003 also established, in Annex II, an exhaustive list of existing active substances to be evaluated under the review programme. That list covered active substances in respect of which at least one notification had been accepted in accordance with Article 4(2) of Regulation (EC) No 1896/2000 or in which a Member State had expressed an interest in accordance with Article 5(3) of that Regulation. That list specified the product types concerned.
(6)
Regulation (EC) No 2032/2003 allowed for a number of active substances or substance/product type combinations that were not originally covered by the review programme, to be examined on the same conditions as the active substances evaluated under the review programme, provided that interested operators submitted complete dossiers before 1 March 2006.
(7)
Article 4(2) of Regulation (EC) No 2032/2003 set 1 September 2006 as the date from which products containing active substances not examined under the review programme should be withdrawn from the market.
(8)
Article 4(3) of Regulation (EC) No 2032/2003 provided that the existing active substances that had not been identified by the persons using them in biocidal products were to be deemed not to have been placed on the market for biocidal purposes before 14 May 2000. However, this assimilation to new active substances should not be taken to mean that the unlawfully non-identified existing active substances may benefit from a provisional authorisation or from the longer data protection period reserved to genuinely new active substances. Whereas a clarification in that sense should be added to that provision.
(9)
Regulation (EC) No 2032/2003 introduced the possibility for Member States to apply for a derogation for biocidal products containing identified existing active substances that are not examined under the review programme, which Member States claim are essential for reasons of health, safety, or protection of cultural heritage or critical for the functioning of society in the absence of technically and economically feasible alternatives or substitutes that are acceptable from the standpoint of environment or health. Such derogation is granted to the requesting Member States only if the requests are justified, if continued use does not give rise to concerns for human health and the environment, and if, where appropriate, alternatives are being developed. It is appropriate to continue to allow Member States to apply for such a derogation, including in respect of an active substance which it has been decided not to include in Annex I, IA or IB to Directive 98/8/EC. Since the review programme referred to in Article 16(2) of Directive 98/8/EC runs only until 14 May 2010, any such derogation should not continue beyond that date.
(10)
Certain substances or products that are normally consumed by humans or animals for their subsistence may also be used to attract or to repel harmful organisms. For these substances, there is general agreement that the authorisation/registration requirements of Directive 98/8/EC seem unjustified and that they should be expressly excluded from its scope. Considering that a revision of Directive 98/8/EC will take a significant amount of time during which the viability of those products on the market might be irreversibly affected, it is appropriate to postpone their withdrawal from the market until 14 May 2010.
(11)
A Member State which has indicated an interest in seeking review of a particular active substance should not be designated Rapporteur Member State for that substance.
(12)
In order to avoid duplication of work, and in particular to reduce testing involving vertebrate animals, the requirements concerning preparation and submission of the complete dossier should be such as to encourage those whose notifications have been accepted, hereinafter ‘participants’, to act collectively, in particular by submitting collective dossiers. It should be possible for the Rapporteur Member State to make available the reference to any test involving vertebrate animals that has been carried out in respect of a notified existing active substance unless that reference is confidential under Article 19 of Directive 98/8/EC. Also, in order to gain experience on the appropriateness of data requirements and to ensure that the review of active substances is carried out in a cost-effective way, participants should be encouraged to provide information on the costs of compiling a dossier and on the need to carry out tests on vertebrate animals.
(13)
In order to avoid delays, participants should start discussions as early as possible with Rapporteur Member States in order to resolve uncertainties in relation to data requirements. Applicants, other than participants, who wish to apply in accordance with Article 11 of Directive 98/8/EC for inclusion in Annex I, IA or IB thereto of an active substance/product type combination being evaluated under the review programme should submit complete dossiers for that combination no earlier or no later than participants so as not to disturb the smooth functioning of the review programme or create a disadvantage to the participants.
(14)
The requirements concerning the content and format of dossiers and the number of dossiers to be submitted should be defined.
(15)
Provision should be made for cases in which a participant is joined by a producer, formulator or association and in which a participant withdraws from the review programme.
(16)
Producers, formulators or associations should within certain time limits have the opportunity of taking over the role of participant for an existing active substance/product type combination in respect of which all participants have withdrawn or none of the dossiers meets the requirements. Subject to the same time-limits, it should also be possible in certain circumstances for Member States to indicate an interest and act as a participant for the inclusion in Annex I, IA or IB to Directive 98/8/EC of such a combination.
(17)
In order to discourage abuse of the opportunity to maintain an active substance on the market while it is examined under the review programme, it should be possible for another person or a Member State to take over the role of participant only once in relation to a given active substance/product type combination. For the same purpose, a person or Member State taking over the role of participant should provide within a certain period evidence of commencing work on a complete dossier.
(18)
Time limits should be specified within which the Rapporteur Member States must verify the completeness of the dossiers. It should be possible, in exceptional circumstances, for the Rapporteur Member States to establish a new deadline for the submission of parts of a dossier, in particular where the participant has demonstrated that it was impossible to submit information in due time or in order to resolve uncertainties regarding data requirements that remain despite earlier discussions between the participant and the Rapporteur Member State.
(19)
For each existing active substance, the Rapporteur Member State should examine and evaluate the dossier and present the results to the Commission and the other Member States in the form of a competent authority report and a recommendation as to the decision to be taken with regard to the active substance concerned. In order not to prolong decision-making unnecessarily, the Rapporteur Member State should at the same time consider carefully the need for additional studies. For the same reason, Rapporteur Member States should be obliged to take into consideration information submitted after acceptance of the dossier only under specified conditions.
(20)
The competent authority reports should be examined by the other Member States before the assessment reports are submitted to the Standing Committee on Biocidal Products.
(21)
Where, despite a recommendation for inclusion of an active substance in Annex I, IA or IB to Directive 98/8/EC, concerns as referred to in Article 10(5) of that Directive remain, it should be possible for the Commission to take into account, but without prejudice to Article 12 of that Directive, the finalisation of the evaluation on other existing active substances applied for the same use. Provision should be made for Rapporteur Member States to update competent authority reports where necessary.
(22)
In order to ensure better access to information, assessment reports should be drafted on the basis of the reports submitted by the competent authorities of the Member States and should be covered by the same rules regarding access to information as the reports of the competent authorities. The assessment reports should be derived from the original competent authority report as amended in the light of all the documents, comments and information taken into account during the evaluation process.
(23)
It should be possible to suspend the procedures provided for in this Regulation in the light of the application of other Community acts, in particular as regards Council Directive 76/769/EEC of 27 July 1976 on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations (4), and after 1 June 2009, as regards Title VIII and Annex XVII of Regulation (EC) No 1907/2006.
(24)
In order to ensure the most efficient course of the review programme, a number of active substance/product type combinations have been reassigned to different rapporteur Member States. These developments should be reflected in Annex II of this Regulation.
(25)
Regulation (EC) No 2032/2003 has been amended on several occasions (5) in order to take into consideration the accession of new Member States, lessons learned from the implementation to date of the review programme, and in particular in order to provide for the non-inclusion in Annex I, IA or IB to Directive 98/8/EC of a number of active substances, either because the requisite information was not submitted within the prescribed period or in cases where the requirements of Article 10 of the said Directive were not satisfied. This practice of constantly updating Regulation (EC) No 2032/2003 in order to follow the evolution of the review programme has proven ineffectual and time-consuming; furthermore it could create confusion to stakeholders as to which rules apply and which active substances are currently under review. In the interest of clarity, it is preferable to repeal and replace Regulation (EC) No 2032/2003 by a new simplified act which will lay down the rules for the review programme, and that the Commission should adopt separate acts for the future non-inclusion decisions.
(26)
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,
HAS ADOPTED THIS REGULATION:
Article 1
Subject matter
This Regulation lays down detailed rules for the implementation of the programme of work for the systematic examination of all active substances already on the market on 14 May 2000 as active substances of biocidal products, hereinafter ‘the review programme’, referred to in Article 16(2) of Directive 98/8/EC.
Article 2
Definitions
For the purposes of this Regulation the definitions in Article 2 of Directive 98/8/EC and Article 2 of Regulation (EC) No 1896/2000 shall apply.
In addition, ‘participant’ means a producer, formulator or association which has submitted a notification that has been accepted by the Commission in accordance with Article 4(2) of Regulation (EC) No 1896/2000 or a Member State which has indicated an interest in accordance with Article 5(3) of that Regulation.
Article 3
Existing active substances
1. The list of active substances identified as available on the market before 14 May 2000 as active substances of biocidal products for purposes other than those referred to in Article 2(2)(c) and (d) of Directive 98/8/EC is set out in Annex I.
2. The exhaustive list of existing active substances to be examined under the review programme is set out in Annex II.
The list includes the following active substances:
(a)
existing active substances notified in accordance with Article 4(1) of Regulation (EC) No 1896/2000 or Article 4(2) of Commission Regulation (EC) No 1687/2002 (6);
(b)
existing active substances that were not notified, but in respect of which a Member State has indicated an interest in supporting their inclusion in Annex I, IA or IB to Directive 98/8/EC;
(c)
existing active substances that were not notified, but for which a dossier was submitted to one of the Member States by 1 March 2006, which was found to comply with the requirements of Annex III to this Regulation and was accepted as complete.
The list specifies, for each existing active substance included, the product types in respect of which the substance will be examined under the review programme, as well as the Rapporteur Member State designated to carry out the evaluation.
Article 4
Non-inclusion
1. Without prejudice to Articles 5 and 6 of this Regulation and paragraph 2 of this Article, biocidal products containing active substances not listed in Annex II to this Regulation or in Annex I or IA to Directive 98/8/EC shall no longer be placed on the market.
In the case of an active substance listed in Annex II to this Regulation, the first subparagraph shall also apply to that substance in relation to any product type not listed in that Annex.
2. Biocidal products containing active substances listed in Annex II to this Regulation for which a decision was taken not to include these active substances for certain or all of their notified product types in Annex I or IA to Directive 98/8/EC, shall no longer be placed on the market for the product types concerned, with effect from 12 months after the date of such a measure being published, unless otherwise stipulated therein.
3. Without prejudice to Articles 12(1)(b) and 15(2) of Directive 98/8/EC, from the day of entry into force of this Regulation, any active substance not listed in Annex I shall be deemed not to have been placed on the market for biocidal purposes before 14 May 2000.
Article 5
Derogation for essential use
1. Member States may apply to the Commission for a derogation from Article 4(1) where they consider that an active substance is essential for them for reasons of health, safety or protection of cultural heritage or is critical for the functioning of society, and where there are no available technically and economically feasible alternatives or substitutes that are acceptable from the standpoint of environment and health.
Applications shall be accompanied by a document stating the reasons and justifications.
2. The applications referred to in paragraph 1 shall be forwarded by the Commission to the other Member States and shall be made publicly available by electronic means.
Member States or any person may for a period of 60 days following reception of an application submit comments in writing to the Commission.
3. Taking account of the comments received, the Commission may grant a derogation from Article 4(1) allowing the placing of the substance on the market of the requesting Member States until 14 May 2010 at the latest, provided that the Member States:
(a)
ensure that continued use is possible only if products containing the substance are approved for the intended essential use;
(b)
conclude that, taking into account all available information, it is reasonable to assume that continued use does not have any unacceptable effect on human or animal health or on the environment;
(c)
impose all appropriate risk reduction measures when granting approval;
(d)
ensure that such approved biocidal products remaining on the market after 1 September 2006 are relabelled in order to match the use conditions laid down by the Member States in accordance with this paragraph; and
(e)
ensure that, where appropriate, alternatives for such uses are being sought by the holders of the approvals or the Member States concerned, or a dossier is being prepared for submission in accordance with the procedure laid down in Article 11 of Directive 98/8/EC by 14 May 2008 at the latest.
4. The Member States concerned shall annually inform the Commission on the application of paragraph 3 and in particular on the actions taken pursuant to point (e).
5. Member States may at any time review the approvals of biocidal products for which the period of placing on the market has been extended in accordance with paragraph 3. Whenever there is reason to believe that any of the conditions set in points (a) to (e) of that paragraph are no longer satisfied, the Member States concerned shall without undue delay take steps to remedy the situation or if that is not possible, withdraw the approvals of the biocidal products concerned.
Article 6
Food and Feed
By way of derogating from Article 4(1), Member States may allow until 14 May 2010 at the latest the placing on the market of active substances consisting solely of food or feed that are intended for use as repellents or attractants of product type 19.
For the purposes of this derogation, ‘food or feed’ means any edible substance or product of plant or animal origin, whether processed, partially processed or unprocessed, which is intended or reasonably expected to be ingested by humans or animals; this category does not comprise extracts or individual substances isolated from food or feed.
Article 7
Examination of existing active substances under the review programme
1. The review of an active substance listed in Annex II, in respect of the product types specified, shall be undertaken by the Rapporteur Member State designated for that purpose on the basis of the complete dossier for that substance/product type combination, provided that:
(a)
the dossier complies with the requirements set out in Annex III to this Regulation;
(b)
the complete dossier is submitted within the period specified in Article 9 of this Regulation for the product type concerned, together with the summary dossier referred to in Article 11(1)(b) of Directive 98/8/EC and defined in Annex III to this Regulation.
An active substance listed in Annex II to this Regulation shall be reviewed exclusively in relation to the product types specified therein.
For the active substance/product type combinations referred to in Article 3(2)(c), with the exception of product types 8 and 14, the evaluation of the dossiers shall commence at the same time as the evaluation of dossiers for active substances contained in the same product types.
2. A Member State which has indicated an interest in supporting the inclusion of an active substance in Annex I, IA or IB to the Directive shall not be designated as Rapporteur Member State in respect of that substance.
3. Without prejudice to Articles 10, 11 and 12 of this Regulation, persons other than participants may apply, in accordance with Article 11 of Directive 98/8/EC, for the inclusion in Annex I, IA or IB thereto of an existing active substance/product type combination that is listed in Annex II to this Regulation. These persons shall submit in that case a complete dossier within the time period specified in Article 9 for that substance/product type combination.
Article 8
Preparation of the complete dossier
1. In the preparation of the complete dossier, all reasonable efforts shall be made, inter alia, to avoid duplication of testing on vertebrate animals and, where appropriate, to establish a collective complete dossier.
2. Before commencing compilation of the complete dossier, a participant shall:
(a)
inform the Rapporteur Member State of any testing on vertebrate animals that it has already carried out;
(b)
contact the Rapporteur Member State for advice as to the acceptability of justifications for waiving certain studies;
(c)
inform the Rapporteur Member State of any intention to carry out further testing on vertebrate animals for the purposes of the complete dossier;
(d)
when informed by the Rapporteur Member State that another participant has notified plans to carry out the same tests, make all reasonable efforts to cooperate with that participant in the performance of common testing.
Advice given by Rapporteur Member States in accordance with point (b) of the first subparagraph shall not predetermine the outcome of the completeness check under Article 13(1).
3. A Rapporteur Member State may make available the reference to any test carried out on vertebrate animals in respect of an active substance listed in Annex II to this Regulation, save where that reference is to be treated as confidential in accordance with Article 19 of Directive 98/8/EC. Such reference may include the name of the active substance concerned, the end points of the tests, and the contact address of the data owner.
4. Where a Rapporteur Member State is aware that more than one participant is seeking review of a particular active substance, it shall inform those participants accordingly.
5. Participants seeking review of the same active substance for the same product types shall undertake all reasonable efforts to submit a collective complete dossier, while fully respecting the Community rules on competition.
Where, in those circumstances, a collective dossier is not submitted, each individual dossier shall detail the efforts made to secure cooperation and the reasons for non-participation.
6. Details shall be given in the complete dossier and in the summary dossier of the efforts made to avoid duplication of testing on vertebrate animals.
7. In order to provide information on the costs entailed in applying for review and on the need for animal testing for the purposes of compiling the complete dossier, participants may submit to the Rapporteur Member State together with the complete dossiers a breakdown of the costs of the respective actions and studies carried out.
The Rapporteur Member State shall communicate that information to the Commission when submitting the competent authority report in accordance with Article 14(4).
8. Information on the costs entailed in compiling the complete dossier and on the animal testing carried out for that purpose shall be included in the report referred to in Article 18(5) of Directive 98/8/EC together with any appropriate recommendations concerning modifications of data requirements in order to reduce to a minimum the need for testing on vertebrate animals, and to ensure cost-effectiveness and proportionality.
Article 9
Submission of the complete dossier
1. Unless otherwise indicated by the Rapporteur Member State, a participant shall submit to the Rapporteur Member State one paper and one electronic copy of the complete dossier.
The participant shall also, in accordance with Article 13(3), submit one paper and one electronic copy of the summary dossier to the Commission and to each of the other Member States. However, any Member State wishing to receive copies only in electronic format or additional copies shall inform the Commission, which shall make that information publicly available by electronic means. If the Member State subsequently decides otherwise, it shall inform the Commission without undue delay, whereupon the Commission shall update accordingly the information made publicly available.
2. For the existing active substances listed in Annex II, complete dossiers must be received by the competent authority of the Rapporteur Member State within the following periods:
(a)
for product types 8 and 14, until 28 March 2004;
(b)
for product types 16, 18, 19 and 21, from 1 November 2005 until 30 April 2006;
(c)
for product types 1, 2, 3, 4, 5, 6 and 13, from 1 February 2007 until 31 July 2007;
(d)
for product types 7, 9, 10, 11, 12, 15, 17, 20, 22 and 23, from 1 May 2008 until 31 October 2008.
Article 10
Joining and replacing of participants
Where, by mutual agreement, a producer, formulator or association joins or replaces a participant for the purposes of submitting the complete dossier, all parties to the agreement shall jointly inform the Commission and the Rapporteur Member State accordingly, attaching any relevant letter of access.
The Commission shall inform accordingly any other participant seeking review of the same active substance in relation to the same product types.
Article 11
Withdrawal of participants
1. Where a participant intends to discontinue participation in the review programme, they shall inform the relevant Rapporteur Member State and the Commission accordingly, in writing and without delay, stating the reasons.
The Commission shall inform accordingly the other Member States and any other participant seeking review of the same active substance in relation to the same product type(s).
2. Where all the participants have withdrawn as regards a particular existing active substance/product type combination, the Commission shall inform the Member States thereof and shall publish that information electronically.
Article 12
Taking over the role of participant
1. Within three months of the electronic publication of the information referred to in Article 11(2), a producer, formulator, association or other person may inform the Commission of their intention to take over the role of participant as regards the existing active substance/product type combination.
Within the time period referred to in the first subparagraph, a Member State may also indicate to the Commission an interest in taking over the role of participant in order to support the inclusion in Annex I, IA or IB to Directive 98/8/EC of the existing active substance/product type combination, where there are uses which the Member State considers essential, in particular for the protection of human health, animal health or the environment.
2. The person or Member State wishing to take over the role of the participant who has withdrawn shall, within three months of informing the Commission of their intention, provide evidence to it that work to compile a complete dossier has been commissioned.
3. On the basis of the evidence referred to in paragraph 2, the Commission shall decide whether or not to allow the interested person or Member State to take over the role of participant.
Where the Commission allows the interested person or Member State to take over the role of participant, it may decide to extend, if necessary, the relevant period for the submission of a complete dossier specified in Article 9.
4. The taking over of the role of participant for a given existing active substance/product type combination may be allowed only once.
5. Where the Commission receives no response pursuant to paragraph 1, it shall take a decision not to include the existing active substance in Annex I, IA or IB to Directive 98/8/EC within the framework of the review programme for the product type(s) concerned.
Article 13
Completeness check of dossiers
1. Within three months of receiving the dossier for an existing active substance/product type combination and no later than three months after the end of the relevant time period specified in Article 9(2) of this Regulation, the Rapporteur Member State shall verify whether the dossier is to be accepted as complete in accordance with Article 11(1)(b) of Directive 98/8/EC.
Where the Rapporteur Member State has initiated consultations with other Member States and the Commission in relation to the acceptability of a dossier, the period may be prolonged until consultations have been finalised, up to a maximum of six months from receipt of the dossier.
2. A Rapporteur Member State may require, as a condition for considering a dossier to be complete, proof of advance payment, in full or in part, of the charges payable under Article 25 of Directive 98/8/EC to be provided in the dossier.
3. Where a dossier is considered to be complete, the Rapporteur Member State shall confirm acceptance of the dossier to the participant and agree to the participant forwarding the summary dossier to the Commission and the other Member States within one month of receiving the confirmation.
If a Member State in receipt of a summary dossier has legitimate reason to believe that the dossier is incomplete, it shall without delay communicate its concerns to the Rapporteur Member State, the Commission and the other Member States.
The Rapporteur Member State shall immediately take up consultations with that Member State and the Commission in order to discuss the concern expressed and resolve divergent opinions.
4. In exceptional circumstances, the Rapporteur Member State may establish a new deadline for the submission of information which, for reasons duly substantiated, the participant was unable to submit in due time.
The participant shall, within three months of being informed of the new deadline, provide evidence to the Rapporteur Member State that work to provide the missing information has been commissioned.
If the Rapporteur Member State considers that it has received sufficient evidence, it shall carry out its evaluation in accordance with Article 14 as if the dossier were complete. Otherwise, the evaluation shall not commence until the missing information is submitted.
5. Where a complete dossier is not received within the period specified in Article 9 or by a new deadline established in accordance with paragraph 4, the Rapporteur Member State shall inform the Commission, giving the reasons put forward by the participant by way of justification.
The Rapporteur Member State shall also inform the Commission in cases where a participant fails to provide the evidence required in accordance with the second subparagraph of paragraph 4. In the cases referred to in the first and second subparagraphs and if no other dossier concerns the same existing active substance/product type combination, all participants shall be deemed to have withdrawn and Articles 11(2) and 12 shall apply mutatis mutandis.
Article 14
Evaluation of dossiers by the Rapporteur Member State
1. Where the Rapporteur Member State considers a dossier to be complete, it shall carry out the evaluation within twelve months of accepting the dossier in accordance with Article 11(2) of Directive 98/8/EC and shall prepare a report on that evaluation, hereinafter ‘the competent authority report’.
Without prejudice to Article 12 of Directive 98/8/EC, the Rapporteur Member State may take into account other relevant technical or scientific information regarding the properties of the active substance, metabolites or residues.
2. At the request of a participant, the Rapporteur Member State may take into account additional information relating to an active substance for which the dossier has been accepted as complete only if the following conditions are fulfilled:
(a)
the participant informed the Rapporteur Member State, at the time of submission of the dossier, that preparation of the additional information was under way;
(b)
the additional information is submitted no later than nine months after acceptance of the dossier in accordance with Article 13(3);
(c)
by comparison with the data originally submitted, the additional information is equally or more reliable owing to the application of the same or higher quality standards;
(d)
by comparison with the data originally submitted, the additional information supports a different conclusion concerning the active substance for the purposes of the recommendation under paragraph 6.
The Rapporteur Member State shall take into account additional information submitted by persons other than the participant only if that information satisfies the conditions set out in points (b), (c) and (d) of the first subparagraph.
3. Where relevant in the application of paragraph 1, in particular when additional information has been requested by a deadline established by the Rapporteur Member State, the latter may request that the participant submit updated summary dossiers to the Commission and the other Member States when the additional information is received.
All participants shall be deemed to have withdrawn and Articles 11(2) and 12 shall apply mutatis mutandis if:
(a)
the additional information is not received by the deadline;
(b)
the participant fails to provide adequate justification for further postponing the deadline;
(c)
no other dossier concerns the same existing active substance/product type combination.
4. The Rapporteur Member State shall, without undue delay, send a copy of the competent authority report to the Commission, the other Member States and to the participant.
5. A Rapporteur Member State may decide to withhold the competent authority report if the charges payable under Article 25 of Directive 98/8/EC have not been paid in full, in which case it shall inform the participant and the Commission accordingly.
All participants shall be deemed to have withdrawn and Articles 11(2) and 12 shall apply mutatis mutandis if:
(a)
full payment is not received within three months of the date of receipt of that information;
(b)
no other dossier concerns the same existing active substance/product type combination.
6. The competent authority report shall be presented in a format to be recommended by the Commission and shall include one of the following:
(a)
a recommendation to include the existing active substance in Annex I, IA or IB to Directive 98/8/EC, stating, where appropriate, conditions for inclusion;
(b)
a recommendation not to include the existing active substance in Annex I, IA or IB to Directive 98/8/EC, stating the reasons.
Article 15
Commission procedures
1. When the Commission receives a competent authority report pursuant to Article 14(4) of this Regulation it shall, without undue delay, prepare the draft decision referred to in Article 27 of Directive 98/8/EC.
2. Before preparing the draft decision referred to in paragraph 1, the Commission shall, when necessary in the light of the comments received on the competent authority report, consult with experts from the Member States to address any problems remaining unresolved. Where necessary and upon a request from the Commission, the Rapporteur Member State shall prepare an updated competent authority report.
3. Where an existing active substance, despite a recommendation for inclusion pursuant to Article 14(6) of this Regulation, still gives rise to concern, as referred to in Article 10(5) of Directive 98/8/EC, the Commission may, without prejudice to Article 12 of that Directive, take into account the finalisation of the evaluation of other existing active substances applied for the same use.
4. On the basis of the documents and information referred to in Article 27(2) of Directive 98/8/EC, the Rapporteur Member State shall prepare an updated competent authority report, the first part of which shall form the assessment report. The assessment report shall be reviewed within the Standing Committee on Biocidal Products. Where several dossiers have been submitted for the same active substance/product type combination, the Rapporteur Member State shall prepare one assessment report based on the information contained in those dossiers.
Article 16
Access to information
Where a Rapporteur Member State has submitted the competent authority report in accordance with Article 14(4) of this Regulation, or where an assessment report has been finalised or updated in the Standing Committee on Biocidal Products, the Commission shall make the report or any updates thereof publicly available by electronic means, except for information that is to be treated as confidential in accordance with Article 19 of Directive 98/8/EC.
Article 17
Suspension of procedures
Where, in respect of an active substance listed in Annex II to this Regulation, the Commission presents a proposal for amending Directive 76/769/EEC or, with effect from 1 June 2009, Annex XVII of Regulation (EC) No 1907/2006 in order to prohibit its placing on the market or its use, including use for biocidal purposes, in certain or all product types, the procedures provided for in this Regulation concerning that substance for use in the product types concerned may be suspended pending a decision on that proposal.
Article 18
Repeal
Regulation (EC) No 2032/2003 is repealed.
References to the repealed Regulation shall be construed as references to this Regulation.
Article 19
Entry into force
This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 4 December 2007.