Nr.72-Dr.Storch-Recherchen.Biozide: 0016Technical Notes for Guidance- Part I-Biocidial Products- EU-Members

Article 16(3) of the Directive requires the Member States shall ensure that, following the decision by the Commission to include or not to include an active substance into Annex I or IA, authorisations or, where relevant, registrations for biocidal products containing the active substances and complying with the provisions of the Directive are granted, modified or cancelled as appropriate.

The article does not give the Commission the power to adopt legal measures that would oblige the Member States to require submission of dossiers for product authorisation or to withdraw products for which no dossiers have been submitted by a given date. Any such actions must come from the Member States themselves.

During the discussions at the 19^th and 20^th CA meetings, Member States however agreed that they should all strive to act in a harmonised way to set deadlines by which:

i. applications for authorisation should be received,

ii. unauthorised products be removed from the market,

iii. authorisations should be granted.

The key principle is that the application for the authorisation of a product already placed on the market should be submitted before the formal inclusion in Annex I or IA of the active substance it contains. Otherwise products should be removed from the market.

Applicants are given a period of two years to prepare their dossiers for product authorisation and Member States then have another period of two years to assess these dossiers and come to a decision. That second two-year period is again subdivided in a first period of 15 months during which the Reference Member State shall assess the dossier and another period of 9 months for the process of mutual recognition (see diagram below).

The purpose of these notes for guidance is to provide up-to-date advice to applicant on the procedures and administrative details of applications for product authorisation and mutual recognition. For that purpose, Members States are invited to report to the Commission any relevant information to be updated in this document.

These notes are the fruit of discussions within the product authorisation and mutual recognition group (PA&MRFG) and are based on a series of agreement between the Member States, to which they might have subscribed to in full or in part.

Applicants should therefore also consult the different annexes of the document for more concrete information and possible deviations in the different Member States. For more specific questions, they can also request additional information to the relevant contact person in each Member State[1].

1. General Principles

1.1. Who can apply for authorisation?

Application for authorisation shall be made by, or on behalf of, the natural person or legal entity responsible for the first placing of the product on the market of the Member State concerned. The applicant may be either native or foreign but shall have a permanent office within the European Union.

The Applicant may be

the future authorisation holder or
person/entity handling practical issues related to the application procedure on behalf of the future authorisation holder.

The Authorisation holder is the person/entity to whom the decision on authorisation is issued to. Responsibility for the placing on the product on the market, classification and labelling etc. always lies on the authorisation holder.

1.2. When to apply for authorisation?

1.2.1. Existing biocidal products:

Existing Biocidal products are those products which will have already been placed on the market of the relevant Member State (as opposed to the EU market as a whole) at the date of inclusion of the substance into Annex I or IA. The concept of existing biocidal product is therefore seen at Member State level.

Either notification numbers, registration or authorisation numbers are considered sufficient evidence that a given product is an existing biocidal product in a Member State territory.

Where the product in question is not covered by a notification, registration or authorisation scheme in the territory of a Member State then, some other form of proof (e.g. sales invoice) is likely to be required to demonstrate that the product in question is an existing biocidal product at time of formal Annex I or IA inclusion.

For existing biocidal products, applicants shall submit:

· either an application for authorisation complying with the requirements of Article 8 of the Directive;

· or an application for mutual recognition in accordance with Article 4 of the Directive[2];

by the date of inclusion of the active substance contained in that product in Annex I or IA.

If a product contains more than one active substance the deadline for the product application shall be the latest of the inclusion dates relating to its active substances

The inclusion dates can be found in the inclusion directives available on the Commission website.

Please note that for products belonging to several product types, the approach is different.

Where a product belongs to several product types, authorisation for each product type shall be applied for separately and before the deadline given for the relevant product type.[3]

Those products, for which an application for either authorisation or mutual recognition has been made in due time, can then remain on the market in accordance with existing provisions in the Member States, while the applications are evaluated.

If no application is received by the date of the Annex I or IA inclusion, the product shall be phased out (see below).

1.2.2. New Products [4]

1.2.2.1. Containing new active substances

For biocidal product containing a new active substance, which is not yet included in Annex I, applications for authorisations can be submitted at any time.

However, it is only after the inclusion in Annex I or IA of the new active substance, that the product can be authorised and placed on the market.

A provisional authorisation [5] can nonetheless be granted in accordance with Article 15(2) of the Directive, which would enable the authorisation holder to place its product on the market before the formal inclusion of the active substance in Annex I or IA. Otherwise, the placing the product on the market is not allowed before authorisation.

Once the first authorisation is obtained, companies can ask for mutual recognition in all other Member States where they wish to place the product on the market.

1.2.2.2. Containing existing active substances

Products containing existing active substances for a product type not covered by the review programme of existing active substances will be treated in the same way as products containing new active substances.

The active substance will have to be included in Annex I or IA for the relevant product type before the product can be authorised and placed on the market.

For these products it is however not possible to grant a provisional authorisation.

1.3. Issues to consider before preparing application

There are a number of important elements to consider before preparing an application for a biocidal product:

Applicants – if they are not owners of the data submitted for the purpose of the inclusion in Annex I or IA of the active substance – will be required to provide information to demonstrate access to the required data on the active substance. This may be achieved in a number of ways:

o By reference to information previously submitted on the active substance to support inclusion in Annex I or IA, which is not protected in accordance with Article 12 of Directive 98/8/EC.

o By providing evidence of access[6] to the information submitted to support inclusion in Annex I or IA, which is protected in accordance with Article 12 of Directive 98/8/EC[7].

o By providing alternative and equivalent studies, including published studies, to those protected. In this case, a complete dossier ("alternative supplier" substance dossier) satisfying the requirements of Annex IIA and IIIA has to be submitted.

o By providing a case justifying why certain data are not relevant to the uses which are claimed to be supported.

If applicants are the owner of an alternative supplier dossier, they are invited to contact the future evaluating Competent Authority to verify whether it would like to receive this dossier in advance of the application for product authorisation – in order to ensure that the dossier complies with the requirements of Article 8(2)(b) and prevents unnecessary delays during the product evaluation.

A standard format to facilitate the comparison between the original and the new data is given at Annex IV and shall be used by applicants submitting an 'alternative supplier' dossier on the active substance.

Additional information related to alternative supplier's dossiers is available on CIRCABC in the Note for Guidance to Member States on Compliance check of applications submitted for the authorisation of biocidal products.

Applicants should be aware that the active substance contained in the product will have to be technically equivalent to the one assessed for the purpose of the Annex I or IA inclusion. This means that the active substance has to be similar in terms of its impurity profile to the one assessed for the purpose of the Annex I or IA inclusion.

The evaluating Competent Authority will make the final decision on the technical equivalence based on the data submitted by the applicant.

If technical equivalence is established, the conclusions reached at the time of the Annex I or IA inclusion can be extrapolated to the active substance and, in particular, the endpoints re-used for preparing the product application.

If the active substance is not technically equivalent to the one included into Annex I or IA, then applicants should explore the possibility to refine the production/manufacturing process of the active substance in order to reduce impurities to an acceptable level.

If this option is not feasible or the evaluating CA considers that this refinement does not meet the required standards, the applicant would have to submit a new application dossier for Annex I or IA inclusion of the active substance not being technically equivalent.

More detailed guidance on technical equivalence is available from the Commission website.

Applicants should make sure that they consider the right product type with respect to the use purpose and pattern of the biocidal product. Further information about scope of the BPD is compiled by the European Commission in the Manual of Decisions (MoD).

In case of any doubts as to whether a product or active substance is falling within the scope of the Directive or to which product type it belongs, applicants are invited to contact the future evaluating Competent Authority.

Applicants should consider carefully the use purpose and pattern of the product and see whether the risk and efficacy assessment conducted with the representative product for the purpose of the Annex I or IA inclusion is valid or relevant for their product.

As in many cases this will not be the case, applicants will have to provide new data to support their own product and carry out a new risk and efficacy assessment.

In order to facilitate the evaluation, it would be preferable for the applicant to request the first product authorisation in the Member State, which was rapporteur for the active substance contained in the product, if, of course, the product is already placed or is intended to be placed on the market of that Member State.

Applicants are however free to choose the Member State where they want to apply to obtain a first authorisation and on the basis of which they can then apply for mutual recognition in other Member States.

1.4. Structure of application and related dossier

1.4.1. General requirements for documentation

Application forms

The application form for authorisation of a biocidal product is created via the Register for Biocidal Products (R4BP). The register is maintained by the European Commission. The application form is available in all of the EU official languages.

In the register the applicant fills in the details on the applicant and the product. The applicant has to indicate in which Member States he applies for the first product authorisation and in which EU/EEA countries mutual recognition. Furthermore, the applicant is requested to indicate in which Member States the product is already on the market.

Note! Some Member States[8] – where mutual recognition will be applied for – require that the product can only stay on their market beyond the deadline for the submission of the product application and until the final decision is reached, if it is indicated in the application form submitted for the first product authorisation that the product is placed on their market.

When filling in the application form, applicants will be requested to provide a summary of the product characteristics (SPC). This SPC shall be provided in all the official languages of the Member State where the application is to be submitted.

Dossiers

The Member States and the European Commission have agreed that the information included in dossiers for product authorisation should be submitted in a standard format. The format is the same in whichever Member State the dossier is submitted. This will make it easier for the applicants to know exactly what must be done and what a dossier must contain.

The application consists of application forms and the dossier. The applicant is responsible for providing the required information and for including the study reports and other documents needed. The evaluation of the data by the applicant will form the basis of the evaluation by the Competent Authority.

A dossier for product authorisation consists of data and documents as presented in Figure 1.

The application for mutual recognition should include all required data and information other than those parts that can only be submitted following the authorisation/registration of the product in the first Member State (for instance the copy of the first authorisation).

Thus, the following information shall be submitted in a first step:

· A covering letter confirming that an application is made for mutual recognition of authorisation for the product;

· A signed paper copy of the application form generated via the Register for Biocidal Products (R4BP);

· One electronic copy of the summary dossier for the product as submitted to the first member state;

· Letters of access.

The remaining items will have to be submitted within 2 months of the decision being taken on the application for a first authorisation/registration of the product in a first Member State (or “Reference Member State”).

Given the difficulties encountered by the first applicants to produce certified copies of the first authorisation within two months and the fact that this information is available in the R4BP, most Member States[9] agreed to accept the dissemination of copies of authorisations by Member States via the R4BP to be equivalent to the submission of certified copies by the applicants; thereby agreeing that the requirement of Article 4 of the Directive would be fulfilled and that it would no longer be necessary for applicants to submit the information themselves.

Most Member States will accept a copy of the first authorisation in English. Those Member States who require a copy of the authorisation in their own language are outlined in the footer 9.

Figure 1. Structure of the dossier required for an application for product authorisation.

1.4.2. Practical details on submission of the application

Further details on what information is expected and when, as well as explanations on specific national provisions are provided in Annex II.

1.4.3. General principles on the submission of experimental studies

The applicant shall submit to the Competent Authority all data on physical-chemical properties, toxicological, environmental fate and ecotoxicological effects, efficacy and other properties of the chemical that is necessary for the assessment of the conditions for issue an authorisation. The Technical Notes for Guidance (TNsG) on Data Requirements describes the data needed which was originally set by Annexes II and III of the Directive.

The original study reports shall be attached to the application. However, the original study reports (Doc IV) and the study summaries (Doc III) are not required if the applicant has a written proof of his right to refer to them in his application (Letter of Access, LoA) and these documents have already been submitted either for the evaluation of the active substance for Annex I or in another application for product authorisation in the Member State where the application is to be submitted.

Studies must be conducted and reported either according to the methods mentioned in the Council Regulation (EC) N°440/2008 on test methods or according to the OECD (Organisation for Economic Co-operation and Development) guidelines for testing of chemicals. The main rule is that studies must also comply with the principles of Good Laboratory Practice (GLP) and the study report shall contain a certificate of this. Further guidance on GLP is given in the TNsG on Data Requirements, Chapter 6 as well as in Annex V of these notes for guidance.

If it is not technically possible or scientifically justifiable to submit the required information or carry out the required studies, or if the studies are not conducted according to the guidelines referred above, then the reasoning must be given in the application. If such justifications are not given, or if the application is otherwise insufficient, the Competent Authority will ask the applicant to submit the missing information and studies. The processing of the application will continue after the supplementary data has been presented.

The BPD encourages limiting the duplication of testing on vertebrate animals, whenever possible. According to this principle, before starting a new test, literature searches should be conducted and the other owners of the required documentation should be consulted in order to find out, whether the available information is sufficient for the reliable evaluation of the possible hazards of the chemical. In order to receive the contact details of other data owners the applicants are invited to contact the Competent Authority.

1.4.4. Risk assessment to be prepared by the applicant

The applicant shall carry out a preliminary risk assessment for the product. This risk assessment shall address the following elements:

the assessment of the effects of all active substances and of substances of concern contained in the product;
the assessment of the effects of the product;
the assessment of physical-chemical properties of the product;
the assessment of the exposure to the product;
the assessment of unacceptable effects of the product;
the risk characterisation for the product;

· the assessment of the efficacy of the product.

In most cases, no reassessment of the human health, environmental effects and physical-chemical properties should be carried out for active substances already included in Annex I or IA. Hence, the documents (Doc.II-A) provided with such applications should be used as basis for the effects assessment for the product.

Applicants should nonetheless check in the assessment report of the active substance if there were issues which were not entirely addressed at the time of the substance evaluation and for which additional or complementary data might have been requested before product authorisation can be granted.

Product-specific data as required by Annex IIB and IIIB of the Directive have to be provided, summarised and evaluated by the applicant.

More guidance is available on TNsG for Preparation of Dossiers and Study Evaluationand TNsG on Product Evaluation. Detailed advice on risk assessment is given in Technical Guidance Document on Risk Assessment (TGD) and Emission/Exposure Scenario Documents available at JRC website.

2. The mutual recognition process [10]

2.1. Role of the Reference Member State

Within 3 months of having received the application, the Reference Member State will verify that the submitted dossiers are complete and that the active substance is the same or technically equivalent to the one included into Annex I or IA.

Once a dossier has been considered to be complete, the Reference Member State will start the evaluation of the dossier and, within 12 months, decide whether to authorise the biocidal product or not. This will be done in accordance with the common principles as established in Annex VI to the Directive. The date of the product authorisation, the authorisation, the summary of the product characteristics and the product assessment report will be made available to the other Member States and the Commission via the Register for Biocidal Products (R4BP).

2.2. Involvement of the Concerned Member States

Within two months of having obtained a first authorisation in the Reference Member State, companies shall submit a certified copy of the first authorisation granted in the Reference Member State in accordance with Article 4 of Directive 98/8/EC. Concerned Member States shall evaluate and decide on the mutual recognition of the first authorisation within 120 days from the date of receipt of the certified copy.

Companies should be advised to submit the certified copies of the first authorisation at the same time so that the applications for mutual recognition can be processed in parallel in the Concerned Member States and that arising issues can be discussed within the same 120-day period.

In most Member States, if within the 2 months following the granting of a first authorisation, the certified copy of this authorisation has not been submitted to the Competent Authority, for a product for which an application for mutual recognition was made, the product concerned will be removed from their market within the next 6 months[11].

2.3. Negative conclusions

In the case, where, for a product for an application for mutual recognition was made, a Reference Member State comes to the conclusion that a dossier submitted is not complete or, after evaluation, that an authorisation cannot be granted, for the sake of harmonisation the RMS should contact other RMS (assessing similar products at the same time) and Concerned Member States before taking a final decision. The Reference Member State(s) and the Concerned Member States could discuss their concerns before a final decision is taken.

In the event that the Reference Member State decides to refuse to grant an authorisation, companies which had submitted an application for mutual recognition will then not be able to send the copy of the authorisation within 2 months of the decision on their application being taken. Consequently, in the absence of the different elements requested in Article 4(1) of the Directive, the applications for mutual recognition should be declared incomplete, rejected and the products for, which the applications were made, removed from the market.

2.4. Procedural steps in the MR procedure

Step

Timing[12]

Legal basis

Step 1: Informal discussions between the Concerned Member State and the applicant about submitting an application for mutual recognition.
Step 2: Applicant enters details of application in R4BP.

For new biocidal products

Step 3: Applicant sends application for mutual recognition and the assessment report from the Reference Member State to the Concerned Member State.
Step 4: Concerned Member State receives the application.
Step 5: Concerned Member State confirms receipt of application (directly to applicant and via the R4BP) and checks validity of application (copy of authorisation, summary dossier and fee) within 15 days.

Alternative path for existing biocidal products (Post-Annex I process)

Step 3: Applicant sends: · A covering letter confirming that an application is made for mutual recognition of authorisation for the product · A filled in paper copy of the application form generated via the R4BP · One electronic copy of the summary dossier for the product as submitted to the first member state.
Step 4: Concerned Member State confirms receipt of application (directly to applicant and via the R4BP), declares it incomplete, stops the clock and indicates the date by which the missing data are expected to be submitted.
Step 4a: Applicant send copy of the first authorisation and of the assessment report from the Reference Member State to the Concerned Member State.
Step 5: Concerned Member State confirms receipt of application (directly to applicant and via the R4BP) and checks validity of application (copy of authorisation, summary dossier and fee) within 15 days.

Common path

Step 6: Concerned Member State confirms receipt of a valid application (directly to applicant and via the R4BP) – the clock starts.	Day 0
Step 7: Evaluation of the application on the basis of the summary dossier and of the certified copy and of the assessment report of the first authorisation granted.
Step 8: Concerns on or divergence of opinions with the conclusions of the assessment of the Reference Member State and the summary of the product characteristics to be communicated to the Reference Member State. Concerned Member State to request applicant that certain conditions referred to in Article 20(3)(e), (f), (h), (j) and (l) of the Directive be adjusted to the different circumstances. [13]	Day 90
Step 9: Reference Member State to respond to concerns or divergence of opinions.	Day 100
Step 10: Applicant to respond to request for adjustment to local circumstances to Concerned Member State.	Day 100
Step 11: If no concerns remain and adjustments are accepted, Concerned Member State to issue the authorisation with a national number and to update the R4BP accordingly.	Day 120	Art. 4.1§1

Start of Formal Conflict Resolution Process

Step 12: Concerned Member State officially notifies the Commission, other Member States and the applicant of any remaining concerns or unaccepted adjustments and updates the R4BP. Concerned Member State sends the explanatory document containing the name of the product and its specification and setting out the grounds on which it proposes to refuse or restrict the authorisation to the Commission, other Member States and the applicant	Day 0	Art. 4.4§1
Step 13: The Commission allows a period of 90 days during which the Member States and the applicant can submit comments in writing	Day 90	Art. 27.1.b
Step 14: The Commission prepare a proposal for a draft decision		Art. 27.2
Step 15: The concerns and the comments are discussed in the CA/PA&MRFG meeting
Step 16: The proposal is voted on in the Standing Committee meeting
Step 17: Commission adopts decision
Step 18: In case the decision confirms the refusal/restriction of mutual recognition, the Reference Member State shall take this refusal/restriction into consideration and withdraw/amend the original authorisation, within 3 months of the decision coming into force. If the decision is in favour of the mutual recognition, the Concerned Member State must recognise and grant the authorisation, within 3 months of the decision coming into force
Step 19: Member States to issue the authorisation with a national number and to update the R4BP accordingly.

3. Phasing-out

In most Member States, when no dossier is submitted by the deadline set to apply for product authorisation, existing products shall no longer be placed on the market within 6 months of the deadline to apply for product authorisation or mutual recognition.

Similarly, when a decision is made that a dossier is not complete or that an authorisation cannot be granted, the product shall no longer be placed on their market within 6 months of the decision being made.

The 6-month deadline for the phasing out of products not supported refers to the first placing on the market. For subsequent storage and stocks, Member State may grant a period of grace in accordance with the provisions of Article 7(3) of the Directive.

More information is available on the phasing-out regimen of the different Member States in Annex II.

4. Frame formulations

Specific guidance has been developed for frame formulations[14]. This guidance gives an overview of the approach to handling frame formulations and authorisation of products covered by a frame formulation. This practical approach was developed in light of the first applications received but some evolution has taken place since its publication.

Note!: The new version of the R4BP allows applicants to create the reference products as well as all additional products within the frame formulation, so it is no longer necessary to send the lists of products within a frame formulation to the Commission for upload in R4BP. The R4BP User Guide for Industry[15] provides guidance on frame formulation applications (pages 24-30).

Annex I

Post-Annex I procedure

Deadline for the submission of applications for product authorisation or for mutual recognition[16]

	2 years after date of adoption of decision	2 years after date of publication of decision	2 years after date of coming into force of decision	Date of inclusion	other
	(e.g. 20.12.2008 for sulfuryl fluorid)	(e.g. 30.12.2008 for sulfuryl fluorid)	(e.g. 19.1.2009 for sulfuryl fluorid)	(e.g. 1.1.2009 for sulfuryl fluorid)

AT		X
BE		X
BU
CH		X
CY		X
CZ			See Annex II
DE	X
DK		X
EE		X
EL		X
ES		X
FI		X
FR		X
HU		X
IE		X
IS
IT		X
LT
LU		X
LV			See Annex II
MT		X
NO		X
NL		X
PL		X
PT		X
RO
SE		X
SI		X
SK		X
UK		X

Nr.72-Dr.Storch-Recherchen.Biozide

Freitag, 15. Mai 2015

0016Technical Notes for Guidance- Part I-Biocidial Products- EU-Members